Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study

Arthritis Rheum. 2008 Apr;58(4):964-75. doi: 10.1002/art.23383.

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.

Conclusion: Golimumab plus MTX effectively reduces the signs and symptoms of RA and is generally well tolerated in patients with an inadequate response to MTX.

Trial registration: ClinicalTrials.gov NCT00207714.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacology
  • Antibodies, Monoclonal / therapeutic use*
  • Antirheumatic Agents / therapeutic use
  • Arthritis, Rheumatoid / drug therapy*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Resistance
  • Female
  • Humans
  • Immunologic Factors / adverse effects
  • Immunologic Factors / pharmacology
  • Immunologic Factors / therapeutic use*
  • Male
  • Methotrexate / therapeutic use
  • Middle Aged
  • Severity of Illness Index

Substances

  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Immunologic Factors
  • golimumab
  • Methotrexate

Associated data

  • ClinicalTrials.gov/NCT00207714