Case and Research Letters
An Analysis of Drug Survival, Effectiveness, and Safety in Moderate to Severe Psoriasis Treated With Ustekinumab: An Observational Study of 69 Patients in Routine Clinical Practice
Análisis de supervivencia, eficacia y seguridad en psoriasis moderada–grave tratada con ustekinumab. Estudio observacional de 69 pacientes en la práctica clínica habitual
I. Salgüero Fernández
, M. Hospital Gil, M. Sigüenza Sanz, G. Roustan Gullón
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Dermatología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid
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Salgüero Fernández, M. Hospital Gil, M. Sigüenza Sanz, G. Roustan Gullón" "autores" => array:4 [ 0 => array:4 [ "nombre" => "I." "apellidos" => "Salgüero Fernández" "email" => array:1 [ 0 => "irenebsf@hotmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "M." "apellidos" => "Hospital Gil" ] 2 => array:2 [ "nombre" => "M." "apellidos" => "Sigüenza Sanz" ] 3 => array:2 [ "nombre" => "G." "apellidos" => "Roustan Gullón" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Dermatología, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Análisis de supervivencia, eficacia y seguridad en psoriasis moderada–grave tratada con ustekinumab. Estudio observacional de 69 pacientes en la práctica clínica habitual" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2258 "Ancho" => 2500 "Tamanyo" => 215575 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Kaplan-Meier analysis of treatment survival (duration in months, 8.3 years of follow-up).</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Psoriasis is a chronic disease with a prevalence of between 1% and 3%. Its clinical manifestations and associated comorbidities have a considerable impact on affected patients.</p><p id="par0010" class="elsevierStylePara elsevierViewall">While the advent of biologic therapy has greatly improved the control of moderate to severe psoriasis,<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">1</span></a> the treatment of this disease is still complicated. We have data on the patients who participated in clinical trials of biologic drugs, but these cases are often unlike those we encounter in clinical practice, as shown by a study of data from the Spanish BIOBADADERM registry.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">2</span></a> That study, which analyzed data from 1042 patients on systemic therapy (classic and biologic), reported that 30% of those patients would have been excluded from clinical trials. The patients who would not have been eligible for inclusion in a clinical trial had a higher risk of developing severe adverse reactions to systemic treatment.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Since we consider that it is important to report data on patients being treated in routine clinical practice, we designed a study to evaluate the efficacy, safety, and survival of treatment with ustekinumab in our hospital. We studied patients with moderate to severe psoriasis who started treatment with ustekinumab in our specialized psoriasis clinic between 1 January 2010 and 30 April 2017.</p><p id="par0020" class="elsevierStylePara elsevierViewall">The characteristics of the patients included in the study are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>. Patients weighing 100 kg or less started treatment with an initial dose of ustekinumab 45<span class="elsevierStyleHsp" style=""></span>mg followed by a second dose at 4 weeks and then 45<span class="elsevierStyleHsp" style=""></span>mg every 12 weeks for at least 12 months. At 1 year, treatment optimization was considered, taking into account the efficacy achieved. In 2 patients who weighed over 100<span class="elsevierStyleHsp" style=""></span>kg, a dose of 90<span class="elsevierStyleHsp" style=""></span>mg was administered initially followed by another at 4 weeks and 90<span class="elsevierStyleHsp" style=""></span>mg every 12 weeks thereafter. Informed consent was obtained from all of the patients before start of treatment.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0025" class="elsevierStylePara elsevierViewall">Treatment survival was calculated as the number of days a patient continued on ustekinumab during follow-up. The longest interval between two injections of the drug considered not to constitute loss to follow-up or treatment interruption was 180 days. We performed 2 analyses: one of the dataset as a whole and the other differentiating between patients who had previously received biologic therapy (naive) and those who had not (non-naive). The data was analyzed using the Kaplan-Meier method.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Treatment resulted in an improvement from the mean baseline Psoriasis Area and Severity Index (PASI) of 13.3 to a final mean PASI score of 3.5, which represents an 83% reduction in absolute PASI.