Efficacy and safety of adalimumab in Chinese patients with moderate‐to‐severe plaque psoriasis: results from a phase 3, randomized, placebo‐controlled, double‐blind study

Abstract

BackgroundThis phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF‐α inhibitor, adalimumab, for Chinese patients with moderate‐to‐severe plaque psoriasis.MethodsIn the 12‐week, double‐blind, placebo‐controlled Period A, patients were randomized 4 : 1 to receive adalimumab 40 mg every‐other‐week (following a single 80 mg dose), or placebo every‐other‐week. In the subsequent 12‐week, open‐label, Period B, all patients received adalimumab 40 mg every‐other‐week starting at week 13, following a single, blinded dose at week 12 of adalimumab 80 mg or matching placebo (for patients receiving placebo or adalimumab in Period A respectively). In Period A, efficacy was analysed for all randomized patients and safety for all patients receiving ≥1 dose of the study drug.ResultsFor the 425 patients in this study (87 placebo; 338 adalimumab), a higher percentage randomized to adalimumab achieved the primary endpoint of ≥75% improvement from baseline in PASI score (PASI 75) at week 12: placebo 11.5% (10/87); adalimumab 77.8% (263/338; P < 0.001). Physician's Global Assessment of clear to minimal was achieved at week 12 by 14.9% placebo (13/87) and 80.5% adalimumab (272/338; P < 0.001). For patients who received adalimumab at any time during the study (All‐adalimumab Population), treatment‐emergent adverse events (AEs) were reported by 63.4%; the most common was upper respiratory infection (16.1%). Serious AEs were reported by 3.5% of the All‐adalimumab Population, and serious infectious AEs by 1.2%, which include lung infection, pneumonia and tuberculosis [2 (0.5%) patients each]. There was one death (chronic heart failure).ConclusionIn these Chinese patients with moderate‐to‐severe psoriasis, a significantly greater percentage treated with adalimumab compared with placebo achieved efficacy endpoints at week 12 and efficacy was sustained to week 24. Safety results were consistent with the known adalimumab safety profile; no new safety signals were identified in the 24 weeks of treatment.

AURIEL ‐PsO: a randomized, double‐blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB 11022 to reference adalimumab in patients with moderate‐to‐severe chronic plaque‐type psoriasis

“…The PASI 75 response rates observed in this study are higher than those seen in previous phase III adalimumab trials; however, they are in line with more recent studies, which may reflect the improved standard of care for patients with psoriasis. In AURIEL‐PsO, the proportion of patients with moderate disease was 70·0%, compared with previous studies ranging from 18·6% to 65·5% . Previous studies with greater proportions of patients with moderate psoriasis also showed higher response rates .…”

“…Therefore, the exclusion criteria in this study were designed to reduce the number of patients with a high body weight in order to increase the sensitivity of the population to show any differences between treatment arms. The mean weight of the study population was lower than in some previous trials establishing the efficacy of the reference product or other adalimumab biosimilars, but it was similar to or higher than weights in other adalimumab trials …”

Consistent responses with guselkumab treatment in Asian and non‐Asian patients with psoriasis: An analysis from VOYAGE 1 and VOYAGE 2

“…Historically, studies of psoriasis therapies in Asian patients have been limited; however, since the introduction of biologic agents, more studies in this population have been reported . Studies of anti‐tumor necrosis factor (TNF) agents in Asian patients have been reported, but many of these studies are smaller and later in the development cycle of the agent than studies in populations of mixed race . Substantial numbers of Asian patients were included in the pivotal studies of agents targeting interleukin (IL)‐12/23, IL‐23, and IL‐17, allowing for subanalyses of the Asian populations in these studies .…”

Failure of response to combination therapy of adalimumab and infliximab in a recalcitrant patient of severe psoriasis and major thalassemia: A case report

“…Tumor necrosis factor‐α is a key mediator in the pathogenesis of psoriasis. Infliximab and adalimumab, the most commonly used biologics in management of psoriasis, are TNF‐α inhibitors which have shown to reduce the disease severity and improve the quality of life . These agents are usually used alone but severe nonresponsive cases may warrant their use together as combination therapy but many times they fail to achieve the desired results.…”