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

ObjectivesAssess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).MethodsAdults 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).Results126/405 (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).ConclusionsLong-term golimumab safety/efficacy in PsA was demonstrated through 5 years.Trial registration numberNCT00265096.

Radiographic Progression of Patients With Psoriatic Arthritis Who Achieve Minimal Disease Activity in Response to Golimumab Therapy: Results Through 5 Years of a Randomized, Placebo‐Controlled Study

“…As reported previously 10, 126 of 405 patients (31.1%) discontinued study treatment through week 252, with the most common reasons for study agent discontinuation being adverse events and unsatisfactory therapeutic response. Baseline disease characteristics, as well as the proportions of patients reporting MTX use at baseline, were generally consistent among randomized treatment groups (see Supplementary Table 1 available on the Arthritis Care & Research web site at http://onlinelibrary.wiley.com/doi/10.1002/acr.22576/abstract) and were generally consistent between patients who continued and discontinued study agent (data not shown).…”

“…The phase III, randomized, double‐blind GO‐REVEAL trial of 405 PsA patients treated with golimumab for up to 5 years 7, 8, 9, 10 provided an opportunity to retrospectively assess the implications of achieving a treatment goal, namely MDA, that is more rigorous than the typical objectives of therapeutic studies in PsA. The composite PsA MDA criteria have been preliminarily validated in both observational and interventional trial cohorts 5, 6.…”

“…Specifically, the institutional review board or ethics committee at each study site approved the protocol, and all patients provided written informed consent prior to the start of any study‐related procedures. Details of the GO‐REVEAL patient eligibility criteria and trial design have been previously published 7, 8, 9, 10. Despite treatment with disease‐modifying antirheumatic or nonsteroidal antiinflammatory drugs, patients had active PsA, defined by the presence of at least 3 swollen and 3 tender joints, and the presence of plaque psoriasis with a qualifying lesion at least 2 cm in diameter.…”

“…As such, we evaluated long‐term radiographic progression and physical function in patients who either achieved or did not achieve MDA through 5 years of participation in the randomized, placebo‐controlled, GO‐REVEAL study of golimumab in PsA patients 7, 8, 9, 10.…”

Five-year Safety Data from 5 Clinical Trials of Subcutaneous Golimumab in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis

“…Our current study was a pooled analysis of previously collected safety data from 5 large multicenter trials [8][9][10][11][12][13][14][15][16][17]18,19,20,21,22,23,24 , each of which was conducted according to the Declaration of Helsinki and the International Committee on Harmonisation Good Clinical Practices. Each of the phase 3 study protocols was approved by central or individual site institutional review boards/ethics committees, and all patients provided written informed consent prior to any study-related procedures.…”