Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis
Journal
Journal of the American Academy of Dermatology
Journal Volume
75
Journal Issue
1
Pages
83-98
Date Issued
2016
Author(s)
Van De Kerkhof P.C.M.
Griffiths C.E.M.
Reich K.
Leonardi C.L.
Blauvelt A.
Gong Y.
Huang J.
Papavassilis C.
Fox T.
Abstract
Background Secukinumab, a fully human anti-interleukin-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. ? 2016 American Academy of Dermatology, Inc.
SDGs
Other Subjects
antiinfective agent; etanercept; placebo; secukinumab; etanercept; IL17A protein, human; immunosuppressive agent; interleukin 17; monoclonal antibody; secukinumab; acute heart infarction; adult; aged; antimicrobial therapy; arthralgia; Article; automutilation; backache; balanitis; brain hemorrhage; brain ischemia; bronchitis; candidiasis; central nervous system infection; cerebrovascular accident; coughing; Crohn disease; depression; diarrhea; drug exposure; drug safety; drug withdrawal; female; folliculitis; gastroenteritis; gastrointestinal infection; genital tract infection; headache; herpes simplex; human; hypertension; incidence; infection; infection rate; influenza; intertrigo; latent tuberculosis; major clinical study; male; middle aged; mouth infection; neutropenia; non melanoma skin cancer; phase 2 clinical trial (topic); phase 3 clinical trial (topic); priority journal; pruritus; psoriasis vulgaris; randomized controlled trial (topic); rhinopharyngitis; sinusitis; skin infection; suicide; ulcerative colitis; upper respiratory tract infection; vulvovaginitis; antagonists and inhibitors; cardiovascular disease; chemically induced; infection; inflammatory bowel disease; mental disease; neoplasm; neutropenia; psoriasis; severity of illness index; time factor; Adult; Antibodies, Monoclonal; Cardiovascular Diseases; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Etanercept; Female; Humans; Immunosuppressive Agents; Infection; Inflammatory Bowel Diseases; Interleukin-17; Male; Mental Disorders; Middle Aged; Neoplasms; Neutropenia; Psoriasis; Randomized Controlled Trials as Topic; Severity of Illness Index; Time Factors
Publisher
Mosby Inc.
Type
journal article