Psoriasis is a chronic erythematous, scaling skin disease that affects between 2% and 3% of white individuals.1 It has a prevalence of 1.4% in the Spanish population.2 The disease has been estimated to account for 8.7% of dermatology consultations,3 and around 25% of patients with a diagnosis of psoriasis have moderate or severe forms of the disease.4 It is usually diagnosed clinically5 and its severity depends on the body surface area (BSA) that is affected.6

Moderate to severe psoriasis is generally treated with systemic drugs and/or phototherapy,7,8 but long-term use can be limited by cumulative toxicity9 and loss of efficacy.10 The introduction of biologic therapies, however, has gone a long way towards overcoming these limitations. Biologic drugs are generally safe and effective,11 have few side effects,12,13 and display little or no interaction with other treatments.14 These drugs are also very versatile, since they can be used alone15 or in combination with other therapies,16 particularly systemic drugs. Nevertheless, treatment of psoriasis should always be individualized.5,17,18

Biologic therapies belong to a group of active proteins that includes monoclonal antibodies, fusion proteins, and recombinant cytokines. In psoriasis, their pharmacology specifically targets the immune mechanisms underlying the pathology of the disease.18 There are currently 4 biologic therapies licensed in Spain for use in patients with psoriasis19: the anti-tumor necrosis factor drugs adalimumab, etanercept, and infliximab, and usterkinumab, a monoclonal antibody against interleukins 12 and 23.18

Good long-term control of psoriasis is essential, particularly in its moderate or severe forms, since it is a highly incapacitating disease that can substantially reduce quality of life in affected patients.20 Dermatology departments are usually responsible for the care of patients with moderate to severe psoriasis.18 Consequently, the experience of specialists in this setting plays a central role in determining the treatment provided. Many clinical practice guidelines are available on the use of biologic drugs in psoriasis.17,18 However, very few studies have addressed the opinions of professionals based on clinical experience.21 Understanding this experience is essential to determining the true picture of how biologic therapies are used to treat moderate to severe psoriasis in Spain.

Of the 207 questionnaires sent to participants between March and June 2009, a total of 190 were returned completed (92% participation). The dermatologists who responded to the questionnaires were distributed throughout Spain in a manner that was proportional to regional differences in the population of the autonomous communities. Men accounted for 57% of respondents. The mean (95% CI) age was 43 (42-44) years and the mean length of professional experience was 15 (14-16) years. Professional experience of less than 13 years was reported by 45% of the dermatologists surveyed. Ninety-eight percent of the respondents worked in an urban or metropolitan setting while 92% worked in hospitals, although not exclusively (42% also practiced in an outpatient clinic and 60% had a private practice).

The mean number of patients seen weekly by the surveyed dermatologists was 145 (133-157), of which around 8% (7%-9%)—approximately 12 patients—consult for moderate psoriasis and 3% (2%-4%)—approximately 4 patients—consult for severe psoriasis. The majority of patients (60% [57%-63%] of those with moderate psoriasis and 65% [61%-69%] of those with severe psoriasis) have already been diagnosed with psoriasis when they are seen by the dermatologists. The diagnosing physicians are primary care physicians in 50% of these cases and dermatologists in 47%. Follow-up of patients was 3 monthly according to 71% of the dermatologists surveyed, and the main measures of disease severity were the psoriasis area and severity index (PASI), used by 97% of dermatologists, and the BSA affected, used by 78% of dermatologists.

The dermatologists reported that 90% (88%-92%) of patients with moderate to severe psoriasis who attend the clinic are receiving active treatment, and of those, 31% (28%-34%) receive biologic drugs. According to the experience of the surveyed specialists, a change of drug is required in around 28% (25%-31%) of patients receiving biologic therapy. This change would mainly involve substitution of the prescribed therapy to another biologic drug, especially in the case of efalizumab (now withdrawn), for which 52% of specialists had prescribed this type of treatment change (Fig. 2A). Dosage changes were only notable in the case of etanercept, with 20% of dermatologists reporting that they would reduce the dose during treatment. The main reason for changes in biological therapy was inadequate treatment response or the occurrence of adverse events (Fig. 2B). Especially noteworthy were the reasons given for changes in treatment with efalizumab, namely programmed surgery (80%) and premature termination of therapy by the patient (72%). Only 9 dermatologists (5%) mentioned withdrawal of marketing authorization for the drug.

