Briakinumab for treatment of XXXX : results of a randomized trial.

@entity1 @entity30 @entity5
BACKGROUND: This study assessed the efficacy and safety of briakinumab, a human anti-IL-12/23p40 monoclonal antibody, compared with placebo for the induction and maintenance of remission in @entity1 with moderately to severely active @entity30 . METHODS: In this phase 2b, multicenter, double-blind, parallel group study, 246 @entity1 stratified by prior @entity5 necrosis factor-antagonist use and response, were randomized (1:1:1:3) to 4 intravenous induction regimens: placebo, 200, 400, or 700 mg briakinumab, at weeks 0/4/8. At week 12, responders in the placebo or 400-mg induction groups entered the maintenance phase with the same regimen, whereas responders in the 700-mg induction group were rerandomized (1:1:1) to receive placebo, 200, or 700 mg briakinumab at weeks 12/16/20. At week 24, @entity1 in remission stopped receiving study drug (withdrawal phase) until relapse. @entity1 experiencing relapse, nonresponders, and nonremitters could enter the open-label phase. RESULTS: The primary end point of clinical remission at week 6 was not met. There were numerically greater rates of remission and response at 6, 12, or 24 weeks in @entity1 treated with briakinumab. The safety and tolerability profile of briakinumab was similar in the induction and maintenance phases of the trial. CONCLUSIONS: Briakinumab showed a similar safety and tolerability profile to placebo in the induction and maintenance phases, and comparable rates of serious adverse events, adverse events leading to discontinuation, and @entity5 . These data provide support for the potential efficacy of briakinumab and other IL-12/23 inhibitors in the treatment of moderate-to-severe @entity30 .
