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Vol. 113. Issue 3.
Pages T261-T277 (March 2022)
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Vol. 113. Issue 3.
Pages T261-T277 (March 2022)
Consensus Document
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Practical Update of the Recommendations Published by the Psoriasis Group of the Spanish Academy of Dermatology and Venereology (GPs) on the Treatment of Psoriasis with Biologic Therapy. Part 1. Concepts and General Management of Psoriasis With Biologic Therapy
Actualización práctica de las recomendaciones del Grupo de Psoriasis de la Academia Española de Dermatología y Venereología (GPS) para el tratamiento de la psoriasis con terapia biológica. Parte 1. Conceptos y manejo general de la psoriasis con terapia biológica
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J.M. Carrascosaa,
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, L. Puigb, I. Belinchón Romeroc, L. Salgado-Boqueted, E. del Alcázara, J.J. Andrés Lencinae, D. Morenof, P. de la Cuevag
a Departamento de Dermatología, Hospital Universitari Germans Trias i Pujol, Badalona, Universitat Autònoma de Barcelona, IGTP, Barcelona, Spain
b Departamento de Dermatología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
c Departamento de Dermatología, Hospital General Universitario de Alicante-ISABIAL, Universidad Miguel Hernández de Elche, Alicante, Spain
d Departamento de Dermatología, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
e Servicio de Dermatología, Hospital Universitario Vega Baja, Alicante, Spain
f Departamento de Dermatología, Hospital Universitario Virgen Macarena, Universidad de Sevilla, Sevilla, Spain
g Servicio de Dermatología, Hospital Universitario Infanta Leonor, Universidad Complutense de Madrid, Madrid, Spain
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J.M. Carrascosa, L. Puig, I. Belinchón Romero, L. Salgado-Boquete, E. del Alcázar, J.J. Andrés Lencina, D. Moreno, P. de la Cueva
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Abstract
Background and objectives

A new, updated AEDV Psoriasis Group (GPs) consensus document on the treatment of moderate to severe psoriasis was needed owing to the approval, in recent years, of a large number of new drugs and changes in the treatment paradigm.

Methodology

The consensus document was developed using the nominal group technique and a scoping review. First, a designated coordinator selected a group of Psoriasis Group members for the panel. The coordinator defined the objectives and key points for the document and, with the help of a documentalist, conducted a scoping review of articles in Medline, Embase, and the Cochrane Library up to January 2021. The review included systematic reviews and meta-analyses as well as clinical trials not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed. Based on these reviews, the coordinator drew up a set of proposed recommendations, which were then discussed and modified in a nominal group meeting. After several review processes, including external review by other GPs members, the final document was drafted.

Results

The present guidelines include general principles for the treatment of patients with moderate to severe psoriasis and also define treatment goals and criteria for the indication of biologic therapy and the selection of initial and subsequent therapies. Practical issues, such as treatment failure and maintenance of response, are also addressed.

Keywords:
Psoriasis
Biologic therapy
Recommendations
Guidelines
Resumen
Antecedentes y objetivos

La aprobación de un gran número de nuevos fármacos en los últimos años y los cambios en el paradigma de tratamiento de la psoriasis hacen recomendable un nuevo documento de recomendaciones del GPS para el tratamiento de la psoriasis moderada-grave.

Metodología

Para la elaboración del consenso se siguió la metodología de grupos nominales, con ayuda de una scoping review. Tras designar a un coordinador, se seleccionó un grupo de integrantes del GPS. El coordinador definió los objetivos y puntos clave del documento y, con ayuda de un documentalista, se realizó una scoping review incluyendo datos de Medline, Embase y Cochrane Library (hasta enero del 2021). Se seleccionaron revisiones sistemáticas, metaanálisis y ensayos clínicos no incluidos en las mismas, así como estudios de calidad en vida real. Se revisaron otras guías de práctica clínica y documentos de consenso nacionales e internacionales sobre el manejo de la psoriasis moderada-grave. El coordinador generó una serie de recomendaciones preliminares que fueron evaluadas y modificadas en una reunión de grupo nominal. Tras varios procesos de revisión, que incluyeron la revisión externa por parte de los miembros del GPS, se redactó el documento definitivo.

Resultados

En el documento se incluyen principios generales sobre el tratamiento de los pacientes con psoriasis moderada-grave, la definición de objetivos terapéuticos y los criterios de indicación y selección de tratamiento tanto en primera como en sucesivas líneas terapéuticas de fármacos biológicos. Se abordan asimismo cuestiones prácticas como el fracaso terapéutico o el mantenimiento de la respuesta.

Palabras clave:
Psoriasis
Terapia biológica
Recomendaciones
Guía
Full Text
Introduction

The Psoriasis Group (GPs) of the Spanish Academy of Dermatology and Venereology (AEDV) launched a project in 2009 to develop and update evidence-based recommendations for the treatment of psoriasis with biologic therapies (including biosimilars and the new generation of synthetic molecules), which would also incorporate proposals derived from clinical practice.1–3 The aim of this consensus statement is to provide dermatologists with a tool for consultation that can support the process of making treatment decisions to ensure that patients with moderate to severe psoriasis receive the best treatment available at any given time. Another objective was to collect and standardize strategies—developed and implemented in clinical practice by dermatologists with expertise in the management of psoriasis who are members of the GPs—that facilitate the treatment of psoriasis, enhancing the patients’ prospects of achieving the best clinical response and the convenience and safety of therapy. To this end, the recommendations cover aspects such as the evaluation of the severity of psoriasis and its practical implications, the prescription of these therapies (first-line and successive treatments), setting treatment goals, and response to treatment.

These recommendations also represent the position, as defined by the GPs, of Spanish dermatologists on the treatment of psoriasis, making them a useful tool for hospital pharmacists, patient associations, hospital managers, and health authorities.

This update incorporates some modifications with respect to previous statements1–3 and new considerations concerning advances in biologic therapies and new international standards derived from accumulated experience.

Justification

The current therapeutic arsenal for the management of moderate to severe psoriasis is very extensive: phototherapy (psoralen+UV-A [PUVA] and narrow-band UV-B), conventional systemic therapies (ciclosporin, methotrexate, acitretin, and fumarates), the new generation of synthetic molecules (apremilast and shortly deucravacitinib), and biologic therapies including some biosimilars (adalimumab, etanercept, infliximab, certolizumab, ustekinumab, secukinumab, ixekizumab, brodalumab, tildrakizumab, guselkumab, risankizumab and, shortly, bimekizumab). The biologics can be used alone or in combination with topical therapies or conventional systemic drugs.

Advances in the treatment of psoriasis have changed expectations for short- to medium-term efficacy and safety and for maintenance of the treatment response over time. Most guidelines and expert group recommendations are setting increasingly demanding treatment goals, reflecting the results obtained in the randomized clinical trials and their long-term extension studies and supported by evidence from real-life studies.

Given the high cost of the new biologic therapies, non-clinical stakeholders, such as managers and health care payers, now play a significant role in the decision-making process. The advent of biosimilars represents an opportunity to expand access to biologic therapies and to increase the efficiency of these treatments.4,5 However, the incorporation of biosimilars into first-line treatment has often led to the use of absolute cost of acquisition as the fundamental criteria for prioritizing treatments, a formula that can give rise to marked variations between regional health services and problems of equity.6 Treatment appraisal reports have imposed reimbursement conditions and mandatory prior treatment with a TNF-α inhibitor in the case of some innovative drugs for the treatment of psoriasis, including guselkumab, risankizumab, and tildrakizumab. These requirements are not supported by the available evidence and are not even consistent with the conclusions of the reports themselves. The GPs has called attention to the need for greater independence, transparency, consistency, and pharmacoeconomic documentation (incremental cost per responder, modeling with a time horizon) in the preparation of documents used by health care payers. This approach is key to ensuring that these decisions really incorporate efficiency as an objective and measurable parameter, in line with common practice in other European countries.7

An updated GPs consensus document on the treatment of moderate to severe psoriasis was needed because of changes in the treatment paradigm and the approval of a large number of new biologic agents, including biosimilars, and new generation synthetic molecules.

MethodologyStudy Design

This consensus document was developed by the GPs of the AEDV. It was developed using the nominal group technique complemented by a scoping review. The process used was fully compliant with the principles for medical research in humans set out in the most recent version of the Declaration of Helsinki and was implemented in accordance with the applicable regulations on good clinical practice.

Participant Selection and Development of the Consensus Statement

First, a designated coordinator was appointed and a group of GPs members were selected for the panel based on their experience and knowledge of psoriasis. The coordinator, with the help of a methodologist, then defined the objectives, sections, and scope of the document, including a definition of its target audience. Finally, a scoping review was conducted given the volume of publications on the efficacy and safety of biologic therapies for the treatment of moderate to severe psoriasis, including biosimilars and new generation synthetic molecules. The scoping review was conducted with the help of an expert documentalist, who designed several strategies based on MeSH terms and free-text terms to search the three major bibliographic databases (Medline, Embase, and the Cochrane Library) up to January 2021. The review included systematic reviews and meta-analyses as well as randomized clinical trials (RCTs) not included in those studies and high-quality real-world studies. National and international clinical practice guidelines and consensus documents on the management of moderate to severe psoriasis were also reviewed.

Based on the results of this review, the coordinator drew up a draft text and a set of preliminary recommendations, which were then evaluated, discussed and modified in a nominal group meeting. The final document was drafted after several review processes, including external review by the GPs members.

ResultsEvaluation of Disease Severity in Psoriasis

Several validated measures are used universally in clinical practice to assess disease severity in patients with psoriasis. The most used are the percentage of the body surface area affected (BSA), the Psoriasis Area and Severity Index (PASI), and global assessment by either the physician (PGA) or patient (PtGA).8 In previous consensus statements, the GPs considered the absolute PASI score to be the most useful measure for assessing whether the patient's response to treatment was within the desired parameters at any time during the course of the disease.1,2

The Dermatology Life Quality Index (DLQI) is the tool most used by dermatologists to measure health-related quality of life in patients with psoriasis. Although easy to use and sensitive to change, this index is limited by its unidimensional structure and variable cross-cultural equivalence.9

Psoriasis is a disease that has a major impact on the whole course of the patient's life. The lifelong impact of the disease is captured by the concept of Cumulative Life Course Impairment (CLCI).10 When making clinical assessments and taking decisions about management of the disease, clinicians should evaluate not only the current but also the potential future impact of the disease on each patient by taking into account sociodemographic factors (e.g., age and gender) as well as clinical variables, such as disease severity and comorbid conditions, which have been identified in a recent systematic review as risk factors for CLCI.11

The location of lesions, associated symptoms, impact on quality of life, and resistance to treatment are other aspects that we will consider in the context of making decisions on the management of moderate to severe psoriasis.3

Classification of Moderate to Severe Psoriasis And Criteria for Systemic Treatment

The GPs criteria for classifying moderate to severe psoriasis were established in 2009 and ratified in 2016 (Table 1).1–3 These criteria represented a qualitative leap because they included, in addition to the parameters accepted by most scientific societies and considered to be objective (although some, such as the rule of tens, are arbitrary), clinical manifestations considered to be criteria for severity owing to their characteristics, extent, location, or association with joint involvement. However, probably the most innovative change was the incorporation of the need for systemic treatment or phototherapy as a criteria defining moderate to severe psoriasis, and, thereby its inclusion as another factor to be taken into account in the decision making process. Similar proposals have also been made by other scientific societies.12–15

Table 1.