Figure 2.

Principal treatment modifications employed with biologic drugs (A) and reason for modification (B) according to the experience of the surveyed dermatologists.

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In their day-to-day clinical practice, most of the dermatologists surveyed (73%; between 67% and 79% according to the drug considered) would administer biologic drugs as monotherapy to treat moderate to severe psoriasis. The most common treatment regimen was continuous treatment, with more than 50% of dermatologists (between 53% and 59% according to the drug under consideration) stating that they used it “always” or “almost always”. Intermittent treatment would be used always or almost always with etanercept by 58% of the dermatologists surveyed, whereas less than 20% of the dermatologists would follow such a regimen with the other drugs considered.

In the opinion of the dermatologists surveyed, an optimal biologic drug should have a good safety profile, long-term efficacy, and good tolerability. These attributes were evaluated as having a mean score on a scale of importance from 0 to 5 of 4.8 (4.7-4.9), 4.6 (4.5-4.7), and 4.5 (4.4-4.6), respectively. These same attributes were also given more consideration when choosing a treatment regimen for patients with moderate to severe psoriasis in clinical practice. Of particular importance for the dermatologists surveyed was the safety of the drug, which was always considered by 79% of the specialists when choosing the most appropriate treatment (Fig. 3).

Figure 3.

Consideration given to the different attributes of a biologic drug when choosing the most appropriate treatment option for moderate to severe psoriasis in clinical practice.

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When establishing a treatment regimen, the participating dermatologists stated that, in addition to the properties of the biologic drug, they always considered other factors such as the severity of psoriasis (79%) or the presence of concomitant disease (63%) (Fig. 4). Other factors that were always taken into account by the majority of specialists consulted in such cases were the likelihood of pregnancy (68% and 70% of dermatologists in the case of intermittent and continuous treatment, respectively) and risk of infection (62% and 69% in the case of intermittent and continuous treatment, respectively). No notable differences were observed between the priorities considered by the surveyed dermatologists when it came to choosing a particular therapeutic regimen. In addition, most of the respondents (81%) reported that they always or almost always followed the recommendations included in clinical practice guidelines; they were also influenced by prescription habits (72%) and the specifications of the package insert (71%). In 12% of cases, the dermatologists reported being always or almost always influenced by the web page of the product.

Figure 4.

Principal factors considered by the surveyed dermatologists when establishing a treatment regimen with a biologic drug.

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This study used a survey to collect data on the main criteria used by Spanish dermatologists to determine the treatment of choice with biologic drugs for patients with moderate to severe psoriasis. These criteria are based on the experience of specialists in day-to-day clinical practice and are informed by the need to tailor these treatments to each patient.18 According to the results obtained, 11% of patients seen by dermatologists consult for moderate or severe psoriasis. This is a much larger proportion than that reported in the literature, which indicates percentages of 9% for patients with psoriasis and 2% for patients with moderate to severe psoriasis.3,22 This difference could be due to 2 main factors. On the one hand, it may be explained by an increasing incidence of this disease23 combined with the fact that surveyed dermatologists were required to have sufficient experience in the use of biologic drugs, which are employed in moderate or severe forms of the disease.5,18 On the other hand, in agreement with previous studies,22 most of the patients consulting a dermatologist would already have been diagnosed in primary care or by another dermatologist, and this could mean that the patients referred to the dermatologists surveyed would have a more advanced stage of the disease; this would support the findings mentioned above. Nonetheless, considering the methods used, in which dermatologists were asked in a questionnaire to estimate the percentage of patients they saw with moderate to severe psoriasis based on their clinical experience, it cannot be ruled out that they might have overestimated this proportion.

There was a notably high percentage of specialists who reported using PASI or BSA to assess disease severity. It has been suggested that, although these measures are the standard method for assessing the severity of psoriasis in clinical trials,24,25 they are used much less frequently in day-to-day clinical practice.22,26 This increase in the use of PASI and BSA could be related to the higher percentage of patients with moderate to severe disease seen by the participating specialists, or indicate a tendency towards standardization by those professionals due to the large number of studies addressing moderate to severe psoriasis that have been reported in recent years.

