Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study).

Abstract

OBJECTIVES:

Assess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).

METHODS:

Adults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs).

RESULTS:

126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8-69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8-72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1-0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate).

CONCLUSIONS:

Long-term golimumab safety/efficacy in PsA was demonstrated through 5 years.

TRIAL REGISTRATION NUMBER:

NCT00265096.

• Authors: Arthur Kavanaugh, Iain B McInnes, Philip Mease, Gerald G Krueger, Dafna Gladman, Désirée van der Heijde, Yiying Zhou, Jiandong Lu, Jocelyn H Leu, Neil Goldstein, Anna Beutler
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 73 Issue 9 Pg. 1689-94 (Sep 2014) ISSN: 1468-2060 [Electronic] England
• PMID: 24748630 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Chemical References

• Antibodies, Monoclonal
• Antirheumatic Agents
• golimumab
• Methotrexate

Topics

• Adult
• Antibodies, Monoclonal (administration & dosage, adverse effects, therapeutic use)
• Antirheumatic Agents (administration & dosage, adverse effects, therapeutic use)
• Arthritis, Psoriatic (diagnostic imaging, drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Male
• Methotrexate (therapeutic use)
• Middle Aged
• Radiography
• Severity of Illness Index
• Treatment Outcome