Criteria for Moderate to Severe Psoriasis in the AEDV Psoriasis Working Group 2009 and 2016 Consensus Documents.a

Criteria for moderate to severe psoriasis 
PASI>10 or BSA>10 or DLQI>10 
Psoriasis requiring systemic treatment at any time (including conventional systemic treatment, biologics, and phototherapy) 
Erythrodermic psoriasisb 
Generalized pustular psoriasisb 
Localized pustular psoriasis causing functional or psychological limitationsb 
Psoriasis affecting visible areas (e.g. the face), palms, soles, genitals, scalp, nails, or recalcitrant plaques when these have a functional or psychological impact on the patient 
Psoriasis associated with psoriatic arthritis 

Abbreviations: AEDV, Spanish Academy of Dermatology and Venerology; BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index.

a

Only one of the criteria must be met.

b

Considered to constitute severe disease.

The purpose of tools that measure the severity of psoriasis is to facilitate the management of the disease and to achieve the best outcomes for the patient in every situation. In this setting, the GPs proposes that the following patients should be considered to be candidates for systemic treatment, including biologic therapies:

  • 1.

    Patients who meet at least 1 of the following criteria: BSA 10% or PASI>10 or DLQI>10.

  • 2.

    Disease affecting visible areas (face and dorsum of hands), palms, soles, genitals, scalp, nails, and also recalcitrant plaques with a functional or psychological impact.

  • 3.

    Psoriasis that is not controlled by topical therapy orphoto-therapy.

This approach includes the failure of properly implemented topical therapy as a criterion comparable to the extent or location of lesions in the decision to prescribe systemic treatment. The choice of systemic treatment is based on the general considerations discussed earlier in this document and on the indications in the Summary of Product Characteristics and the criteria for approval of systemic treatment by the regulatory agencies for all available therapies. This proposal is also in line with the approach approved through consensus by international organizations, such as the International Psoriasis Council.12

General Principles for the Management of Patients with Moderate to Severe Psoriasis

All the biologic therapies (including biosimilars) and new generation synthetic molecules that have demonstrated efficacy and safety and have been approved by the European Medicines Agency (EMA) can be prescribed in routine clinical practice and dermatologists should be able to prescribe therapies as indicated in the Summary of Product Characteristics for each drug without any delays or restrictions, which could give rise to inequities between different regions or hospitals. These therapies should be prescribed by dermatologists with experience in their use, who can evaluate and take into account all the variables to optimize the decision making process and ensure the best possible clinical results in terms of efficacy and safety.

Several factors must be taken into account when selecting or prioritizing these therapies:

  • Related to the drug: available evidence (short- and long-term efficacy, maintenance of response, better efficacy in direct and indirect comparisons between drugs in meta-analyses, safety, efficiency), route of administration, speed of onset of effect, convenience.

  • Related to the patient and the disease: the type, course, severity, and extent of disease, its impact on the patient's quality of life and symptoms, prior therapies and adherence to treatment, age, sex, weight, and the presence of comorbidities, especially psoriatic arthritis.

  • Related to the health system and its organization: results of cost-effectiveness studies. GPs recommends that the following parameter should be evaluated as part of any prioritization by efficiency criteria: number needed to treat (NNT), always taking as a reference the generally accepted clinical endpoints (e.g. PASI 90 and PASI 100 response and absolute PASI score<3). Prioritization by cost of acquisition is considered arbitrary if not supported by the evaluation of efficiency criteria to demonstrate real efficiency.

The final decision about which drug to prescribe should be left to the clinical judgment of the dermatologist, who will make a well-founded decision after assessing the above criteria and applying them to the case under consideration.

Treatment Goals for Patients with Moderate to Severe Psoriasis

The clinical assessment of patients with psoriasis is an essential component of the process of making decisions about treatment. It informs the setting of a treatment goal (which in turn guides the selection of a specific therapy for each patient) and facilitates monitoring of the treatment response. Disease activity is a fundamental aspect of the clinical assessment in psoriasis. Despite its limitations, the PASI is the accepted standard for evaluating disease activity and should be assessed at every visit. Measures of relative improvement, such as PASI 90 (90% improvement over baseline) are appropriate for assessing response to treatment in RCTs and for direct and indirect comparisons. However, GPs considers the absolute PASI score to be a more useful measure than relative PASI when assessing severity in clinical practice for the purpose of setting a treatment goal and measuring response to treatment because it is independent of the baseline PASI value. DLQI, BSA, and PGA can be used to complement the PASI when deciding on a treatment strategy. When the PGA is used, BSA should always be calculated as well. A visual analog scale to assess itching and patient satisfaction with treatment can be included in the assessment of the impact on quality of life.16 PGA should be used to assess psoriasis involving special areas (genitalia, scalp, palms and soles) and the Nail Psoriasis Severity Index (NAPSI) when there is nail involvement because the PASI is not an appropriate tool for evaluating such lesions.

New drugs and new evidence on the effectiveness of therapies17–22 have emerged since the publication of the GPs guidelines and recommendations in 2009, 2013, and 2016,1–3 further raising expectations regarding treatment outcomes in patients with moderate to severe psoriasis. Several studies (especially those involving recently introduced drugs) have shown that a relatively high percentage of patients with moderate to severe psoriasis can achieve complete clearance. At 16 weeks, PASI 100 responses ranging from 13.7% to 57.2% have been reported depending on the drug.23–85

Given the clinical heterogeneity of psoriasis and the variability of response to treatment, the GPs believes that in the current management of patients with moderate to severe psoriasis, optimal or ideal treatment objectives and clinically acceptable goals can be established for each patient (Table 2).

Table 2.

Updated Recommendations (2021) on Setting Treatment Goals in Moderate to Severe Psoriasis.

Recommendations 
Treatment goals should be:∘Individualized∘Adapted to the characteristics of the patient's disease in each case∘Adapted to the individual characteristics of the patient∘Established independently of the class of drug 
When setting treatment goals, the clinician should differentiate between:∘Optimal goals∘Clinically acceptable goals 
Optimal treatment goals should include:∘Achieving a PASI 100 response, absolute PASI score of 0, or complete clearance∘Absence of clinical signs or symptoms of psoriasis∘Absence of any impact on the patient's psychological, emotional, social, or occupational well-being. 
Clinically acceptable goals should include:∘Achieving a PASI 90 response∘Achieving an absolute PASI score of ≤3∘BSA<3% and PGA 0–1∘In special areas: PGA1∘Minimize the impact of disease on quality of life∘Reduce disease activity to a minimum∘A DLQI of 0/1 assessed independently of clinical response is not an appropriate treatment goal. 
In specific patients or situations (prior treatment failure, associated comorbid conditions), other treatment goals can be considered clinically acceptable (a PASI 75 response, an absolute PASI score of ≤5) 

Abbreviations: BSA, body surface area; DLQI, Dermatology Life Quality Index; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment.

For establishing optimal and clinically acceptable treatment goals, the GPs recommends the use of the PASI, and preferably the absolute score, although PASI response relative to baseline is also acceptable. Despite the limitations of the PASI,8,86–95 there are several factors in its favor: its generalized use, the correlation between an absolute PASI score<2–3 and a PASI 90 response and between PASI 90 and DLQI 0/1, and the recommendations of recent international guidelines and recommendations.96–108

Another change from earlier GPs consensus documents1–3 relates specifically to optimal treatment targets. For the first time, based on new evidence,23–85 complete clearance—defined as an absolute PASI score of 0 or a PASI 100 response—have been included among the optimal treatment goals, recognizing that these outcomes are now achievable in at least a subgroup of patients. Clinically acceptable treatment goals have also changed. Based on current evidence,23–85 the upper limit for these goals has been increased to include a PASI 90 response and an absolute PASI2–3 (the goals specified in earlier guidelines were a PASI 75 response and an absolute PASI5).1 Nevertheless, the GPs recognizes there are scenarios in clinical practice—particularly among patients whose condition, for whatever reason, has not responded to several biologic therapies—in which less demanding treatment goals may be acceptable and in which a PASI 75 response or an absolute PASI score of ≤ 5 may be adequate.

On the other hand, the clinician should also evaluate—and take into account in the decision making process—the impact in terms of quality of life, safety, and efficiency of trying to achieve a PASI 100 response or and absolute PASI score of 0 in all patients.

As an alternative to the above, another method of assessing disease activity is the concept of minimal disease activity (MDA), which the GPs has defined as the absence of active arthritis and at least 3 of the following criteria109,110:

  • Itching1/10

  • Scaling2/10

  • Erythema2/10

  • Visibility2/10

  • BSA2

  • DLQI2

  • No lesions in special areas

First Line Therapy Indication and Selection

Infliximab, etanercept, and ustekinumab are indicated in patients who have intolerance or contraindications to other systemic treatments, such as methotrexate and PUVA. According to their respective Summaries of Product Characteristics, the rest of the biologic therapies approved for psoriasis are indicated as first-line therapy for patients with psoriasis who are candidates for systemic treatment (Table 3).

Table 3.

Indications for Biologic Drugs in Different Subpopulations.

Drug  Indication as per summary of product characteristics (EMA)
  Psoriasis in adults  Psoriasis in children  Psoriatic arthritis  Pregnant women 
Infliximab  Adults who failed to respond to, have a contraindication to, or are intolerant to other systemic therapies, including ciclosporin, MTX and PUVA  –  Adults with active psoriatic arthritis who have an inadequate response to or intolerance to DMARDs  Certolizumab pegol approved 
Etanercept    Chronic severe plaque psoriasis in children and adolescents from 6 years of age who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies     
Ustekinumab    Moderate to severe plaque psoriasis in adolescents from 12 years of age who have responded inadequately to, or are intolerant to, other systemic therapies or phototherapies.     
Apremilast    –     
Adalimumab  Adults who are candidates for systemic treatment  Severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to, or are inappropriate candidates for, topical therapy and phototherapy     
Certolizumab pegol    –     
Ixekizumab    Moderate to severe plaque psoriasis in children from the age of 6 years with a body weight of at least 25kg and in adolescents who are candidates for systemic therapy     
Secukinumab    Moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy     
Brodalumab    –  –   
Guselkumab    –  –   
Risankizumab    –  –   
Tildrakizumab    –  –   

Abbreviations: DMARDS, disease modifying antirheumatic drugs; EMA, European Medicines Agency; MTX, methotrexate; PUVA, psoralen plus UV-A photochemotherapy.

