title: Golimumab 3-year safety update: an analysis of pooled data from the long-term extensions of randomised, double-blind, placebo-controlled trials conducted in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis.
abstract: OBJECTIVE
  To assess pooled golimumab safety up to year 3 of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) trials.
  
  
  METHODS
  Golimumab 50 and 100 mg, administered subcutaneously (SC) every 4 weeks (q4wk), were assessed in patients with active RA (methotrexate-naïve, methotrexate-experienced and anti-TNF (tumour necrosis factor)-experienced), PsA or AS, despite conventional therapy. Placebo control continued up to week (wk) 24 (wk 52, methotrexate-naïve), with early escape at wk 16 (wk 28, methotrexate-naïve); subsequently, all patients received golimumab 50 or 100 mg q4wk. After the blinded controlled period, golimumab doses could be adjusted per investigator discretion. Pooled safety analyses reported herein include data from placebo-controlled and uncontrolled study periods up to wk 160. Determinations of incidences/100 patient-years (pt-yrs) for rare events also included RA patients from a phase IIb trial.
  
  
  RESULTS
  Across five phase III trials of SC golimumab, 639 patients received placebo and 2226 received golimumab 50 mg (n=1249) and/or 100 mg (n=1501) up to wk 160 (patients may be included in more than one group because non-responders were allowed early escape); 1179 patients were treated for ≥156 weeks. For placebo, golimumab 50 mg and golimumab 100 mg, respective adverse event incidences/100 pt-yrs (95% CIs) up to wk 160 were: 0.28 (0.01 to 1.56), 0.30 (0.12 to 0.62), 0.41 (0.23 to 0.69) for death; 5.31 (3.20 to 8.30), 3.03 (2.36 to 3.82), 5.09 (4.36 to 5.90) for serious infection; 0.00 (0.00 to 0.84), 0.17 (0.05 to 0.44), 0.35 (0.18 to 0.62) for tuberculosis; 0.00 (0.00 to 0.84), 0.13 (0.03 to 0.38), 0.24 (0.10 to 0.46) for opportunistic infection; 0.00 (0.00 to 0.84), 0.00 (0.00 to 0.13), 0.12 (0.03 to 0.30) for demyelination; and 0.00 (0.00 to 0.84), 0.04 (0.00 to 0.24), 0.18 (0.06 to 0.38) for lymphoma.
  
  
  CONCLUSIONS
  SC golimumab safety up to 3 years remained consistent with that of other TNF antagonists. Golimumab 100 mg showed numerically higher incidences of serious infections, demyelinating events and lymphoma than 50 mg; safety follow-up up to year 5 continues.
authors.affiliation: Division of Rheumatology, Department of Medicine, University of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kay
authors.affiliation: Department of Rheumatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
authors.forename: Roy
authors.initials: R
authors.lastname: Fleischmann
authors.affiliation: Department of Rheumatology, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Edward
authors.initials: E
authors.lastname: Keystone
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Hsu
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Janssen Research & Development, LLC, Spring House, Pennsylvania, USA.
authors.forename: Neil
authors.initials: N
authors.lastname: Goldstein
authors.affiliation: Department of Rheumatology, Rheumazentrum Ruhrgebeit, Herne, Germany.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Braun
authors.affiliation: Division of Rheumatology, Allergy and Immunology, University of California, San Diego, California, USA.
authors.forename: Arthur
authors.initials: A
authors.lastname: Kavanaugh
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects*; D018501:Antirheumatic Agents / Q000009:adverse effects*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D013167:Spondylitis, Ankylosing / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab; D008727:Methotrexate