title: Secukinumab long-term safety experience: A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis.
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).
  
  
  CONCLUSIONS
  There was a limited number of patients in comparator groups and the exposure to placebo was short.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. Electronic address: peter.vandeKerkhof@radboudumc.nl.
authors.forename: Peter C M
authors.initials: PC
authors.lastname: van de Kerkhof
authors.affiliation: Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.
authors.forename: Christopher E M
authors.initials: CE
authors.lastname: Griffiths
authors.affiliation: Dermatologikum Hamburg and Georg-August-University, Göttingen, Germany.
authors.forename: Kristian
authors.initials: K
authors.lastname: Reich
authors.affiliation: Saint Louis University Health Sciences Center, Saint Louis, Missouri.
authors.forename: Craig L
authors.initials: CL
authors.lastname: Leonardi
authors.affiliation: Oregon Medical Research Center, Portland, Oregon.
authors.forename: Andrew
authors.initials: A
authors.lastname: Blauvelt
authors.affiliation: National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
authors.forename: Tsen-Fang
authors.initials: TF
authors.lastname: Tsai
authors.affiliation: Beijing Novartis Pharma Co Ltd, Shanghai, China.
authors.forename: Yankun
authors.initials: Y
authors.lastname: Gong
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Jiaqing
authors.initials: J
authors.lastname: Huang
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Charis
authors.initials: C
authors.lastname: Papavassilis
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Todd
authors.initials: T
authors.lastname: Fox
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D061067:Antibodies, Monoclonal, Humanized; D002318:Cardiovascular Diseases / Q000139:chemically induced; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D000068800:Etanercept / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects*; D007239:Infections / Q000139:chemically induced*; D015212:Inflammatory Bowel Diseases / Q000139:chemically induced; D020381:Interleukin-17 / Q000037:antagonists & inhibitors; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced; D008875:Middle Aged; D009369:Neoplasms / Q000139:chemically induced*; D009503:Neutropenia / Q000139:chemically induced*; D011565:Psoriasis / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D013997:Time Factors
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C508717:IL17A protein, human; D007166:Immunosuppressive Agents; D020381:Interleukin-17; C555450:secukinumab; D000068800:Etanercept
keywords: long-term safety; phase II studies; phase III studies; pooled analysis; psoriasis; secukinumab