Journal
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Volume 75, Issue 1, Pages 83-+Publisher
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2016.03.024
Keywords
long; term safety; phase II studies; phase III studies; pooled analysis; psoriasis; secukinumab
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Funding
- Novartis Pharma AG
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Background: Secukinumab, a fully human antieinterleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis. Objective: We reviewed safety data from the secukinumab psoriasis phase II/III program. Methods: Data were pooled from 10 phase II/III secukinumab psoriasis studies. Results: Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). Limitations: There was a limited number of patients in comparator groups and the exposure to placebo was short. Conclusion: Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis.
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