Golimumab, a New Human Tumor Necrosis Factor Alpha Antibody, Administered Every Four Weeks as a Subcutaneous Injection in Psoriatic Arthritis: Twenty-four-week Efficacy and Safety Results of a Randomized, Placebo-Controlled Study

Arthritis Rheum. 2009 Apr;60(4):976-86. doi: 10.1002/art.24403.

Abstract

Objective: To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA).

Methods: Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic nail disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index).

Results: At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric nail disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated.

Conclusion: Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and nail psoriasis through week 24.

Publication types

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

MeSH terms

  • Adult
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Antirheumatic Agents / administration & dosage*
  • Antirheumatic Agents / adverse effects
  • Antitubercular Agents / therapeutic use
  • Arthritis, Psoriatic / complications
  • Arthritis, Psoriatic / drug therapy*
  • Arthritis, Psoriatic / immunology*
  • Disability Evaluation
  • Female
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Motor Activity
  • Placebos
  • Quality of Life
  • Treatment Outcome
  • Tuberculosis, Pulmonary / complications
  • Tuberculosis, Pulmonary / drug therapy
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / immunology*

Substances

  • Antibodies, Monoclonal
  • Antirheumatic Agents
  • Antitubercular Agents
  • Placebos
  • Tumor Necrosis Factor-alpha
  • golimumab