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- Title
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis.
- Authors
Gordon, Kenneth B; Langley, Richard G; Gottlieb, Alice B; Papp, Kim A; Krueger, Gerald G; Strober, Bruce E; Williams, David A; Gu, Yihua; Valdes, Joaquin M
- Abstract
A previous phase II trial demonstrated that the fully human anti-IL-12/23 mAb briakinumab was efficacious in moderate-to-severe psoriasis. A subsequent 52-week, double-blind, placebo-controlled phase III study evaluated induction and maintenance treatment. Patients were randomized 2:1 to briakinumab (200 mg at weeks 0 and 4 and 100 mg at week 8) or placebo; those with physician's global assessment 'clear' or 'minimal' (PGA 'clear/minimal') at week 12 were then re-randomized 2:2:1 to briakinumab 100 mg every 4 weeks (q4-wk), every 12 weeks (q12-wk), or to matching placebo to week 52. Primary analyses conducted by nonresponder imputation compared proportions achieving PGA 'clear/minimal' (weeks 12 and 52) and 75% improvement in psoriasis area and severity index (PASI 75; week 12). In all, 76.0% of briakinumab vs. 4.3% of placebo-treated patients achieved PGA 'clear/minimal,' and 80.7% vs. 4.5%, respectively, achieved PASI 75 at week 12 (P<0.001 each). At week 52, 79.2% of q4-wk-treated patients achieved PGA 'clear/minimal' compared with 41.6% and 6.0% of q12-wk and placebo-treated patients, respectively (P<0.001 for all treatment comparisons). Higher numbers of the following adverse events (AEs) of interest were observed with briakinumab during the placebo-controlled period, suggesting the need for surveillance for these events: serious infections (five vs. one event with briakinumab vs. placebo, respectively), nonmelanoma skin cancers (NMSCs; four vs. zero squamous cell carcinomas (SCCs)), and major adverse cardiovascular events (MACEs; five vs. zero events).
- Subjects
DRUG efficacy; PSORIASIS treatment; RANDOMIZED controlled trials; PLACEBOS; BLIND experiment; ADVERSE health care events; SKIN cancer; SQUAMOUS cell carcinoma
- Publication
Journal of Investigative Dermatology, 2012, Vol 132, Issue 2, p304
- ISSN
0022-202X
- Publication type
Article
- DOI
10.1038/jid.2011.304