Thewas published in May in the Journal of the European Academy of Dermatology and Venereology.
High efficacy rates, which include PASI 100 scores, have been reported in randomized trials of biologics that include anti–interleukin (IL)–17A therapies (secukinumab and ixekizumab), anti–IL-17A–receptor therapies (brodalumab), and anti–IL-23 therapies (guselkumab and risankizumab), but information on rates in real-world cohorts has been limited. “Real-world evidence provided by registries is only beginning to emerge, and efficacy data have mostly been derived from clinical trials,” senior author, professor for translational research in inflammatory skin diseases at the Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf (Germany), said in an interview.
He and his coinvestigators conducted the PSO-BIO-REAL (Plaque Psoriasis Treated With Biologics in a Real World Setting) prospective trial in five countries, to evaluate the effectiveness of treatments in patients with moderate to severe plaque psoriasis over a year’s time following administration of a biologic therapy. Patients were 18 years of age or older and had either started a biologic for the first time (biologic-naive) or were transitioning to another biologic (biologic-experienced).
Among 846 participants, 32% were in the United States, followed by France (28%), Italy (22%), the United Kingdom (11%), and Germany (8%). Investigators estimated the proportion of patients achieving a PASI 100 (complete skin clearance) 6 months after starting a biologic as a primary objective, and as secondary objectives, PASI 100 scores at 1 year and PASI 100 maintenance from 6 to 12 months.
Nearly 200 patients withdrew during the course of the study, and 108 switched treatments. Therapies varied among patients: 61% received an anti–tumor necrosis factor agent such as etanercept, infliximab, adalimumab, or certolizumab pegol as an initial biologic treatment, 30% received an anti–IL-12/-23 agent (ustekinumab), and 9% received an anti-IL-17 agent (secukinumab). Additionally, 23% received a concomitant psoriasis medication.
PASI assessments were completed in 603 patients at 6 months, and 522 patients at 12 months. At 6 and 12 months respectively, 23% and 26% of the patients had achieved a PASI 100 score. Investigators noted that the rate of complete skin clearance declined as the number of baseline comorbidities and the number of prior biologics increased.
Biologic-experienced patients at study entry had lower PASI 100 response rates (about 20% at 6 and 12 months) than the biologic-naive patients (25% at 6 months, 30% at 12 months). Dr. Reich pointed out that many biologic-experienced patients often have active disease, despite previous use of biologics, and “they’re likely to represent a more difficult-to-treat population.” Factors such as convenience, safety, and the fact that more complicated patients – those with weight issues, more comorbidities and pretreatments, and lower compliance – are treated in real life than in clinical trials, are likely to influence lack of response in real-world data, Dr. Reich said.
The study’s enrollment period took place from 2014 to 2015, so it did not include patients on newer biologics such as brodalumab, guselkumab, ixekizumab, and tildrakizumab. “Some of these newer therapies have shown greater efficacy than drugs such as ustekinumab and etanercept in clinical trials, and patients are more likely to achieve complete skin clearance. Therefore, real-world rates of complete clearance may have improved since this study concluded,” the investigators pointed out.
Possible limitations of the study include selection bias and possible confounders, they noted.
The study was sponsored by Amgen/AstraZeneca; the manuscript was sponsored by LEO Pharma. One author was an AstraZeneca employee, two are LEO pharma employees, one author had no disclosures, and the remaining authors, including Dr. Reich, disclosed serving as an adviser, paid speaker, consultant, and/or investigator for multiple pharmaceutical companies.
SOURCE: Seneschal J et al. J Eur Acad Dermatol Venereol. 2020 May 4. .