Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis

Background The tumour necrosis factor-alpha antagonist etanercept and the interleukin (IL)-12/23p40 antagonist ustekinumab have been shown to be effective psoriasis therapies. The IL-12/23p40 antagonist briakinumab was shown to be effective psoriasis treatment in a phase II study. Objectives To assess the efficacy, safety and tolerability of briakinumab compared with etanercept and placebo in patients with moderate to severe psoriasis. Methods Three hundred and fifty patients were enrolled in this phase III, 12-week study (M10-315, NCT00710580) and randomized in the following 2: 2: 1 ratio: 139 patients received 200 mg briakinumab at weeks 0 and 4 followed by 100 mg briakinumab at week 8; 139 patients received 50 mg of etanercept twice weekly 3-4 days apart at weeks 0-11; 72 patients received placebo injections matching active treatment. The co-primary efficacy endpoints were the proportion of patients achieving a Physician's Global Assessment (PGA) of 0/1 at week 12, and the proportion of patients achieving a Psoriasis Area and Severity Index (PASI) 75 response at week 12. Results Of the briakinumab-treated patients, 72.7% achieved a PGA of 0/1 at week 12 as compared with 29.5% of etanercept-treated patients and 4.2% of placebo-treated patients (P < 0.001, for both comparisons). Of the briakinumab-treated patients, 80.6% achieved a PASI 75 response at week 12 as compared with 39.6% of etanercept-treated and 6.9% of placebo-treated patients (P < 0.001, for both comparisons). Serious adverse events were reported in two (1.4%) briakinumab-treated patients, one (0.7%) etanercept-treated patient and two (2.8%) placebo-treated patients. Conclusions In patients with moderate to severe psoriasis, briakinumab had superior efficacy to both placebo and etanercept at 12 weeks as administered in this study.