Van De Kerkhof P.C.M.Griffiths C.E.M.Reich K.Leonardi C.L.Blauvelt A.TSEN-FANG TSAIGong Y.Huang J.Papavassilis C.Fox T.2020-10-222020-10-2220160190-9622https://www.scopus.com/inward/record.uri?eid=2-s2.0-84966680721&doi=10.1016%2fj.jaad.2016.03.024&partnerID=40&md5=328678ba5c2219b5a882728849a86e55https://scholars.lib.ntu.edu.tw/handle/123456789/517599Background 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]SDG3antiinfective 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 Factorsjournal article10.1016/j.jaad.2016.03.024271809262-s2.0-84966680721