Efficacy and Safety of Intravenous Golimumab through 1 Year in Patients with Active Psoriatic Arthritis.

Objective The present study was undertaken to evaluate the safety and efficacy of intravenous (IV) golimumab in patients with active psoriatic arthritis (PsA) through 1 year. Methods GO-VIBRANTwas a phaseIII, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to receiveIVplacebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, and every 8 weeks, with placebo crossover to golimumab at weeks 24, 28, and every 8 weeks thereafter. Efficacy through week 52 was assessed using the American College of Rheumatology (ACR) >= 20%, 50%, or 70% improvement criteria (ACR20/50/70), and the Psoriasis Area and Severity Index >= 75% improvement criteria (PASI75). Radiographic progression was measured using the PsA-modified Sharp/van der Heijde score (SHS). Adverse events (AEs) were monitored through week 60. Results The primary and major secondary end points 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 anACR20 response, 58.1% and 53.6%, respectively, achieved anACR50 response, and 38.6% and 33.9%, respectively, achieved anACR70 response. Among patients with >= 3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved aPASI75 response at week 52. Mean change from baseline in totalSHSat week 52 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 >= 1AE, and 5.2% had >= 1 seriousAE. There were no opportunistic infections, 2 malignancies, and 1 death in patients treated with golimumab. Conclusion Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in theGO-VIBRANTstudy. No new safety signals forIVgolimumab were identified.