Journal
INFLAMMATORY BOWEL DISEASES
Volume 21, Issue 6, Pages 1329-1340Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/MIB.0000000000000366
Keywords
IL-12; IL-23; monoclonal antibody
Categories
Funding
- AbbVie
- Amgen
- AstraZeneca
- Aptalis
- Biogen Idec
- Bristol-Myers Squibb
- Centocor
- ChemoCentryx
- Eisai Medical Research Inc.
- Elan Pharmaceuticals
- Ferring
- Genentech
- GlaxoSmithKline
- Janssen
- Merck Sharp and Dohme Corp.
- Takeda
- Ocera Therapeutics Inc.
- Otsuka America Pharmaceutical
- Pfizer
- Shire Pharmaceuticals
- Prometheus Labs
- Schering-Plough
- Synta Pharmaceuticals Corp.
- Teva
- UCB Pharma
- Warner Chilcott
- Millennium
- Novartis
- Procter and Gamble Pharmaceuticals
- Falk
- Furlex
- GSK
- Lexicon
- Prometheus
- Salix
- Shire
- Tranzyme
- UCB
- Tioga
- Sanofi-Aventis
- Coronado
- Apthalis
- Abbott Pharmaceuticals
- Janssen Pharmaceuticals Inc.
- Salix Pharmaceuticals
- Millennium Pharmaceuticals
- Prometheus Laboratories
- Janssen Pharmaceuticals
- ActoGeniX
- CombinatoRx
- Elan/Biogen
- Johnson & Johnson/Janssen
- Roche/Genentech
- Merck
- Protein Design Labs
- Tillotts
- Wyeth
- Celgene Cellular Therapeutics
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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 patients with moderately to severely active Crohn's disease.Methods:In this phase 2b, multicenter, double-blind, parallel group study, 246 patients stratified by prior tumor 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, patients in remission stopped receiving study drug (withdrawal phase) until relapse. Patients 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 patients 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 malignancy. These data provide support for the potential efficacy of briakinumab and other IL-12/23 inhibitors in the treatment of moderate-to-severe Crohn's disease.
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