Risankizumab is significantly more effective than adalimumab in treating patients with moderate to severe chronic plaque psoriasis, according to a study published in The Lancet.
According to the study, IMMvent was a phase 3, randomized, double-blind, double-dummy, active-comparator trial that consisted of two parts. Part A (from week 0 to week 16) was aimed at evaluating the superiority of risankizumab over adalimumab, and part B (week 16 to week 44) was mainly aimed at evaluating the efficacy of risankizumab in patients with an intermediate response (Psoriasis Area and Severity Index [PASI] ≥50 to PASI <90 to adalimumab). Eligible participants were 18 years of age or older and showed stable moderate to severe chronic plaque psoriasis (with or without psoriatic arthritis) involving at least 10% of the body surface area, with a PASI of ≥12 and a static physician global assessment score of 3 or higher. More than 600 patients completed the study.
All participants in part A were randomly assigned to either risankizumab or adalimumab. At the start of part B, patients initially randomly assigned to adalimumab who showed ≥90% improvement from baseline on the PASI were allowed to remain on adalimumab, while patients who showed <50% improvement were transferred to risankizumab. The intermediate responding patients to adalimumab (PASI ≥50 to PASI <90) were randomly reassigned 1:1 to either continue adalimumab or switch to risankizumab in part B. Randomizations were classified by weight (≤100 kg vs >100 kg) and previous exposure to tumor necrosis factor inhibitor (0 vs ≥1).
Risankizumab was more effective than adalimumab in treating patients with moderate to severe chronic plaque psoriasis. Furthermore, the onset of response was rapid and was reported to be as early as 4 weeks after the first dose of risankizumab. In addition, the response lasted throughout the 44-week study period. Nonresponding and intermediate-responding patients also showed improvement when they were switched to risankizumab. Treatment-emergent adverse events were comparable between groups, and no new safety concerns were recorded in individuals continuing risankizumab or switching from adalimumab to risankizumab.
Regarding the limitations of the study, investigators pointed out the timing of the last treatment dose and the assessment. They said that the slight tapering of PASI and static physician’s global assessment responses at week 44 compared with week 40 could be the result of the prolonged interval between the final dose and final assessment.
Investigators of the study concluded that risankizumab was significantly more effective than adalimumab in causing skin clearance in patients with moderate to severe plaque psoriasis, and that risankizumab provides flexibility in the long-term treatment of psoriasis.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Reich K, Gooderham M, Thaçi D et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586.