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The treatment survival rate at the end of the 8.3 years of follow-up was 75.3%, and the rate was higher in the group of patients who had not previously been treated with a biologic agent than in the non-naive group (80% vs 60%) (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> includes the patients who continued on ustekinumab and those in whom treatment was withdrawn. In this series, 6 patients reported adverse events, most of which were considered to be mild and did not lead to cessation of treatment. Treatment was withdrawn due to an adverse event in 2 patients: one who presented with infectious spondylodiscitis and another who developed severe palmoplantar pustulosis. A patient who developed psoriatic arthritis 3 months after starting ustekinumab continued on treatment, achieving a good response in terms of both skin lesions and joint involvement.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Tuberculin skin test conversion occurred in 12 patients, who were prescribed 6 to 9 months of treatment with isoniazid. No cases of active tuberculosis were recorded.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Several recent studies, including the PSOLAR<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">3</span></a> and BABDIR<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">4</span></a> studies, have collected data on the survival of biologic therapy in clinical practice. The findings of the Spanish ORBIT<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">5</span></a> study—based on data from 427 patients collected over a 4-year period—highlight the efficacy and safety of long-term biologic therapy.</p><p id="par0055" class="elsevierStylePara elsevierViewall">The treatment survival rate in this series was high (76.3% at 100 months). The 83% decline in absolute PASI score was similar to results reported by other authors in the literature. Puig et al.,<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">6</span></a> in a 3-year study of 67 patients receiving ustekinumab, reported a PASI 75 response at 1 year in 86% of the patients. Also of interest is the study by Molina-Leyva et al.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">7</span></a> of 30 patients treated with ustekinumab, in which the PASI 75 response at 1 year was 81.5%.</p><p id="par0060" class="elsevierStylePara elsevierViewall">In the present series, we should note that the baseline PASI was probably underestimated because none of the patients underwent a washout period before start of treatment with ustekinumab.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Withdrawal of treatment due to lack of efficacy (both primary and secondary treatment failure) was 13%. This low percentage may be due to the practice in our clinic of having a “watch and wait” period before deciding on loss of efficacy or withdrawal of treatment and to our patient's high degree of satisfaction with the efficacy achieved.</p><p id="par0070" class="elsevierStylePara elsevierViewall">In the literature we reviewed, we found no cases of paradoxical psoriatic reactions associated with the use of IL-23 inhibitors. By contrast, their use as an alternative treatment for such reactions is reported.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">8</span></a> We did, however, find a report of a case in which paradoxical psoriasis worsened following treatment with ustekinumab.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">9</span></a></p><p id="par0075" class="elsevierStylePara elsevierViewall">The limitations of this study include its retrospective design and the use of the treatment survival rate as a measure of treatment success because this endpoint does not provide any information on how patients were included or take into account cases in which treatment was discontinued because the lesions had cleared.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of Interest</span><p id="par0080" class="elsevierStylePara elsevierViewall">Irene Salgüero has participated in clinical trials and has been invited to give papers by Janssen, Abbvie, and Novartis.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of Interest" ] 1 => array:1 [ "titulo" => "Références" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Salgüero Fernández I, Gil MH, Sanz MS, Gullón GR. Análisis de supervivencia, eficacia y seguridad en psoriasis moderada–grave tratada con ustekinumab. Estudio observacional de 69 pacientes en la práctica clínica habitual. Actas Dermosifiliogr. 2019;110:244–246.</p>" ] ] "multimedia" => array:2 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2258 "Ancho" => 2500 "Tamanyo" => 215575 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Kaplan-Meier analysis of treatment survival (duration in months, 8.3 years of follow-up).