Golimumab in psoriatic arthritis: One‐year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo‐controlled trial

Abstract

Objective. 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.Methods. 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 secClinicalTrials.gov identifier: NCT00265096.

Brief Report: Secukinumab Provides Significant and Sustained Inhibition of Joint Structural Damage in a Phase III Study of Active Psoriatic Arthritis

“…However, failure of anti‐TNF treatment, loss of efficacy, and intolerance in some patients highlight the unmet need for new therapies with an alternative mechanism of action 12. The radiographic findings from this study are consistent with those from other trials of TNF and IL‐12/23 inhibitors involving anti‐TNF–naive populations 13, 14, 15, 16, 17 and suggest that IL‐17A may offer an additional therapeutic option for patients with PsA.…”

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

“…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.…”

Behçet Disease-associated Uveitis Successfully Treated with Golimumab

“…1,2 Golimumab (GLM) is a novel fully human anti-TNF monoclonal antibody, recently approved for a variety of rheumatic conditions, [3][4][5] with very promising results. Herein we describe a case that exemplifies the efficacy of GLM in a patient with refractory Behçet uveitis, and represents, to our knowledge, the first report about the use of GLM in Behçet uveitis.…”