title: One-year efficacy and safety results of secukinumab in patients with rheumatoid arthritis: phase II, dose-finding, double-blind, randomized, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis.
  
  
  METHODS
  In this 52-week, double-blind, placebo-controlled (up to Week 20) study (NCT00928512), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety results up to Week 20 have been reported previously. Here, efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented.
  
  
  RESULTS
  Of 237 patients randomized, 174 (73.4%) completed the study. Patients with improved American College of Rheumatology (ACR) and 28-joint Disease Activity Score (DAS28) C-reactive protein (CRP) responses at Week 16 sustained their responses through Week 52. In patients taking 150 mg of secukinumab, responses were improved through Week 52 (ACR50: Week 16 = 45%, Week 52 = 55%; DAS28-CRP ≤ 2.6: Week 16 = 25%, Week 52 = 40%). The rate of adverse events (AE) from weeks 20 to 60 was 64.8%, with most AE being mild to moderate in severity. The overall rate of infections was 31.9%, most being mild. The most predominant infection was nasopharyngitis, and was not associated with dose or concurrent neutropenia. Serious AE were reported in 21 patients (8.9%). There were 3 reports of malignancies (ovarian, lung, basal cell), and no deaths between weeks 20 and 60.
  
  
  CONCLUSIONS
  Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab. The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks.
authors.affiliation: From Stanford University, Palo Alto, California, USA; Pôle de Recherche en Rhumatologie, Institut de Recherche Expérimentale et Clinique, Université catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels, Belgium; Novartis Pharma AG, Basel, Switzerland; NZOZ Centrum Medyczne Artur Racewicz, Bialystok, Poland; Medical Plus, Uherske Hradiste, Czech Republic; Arthritis Clinic, Jackson, Tennessee, USA; Konkuk University Medical Center, Seoul, South Korea; Health Research of Oklahoma, Oklahoma City, Oklahoma, USA; Centre for Inflammatory Joint Diseases, Munich, Germany; Kobe-Konan Yamate Clinic, Kobe, Japan; Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Genovese
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.forename: Hanno B
authors.initials: HB
authors.lastname: Richards
authors.forename: Jerzy
authors.initials: J
authors.lastname: Supronik
authors.forename: Eva
authors.initials: E
authors.lastname: Dokoupilova
authors.forename: Jacob A
authors.initials: JA
authors.lastname: Aelion
authors.forename: Sang-Heon
authors.initials: SH
authors.lastname: Lee
authors.forename: Christine E
authors.initials: CE
authors.lastname: Codding
authors.forename: Herbert
authors.initials: H
authors.lastname: Kellner
authors.forename: Takashi
authors.initials: T
authors.lastname: Ikawa
authors.forename: Sophie
authors.initials: S
authors.lastname: Hugot
authors.forename: Gregory
authors.initials: G
authors.lastname: Ligozio
authors.forename: Shephard
authors.initials: S
authors.lastname: Mpofu
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007279:Injections, Subcutaneous; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; C555450:secukinumab
keywords: AUTOIMMUNE DISEASES; INTERLEUKINS; METHOTREXATE; MONOCLONAL ANTIBODIES; RHEUMATOID ARTHRITIS; SECUKINUMAB