This is the only fully human anti-TNF-α infused therapy approved for psoriatic arthritis, ankylosing spondylitis, and rheumatoid arthritis.
SIMPONI ARIA® (golimumab), the only fully human anti–tumor necrosis factor (TNF)-Î± therapy administered via a 30-minute infusion, has received FDA approval for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis, Janssen Biotech, Inc, announced in a press release.
The approvals follow the first FDA approval of SIMPONI ARIA®, in 2013, for the treatment of moderately to severely active rheumatoid arthritis.
The psoriatic arthritis and ankylosing spondylitis approvals are supported by comprehensive clinical development programs that demonstrated significant efficacy of SIMPONI ARIA® over placebo while offering a consistent safety profile across all indications.
In the study of treatment of active psoriatic arthritis, patients experienced improvement in joint symptoms and inhibition of structural damage. In the study of treatment of active ankylosing spondylitis, results showed improvement in measures of disease activity.
“There is a need for new treatment options for patients with psoriatic arthritis,” said Arthur Kavanaugh, MD, Professor of Medicine, University of California San Diego, and Chair of the GO-VIBRANT steering committee. “The results of the Phase 3 study of intravenous (IV) golimumab in patients with psoriatic arthritis demonstrated significant and clinically important efficacy across various domains including the inhibition of structural damage.”
He added, “The approval of IV 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.”
The approvals of SIMPONI ARIA® for psoriatic arthritis and ankylosing spondylitis are based on 2 large-scale, pivotal Phase 3 studies that involve more than 600 patients. In both studies, the primary end points were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of psoriatic arthritis and ankylosing spondylitis in the groups who received treatment with SIMPONI ARIA® compared with those who received placebo.
In the GO-VIBRANT (psoriatic arthritis) study, 75% of patients who received SIMPONI ARIA®, compared with 22% of patients who received placebo, achieved at least a 20% improvement in the American College of Rheumatology (ACR20) response at week 14. Treatment with SIMPONI ARIA® resulted in the inhibition of the progression of structural joint damage and improvement in physical function associated with Ps psoriatic arthritis at week 24.
In the GO-ALIVE (ankylosing spondylitis) study, 73% of patients who received SIMPONI ARIA®, compared with 26% of patients who received placebo, achieved at least a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16.
“Ankylosing spondylitis is a disease that adversely affects quality of life and the choices for treating this disabling condition are limited,” said Atul Deodhar, MD, Professor of Medicine at the Oregon Health & Science University in Portland and Chair of the GO-ALIVE steering committee. “The approval of IV golimumab for the treatment of active ankylosing spondylitis provides a welcomed new option. The GO-ALIVE Phase 3 study demonstrated the efficacy of IV golimumab in reducing the signs and symptoms of disease, as well as improving physical function and quality of life in patients.”
Said Andrew Greenspan, MD, Vice President of Medical Affairs at Janssen Scientific Affairs, LLC, “SIMPONI ARIA® has been helping patients with rheumatoid arthritis since its approval in 2013. With today’s FDA approvals, we are pleased to extend the benefits of SIMPONI ARIA® to adult patients living with active psoriatic arthritis or active ankylosing spondylitis. We know having all three indications is valuable to rheumatologists and for patients who prefer to have their treatment administered by their healthcare provider.”
A human anti-TNF-Î± monoclonal antibody, SIMPONI ARIA® targets both soluble and transmembrane bioactive forms of human TNF-Î±, a protein that when overproduced in the body as a result of chronic inflammatory diseases can cause inflammation. By binding with and blocking TNF-Î±, SIMPONI ARIA® helps control inflammation.
SIMPONI ARIA® is approved as a 30-minute infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis used in combination with methotrexate, active psoriatic arthritis, or active ankylosing spondylitis. SIMPONI ARIA® is approved in 22 countries, including the United States.