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New Golimumab Approval May Improve Function in Patients with Psoriatic Arthritis and Ankylosing Spondylitis

November 30, 2017
Two randomized, controlled, multicenter Phase 3 studies of IV-infused Simponi Aria demonstrate significant improvement in disease management.

With Arthur Kavanaugh, MD

The US FDA has approved SIMPONI ARIA (golimumab) for the treatment of psoriatic arthritis and active ankylosing spondylitis.1 The therapy is the only fully-human anti-tumor necrosis factor (TNF)-alpha therapy administered via 30-minute infusion. Ankylosing spondylitis (AS), a type of inflammatory arthritis that most often affects the sacroiliac joints and spine, has been diagnosed among an estimated 700,000 people in the United States. Psoriatic arthritis (PsA), which affects approximately 1 million Americans, causes painful joint inflammation  throughout the body, as well as skin lesions.

The announcement follows SIMPONI ARIA’s original FDA approval for severely active rheumatoid arthritis in 2013.1 The agency’s recent decision is based on the results of two large, randomized, controlled multicenter studies by developer Janssen Biotech: the GO-VIBRANT study, which followed PsA patients, and the GO-ALIVE study, which followed AS patients.

Arthur Kavanaugh, MD, professor of medicine at the University of California San Diego and chair of the GO-VIBRANT steering committee, said the approval means patients with psoriatic arthritis and ankylosing spondylitis will now have more choices when it comes to treating their condition. “Our goal is always to find the right drug for the right person,” he told Practical Pain Management. “The more therapeutic options we have, the better.”

Administered via 30-minute IV infusion, this latest addition to the class of TNF-alpha inhibitor medications offers an alternative for patients who may prefer infusion to subcutaneous injection.

Findings Demonstrate Improved Disease Management

The GO-VIBRANT and GO-ALIVE Phase 3 studies followed more than 600 patients diagnosed with PsA or AS. Both studies demonstrated “significant improvement” in disease management when using SIMPONI ARIA compared to placebo.

In the GO-VIBRANT study, 75% of PsA patients in the group receiving SIMPONI ARIA had at least a 20% improvement 14 weeks after starting treatment, compared to 22% in the placebo group  (p < 0.001). The investigational biologic was also associated with a slowed progression of structural joint damage and improved function 24 weeks after beginning treatment. Researchers used the American College of Rheumatology’s response criteria.

In the GO-ALIVE study, 73% of AS patients receiving SIMPONI ARIA reported at least a 20% improvement in disease activity 16 weeks after starting treatment, compared to 26% of patients in the placebo group (p < 0.001). Researchers used the Assessment of Spondyloarthritis International Society criteria.

SIMPONI ARIA has common side effects similar to those of products already on the market (eg, upper respiratory infection, abnormal liver tests, decreased blood cells that fight infection, viral infections, bronchitis, high blood pressure, and rash).

“We worry about ‘weird’ infections with any TNF inhibitor,” said Dr. Kavanaugh. “For example, if you get a cold, and it doesn’t go away with antibiotics.”  

Dr. Kavanaugh added that certain patients may not be ideal candidates for SIMPONI ARIA, or any other TNF-alpha inhibitor. These patients include those with an active infection, a central nervous system disorder, decompensated congestive heart failure, or those who have been exposed to tuberculosis.

 

 

 

Last updated on: November 30, 2017
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