Friday, 21 Jul 2017

You are here

IV Golimumab in Psoriatic Arthritis

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.

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Obesity Impairs TNF Inhibitor Responses in Axial Spondyloarthritis

Investigators with the Swiss Clinical Quality Management (SCQM) program have studied the effects of obesity on patients with axial spondyloarthritis (axSpA) and, specifically, their response to tumor necrosis factor inhibitors (TNFi).

FDA Approves Tremfya (guselkumab) for Plaque Psoriasis

The U.S. Food and Drug Administration (FDA) has approved the IL-23 inhibitor, Tremfya (guselkumab), for patients with moderate to severe plaque psoriasis.

Statins Improve Survival in Ankylosing Spondylitis

Systemic inflammation (from underling inflammatory polyarthritis) clearly accelerates atherosclerosis with a resultant increase risk of cardiovascular disease.

Orencia Approved for Use in Psoriatic Arthritis

The FDA has approved both IV and SC ORENCIA (abatacept) for the treatment of adults with active Psoriatic Arthritis.

Tildrakizumab, an IL-23 Inhibitor, is Successful in Plaque Psoriasis

Therapeutic options for cutaneous psoriasis (and psoriatic arthritis as well) are rapidly expanding.  Lancet has published the impressive results of two phase III trials of tildrakizumab, a IgG1 antibody against interleukin 23 p19, in patients with active chronic plaque psoriasis.