FDA Approves SIMPONI ARIA for Ankylosing Spondylitis and Psoriatic Arthritis

By Spondylitis Association of America

Friday, October 27, 2017

On October 20th, 2017 Janssen Biotech, Inc. announced that the FDA has approved SIMPONI ARIA (IV administered golimumab) for the treatment of adults with active ankylosing spondylitis (AS) or active psoriatic arthritis (PsA.)

SIMPONI ARIA is a biologic, a fully-human TNFi medication, that is administered intravenously via a 30-minute infusion. (Injectable SIMPONI has been approved for AS and PsA since 2009.)

These new AS and PsA approvals are supported by two clinical trials: an AS clinical trial named GO-ALIVE, and a PsA clinical trial named GO-VIBRANT.

              

The Ankylosing Spondylitis, “GO-ALIVE” Clinical Trial

This was a 60 week long, Phase 3, multicenter clinical trial with 208 adult AS patients, with half of the patients randomly selected to receive the study medication, and half receiving placebo.

As this was a double-blinded, placebo-controlled trial, neither the patients nor the physicians knew who was receiving the medication and who was receiving placebo.

               Study Results:

Of those receiving the study medication, 73% saw clinical improvement of 20% or more in disease activity – including in their AS signs and symptoms, and physical function. In comparison, 26% of patients receiving placebo experienced similar improvements.

 

The Psoriatic Arthritis, “GO-VIBRANT” Clinical Trial

This was also a 60 week long, Phase 3, multicenter clinical trial; also double-blinded and placebo- controlled. 480 adult psoriatic arthritis patients, who had not taken a biologic medication in the past, were enrolled, with half of the patients randomly selected to receive the study medication, and half receiving placebo.

               Study Results:

75% of those receiving the study medication saw a clinical improvement of 20% or more. In comparison, only 22% of the participants receiving placebo experienced similar improvements. Study results indicated that SIMPONI ARIA was able to inhibit progression of structural joint damage and improve physical function in psoriatic arthritis.

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