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.

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Figures

Figure 1

The proportions of patients achieving clinical improvement at week 256, defined by at least 20%, 50% and/or 70% improvement in the American College of Rheumatology response criteria (ACR20, ACR50 and ACR70, respectively; A–C) or at least 50%, 75% and/or 90% improvement in the Psoriasis Area and Severity Index response criteria (PASI50, PASI75 and PASI90, respectively) among randomised patients with baseline psoriasis involving ≥3% body surface area (D–F) among all patients (A, D) patients with methotrexate (MTX) use at baseline (B, E), and patients with no MTX use at baseline (C, F). Analyses were based on intent-to-treat analyses by randomised group, irrespective of treatment changes during the study. The placebo group includes patients who were initially randomised to placebo and later early escaped/crossed over at week 16/24 to receive golimumab 50 mg, with the possibility to increase golimumab from 50 to 100 mg after the week-52 database lock. The golimumab 50 mg group includes patients who were initially randomised to golimumab 50 mg and later early escaped at week 16 or dose escalated after the week 52 database lock to receive golimumab 100 mg. All patients could decrease the golimumab dose from 100 to 50 mg after the week-52 database lock.