In the Spanish public health system, the cost of treatment with guselkumab, risankizumab, and tildrakizumab is only reimbursed if the patient has previously received treatment with a TNF-α inhibitor. This restriction (included in the final remarks made by the treatment appraisal working group) is arbitrary and has no basis in the text of the treatment appraisal report itself, which proposes that the decision on therapy should be based on efficiency criteria.

Decisions on first-line biologic therapy (including biosimilars and new generation synthetic molecules) should be made based on the general principles described above. The GPs recommends that prescribers should evaluate the pertinent review articles and network meta-analyses17,19,21,111–114 (see Figs. 1 and 2) to inform their decisions on the choice of therapy, depending on the treatment goals recommended. The following considerations should also be taken into account:

  • Given their favorable safety profile and efficacy in direct and indirect comparisons with other drugs, drugs targeting interleukin (IL)-17 and its receptor or IL-23 (anti-p19) offer, on the whole, the best prospects for achieving the treatment goals set out in this document.

  • Other classes of drugs, including TNF-α inhibitors and drugs targeting IL-12/23 (anti-p40), may be considered to be the most indicated therapies for first-line treatment in certain patients and clinical scenarios.

  • Based on efficiency criteria, biosimilars of any class emerge as the most indicated therapies for first-line treatment (provided there are no contraindications or safety considerations in the case of the individual patient) provided that the decision is based on studies or assessments that demonstrate their efficiency.

  • When taking a decision on the best treatment for a particular patient, the clinician should also take into account the impact the selected therapy may have on psoriatic arthritis.

  • Comorbid conditions—such as inflammatory bowel disease, fatty liver disease, cardiovascular disease, or demyelinating disease—may influence or condition the choice of treatment, owing to safety issues in certain cases.

Figure 1.

Studies included in a recent network meta-analysis of biologic therapies, including biosimilars and new generation synthetic molecules, currently approved for the treatment of moderate to severe psoriasis.

Source: Armstrong et al.114

(0.31MB).
Figure 2.

Additional number of patients needed to treat, relative to placebo, to achieve a PASI 75, PASI 90, or PASI 100 response, estimated in a recent network meta-analysis of biologic therapies and new generation synthetic molecules currently approved for the treatment of moderate to severe psoriasis. PASI, Psoriasis Area and Severity Index.

Source: Armstrong et al.113

(0.2MB).

The safety profile of biologic therapies should also be taken into account when selecting a treatment (see risk management section below).17,19,21,111,112 There is, however, still insufficient long-term data on safety available for the drugs approved in recent years.

Single-Drug Therapy vs. Combination Therapy

The GPs recommends the use of biologic therapies as single-drug therapy. However, regimens combining biologic agents with conventional systemic drugs, phototherapy, or topical treatments can be considered depending on the patient characteristics and the disease characteristics, preferably intermittently or in the short-term. There is no consistent evidence that combination therapy is clearly more effective than single-drug therapy.115,116 Moreover, the use of combinations may increase the risk of toxicity.115 Combining certain biologic drugs with methotrexate may decrease or minimize the risk and impact of immunogenicity, but the evidence available only relates to combinations of methotrexate with infliximab or adalimumab.115,117

Presence of Comorbid Conditions

In recent years, several authors have described the potential effects of certain therapies or classes of drugs on comorbidities related to low-grade inflammation. Although there is evidence that some of these drugs improve cardiovascular risk parameters,118–120 it is currently not sufficient to prioritize one drug over another on this basis.121 New evidence may change this view.

Dermatologists should take psoriatic arthritis into account when taking decisions about treatment.

Concept of Treatment Failure

The current consensus proposes eliminating the concept of rebound, which was included in the 2016 GPs statement,1 because the rebound effect does not influence therapeutic decisions in routine clinical practice.

In this 2021 update, the GPs considers a treatment to have failed when any of the following conditions are met:

  • The desired treatment goal is not achieved after 16–24 weeks of treatment (the induction phase): primary treatment failure.

  • The treatment goal is initially achieved but subsequently lost during the maintenance phase: secondary treatment failure.

  • The treatment goal is achieved, but the therapy results in significant toxicity that requires cessation of treatment: failure due to safety issues.

The GPs also emphasizes the importance of assessing patient adherence to treatment before making a decision on whether or not treatment has failed.122

Indication and Selection of Therapy for Second and Subsequent Lines of Treatment

When a patient with moderate to severe psoriasis does not respond to biologic therapies, including biosimilars and new generation synthetic molecules, the GPs recommends any one the following options:

  • Switching to another biologic therapy, including biosimilars and new generation synthetic molecules.

  • In certain cases, the following may be considered:

    • 1.

      Combinations with other conventional systemic treatments or topical treatments, preferably on an intermittent or short-term basis.

    • 2.

      Dose increase/interval shortening (for drugs where this is permitted). In such cases, the clinician must take into account the safety and efficiency considerations in the drug's Summary of Product Characteristics.

The selection of the second and successive lines of treatment with biologic therapies, including biosimilars and new generation synthetic molecules, depends on all the factors mentioned in the general principles described above and should also take the following into account:

  • The evidence (efficacy and safety) is currently limited (especially as the number of treatment lines increases).

  • In cases of patients with primary treatment failure (when the treatment goal is not reached at any time) or secondary failure (the desired response is achieved but subsequently lost), drugs having the same mechanism of action or an alternative mechanism of action may be used.

  • In the case of primary failure, a change of mechanism of action/therapeutic class is recommended.

  • When treatment failure is due to a significant adverse event related to the drug class, a change of mechanism of action/therapeutic class should be considered.

  • There is no data on the effect of previous treatment failures on the success of any particular subsequent line of treatment.

  • In certain cases, such as patients with specific comorbidities or prior failure to respond adequately to a number of biologic therapy regimens, flexibility in the treatment goals is advisable. The criteria for an adequate response should be individualized in patients who have failed to respond to multiple therapies.

Table 4 summarizes the available evidence on the main outcomes achieved after a switch in therapy.

Table 4.

Summary of Available evidence on PASI 75, PASI 90, and PASI 100 Response after Switching a Biologic Drug.

Drug  Study design  Prior biologic therapy  Week  PASI 75 (%)  PASI 90 (%)  PASI 100 (%) 
TNF-α inhibitors
EtanerceptRegistry (n=23)124  Infliximab or adalimumab  1624  1424  –  – 
Open prospective, (n=27)125  Infliximab or efalizumab  24  65.2  –  – 
AdalimumabOpen prospective, (n=85)126  Etanercept  1224  40a31b52a63b  –  – 
Registry (n=30)127  Etanercept  1224  2736  –  – 
Registry (n=43)124  Etanercept or infliximab  1624  3858  –  – 
Retrospective128  Any TNF-α inhibitor (n=52)  122412  56.982.743.4  3451.930.2  24.544.222.6 
  Ustekinumab (n=53)  24  71.4  55.1  40.8 
Prospective cohort (n=29)129  Secukinumab  52  75.9  15.4  3.85 
InfliximabRegistry (n=39)124  Etanercept or adalimumab  1624  2740  –  – 
Open prospective, (n=215)130  Etanercept  10  52  –  – 
Open Prospective, (n=38)131  Etanercept  101824  719474  –  – 
IL-23 inhibitors
GuselkumabVoyage 1 (RCT)132  Adalimumab  100  –  81.1  51.6 
Voyage 2 (RCT)132  Adalimumab  100  –  81.4  51.4 
ECLIPSE (RCT)133  TNF-α inhibitor IL-12/23, IL-23 inhibitorIL-17 inhibitor (excluding secukinumab)  484848  –  76.873.385.5  57.355.659.4 
RisankizumabLIMMitless (extension)134  Ustekinumab  84  –  82.6  44.8 
UltIMMa-1,2 (RCT)135  TNF-α inhibitorIL-17 inhibitor  5252  –  81.378.4  –– 
IMMvent (RCT)136  Adalimumab  44  –  – 
IL-17/IL-17i inhibitors
Secukinumab  ECLIPSE (RCT)133  TNF-α inhibitor  48  –  –  42.4 
    IL-12/23, IL-23 inhibitor  48      40.9 
    IL-17 inhibitor (excluding secukinumab)  48      52.2 
IxekizumabRetrospective (n=31)137  Secukinumab  12  71     
Retrospective (n=69)138  Secukinumab  1224  81.180  72.468  40.538 
Retrospective (n=17)139  Secukinumab  12  88.2  –  – 
Retrospective (n=18)140  Secukinumab  12  50  –  – 
BrodalumabAMAGINE-2,3 (RCT)43  Ustekinumab  52  91, 87  –  46, 40 
Open prospective, (n=39)141  Secukinumab o ixekizumab  16  67  44  28 
Retrospective (n=23)142  Secukinumab or ixekizumab  12  47.8  –  – 
Retrospective143  Secukinumab (n=7) ixekizumab (n=3)  12  67  –  – 
IL-12/23 inhibitor
UstekinumabUltIMMa-1,2 (RCT)135  TNF-α inhibitorIL-17 inhibitor  5252  –  –  – 
ACCEPT (RCT)144  Etanercept  12  –  23.4  – 
Retrospective (n=21)145  Secukinumab  48  69.2  50  – 
Prospective cohort (n=21)129  Secukinumab  52  85.7  19.1  4.8 

Abbreviations: IL, interleukin; PASI, Psoriasis Area and Severity Index; RCT, randomized controlled trial; TNF, tumor necrosis factor.

a Study group A

b Study group N

Modified from Tsai and Tsai.123

The evidence available on third lines of treatment is currently very scant and of only moderate-to-low quality. It comes from a few subanalyses of RCT results and observational studies.45,146–150

Although the actions and criteria for the selection of a third-line treatment are the same as those described for the first and second lines, the GPs considers that each time a treatment fails it is vital to reassess the treatment goals and that it is increasingly difficult to achieve optimal or even acceptable results in the case of third and successive lines of treatment. Consequently, treatment goals can be individualized in patients who have experienced several treatment failures, taking into account the characteristics of past failures.

