Golimumab Gets FDA Nod for Two New Indications

Megan Brooks

October 24, 2017

The US Food and Drug Administration (FDA) has approved golimumab (Simponi Aria, Janssen Biotech) for adults with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS).

Golimumab, an inhibitor of tumor necrosis factor (TNF)-α, is already approved for treatment of moderately to severely active rheumatoid arthritis (RA).

The approval of golimumab for PsA and AS follows two phase 3 studies involving more than 600 patients. Both studies met their primary endpoints, with a higher proportion of patients treated with golimumab showing significant improvement in the signs and symptoms of PsA and AS compared with their counterparts treated with placebo, the company said in a news release

In the PsA trial GO-VIBRANT, the rate of American College of Rheumatology 20 response was 75% in the golimumab group vs 22% in the placebo group (P < .001) at 14 weeks.  At 24 weeks, golimumab treatment was associated with less progression of structural joint damage and improved physical function associated with PsA.

"There is a need for new treatment options for patients with psoriatic arthritis," Arthur Kavanaugh, MD, from University of California San Diego, and chair of the GO-VIBRANT steering committee, said in the release. The results this trial "demonstrated significant and clinically important efficacy across various domains, including the inhibition of structural damage. The approval of IV [intravenous] golimumab for the treatment of active psoriatic arthritis brings an important new treatment option to patients, especially those who prefer IV administration, and offers one with a 30-minute infusion time," Dr Kavanaugh added.

In the AS trial GO-ALIVE, at 16 weeks, 73% of patients receiving golimumab achieved at least a 20% improvement in Assessment of Spondyloarthritis International Society criteria, compared with 26% of patients receiving placebo (P < .001).

"Ankylosing spondylitis is a disease that adversely affects quality of life and the choices for treating this disabling condition are limited. The approval of IV golimumab for the treatment of active ankylosing spondylitis provides a welcomed new option," Atul Deodhar, MD, from the Oregon Health & Science University in Portland, and chair of the GO-ALIVE steering committee, said in the release.

Janssen Biotech said it is working with payers, providers, and pharmacy benefit managers to ensure golimumab is "broadly accessible for patients and that the cost for payers is competitive with currently available biologic therapies for PsA and AS."

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