FDA Extends Simponi Approval to Psoriatic Arthritis and Ankylosing Spondylitis
The US Food and Drug Administration recently approved Simponi (golimumab) for the treatment of adult patients with active psoriatic arthritis (PsA) or active ankylosing spondylitis (AS), which is administered as a 30-minute infusion.
Simponi was originally approved in 2013 for the treatment of moderate-to-severe active rheumatoid arthritis. Simponi® is one of five marketed TNF inhibitors (TNFi) that is FDA approved. This new approval was based on data from 2 large-scale pivotal phase 3 trials that demonstrated significant improvements in signs and symptoms of PsA and AS in adult patients compared with placebo.
Psoriatic arthritis is a condition that stems from psoriasis, an autoimmune disease in which the body’s immune system attacks the skin, resulting in scaly, red patches on the skin. In some psoriasis patients, the immune system attacks the joints as well, leading to inflammation and the condition known as psoriatic arthritis, or PsA. Symptoms of PsA are highly variable among patients, coming and going over time and affecting one or many joints of the body. Ankylosing spondylitis is an autoimmune disease that affects the spine and large joints, causes inflammation that can lead to severe, chronic pain, and in worst cases can lead to new bone formations resulting in spinal fusion.
The approvals of Simponi® for PsA and AS are based on two large-scale, pivotal Phase 3 studies involving more than 600 patients. In both studies, the primary endpoints were met, with a higher proportion of patients demonstrating significant improvement in the signs and symptoms of PsA and AS in the groups receiving treatment with Simponi.
In the GO-VIBRANT (PsA) study, 75 percent of patients receiving Simponi®, compared with 22 percent of patients receiving placebo achieved at least a 20 percent 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 PsA at week 24.
In the GO-ALIVE (AS) study, 73 percent of patients receiving Simponi®, compared with 26 percent of patients receiving placebo achieved at least a 20 percent improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at week 16. ACR20 and ASAS20 are standard measures used to assess clinical improvement in PsA and AS, respectively.
There were no new side effects reported in these studies other than those previously known to be associated with Simponi Aria; abnormal liver tests, decreased blood cell counts, viral infections, bronchitis, high blood pressure, and skin rash.