title: Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomized, double-blind, placebo-controlled, dose-ranging study.
abstract: OBJECTIVE
  To assess the efficacy, safety, and pharmacology of subcutaneous administration of golimumab in patients with active rheumatoid arthritis (RA) despite treatment with methotrexate (MTX).
  
  
  METHODS
  Patients were randomly assigned in a double-blinded manner to receive injections of placebo plus MTX or 50 mg or 100 mg golimumab every 2 or 4 weeks plus MTX through week 48. Patients originally assigned to receive injections every 2 weeks had the interval increased to every 4 weeks starting at week 20. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) at week 16. The study was powered to detect a difference in the primary end point when the combined golimumab groups and at least 1 of the individual dose groups were compared with placebo.
  
  
  RESULTS
  The primary end point was attained. Sixty-one percent of patients in the combined golimumab plus MTX dose groups achieved an ACR20 response at week 16 compared with 37% of patients in the placebo plus MTX group (P=0.010). In addition, 79% of patients in the group receiving 100 mg golimumab every 2 weeks achieved an ACR20 response (P<0.001 versus placebo). Through week 20 (after which patients receiving placebo were switched to active infliximab therapy), serious adverse events were reported in 9% of patients in the combined golimumab groups and in 6% of patients in the placebo group.
  
  
  CONCLUSIONS
  Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.
authors.affiliation: Rheumatology Unit, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts 02114, USA. jkay@partners.org
authors.forename: Jonathan
authors.initials: J
authors.lastname: Kay
authors.forename: Eric L
authors.initials: EL
authors.lastname: Matteson
authors.forename: Bhaskar
authors.initials: B
authors.lastname: Dasgupta
authors.forename: Peter
authors.initials: P
authors.lastname: Nash
authors.forename: Patrick
authors.initials: P
authors.lastname: Durez
authors.forename: Stephen
authors.initials: S
authors.lastname: Hall
authors.forename: Elizabeth C
authors.initials: EC
authors.lastname: Hsia
authors.forename: John
authors.initials: J
authors.lastname: Han
authors.forename: Carrie
authors.initials: C
authors.lastname: Wagner
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Xu
authors.forename: Sudha
authors.initials: S
authors.lastname: Visvanathan
authors.forename: Mahboob U
authors.initials: MU
authors.lastname: Rahman
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004351:Drug Resistance; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D008875:Middle Aged; D012720:Severity of Illness Index
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D007155:Immunologic Factors; C529000:golimumab; D008727:Methotrexate