Response Maintenance

The GPs consensus on the maintenance of response is as follows:

  • Patients who achieve an optimal or clinically adequate response are considered to be responders and treatment should be maintained.

  • In routine clinical practice, when the treatment goals (whether optimal or clinically acceptable) are met over a sustained period (6 months to 1 year) in a patient with moderate to severe psoriasis, a change in the treatment strategy can be considered, which may take the form of a reduction in the dose or an increase in the interval between doses.

  • Treatment reduction protocols (increased interval or reduced dose) should be implemented gradually with close monitoring of the maintenance of the treatment goal. There is no solid evidence to indicate the best strategy for optimizing the results of a reduction in treatment. However, in clinical practice, the interval between doses is generally increased cautiously (30–50%) following easy-to-remember guidelines: for example, an increase to 5–6 weeks for drugs administered every 4 weeks or to 10–16 weeks for drugs administered every 8 or 12 weeks. Each change in interval should be followed up at 1 or 2 follow-up visits to monitor clinical progress before any further changes are made.

  • If the desired response is lost when the dosage is reduced, the regimen that originally achieved the treatment goal should be reinstated.

  • Continuous therapy is required to maintain the response over time in most patients. However, when the patient's condition continues to meet the treatment goal on the reduced dosage, withdrawal of treatment can be considered. The GPs would like to point out that there is no clear evidence on how many patients will experience a relapse or exacerbation when the dosage is reduced or on the response that can be achieved if the original treatment is reintroduced. There is evidence in the literature that some patients may not regain the level of response they achieved prior to withdrawal of treatment.82,151–155

  • When the patient's condition no longer meets the treatment goal following cessation of treatment, a return to the regimen that achieved that goal should be considered.

Final Conclusions

The rapid evolution of the concept of psoriasis and of the therapeutic arsenal for this skin disease demands a flexible and continuous adaptation of the disease's definition and of the practical recommendations for dermatologists involved in its management. In recent years, the inclusion of the impact of psoriasis on quality of life has led to the relativization of earlier classification criteria and to the search for more practical definitions that can be adapted to the majority of patients. The rapidly evolving situation regarding the efficacy and safety of treatment, owing to changes in our knowledge and understanding of the disease, also justifies the establishment of more demanding goals for clinical outcomes, reflecting the improved prospects of treatment with new classes of drugs. The advent of biosimilars is an opportunity to bring biologic therapy to a larger number of patients with severe to moderate psoriasis, and there is no doubt that this class of drugs as a whole represents a qualitative leap in treatment over classic conventional therapy. At the same time, the advent of biosimilars and the financial implications of their introduction also poses certain risks in the application of the clinical criteria and in terms of equity. These risks must be minimized to favor the evaluation of efficiency. Finally, the consideration of psoriasis as a systemic disease and the importance of assessing comorbid conditions are also an integral part of the therapeutic decision making process and the definition of clinical response.

Funding

This is an independent document authored by the GPs. The GPs received no funding to support the development of this consensus statement.

Conflicts of Interest

José Manuel Carrascosa has served as a PI/SI and/or received honoraria as a speaker and/or member of an expert or steering committee for Abbvie, Novartis, Janssen, Lilly, Sandoz, Amgen, Almirall, BMS, Boehringer Ingelheim, Biogen, and UCB.

Laura Salgado-Boquete has served as a PI/SI and/or received honoraria as a speaker or for serving on an expert committee or as scientific advisor for Abbvie, Celgene, Leo Pharma, Novartis, Janssen, Lilly, Sandoz, Amgen, Almirall, UCB, Pfizer, and MSD.

Lluis Puig has served as a PI/SI and/or received honoraria as a speaker or for serving on an expert committee or as a scientific advisor for Abbvie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, JS BIOCAD, Leo-Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi, and UCB.

Elena del Alcázar has served as a PI/SI and/or received honoraria as a speaker for Abbvie, Almirall, Amgen, Celgene, Janssen, Leo-Pharma, Lilly, Novartis, Sanofi, and UCB.

Isabel Belinchón has served as a PI/SI and has received honoraria as a speaker or scientific advisor or for serving on an expert committee for Abbvie, Almirall, Amgen, BMS, Celgene, Janssen, Lilly, Leo-Pharma, Novartis, and UCB.

Pablo de la Cueva has served as an advisor and/or speaker for and/or has participated as an investigator in trials sponsored by the following pharmaceutical companies: Abbvie, Almirall, Amgen, Astellas, Biogen, BMS, Boehringer, Celgene, Gebro, Janssen, LEO Pharma, Lilly, MSD, Novartis, Pfizer, Sandoz, Sanofi, and UCB.

David Moreno has participated as PI or Co-PI in clinical trials sponsored by Lilly, Novartis, Amgen, Almirall, Boehringer, and Leo-Pharma.

Juan José Andrés Lencina has served as a PI/SI and/or has received honoraria as a speaker and/or member of an expert committee or an scientific advisor for Abbvie, Leo Pharma, Novartis, Janssen, and UCB.

Acknowledgments

The authors wish to thank the following members of the GPs for their contribution to this document: M. Teresa Abalde Pintos, Ignacio Alonso García, María Luisa Alonso Pacheco, Alsina Gibert Mercé, Gloria Aparicio Español, Mariano Ara Martín, Susana Armesto Alonso, Antoni Azón Masoliver, Ferrán Ballescá López, Ofelia Baniandres Rodríguez, Didac Barco Nebreda, Alvaro Barranquero Fernández, Ana Batalla Cebey, Isabel Bielsa Marsol, Xavier Bordas Orpinell, Leopoldo Borrego Hernando, Rafael Botella Estrada, Jesús María Careaga Alzaga, Rafael Carmena Ramón, Gregorio Carretero Hernández, Ana María Carrizosa Esquivel, Jose Manuel Casanova Seuma, Alberto Conde Taboada, Marisol Contreras Stelys, Pablo Coto Segura, Esteban Daudén Tello, Carlos de la Torre Fraga, Rubén del Río Gil, Aleisandre Docampo Simón, Noemí Eiris Salvado, Juan Escalas Taberner, Esther Eusebio Murillo, Jose Manuel Fernandez Armenteros, Emilia Fernandez López, M. Luisa Fernández Díaz, Almudena Fernández Orland, Carlos Ferrándiz Foraster, Marta Ferrán Farrés, Lara Ferrándiz Pulido, Eduardo Fonseca Capdevila, Manuel Galán Gutiérrez, Francisco Javier Garcia Latasa de Araníbar, Pilar Garcia Muret, Vicente Garcia-Patos Briones, Marta García Bustínduy, Ignacio García Doval, Rosa García Felipe, Alicia L. González Quesada, Beatriz González Sixto, Alfonso González Morán, Teresa Gárate Ayastui, Francisco José Gómez García, Jose Manuel Hernanz Hermosa, M. Isabel Hernández García, Pedro Herranz Pinto, Enrique Herrera Ceballos, Marta Herrera Sánchez, Rafael Jesús Jiménez Puya, Enrique Jorquera Barquero, Rosario de Fátima Lafuente Urrez, Salvador V. Laguarda Porter, Mónica Larrea Garcia, M. del Mar Llamas Velasco, Anna López Ferrer, Jesús Luelmo Aguilar, Pablo Lázaro Ochaita, Jose Luis López Estebaranz, María Marcellán Fernández, Amparo Marquina Vila, Eugenio Marrón Moya Servando, Trinidad Martin González, Antonio Martorell Calatayud, Francisco Javier Mataix Díaz, Almudena Mateu Puchades, Carolina Medina Gil, M. Victoria Mendiola Fernández, Miren Josune Michelena Eceiza, Jordi Mollet Sánchez, José Carlos Moreno Giménez, Carlos Muñoz Santos, Antoni Nadal Nadal, Belén Navajas Pinedo, Jaime Notario Rosa, Francisco Peral Rubio, Narciso Perez Oliva, Celia Posada García, Josep A. Pujol Montcusi, Conrado Pujol Marco, Silvia Pérez Barrio, Amparo Pérez Ferriols, Beatriz Pérez Suárez, Trinidad Repiso Montero, Miquel Ribera Pibernat, Raquel Rivera Díaz, Vicente Rocamora Durán, Jesús Rodero Garrido, Sabela Rodríguez Blanco, M. del Carmen Rodríguez Cerdeira, Lourdes Rodríguez Fernández-Freire, Manuel Ángel Rodríguez Prieto, Jorge Romani de Gabriel, Alberto Romero Maté, Mónica Roncero Riesco, Cristina Rubio Flores, José Carlos Ruiz Carrascosa, Diana Patricia Ruiz Genao, Ricardo Ruiz Villaverde, Montserrat Salleras Redonnet, Jorge Santos-Juanes Jiménez, María José Seoane Pose, Patricia Serrano Grau, Estrella Simal Gil, Caridad Soria Martínez, José Luis Sánchez Carazo, Manuel Sánchez Regaña, M. Dolores Sánchez-Aguilar Rojas, Rosa Taberner Ferrer, Lucía Tomás Aragonés, Francisco Valverde Blanco, Ricardo Valverde Garrido, Francisco Vanaclocha Sebastián, Manel Velasco Pastor, Diana Velázquez Tarjuelo, Asunción Vicente Villa, David Vidal Sarró, Jaime Vilar Alejo, Eva Vilarrasa Rull, Marta Vilavella Riu, Rosario Vives Nadal, Hugo Alberto Vázquez Veiga, Juan Ignacio Yanguas Bayona, Ander Zulaica Garate.