</p>" ] ] 1 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Total number of patients n=69 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Women, 31.88% (21); Men, 69.57% (48) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Naive patients, 39% (28); Non-naive patients, 61% (41) \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">% patients = 1 prior biologic, 34.78%; > 1 prior biologic, 23.18% \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="" valign="top"> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleBold"><span class="elsevierStyleItalic">Mean</span></span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleBold"><span class="elsevierStyleItalic">Median</span></span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Age on starting ustekinumab, y \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">47.91 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">49 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Baseline PASI score \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">13.34 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">12 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Final PASI score \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">3.53 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Number of prior biologic therapies \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">1.63 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">1 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Duration of follow-up, mo \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">36.12 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">23.79 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleItalic"><span class="elsevierStyleBold">Patients Still on Therapy and Reasons for Withdrawal</span></span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleItalic"><span class="elsevierStyleBold">Number</span></span> \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleItalic"><span class="elsevierStyleBold">%</span></span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Patients still on UST \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">52 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">75.36 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Withdrawal due to adverse events \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">2.90 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Withdrawal due to lack of efficacy \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">9 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">13.04 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Withdrawal due to good response \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">4.35 \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Withdrawal because patient was lost to follow-up \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">3 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">4.35 \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2003845.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Patient Characteristics.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "Références" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:9 [ 0 => array:3 [ "identificador" => "bib0045" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Accumulated disability in the life course: the scar of psoriasis in the patient's life" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "S. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 12 | 11 | 23 |
| 2024 Octubre | 58 | 49 | 107 |
| 2024 Septiembre | 69 | 34 | 103 |
| 2024 Agosto | 87 | 65 | 152 |
| 2024 Julio | 65 | 43 | 108 |
| 2024 Junio | 70 | 38 | 108 |
| 2024 Mayo | 57 | 41 | 98 |
| 2024 Abril | 65 | 29 | 94 |
| 2024 Marzo | 64 | 44 | 108 |
| 2024 Febrero | 47 | 42 | 89 |
| 2024 Enero | 54 | 41 | 95 |
| 2023 Diciembre | 60 | 21 | 81 |
| 2023 Noviembre | 63 | 34 | 97 |
| 2023 Octubre | 65 | 22 | 87 |
| 2023 Septiembre | 51 | 38 | 89 |
| 2023 Agosto | 47 | 25 | 72 |
| 2023 Julio | 44 | 32 | 76 |
| 2023 Junio | 54 | 25 | 79 |
| 2023 Mayo | 53 | 23 | 76 |
| 2023 Abril | 25 | 21 | 46 |
| 2023 Marzo | 45 | 23 | 68 |
| 2023 Febrero | 36 | 25 | 61 |
| 2023 Enero | 33 | 34 | 67 |
| 2022 Diciembre | 56 | 41 | 97 |
| 2022 Noviembre | 32 | 34 | 66 |
| 2022 Octubre | 30 | 29 | 59 |
| 2022 Septiembre | 20 | 38 | 58 |
| 2022 Agosto | 23 | 55 | 78 |
| 2022 Julio | 22 | 43 | 65 |
| 2022 Junio | 21 | 38 | 59 |
| 2022 Mayo | 37 | 41 | 78 |
| 2022 Abril | 73 | 44 | 117 |
| 2022 Marzo | 76 | 55 | 131 |
| 2022 Febrero | 84 | 24 | 108 |
| 2022 Enero | 67 | 47 | 114 |
| 2021 Diciembre | 46 | 45 | 91 |
| 2021 Noviembre | 51 | 34 | 85 |
| 2021 Octubre | 41 | 52 | 93 |
| 2021 Septiembre | 34 | 36 | 70 |
| 2021 Agosto | 32 | 23 | 55 |
| 2021 Julio | 53 | 12 | 65 |
| 2021 Junio | 47 | 28 | 75 |
| 2021 Mayo | 32 | 40 | 72 |
| 2021 Abril | 76 | 31 | 107 |
| 2021 Marzo | 35 | 21 | 56 |
| 2021 Febrero | 48 | 18 | 66 |
| 2021 Enero | 38 | 14 | 52 |
| 2020 Diciembre | 20 | 9 | 29 |
| 2020 Noviembre | 20 | 18 | 38 |
| 2020 Octubre | 19 | 11 | 30 |
| 2020 Septiembre | 20 | 9 | 29 |
| 2020 Agosto | 26 | 22 | 48 |
| 2020 Julio | 18 | 13 | 31 |
| 2020 Junio | 30 | 23 | 53 |
| 2020 Mayo | 32 | 12 | 44 |
| 2020 Abril | 19 | 13 | 32 |
| 2020 Marzo | 21 | 6 | 27 |
| 2020 Febrero | 4 | 0 | 4 |
| 2019 Mayo | 2 | 0 | 2 |
| 2019 Abril | 1 | 0 | 1 |
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