Briakinumab Superior to Placebo in Three Phase 3 Trials

New Orleans—A pooled analysis of three phase 3, randomized, double-blind, placebo-controlled trials of patients with moderate-to-severe psoriasis found that patients taking briakinumab had superior results to those taking placebo as measured by the Physician Global Assessment (PGA), Psoriasis Area and Severity Index (PASI), and Dermatology Life Quality Index (DLQI). However, the briakinumab group had higher rates of infection, nonmelanoma skin cancer (NMSC), and major adverse cardiac events (MACEs). Richard Langley, MD, Dalhousie University School of Medicine in Halifax, Nova Scotia, presented the results during an oral abstracts session at the AAD meeting. The trial was titled A Pooled Analysis of Phase III, Randomized, Placebo-Controlled Clinical Trials of the Anti-Interleukin 12/23 Monoclonal Antibody, Briakinumab. Briakinumab, a full human monoclonal antibody, is an injectable biologic agent targeting the p40 subunit of interleukins 12 and 23. In this analysis, the authors compared the 3 trials for safety and efficacy at week 12. Two of the studies analyzed compared briakinumab with placebo and etanercept, whereas the other trial compared briakinumab with placebo. In all 3 studies, patients received either placebo or subcutaneous 200-mg doses of briakinumab at weeks 0 and 4 and 100 mg at week 8. The efficacy measures were PGA, PASI, and DLQI. The authors examined adverse events throughout the trials and ≤45 days after the last dose of the drug. Patients were included in the trials if they were ≥18 years of age and had a plaque psoriasis diagnosis for ≥6 months but had been stable for ≥2 months before baseline. They also had to have moderate-to-severe psoriasis as measured by an affected body surface area of ≥10%, a PGA of at least moderate, and a PASI ≥12. The primary end points were the percentage of patients at week 12 who had a PGA of clear or minimal, ≥75% reduction from baseline PASI, ≥90% reduction from baseline PASI, 100% reduction from baseline PASI, and change from baseline in DLQI. The pooled analysis included 1258 patients who received briakinumab and 624 who received placebo. However, 20.2% of the briakinumab group and 76.0% of the placebo group discontinued the trial. The baseline demographics were similar in the groups. In the briakinumab group, 75.1% of patients had a PGA of clear or minimal at week 12 compared with 4.2% of patients in the placebo group (P<.001). In addition, 80.8% of the briakinumab cohort achieved PASI 75 at week 12 compared with 5.1% of the placebo group. The briakinumab group also had a higher percentage of patients achieving PASI 90 and PASI 100 compared with the placebo group (60.7% vs 1.8% and 32.4% vs 0%, respectively). Patients receiving briakinumab had a mean reduction of 10.2 points from baseline to week 12 in DLQI, whereas the placebo group had a mean reduction of 1.0 point. The briakinumab group had more serious adverse events, with 6 patients having NMSC and 5 experiencing a MACE. None of the patients in the placebo group had NMSC or a MACE.