Dr. Kavanaugh has received consulting fees, speaking fees, and/or honoraria from Centocor Ortho Biotech, now Janssen Biotech (less than $10,000) and has received funding for clinical research sponsored by Abbott, Amgen, Janssen, and UCB.
Golimumab in psoriatic arthritis: One-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial†
Version of Record online: 27 JUL 2012
Copyright © 2012 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 64, Issue 8, pages 2504–2517, August 2012
How to Cite
Kavanaugh, A., van der Heijde, D., McInnes, I. B., Mease, P., Krueger, G. G., Gladman, D. D., Gómez-Reino, J., Papp, K., Baratelle, A., Xu, W., Mudivarthy, S., Mack, M., Rahman, M. U., Xu, Z., Zrubek, J. and Beutler, A. (2012), Golimumab in psoriatic arthritis: One-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial. Arthritis & Rheumatism, 64: 2504–2517. doi: 10.1002/art.34436
ClinicalTrials.gov identifier: NCT00265096.
- Issue online: 27 JUL 2012
- Version of Record online: 27 JUL 2012
- Accepted manuscript online: 29 FEB 2012 12:47PM EST
- Manuscript Accepted: 9 FEB 2012
- Manuscript Received: 31 MAR 2011
- Janssen Research & Development LLC (formerly Centocor Research and Development, a subsidiary of Johnson & Johnson)
Golimumab, administered subcutaneously every 4 weeks, has been shown to be effective in reducing the signs and symptoms of active psoriatic arthritis (PsA) through week 24 of the GO-REVEAL study. Herein we report 1-year clinical, radiographic, and safety findings.
Adult patients with active PsA (≥3 swollen and ≥3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. At week 16, patients with <10% improvement from baseline in swollen and tender joint counts entered a blinded early escape phase, with placebo crossover to golimumab 50 mg, golimumab 50 mg increased to 100 mg, and golimumab 100 mg continued at 100 mg. Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24. Findings through 1 year are reported, including the second of 2 coprimary end points (i.e., change from baseline to week 24 in PsA-modified Sharp/van der Heijde score [SHS]).
A total of 405 patients were randomized: 113 to placebo and 146 each to the golimumab 50 mg and 100 mg groups. Mean changes in PsA-modified SHS from baseline to week 24 for the combined golimumab 50 mg and 100 mg group (−0.09) and the golimumab 50 mg group (−0.16) were significantly different versus placebo (0.27) (P = 0.015 and P = 0.011, respectively). Radiographic benefit was maintained through week 52 with golimumab. Clinical efficacy, including improvement in joint and skin responses and physical function, was maintained through 1 year. The frequency/types of adverse events were similar to those reported through week 24.
Treatment of PsA with golimumab inhibited structural damage progression and demonstrated continued clinical efficacy and safety through 1 year.