References
[1]
E. Dauden, L. Puig, C. Ferrandiz, J.L. Sanchez-Carazo, J.M. Hernanz-Hermosa, Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology.
Consensus document on the evaluation and treatment of moderate-to-severe psoriasis: Psoriasis Group of the Spanish Academy of Dermatology and Venereology.
J Eur Acad Dermatol Venereol, 30 (2016), pp. 1-18
[2]
L. Puig, J.M. Carrascosa, G. Carretero, P. de la Cueva, R.F. Lafuente-Urrez, I. Belinchon, et al.
Spanish evidence-based guidelines on the treatment of psoriasis with biologic agents, 2013. Part 1: On efficacy and choice of treatment. Spanish Psoriasis Group of the Spanish Academy of Dermatology and Venereology.
Actas Dermosifiliogr, 104 (2013), pp. 694-709
[3]
L. Puig, X. Bordas, J.M. Carrascosa, E. Daudén, C. Ferrándiz, J.M. Hernanz, et al.
Consensus document on the evaluation and treatment of moderate-to-severe psoriasis. Spanish psoriasis group of the Spanish Academy of Dermatology and Venereology.
Actas Dermosifiliogr, 100 (2009), pp. 277-286
[4]
F. De Mora, A. Balsa, M. Cornide-Santos, J.M. Carrascosa, S. Marsal, J.P. Gisbert, et al.
Biosimilar and interchangeable: inseparable scientific concepts?.
Br J Clin Pharmacol, 85 (2019), pp. 2460-2463
[5]
L. Puig, G. Carretero, E. Dauden, C. Ferrandiz, S.E. Marron, A. Martorell, et al.
Biosimilars in dermatology: current situation (Part I).
Actas Dermosifiliogr, 106 (2015), pp. 545-549
[6]
L. Puig, J.M. Carrascosa, J. Notario.
Biosimilars in the treatment of psoriasis: an update.
Actas Dermosifiliogr (Engl Ed), 111 (2020), pp. 809-814
[7]
L. Puig, J.M. Carrascosa, J. Notario, I. Belinchon, en nombre del Grupo de Psoriasis de la AEDV.
Treatment appraisal reports: usefulness and transparency.
Actas Dermosifiliogr (Engl Ed), 111 (2020), pp. 3-6
[8]
P.I. Spuls, L.L. Lecluse, M.L. Poulsen, J.D. Bos, R.S. Stern, T. Nijsten.
How good are clinical severity and outcome measures for psoriasis? Quantitative evaluation in a systematic review.
J Invest Dermatol, 130 (2010), pp. 933-943
[9]
V. Bronsard, C. Paul, S. Prey, E. Puzenat, P.A. Gourraud, S. Aractingi, et al.
What are the best outcome measures for assessing quality of life in plaque type psoriasis? A systematic review of the literature.
J Eur Acad Dermatol Venereol, 24 (2010), pp. 17-22
[10]
S. Ros, L. Puig, J.M. Carrascosa.
Cumulative life course impairment: the imprint of psoriasis on the patient's life.
Actas Dermosifiliogr, 105 (2014), pp. 128-134
[11]
C.C. Von Stulpnagel, M. Augustin, L. Dupmann, N. da Silva, R. Sommer.
Mapping risk factors for cumulative life course impairment in patients with chronic skin diseases—a systematic review.
J Eur Acad Dermatol Venereol, 35 (2021), pp. 2166-2184
[12]
B. Strober, C. Ryan, P. van de Kerkhof, J. van der Walt, A.B. Kimball, J. Barker, et al.
Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council.
J Am Acad Dermatol, 82 (2020), pp. 117-122
[13]
D.M. Pariser, J. Bagel, J.M. Gelfand, N.J. Korman, C.T. Ritchlin, B.E. Strober, et al.
National Psoriasis Foundation clinical consensus on disease severity.
Arch Dermatol, 143 (2007), pp. 239-242
[14]
A. Menter, A. Gottlieb, S.R. Feldman, A.S. Van Voorhees, C.L. Leonardi, K.B. Gordon, et al.
Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics.
J Am Acad Dermatol, 58 (2008), pp. 826-850
[15]
A. Menter, N.J. Korman, C.A. Elmets, S.R. Feldman, J.M. Gelfand, K.B. Gordon, et al.
Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions.
J Am Acad Dermatol, 65 (2011), pp. 137-174
[16]
G. Carretero, L. Puig, J.M. Carrascosa, L. Ferrándiz, R. Ruiz-Villaverde, P. de la Cueva, et al.
Redefining the therapeutic objective in psoriatic patients candidates for biological therapy.
J Dermatol Treat, 29 (2018), pp. 334-346
[17]
E. Sbidian, A. Chaimani, S. Afach, L. Doney, C. Dressler, C. Hua, et al.
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.
Cochrane Database Syst Rev, 1 (2020), pp. CD011535
[18]
A. Blauvelt, K. Papp, A. Gottlieb, A. Jarell, K. Reich, C. Maari, et al.
A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial.
Br J Dermatol, 182 (2020), pp. 1348-1358
[19]
G. Obeid, G. Do, L. Kirby, C. Hughes, E. Sbidian, L. Le Cleach.
Interventions for chronic palmoplantar pustulosis.
Cochrane Database Syst Rev, 1 (2020), pp. CD011628
[20]
V.K. Sandhu, A. Ighani, P. Fleming, C.W. Lynde.
Biologic treatment in elderly patients with psoriasis: a systematic review.
J Cutan Med Surg, 24 (2020), pp. 174-186
[21]
A.W. Armstrong, L. Puig, A. Joshi, M. Skup, D. Williams, J. Li, et al.
Comparison of biologics and oral treatments for plaque psoriasis: a meta-analysis.
JAMA Dermatol, 156 (2020), pp. 258-269
[22]
O.Y. Carrasquillo, G. Pabon-Cartagena, L.A. Falto-Aizpurua, M. Santiago-Vazquez, K.J. Cancel-Artau, G. Arias-Berrios, et al.
Treatment of erythrodermic psoriasis with biologics: a systematic review.
J Am Acad Dermatol, 83 (2020), pp. 151-158
[23]
A.W. Armstrong, D.G. Villanueva Quintero, C.M. Echeverría, Y. Gu, M. Karunaratne, O. Reyes Servín.
Body region involvement and quality of life in psoriasis: analysis of a randomized controlled trial of adalimumab.
Am J Clin Dermatol, 17 (2016), pp. 691-699
[24]
K.B. Gordon, R.G. Langley, C. Leonardi, D. Toth, M.A. Menter, S. Kang, et al.
Clinical response to adalimumab treatment in patients with moderate to severe psoriasis: double-blind, randomized controlled trial and open-label extension study.
J Am Acad Dermatol, 55 (2006), pp. 598-606
[25]
K. Gordon, K. Papp, Y. Poulin, Y. Gu, S. Rozzo, E.H. Sasso.
Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL.
J Am Acad Dermatol, 66 (2012), pp. 241-251
[26]
A. Menter, S.K. Tyring, K. Gordon, K. Papp, R.G. Langley, J.P. Ortonne, et al.
Adalimumab therapy for moderate to severe psoriasis: a randomized, controlled phase III trial.
J Am Acad Dermatol, 58 (2008), pp. 106-115
[27]
J.H. Saurat, G. Stingl, L. Dubertret, K. Unnebrink, E.H. Sasso, W. Kampman.
Efficacy and safety results from the randomized controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION).
Br J Dermatol, 158 (2008), pp. 558-566
[28]
J.H. Saurat, R.G. Langley, K. Reich, K. Unnebrink, E.H. Sasso, W. Kampman.
Relationship between methotrexate dosing and clinical response in patients with moderate to severe psoriasis: subanalysis of the CHAMPION study.
Br J Dermatol, 165 (2011), pp. 399-406
[29]
A.A. Navarini, Y. Poulin, A. Menter, Y. Gu, H.D. Teixeira.
Analysis of body regions and components of PASI scores during adalimumab or methotrexate treatment for patients with moderate-to-severe psoriasis.
J Drugs Dermatol, 13 (2014), pp. 554-562
[30]
K. Papp, H. Bachelez, A. Costanzo, P. Foley, M. Gooderham, P. Kaur, et al.
Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: a randomized, double-blind, multicenter, phase III study.
J Am Acad Dermatol, 76 (2017), pp. 1093-1102
[31]
K. Papp, H. Bachelez, A. Costanzo, P. Foley, M. Gooderham, P. Kaur, et al.
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.
Br J Dermatol, 177 (2017), pp. 1562-1574
[32]
B.E. Strober, J.J. Crowley, P.S. Yamauchi, M. Olds, D.A. Williams.
Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis.
Br J Dermatol, 165 (2011), pp. 661-668
[33]
A. Blauvelt, K.A. Papp, C.E.M. Griffiths, L. Puig, J. Weisman, Y. Dutronc, et al.
Efficacy and safety of switching to ixekizumab in etanercept non-responders: a subanalysis from two phase III randomized clinical trials in moderate-to-severe plaque psoriasis (UNCOVER-2 and -3).
Am J Clin Dermatol, 18 (2017), pp. 273-280
[34]
K.B. Gordon, A. Blauvelt, K.A. Papp, R.G. Langley, T. Luger, M. Ohtsuki, et al.
Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis.
N Engl J Med, 375 (2016), pp. 345-356
[35]
A.B. Gottlieb, J.P. Lacour, N. Korman, S. Wilhelm, Y. Dutronc, A. Schacht, et al.
Treatment outcomes with ixekizumab in patients with moderate-to-severe psoriasis who have or have not received prior biological therapies: an integrated analysis of 2 phase III randomized studies.
J Eur Acad Dermatol Venereol, 31 (2017), pp. 679-685
[36]
C.E. Griffiths, K. Reich, M. Lebwohl, P. van de Kerkhof, C. Paul, A. Menter, et al.
Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from 2 phase 3 randomised trials.
[37]
L. Kemeny, L. Berggren, M. Dossenbach, Y. Dutronc, C. Paul.
Efficacy and safety of ixekizumab in patients with plaque psoriasis across different degrees of disease severity: results from UNCOVER-2 and UNCOVER-3.
J Dermatol Treat, 30 (2019), pp. 19-26
[38]
K.A. Papp, C.L. Leonardi, A. Blauvelt, K. Reich, N.J. Korman, M. Ohtsuki, et al.
Ixekizumab treatment for psoriasis: integrated efficacy analysis of 3 double-blinded, controlled studies (UNCOVER-1, UNCOVER-2, UNCOVER-3.
Br J Dermatol, 178 (2018), pp. 674-681
[39]
G. Yosipovitch, A. Reich, M. Steinhoff, A. Beselin, T. Kent, M. Dossenbach, et al.
Impact of ixekizumab treatment on itch and Psoriasis Area and Severity Index in patients with moderate-to-severe plaque psoriasis: an integrated analysis of two phase III randomized studies.
Dermatol Ther (Heidelb), 8 (2018), pp. 621-637
