Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial.

Journal article

OBJECTIVE: The authors tested whether the anti-interleukin (IL)-17A monoclonal antibody secukinumab was safe and effective for the treatment of active Crohn's disease. DESIGN: In a double-blind, randomised, placebo-controlled proof-of-concept study, 59 patients with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥220 to ≤450) were assigned in a 2:1 ratio to 2×10 mg/kg intravenous secukinumab or placebo. The primary end point, addressed by bayesian statistics augmen...

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Authors: Hueber, W; Sands, B; Lewitzky, S; Vandemeulebroecke, M; Reinisch, W

• Publication status: Published
• Journal: Gut
• Volume: 61
• Issue: 12
• Pages: 1693-1700
• Publication date: 2012-12-01
• DOI: 10.1136/gutjnl-2011-301668
• EISSN: 1468-3288
• ISSN: 0017-5749
• Language: English
• Keywords: Biological Markers; Middle Aged; Adolescent; Aged; Antibodies, Monoclonal; Humans; Adult; Crohn Disease; Double-Blind Method; Drug Administration Schedule; Male; Female; Bayes Theorem; Anti-Inflammatory Agents; Treatment Failure; Polymorphism, Single Nucleotide; Leukocyte L1 Antigen Complex; Interleukin-17; Severity of Illness Index; Young Adult; Genetic Markers; Infusions, Intravenous; Secukinumab in Crohn's Disease Study Group