Safety and Efficacy of Intravenous Golimumab in Psoriatic Arthritis

Patients with psoriatic arthritis (PsA) receiving treatment with intravenous (IV) golimumab 2 mg/kg experienced significantly greater improvements in the signs and symptoms of their disease, according to an ongoing study published in Arthritis & Rheumatology.     

In this phase 3, double-blind, multicenter trial, researchers randomly assigned patients to receive IV infusions of placebo (n=239) or golimumab 2 mg/kg (n=241) at weeks 0, 4, and every 8 weeks. There were no significant differences in demographics and disease characteristics between groups, or in patients receiving concomitant medications at baseline.    

The primary endpoint of the percentage of patients with at least 20% improvement in American College of Rheumatology criteria (ACR20) at week 14 was met in 75.1% of patients in the golimumab group compared with 21.8% of patients receiving placebo (P <.001). In addition, significantly more patients receiving golimumab compared with patients receiving placebo achieved at least 50% improvement in ACR criteria (ACR50) (43.6% vs 6.3%), at least 70% improvement in ACR criteria (ACR70) (24.5% vs 2.1%), and at least 75% improvement in Psoriasis Area and Severity Index (PASI175) (59.2% vs 13.6%) at week 14 (P <.001). The researchers also observed greater improvement in physical function, radiographic progression, and health-related quality of life (HRQoL) in patients receiving golimumab compared with patients receiving placebo. 

Adverse events reported through week 24 were consistent with previous studies conducted with golimumab, as well as the safety profiles of similar agents.

The investigators concluded that “patients with PsA treated with IV golimumab 2 mg/kg at weeks 0, 4, and every 8 weeks thereafter experienced significantly greater improvements in measures of disease activity (both joint and skin), HRQoL, and radiographic progression compared with patients receiving placebo.” They will also continue the study through 1 year and subsequently publish these data.

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Reference

Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: Results through week 24 of the GO-VIBRANT study [published online August 13, 2017]. Arthritis Rheumatol. doi:10.1002/art.40226