[40]
S. Adsit, E.R. Zaldivar, H. Sofen, I. Dei-Cas, C. Maldonado-García, E.O. Peñaranda, et al.
Secukinumab is efficacious and safe in Hispanic patients with moderate-to-severe plaque psoriasis: pooled analysis of four phase 3 trials.
Adv Ther, 34 (2017), pp. 1327-1339
[41]
A.B. Gottlieb, A. Blauvelt, D. Thaçi, C.L. Leonardi, Y. Poulin, J. Drew, et al.
Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from 2 phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2).
J Am Acad Dermatol, 79 (2018), pp. 302-314
[42]
R.G. Langley, A.W. Armstrong, M.G. Lebwohl, A. Blauvelt, S. Hsu, S. Tyring, et al.
Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase iii trials.
Br J Dermatol, 180 (2019), pp. 306-314
[43]
M. Lebwohl, B. Strober, A. Menter, K. Gordon, J. Weglowska, L. Puig, et al.
Phase 3 studies comparing brodalumab with ustekinumab in psoriasis.
N Engl J Med, 373 (2015), pp. 1318-1328
[44]
A. McMichael, S.R. Desai, A. Qureshi, S. Rastogi, A.F. Alexis.
Efficacy and safety of brodalumab in patients with moderate-to-severe plaque psoriasis and skin of color: results from the Pooled AMAGINE-2/-3 randomized trials.
Am J Clin Dermatol, 20 (2019), pp. 267-276
[45]
K.A. Papp, K.B. Gordon, R.G. Langley, M.G. Lebwohl, A.B. Gottlieb, S. Rastogi, et al.
Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3.
Br J Dermatol, 179 (2018), pp. 320-328
[46]
L. Puig, M. Lebwohl, H. Bachelez, J. Sobell, A.A. Jacobson.
Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial.
J Am Acad Dermatol, 82 (2020), pp. 352-359
[47]
A. Blauvelt, M. Gooderham, L. Iversen, S. Ball, L. Zhang, N.O. Agada, et al.
Efficacy and safety of ixekizumab for the treatment of moderate-to-severe plaque psoriasis: results through 108 weeks of a randomized, controlled phase 3 clinical trial (UNCOVER-3).
J Am Acad Dermatol, 77 (2017), pp. 855-862
[48]
A. Blauvelt, K.A. Papp, H. Sofen, M. Augustin, G. Yosipovitch, N. Katoh, et al.
Continuous dosing versus interrupted therapy with ixekizumab: an integrated analysis of two phase 3 trials in psoriasis.
J Eur Acad Dermatol Venereol, 31 (2017), pp. 1004-1013
[49]
A. Blauvelt, T.M. Muram, K. See, C.H. Mallinckrodt, J.J. Crowley, P. van de Kerkhof.
Improvements in psoriasis within different body regions vary over time following treatment with ixekizumab.
J Dermatol Treat, 29 (2018), pp. 220-229
[50]
S. Imafuku, H. Torisu-Itakura, A. Nishikawa, F. Zhao, G.S. Cameron.
Efficacy and safety of ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis: subgroup analysis of a placebo-controlled, phase 3 study (UNCOVER-1).
J Dermatol, 44 (2017), pp. 1285-1290
[51]
R.G. Langley, K. Papp, M. Gooderham, L. Zhang, C. Mallinckrodt, N. Agada, et al.
Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P).
Br J Dermatol, 178 (2018), pp. 1315-1323
[52]
C. Paul, C.E.M. Griffiths, P.C.M. van de Kerkhof, L. Puig, Y. Dutronc, C. Henneges, et al.
Ixekizumab provides superior efficacy compared with ustekinumab over 52 weeks of treatment: results from IXORA-S, a phase 3 study.
J Am Acad Dermatol, 80 (2019), pp. 70-79
[53]
H. Saeki, H. Nakagawa, T. Ishii, Y. Morisaki, T. Aoki, P.Y. Berclaz, et al.
Efficacy and safety of open-label ixekizumab treatment in Japanese patients with moderate-to-severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis.
J Eur Acad Dermatol Venereol, 29 (2015), pp. 1148-1155
[54]
H. Saeki, H. Nakagawa, K. Nakajo, T. Ishii, Y. Morisaki, T. Aoki, et al.
Efficacy and safety of ixekizumab treatment for Japanese patients with moderate to severe plaque psoriasis, erythrodermic psoriasis and generalized pustular psoriasis: results from a 52-week, open-label, phase 3 study (UNCOVER-J).
J Dermatol, 44 (2017), pp. 355-362
[55]
R.G. Langley, B.E. Elewski, M. Lebwohl, K. Reich, C.E. Griffiths, K. Papp, et al.
Secukinumab in plaque psoriasis—results of two phase 3 trials.
N Engl J Med, 371 (2014), pp. 326-338
[56]
J. Bagel, J. Nia, P.W. Hashim, M. Patekar, A. de Vera, S. Hugot, et al.
Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis (16-Week CLARITY Results).
Dermatol Therapy, 8 (2018), pp. 571-579
[57]
R. Bissonnette, T. Luger, D. Thaci, D. Toth, I. Messina, R. You, et al.
Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study.
Br J Dermatol, 177 (2017), pp. 1033-1042
[58]
R. Bissonnette, T. Luger, D. Thaci, D. Toth, A. Lacombe, S. Xia, et al.
Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study).
J Eur Acad Dermatol Venereol, 32 (2018), pp. 1507-1514
[59]
A. Blauvelt, J.C. Prinz, A.B. Gottlieb, K. Kingo, H. Sofen, M. Ruer-Mulard, et al.
Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).
Br J Dermatol, 172 (2015), pp. 484-493
[60]
A.B. Gottlieb, A. Blauvelt, J.C. Prinz, P. Papanastasiou, R. Pathan, J. Nyirady, et al.
Secukinumab self-administration by prefilled syringe maintains reduction of plaque psoriasis severity over 52 weeks: results of the FEATURE Trial.
J Drugs Dermatol, 15 (2016), pp. 1226-1234
[61]
J.P. Lacour, C. Paul, S. Jazayeri, P. Papanastasiou, C. Xu, J. Nyirady, et al.
Secukinumab administration by autoinjector maintains reduction of plaque psoriasis severity over 52 weeks: results of the randomized controlled JUNCTURE trial.
J Eur Acad Dermatol Venereol, 31 (2017), pp. 847-856
[62]
M. Ohtsuki, A. Morita, M. Abe, H. Takahashi, N. Seko, A. Karpov, et al.
Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study.
J Dermatol, 41 (2014), pp. 1039-1046
[63]
Y. Okubo, M. Ohtsuki, A. Morita, M. Yamaguchi, T. Shima, Y. Tani, et al.
Long-term efficacy and safety of secukinumab in Japanese patients with moderate to severe plaque psoriasis: 3-year results of a double-blind extension study.
J Dermatol, 46 (2019), pp. 186-192
[64]
C. Paul, J.P. Lacour, L. Tedremets, K. Kreutzer, S. Jazayeri, S. Adams, et al.
Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).
J Eur Acad Dermatol Venereol, 29 (2015), pp. 1082-1090
[65]
K. Reich, L. Puig, J.C. Szepietowski, C. Paul, J.P. Lacour, A. Tsianakas, et al.
Secukinumab dosing optimization in patients with moderate to severe plaque psoriasis: results from the randomised, open-label OPTIMISE study.
Br J Dermatol, (2019),
[66]
M. Sticherling, U. Mrowietz, M. Augustin, D. Thaci, N. Melzer, C. Hentschke, et al.
Secukinumab is superior to fumaric acid esters in treating patients with moderate-to-severe plaque psoriasis who are naive to systemic treatments: results from the randomized controlled PRIME trial.
Br J Dermatol, 177 (2017), pp. 1024-1032
[67]
B. Strober, A.B. Gottlieb, B. Sherif, P. Mollon, I. Gilloteau, L. McLeod, et al.
Secukinumab sustains early patient-reported outcome benefits through 1 year: results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept.
J Am Acad Dermatol, 76 (2017), pp. 655-661
[68]
D. Thaci, A. Blauvelt, K. Reich, T.F. Tsai, F. Vanaclocha, K. Kingo, et al.
Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial.
J Am Acad Dermatol, 73 (2015), pp. 400-409
[69]
A. Blauvelt, K.A. Papp, C.E. Griffiths, B. Randazzo, Y. Wasfi, Y.K. Shen, et al.
Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.
J Am Acad Dermatol, 76 (2017), pp. 405-417
[70]
L.K. Ferris, E. Ott, J. Jiang, H.C. Hong, S. Li, C. Han, et al.
Efficacy and safety of guselkumab, administered with a novel patient-controlled injector (One-Press), for moderate-to-severe psoriasis: results from the phase 3 ORION study.
J Dermatol Treat, 31 (2020), pp. 152-159
[71]
C.E.M. Griffiths, K.A. Papp, A.B. Kimball, B. Randazzo, M. Song, S. Li.
Long-term efficacy of guselkumab for the treatment of moderate-to-severe psoriasis: results from the phase 3 VOYAGE 1 Trial through two years.
J Drugs Dermatol, 17 (2018), pp. 826-832
[72]
K. Reich, A.W. Armstrong, P. Foley, M. Song, Y. Wasfi, B. Randazzo, et al.
Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: results from the phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial.
J Am Acad Dermatol, 76 (2017), pp. 418-431
[73]
M. Ohtsuki, H. Fujita, M. Watanabe, K. Suzaki, M. Flack, X. Huang, et al.
Efficacy and safety of risankizumab in Japanese patients with moderate to severe plaque psoriasis: results from the SustaIMM phase 2/3 trial.
J Dermatol, (2019),
[74]
K.B. Gordon, B. Strober, M. Lebwohl, M. Augustin, A. Blauvelt, Y. Poulin, et al.
Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials.
[75]
B. Elewski, A. Menter, J. Crowley, S. Tyring, Y. Zhao, S. Lowry, et al.
Sustained and continuously improved efficacy of tildrakizumab in patients with moderate-to-severe plaque psoriasis.
J Dermatol Treat, 31 (2020), pp. 763-768
[76]
K.A. Papp, K. Reich, A. Blauvelt, A.B. Kimball, M. Gooderham, S.K. Tyring, et al.
Efficacy of tildrakizumab for moderate-to-severe plaque psoriasis: pooled analysis of three randomized controlled trials at weeks 12 and 28.
J Eur Acad Dermatol Venereol, 33 (2019), pp. 1098-1100
[77]
K. Reich, K.A. Papp, A. Blauvelt, S.K. Tyring, R. Sinclair, D. Thaci, et al.
Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.
[78]
K. Reich, R.B. Warren, L. Iversen, L. Puig, I. Pau-Charles, A. Igarashi, et al.
Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomised phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks.
Br J Dermatol, 182 (2020), pp. 605-617
[79]
A.B. Kimball, K.B. Gordon, S. Fakharzadeh, N. Yeilding, P.O. Szapary, B. Schenkel, et al.
Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years.
Br J Dermatol, 166 (2012), pp. 861-872
[80]
A.B. Kimball, K.A. Papp, Y. Wasfi, D. Chan, R. Bissonnette, H. Sofen, et al.
Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study.
J Eur Acad Dermatol Venereol, 27 (2013), pp. 1535-1540
[81]
R.G. Langley, M. Lebwohl, G.G. Krueger, P.O. Szapary, Y. Wasfi, D. Chan, et al.
Long-term efficacy and safety of ustekinumab, with and without dosing adjustment, in patients with moderate-to-severe psoriasis: results from the PHOENIX 2 study through 5 years of follow-up.
Br J Dermatol, 172 (2015), pp. 1371-1380
[82]
C.L. Leonardi, A.B. Kimball, K.A. Papp, N. Yeilding, C. Guzzo, Y. Wang, et al.
Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1).
Lancet, 371 (2008), pp. 1665-1670
[83]
T.F. Tsai, J.C. Ho, M. Song, P Szapary, C. Guzzo, Y.K. Shen, et al.
Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL).
J Dermatol Sci, 63 (2011), pp. 154-163
[84]
X. Zhu, M. Zheng, M. Song, Y.K. Shen, D. Chan, P.O. Szapary, et al.
Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS).
J Drugs Dermatol, 12 (2013), pp. 166-174
[85]
I. Belinchon Romero, E. Dauden, C. Ferrandiz Foraster, A. Gonzalez-Cantero, J.M. Carrascosa Carrillo, Psoriasis Group of the Spanish Academy of Dermatology and Venereology.
PASI 100 response rates in moderate to severe psoriasis: a systematic literature review and analysis of clinical practice guidelines.
J Dermatol Treat, (2021), pp. 1-9
[86]
J. Berth-Jones, K. Grotzinger, C. Rainville, B. Pham, J. Huang, S. Daly, et al.
A study examining inter- and intra-rater reliability of three scales for measuring severity of psoriasis: Psoriasis Area and Severity Index. Physician's Global Assessment and Lattice System Physician's Global Assessment.
Br J Dermatol, 155 (2006), pp. 707-713
[87]
R.J. Chalmers.
Assessing psoriasis severity and outcomes for clinical trials and routine clinical practice.
Dermatol Clin, 33 (2015), pp. 57-71
[88]
S.R. Feldman, A.B. Fleischer Jr., D.M. Reboussin, S.R. Rapp, M.L. Exum, A.R. Clark, et al.
Self-Administered Psoriasis Area and Severity Index is valid and reliable.
J Invest Dermatol, 106 (1996), pp. 183-186
[89]
T. Fredriksson, U. Pettersson.
Severe psoriasis—oral therapy with a new retinoid.
Dermatologica, 157 (1978), pp. 238-244
[90]
C.E. Griffiths, C.M. Clark, R.J. Chalmers, A. Li Wan Po, H.C. Williams.
A systematic review of treatments for severe psoriasis.
Health Technol Assess, 4 (2000), pp. 1-125
[91]
R.G. Langley, C.N. Ellis.
Evaluating psoriasis with Psoriasis Area and Severity Index, Psoriasis Global Assessment, and Lattice System Physician's Global Assessment.
J Am Acad Dermatol, 51 (2004), pp. 563-569
[92]
L. Naldi, A. Svensson, T. Diepgen, P. Elsner, J.J. Grob, P.J. Coenraads, et al.
Randomized clinical trials for psoriasis 1977–2000: the EDEN survey.
J Invest Dermatol, 120 (2003), pp. 738-741
[93]
J. Schmitt, G. Wozel.
The Psoriasis Area and Severity Index is the adequate criterion to define severity in chronic plaque-type psoriasis.
Dermatology, 210 (2005), pp. 194-199
[94]
M.J. Simpson, C. Chow, H. Morgenstern, T.A. Luger, C.N. Ellis.
Comparison of three methods for measuring psoriasis severity in clinical studies (Part 2 of 2): use of quality of life to assess construct validity of the Lattice System Physician's Global Assessment Psoriasis Area and Severity Index, and Static Physician's Global Assessment.
J Eur Acad Dermatol Venereol, 29 (2015), pp. 1415-1420
[95]
B. Strober, K.A. Papp, M. Lebwohl, K. Reich, C. Paul, A. Blauvelt, et al.
Clinical meaningfulness of complete skin clearance in psoriasis.
J Am Acad Dermatol, 75 (2016), pp. 77-82
[96]
P.L. Mattei, K.C. Corey, A.B. Kimball.
Psoriasis Area Severity Index (PASI) and the Dermatology Life Quality Index (DLQI): the correlation between disease severity and psychological burden in patients treated with biological therapies.
J Eur Acad Dermatol Venereol, 28 (2014), pp. 333-337
[97]
M. Abrouk, M. Nakamura, T.H. Zhu, B. Farahnik, J. Koo, T. Bhutani.
The impact of PASI 75 and PASI 90 on quality of life in moderate to severe psoriasis patients.
J Dermatol Treat, 28 (2017), pp. 488-491
[98]
F. Amatore, A.P. Villani, M. Tauber, M. Viguier, B. Guillot.
French guidelines on the use of systemic treatments for moderate-to-severe psoriasis in adults.
J Eur Acad Dermatol Venereol, 33 (2019), pp. 464-483
[99]
C. Baker, A. Mack, A. Cooper, G. Fischer, S. Shumack, S. Sidhu, et al.
Treatment goals for moderate to severe psoriasis: an Australian consensus.
Aust J Dermatol, 54 (2013), pp. 148-154
[100]
U. Mrowietz, K. Kragballe, K. Reich, P. Spuls, C.E. Griffiths, A. Nast, et al.
Definition of treatment goals for moderate to severe psoriasis: a European consensus.
Arch Dermatol Res, 303 (2011), pp. 1-10
[101]
A. Nast, P. Gisondi, A.D. Ormerod, P. Saiag, C. Smith, P.I. Spuls, et al.
European S3-guidelines on the systemic treatment of psoriasis vulgaris—update 2015-Short version-EDF in cooperation with EADV and IPC.
J Eur Acad Dermatol Venereol, 29 (2015), pp. 2277-2294
[102]
A. Nast, A. Jacobs, S. Rosumeck, R.N. Werner.
Methods REPORT: European S3-Guidelines on the systemic treatment of psoriasis vulgaris—update 2015-EDF in cooperation with EADV and IPC.
J Eur Acad Dermatol Venereol, 29 (2015), pp. e1-e22
[103]
A. Nast, P.I. Spuls, G. van der Kraaij, P. Gisondi, C. Paul, A.D. Ormerod, et al.
European S3-Guideline on the systemic treatment of psoriasis vulgaris—update apremilast and secukinumab-EDF in cooperation with EADV and IPC.
J Eur Acad Dermatol Venereol, 31 (2017), pp. 1951-1963
[104]
P. Gisondi, G. Altomare, F. Ayala, F. Bardazzi, L. Bianchi, A. Chiricozzi, et al.
Italian guidelines on the systemic treatments of moderate-to-severe plaque psoriasis.
J Eur Acad Dermatol Venereol, 31 (2017), pp. 774-790
[105]
C.H. Smith, Z.K. Jabbar-Lopez, Z.Z. Yiu, T. Bale, A.D. Burden, L.C. Coates, et al.
British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017.
Br J Dermatol, 177 (2017), pp. 628-636
[106]
C.A. Elmets, H.W. Lim, B. Stoff, C. Connor, K.M. Cordoro, M. Lebwohl, et al.
Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy.
J Am Acad Dermatol, 81 (2019), pp. 775-804
[107]
A. Menter, B.E. Strober, D.H. Kaplan, D. Kivelevitch, E.F. Prater, B. Stoff, et al.
Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.
J Am Acad Dermatol, 80 (2019), pp. 1029-1072
[108]
S.K. Mahil, N. Wilson, N. Dand, N.J. Reynolds, C.E.M. Griffiths, R. Emsley, et al.
Psoriasis treat to target: defining outcomes in psoriasis using data from a real-world, population-based cohort study (the British Association of Dermatologists Biologics and Immunomodulators Register, BADBIR).
Br J Dermatol, 182 (2020), pp. 1158-1166
[109]
G. Carretero, J.M. Carrascosa, L. Puig, J.L. Sanchez-Carazo, A. Lopez-Ferrer, P. Cueva, et al.
Definition of minimal disease activity in psoriasis.
J Eur Acad Dermatol Venereol, 35 (2021), pp. 422-430
[110]
L. Salgado-Boquete, J.M. Carrascosa, M. Llamas-Velasco, R. Ruiz-Villaverde, P. de la Cueva, I. Belinchon.
A new classification of the severity of psoriasis: what's moderate psoriasis?.
Life (Basel), 11 (2021), pp. 627
[111]
G.G. Song, Y.H. Lee.
Relative efficacy and safety of tofacitinib for treating psoriasis: a Bayesian network meta-analysis of randomized controlled trials.
Int J Clin Pharmacol Ther, 59 (2021), pp. 308-314
[112]
N. Yasmeen, L.M. Sawyer, K. Malottki, L.A. Levin, E. Didriksen Apol, G.B. Jemec.
Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year.
J Dermatol Treat, (2020), pp. 1-15
[113]
A.W. Armstrong, L. Puig, A. Joshi, M. Skup, D. Williams, J. Li, et al.
Comparison of biologics and oral treatments for plaque psoriasis: a meta-analysis.
JAMA Dermatol, 156 (2020), pp. 258-269
[114]
A.W. Armstrong, A.M. Soliman, K.A. Betts, Y. Wang, Y. Gao, L. Puig, et al.
Comparative efficacy and relative ranking of biologics and oral therapies for moderate-to-severe plaque psoriasis: a network meta-analysis.
Dermatol Ther (Heidelb), 11 (2021), pp. 885-905
[115]
C. Busard, J. Zweegers, J. Limpens, M. Langendam, P.I. Spuls.
Combined use of systemic agents for psoriasis: a systematic review.
JAMA Dermatol, 150 (2014), pp. 1213-1220
[116]
C.I. Busard, A.D. Cohen, P. Wolf, S. Gkalpakiotis, S. Cazzaniga, R.S. Stern, et al.
Biologics combined with conventional systemic agents or phototherapy for the treatment of psoriasis: real-life data from PSONET registries.
J Eur Acad Dermatol Venereol, 32 (2018), pp. 245-253
[117]
P. Davila-Seijo, E. Dauden, M.A. Descalzo, G. Carretero, J.M. Carrascosa, F. Vanaclocha, et al.
Infections in moderate to severe psoriasis patients treated with biological drugs compared to classic systemic drugs: findings from the BIOBADADERM Registry.
