IV Golimumab Shines in Psoriatic Arthritis Save

Golimumab (GOL) is one of five marketed TNF inhibitors (TNFi) that is FDA approved for use in psoriatic arthritis (PsA). PsA approval was based on a 259 patient, randomized, controlled trial wherein GOL treated patients exhibited at week 24 ACR20/50/70 response of 52%, 32%, and 19%, respectively.

The results of the GO-VIBRANT study were presented at EULAR 2017 and published in Arthritis & Rheumatology this month. In this phase 3, randomized, double-blind, placebo-controlled trial, 480 PsA patients were treated with either placebo (PBO) or intravenous golimumab 2 mg/kg (n=241) at weeks 0, 4, 12, and 20. The primary endpoint was the ACR20 response at week14. They also assessed Psoriasis Area and Severity Index (PASI75) at week14, and change from baseline in total PsA-modified van der Heijde-Sharp (vdH-S) score at week24.

High-level responses were seen at week 14. The ACR20 was 75.1% in GOL group and  21.8% in the PBO group (p<0.001). ACR50 (43.6% vs 6.3%), ACR70 (24.5% vs 2.1%), and PASI75 (59.2% vs 13.6%) were also significantly better at week 14 (p<0.001).

The week 24 radiographic data favored GOL treated patients with a mean change in total modified vdH-S score of -0.4 for GOL vs. +2.0 for PBO patients (p<0.001).

These data showed strong efficacy and consistent safety results when GOL was given intravenously. While these intravenous results appear superior to subcutaneously administered GOL in PsA, there are no head to head trials comparing the IV and subcutaneous formulations of GOL in a single PsA trial.