Efficacy and safety of briakinumab vs. etanercept and placebo in patients with moderate to severe chronic plaque psoriasis.

BACKGROUND: The anti-interleukin-12/23p40 monoclonal antibody briakinumab has been shown in a phase II study to be effective psoriasis treatment.

OBJECTIVES: The aim of the current study was to assess the efficacy, safety and tolerability of briakinumab compared with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis.

METHODS: In this phase III, 12-week study (M10-114, NCT00691964), 347 patients were randomized in a 2 : 2 : 1 ratio to receive 200 mg briakinumab at weeks 0 and 4 followed by 100 mg briakinumab at week 8 (n = 138); 50 mg of etanercept twice weekly 3-4 days apart at weeks 0-11 (n = 141); or placebo injections matching active treatment (n = 68). 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, 71·0% achieved a PGA of 0/1 at week 12 as compared with 39·7% of etanercept-treated patients and 2·9% of placebo-treated patients, (P < 0·001, for both comparisons). Of the briakinumab-treated patients 81·9% achieved a PASI 75 response at week 12 as compared with 56·0% of etanercept-treated and 7·4% of placebo-treated patients (P < 0·001, for both comparisons). Serious adverse event rates were reported in four (2·9%) patients receiving briakinumab, one (0·7%) patient receiving etanercept and one (1·5%) placebo-treated patient.

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.