J Invest Dermatol, 137 (2017), pp. 313-321
[118]
A. Nast, C. Smith, P.I. Spuls, G. Avila Valle, Z. Bata-Csorgo, H. Boonen, et al.
EuroGuiDerm Guideline on the systemic treatment of Psoriasis vulgaris—Part 2: Specific clinical and comorbid situations.
J Eur Acad Dermatol Venereol, 35 (2021), pp. 281-317
[119]
P. Gisondi, V. Lora, C. Bonauguri, A. Russo, G. Lippi, G. Girolomoni.
Serum chemerin is increased in patients with chronic plaque psoriasis and normalizes following treatment with infliximab.
Br J Dermatol, 168 (2013), pp. 749-755
[120]
J.M. Gelfand, D.B. Shin, A. Alavi, D.A. Torigian, T. Werner, M. Papadopoulos, et al.
A phase iv randomized, double-blind placebo-controlled crossover study of the effects of ustekinumab on vascular inflammation in psoriasis (the VIP-U Trial).
J Invest Dermatol, 140 (2020), pp. 85-93
[121]
C. Lasagni, L. Bigi, A. Conti, G. Pellacani.
Successful therapy of plaque-type psoriasis with secukinumab in patients with multiple comorbidities treated with previous biologic therapies.
J Dermatol Treat, 29 (2018), pp. 5-8
[122]
D.Y. Hsu, R. Gniadecki.
Patient adherence to biologic agents in psoriasis.
Dermatology, 232 (2016), pp. 326-333
[123]
Y.C. Tsai, T.F. Tsai.
Switching biologics in psoriasis—practical guidance and evidence to support.
Expert Rev Clin Pharmacol, 13 (2020), pp. 493-503
[124]
S. Piaserico, S. Cazzaniga, S. Chimenti, A. Giannetti, M. Maccarone, M. Picardo, et al.
Efficacy of switching between tumor necrosis factor-alfa inhibitors in psoriasis: results from the Italian Psocare registry.
J Am Acad Dermatol, 70 (2014), pp. 257-262
[125]
A. Mazzotta, M. Esposito, A. Costanzo, S. Chimenti.
Efficacy and safety of etanercept in psoriasis after switching from other treatments: an observational study.
Am J Clin Dermatol, 10 (2009), pp. 319-324
[126]
R. Bissonnette, C. Bolduc, Y. Poulin, L. Guenther, C.W. Lynde, C. Maari.
Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept.
J Am Acad Dermatol, 63 (2010), pp. 228-234
[127]
P.P. Van Lumig, L.L. Lecluse, R.J. Driessen, P.I. Spuls, J.B. Boezeman, P.C. van de Kerkhof, et al.
Switching from etanercept to adalimumab is effective and safe: results in 30 patients with psoriasis with primary failure, secondary failure or intolerance to etanercept.
Br J Dermatol, 163 (2010), pp. 838-846
[128]
M. Talamonti, M. Galluzzo, N. Bernardini, G. Caldarola, S. Persechino, F. Cantoresi, et al.
Psoriasis Area and Severity Index response in moderate-severe psoriatic patients switched to adalimumab: results from the OPPSA study.
J Eur Acad Dermatol Venereol, 32 (2018), pp. 1737-1744
[129]
G. Damiani, R.R.Z. Conic, V. de Vita, A. Costanzo, R. Regazzini, P.D.M. Pigatto, et al.
When IL-17 inhibitors fail: real-life evidence to switch from secukinumab to adalimumab or ustekinumab.
Dermatol Ther, 32 (2019), pp. e12793
[130]
A.B. Gottlieb, R.E. Kalb, A. Blauvelt, M.P. Heffernan, H.L. Sofen, L.K. Ferris, et al.
The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study.
J Am Acad Dermatol, 67 (2012), pp. 642-650
[131]
F. Ayala, J. Lambert, T.S. Group.
Efficacy, tolerability and safety of switching from etanercept to infliximab for the treatment of moderate-to-severe psoriasis: a multicenter, open-label trial (TANGO).
J Dermatol Treat, 26 (2015), pp. 304-311
[132]
K. Reich, C.E.M. Griffiths, K.B. Gordon, K.A. Papp, M. Song, B. Randazzo, et al.
Maintenance of clinical response and consistent safety profile with up to 3 years of continuous treatment with guselkumab: results from the VOYAGE 1 and VOYAGE 2 trials.
J Am Acad Dermatol, 82 (2020), pp. 936-945
[133]
A. Blauvelt, A.W. Armstrong, R.G. Langley, K. Gebauer, D. Thaçi, J. Bagel, et al.
Efficacy of guselkumab versus secukinumab in patients with moderate-to-severe plaque psoriasis in subgroups defined by previous psoriasis medication history: results from the ECLIPSE study.
J Dermatol Treat, (2021), pp. 1-8
[134]
K.A. Papp, M.G. Lebwohl, L. Puig, M. Ohtsuki, S. Beissert, J. Zeng, et al.
Long-term efficacy and safety of switching from ustekinumab to risankizumab: results from the open-label extension LIMMitless.
28th European Academy of Dermatology and Venereology Congress,
[135]
P. Foley, B. Strober, W.C. Valdecantos, H. Photowala, T. Zhan, A. Menter.
Durable efficacy of risankizumab compared with ustekinumab across subgroups of patients with moderate-to-severe plaque psoriasis: integrated analysis of two phase 3 trials.
J Am Acad Dermatol., 81 (2019), pp. AB49
[136]
K. Reich, M. Gooderham, D. Thaci, J.J. Crowley, C. Ryan, J.G. Krueger, et al.
Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial.
Lancet, 394 (2019), pp. 576-586
[137]
J.R. Georgakopoulos, M. Phung, A. Ighani, K. Lam, J. Yeung.
Biologic switching between interleukin 17A antagonists secukinumab and ixekizumab: a 12-week, multicenter, retrospective study.
J Eur Acad Dermatol Venereol, 33 (2019), pp. e7-e8
[138]
A. Conti, F. Peccerillo, P. Amerio, A. Balato, F. Bardazzi, L. Bianchi, et al.
Efficacy and safety of switching to ixekizumab in secukinumab nonresponder patients with psoriasis: results from a multicentre experience.
Br J Dermatol, 180 (2019), pp. 1547-1548
[139]
J.R. Georgakopoulos, M. Phung, A. Ighani, J. Yeung.
Efficacy and safety of switching to ixekizumab in secukinumab nonresponders with plaque psoriasis: a multicenter retrospective study of interleukin 17A antagonist therapies.
J Am Acad Dermatol, 79 (2018), pp. 155-157
[140]
I. Gasslitter, N. Kirsten, M. Augustin, K. Torz, U. Mrowietz, K. Eyerich, et al.
Successful intra-class switching among IL-17 antagonists: a multicentre, multinational, retrospective study.
Arch Dermatol Res, 311 (2019), pp. 421-424
[141]
G. Kimmel, M. Chima, H.J. Kim, J. Bares, C.J. Yao, G. Singer, et al.
Brodalumab in the treatment of moderate to severe psoriasis in patients when previous anti-interleukin 17A therapies have failed.
J Am Acad Dermatol, 81 (2019), pp. 857-859
[142]
C. Kromer, D. Wilsmann-Theis, S. Gerdes, S. Krebs, A. Pinter, S. Philipp, et al.
Changing within the same class: efficacy of brodalumab in plaque psoriasis after treatment with an IL-17A blocker—a retrospective multicenter study.
J Dermatol Treat, (2020), pp. 1-5
[143]
E.L. Williams, S. Gadola, C.J. Edwards.
Anti-TNF-induced lupus.
Rheumatology (Oxford), 48 (2009), pp. 716-720
[144]
C.E. Griffiths, B.E. Strober, P. van de Kerkhof, V. Ho, R. Fidelus-Gort, N. Yeilding, et al.
Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis.
N Engl J Med, 362 (2010), pp. 118-128
[145]
A. Chiricozzi, A. Conti, M. Burlando, G. Odorici, F. Gaiani, S. Panduri, et al.
Switching from secukinumab to ustekinumab in psoriasis patients: results from a multicenter experience.
Dermatology, 235 (2019), pp. 213-218
[146]
G. Ganzetti, A. Campanati, A. Bettacchi, G Brandozzi, V. Brisigotti, L. Bugatti, et al.
Switching from a biological therapy to another biologic agent in psoriatic patients: the experience of PsOMarche group.
G Ital Dermatol Venereol, 153 (2018), pp. 5-10
[147]
M.D. Gil-Sierra, E. Rios-Sanchez, M.D.P. Briceno-Casado.
Use of ustekinumab after other biological therapies in moderate-severe psoriasis: real long-term data.
Farm Hosp, 44 (2020), pp. 218-221
[148]
E. Rallis, C.D. Verros.
Ustekinumab treats psoriasis refractory to seven conventional and biologic therapies.
Dermatol Online J, 17 (2011), pp. 14
[149]
K. Haycraft, L. Cooke.
Rapid and sustained improvement in a patient with plaque psoriasis switched to brodalumab after failing treatment clearance on six other biologic therapies.
J Drugs Dermatol, 19 (2020), pp. 86-88
[150]
Y. Kurosaki, K. Takamori, Y. Suga.
Refractory psoriasis vulgaris with itching successfully treated with the anti-interleukin-17a antibody secukinumab: a case of secondary failure of other biologic agents.
Indian J Dermatol, 62 (2017), pp. 441
[151]
J.P. Ortonne, A. Taïeb, A.D. Ormerod, D. Robertson, J. Foehl, R. Pedersen, et al.
Patients with moderate-to-severe psoriasis recapture clinical response during re-treatment with etanercept.
Br J Dermatol, 161 (2009), pp. 1190-1195
[152]
K.B. Gordon, A.B. Gottlieb, C.L. Leonardi, B.E. Elewski, A. Wang, A. Jahreis, et al.
Clinical response in psoriasis patients discontinued from and then reinitiated on etanercept therapy.
J Dermatol Treat, 17 (2006), pp. 9-17
[153]
K.B. Gordon, A.B. Gottlieb, R.G. Langely, P. van de Kerkhof, K.T. Belasco, M. Sundaram, et al.
Adalimumab retreatment successfully restores clinical response and health-related quality of life in patients with moderate to severe psoriasis who undergo therapy interruption.
J Eur Acad Dermatol Venereol, 29 (2015), pp. 767-776
[154]
K. Papp, J. Crowley, J.P. Ortonne, J. Leu, M. Okun, S.R. Gupta, et al.
Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy.
Br J Dermatol, 164 (2011), pp. 434-441
[155]
D. Thaci, S. Piaserico, R.B. Warren, A.K. Gupta, W. Cantrell, Z. Draelos, et al.
Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2).
Br J Dermatol, 185 (2021), pp. 323-334
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