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Simponi (golimumab) is approved by the FDA for use in rheumatoid arthritis, psoriatic arthritis (PsA), anklylosing spondylitis (AS) and ulcerative colitis. The intravenous (IV) formulation of golimumab (GOL) is approved for RA only.
Based on recent clinical trials, the makers of GOL have petitioned the FDA for new indications in PsA and AS. Trials for PsA (GO-VIBRANT) and AS (GO-ALIVE) were presented at last weeks EULAR 2017 meeting in Madrid, Spain.
The GO-VIBRANT trial results of IV GOL in PsA garnered enthusiastic reviews from KOLs and those in attendance.
This phase 3 study was a multicenter, double-blind, placebo-controlled trial, of IV GOL in biologic-naïve adult PsA patients. They enrolled 480 patients to receive either placebo or Simponi Aria 2mg/kg at Weeks 0, 4, and every 8 weeks for 24 weeks. The primary endpoint was the ACR20 response at Week 14.
At Week 14, the ACR 20 responses were 75.1% GOL vs. 21.8% PBO. Similar, impressive ACR50 and ACR70 responses were seen at week 14. (43.6% and 24.5%, respectively). At week 24 the ACR 50 responses were superior to PBO (53.5% vs. 6.3%). Significant responses in enthesitis, dactylitis and skin were seen. The PASI75 responses were superior to PBO (59.2% vs. 13.6%).
At week 24 there was also significant inhibition of joint destruction and damage, joint erosion, and joint space narrowing compared to placebo.
There were 2 deaths, 2 malignancies, and 1 demyelinating event; no opportunistic infections or tuberculosis noted.