According to the surveyed dermatologists, almost all of the patients with moderate to severe psoriasis (90%) who are seen in the clinic are in active treatment. This finding is consistent with clinical practice guidelines on the management of these patients.5 The information provided by dermatologists in this study indicates that the use of biologic therapy in these patients has been increasing in recent years. Based on data from previous studies,26 the use of these drugs in patients with moderate to severe psoriasis in Spain would have increased from 23% to 31%. This proportion, however, would still be lower than that reported in other countries.27 The treatment regimen preferred by the surveyed dermatologists was monotherapy and, wherever possible, continuous treatment. Nevertheless, more than half of the respondents (58%) would also consider intermittent treatment in the case of etanercept.

Unlike with conventional treatments,28 only 28% of patients would require a change in biologic therapy at some point during treatment according to the surveyed dermatologists. The most common reasons for this change would be a lack of treatment response or the appearance of adverse effects, and the solution would generally involve changing to another biologic drug (especially in the case of efalizumab). When the study was designed, efalizumab was still marketed in Spain. Due to safety concerns, however, marketing authorization was withdrawn on February 19, 2009.19 This withdrawal would be the main explanation for the finding that efalizumab had the highest rate of treatment modification involving substitution of another biologic drug.

With the exception of efalizumab, biologic drugs have been shown to have a good safety profile with few adverse effects,21 qualities that are valued highly by dermatologists seeking to improve the quality of life of patients with moderate to severe psoriasis.26 Consistent with this, the main properties considered by the surveyed dermatologists to be important when choosing a biologic drug would be, in order of priority, safety, long-term efficacy, and tolerability. It is not surprising, then, that one of the main criteria used to choose a particular drug was, in addition to the severity of psoriasis, the presence of concomitant disease. It is known that most biologic drugs are a good treatment option in patients with comorbidities.16 In addition, most of the surveyed dermatologists reported that they always took into consideration the possibility of pregnancy in women treated with biologic drugs; while they are not recommended during gestation, these drugs may be used with caution in women of fertile age.29 The use of biologic drugs, however, also requires special precautions such as assessment of the risk of infection,18 an observation that was confirmed by most of the specialists surveyed in this study.

Given the nature of this study, designed as an opinion survey, the data presented here should be interpreted with caution. Differences in the practice settings of the 190 participating dermatologists could explain the high degree of variability in the results obtained. Nevertheless, the results represent an important source of information given that they are based on the professional experience and day-to-day clinical practice of the dermatologists surveyed. In order to obtain more objective responses, methods were used to guarantee that participants were free to choose their responses. All of the questionnaires were completed anonymously and without supervision. This was communicated in the information sheet provided to all of the participating dermatologists and also in the informed consent form which they subsequently signed. In addition, the possibility of regional bias was addressed by ensuring that the participating dermatologists were distributed in a proportion that reflected the general population of the different Spanish regions.30 Furthermore, the questionnaire was completed by specialists working in both hospital and outpatient settings, independently of the funding source (public or private).

The results obtained in this study are of widespread interest, since opinion surveys based on the clinical experience of specialists yield data on real-life decision making that are not reflected in patient records. Nevertheless, it would also be of interest to compare data based on the professional opinion of the specialists with clinical data contained within patient records.

Biologic therapy is undoubtedly an important treatment option for patients with moderate to severe psoriasis. This is confirmed by a large number of reports in the scientific literature. In Spain, according to the opinion of dermatologists with experience in the use of these drugs, slightly more than a quarter of all patients with moderate to severe psoriasis are treated with biologic drugs. Although these findings are derived from an opinion survey and therefore cannot be extrapolated to the general situation, comparison with similar studies indicates that the use of biologic drugs in patients with moderate to severe psoriasis has increased in recent years.

In the opinion of the majority of the specialists consulted, biologic drugs should display, in order of importance, a good safety profile, long-term efficacy, and good tolerability.

This study was supported by a grant from Wyeth Farma, S.A. (now Pfizer) and received technical and logistic support from IMS Health.

Dr Ara has participated in advisory boards for Pfizer, Janssen, and Abbott. He has also received speaker's fees from the following pharmaceutical companies: Abbott, Janssen, MSD, and Pfizer. Dr Pérez reports that she has no conflicts of interest. Dr Ferrando has given presentations for Abbott and Janssen. He has also been involved in studies for Pfizer.