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Long-term efficacy


Long-term efficacy of biologics in the treatment of psoriasis


This article summarises the major outcomes of meta-analyses of clinical data on the use of biologics in the treatment of psoriasis vulgaris and subsequently addresses the major areas of uncertainty and need for further studies


Robert Gniadecki MD Department of Dermatology, Bispebjerg Hospital and Faculty of Health Sciences, University of Copenhagen, Denmark


Ten years of using biologics in dermatology has revealed their unparalleled usefulness in the treatment of psoriasis vulgaris. The currently approved biologics include monoclonal antibodies against tumour necrosis factor a (TNFa) (infliximab, adalimumab) or the p40 subunit of interleukin-12/23 (ustekinumab) and a fusion protein against TNFa (etanercept). Each of these drugs has been thoroughly tested in randomised, controlled trials on thousands of patients. The total body of evidence documenting the efficacy of biologics surpasses any other conventional therapeutic modality for psoriasis. An equally large dataset has been collected for psoriatic arthritis (PsA), successfully documenting the activity of the biologics in this manifestation of psoriasis. Several exhaustive meta-analyses have recently analysed the clinical data and reconfirmed the excellent clinical efficacy of biologics in psoriasis.1–3


Results from the randomised controlled trials


A recent review by Reich et al2 identified


15 clinical trials in which the efficacy of the currently used biologics has been


100 80 60 40 20 0 PASI50 PASI75 PASI response


Figure 1: Short-term (10–16 weeks) efficacy of different biologics for psoriasis vulgaris. Graph shows the mean percentages of patients (with 95% confidence intervals, y-axis) achieving PASI reduction of 50%, 75% or 90%. Pooled data from randomised clinical trials as calculated by Reich et al2


compared to placebo or an active comparator (adalimumab-methotrexate, ustekinumab-etanercept). The median duration of the controlled period was 12 weeks (range 10–16 weeks). The mean Psoriasis Activity and Severity Index (PASI) responses for pooled clinical trial data are shown in Figure 1. There are several interesting conclusions to be drawn. First, the percentages of patients achieving a predetermined PASI reduction of 50%, 75% or 90% (PASI50 PASI75, PASI90


, , respectively) decrease


non-linearly. Thus, the efficacy gap between the most potent (infliximab) and


least potent (etanercept) drug increases from 17% for PASI50


to 30% for PASI90 , PASI75 or PASI90 ). .


Second, the rank of the biologic according to its potency does not depend on the endpoint (PASI50


Infliximab is the most potent biologic, followed by ustekinumab, adalimumab and etanercept.2


This conclusion has


been confirmed independently in a 12-week head-to-head trial of ustekinumab and etanercept, where superiority of the former was formally proven.4


The data from randomised clinical trials are consistent but cannot answer all


www.hospitalpharmacyeurope.com 17 PASI90


Etanercept (50mg)


Adalimumab Infliximab


Ustekinumab (45mg)


% of patients


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