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

Abstract

Background: The tumour necrosis factor-α 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.