Arthritis Care Res (Hoboken) 2019 Apr 12. Epub 2019 Apr 12.
Janssen Research & Development, LLC, Spring House, PA, USA.
Objective: Evaluate safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis (PsA) through 1 year.
Methods: GO-VIBRANT was a Phase 3, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to intravenous placebo (n=239) or golimumab 2 mg/kg (n=241) at weeks 0, 4, 12, and 20, with placebo crossover to golimumab at weeks 24, 28, and q8w. Efficacy through week52 was assessed by ≥20%/50%/70% improvement in ACR criteria (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI), and ≥75% improvement in Psoriasis Area and Severity Index (PASI75); radiographic progression was measured using the PsA-modified van der Heijde-Sharp (vdH-S) score. Adverse events (AEs) were monitored through week60.
Results: The primary and major secondary endpoints through week 24 were achieved. At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved an ACR20 response, 58.1% and 53.6%, respectively, achieved an ACR50 response, and 38.6% and 33.9%, respectively, achieved an ACR70 response. Among patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total vdH-S score was -0.5 in the golimumab group and 0.8 in the placebo-crossover group. Through week 60, 50.9% of all golimumab-treated patients had ≥1 AE, and 5.2% had ≥1 SAE. There were no opportunistic infections, two malignancies, and one death in golimumab-treated patients.
Conclusion: Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study. No new safety signals for IV golimumab were identified. This article is protected by copyright. All rights reserved.