Secukinumab Approved for Active Non-radiographic Axial Spondyloarthritis

Secukinumab, an IL-17a inhibitor currently approved in the United States for moderate to severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis, has been approved by the U.S. Food and Drug Administration for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA).

It is the only biologic to date that directly inhibits IL-17a. The announcement was made on Tuesday by Novartis, the company that manufactures secukinumab (Cosentyx).

“The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo,” said Atul Deodhar, M.D., in a statement issued by the company. Dr. Deodhar is a professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the PREVENT clinical trial, the two-year randomized, double-blind, placebo-controlled phase III clinical trial that examined the efficacy and safety of secukinumab in patients with active nr-axSpA.

PREVENT included 555 male and female adults with active nr-axSpA (with onset before 45 years of age, spinal pain of at least ≥40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4). In this trial, the patients had to have had a history of being treated with at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the maximum dose up to four weeks to the start of the study. In this study, 10% of the patients had tried a TNF inhibitor, but had an inadequate response.

The patients were assigned to one of three groups:secukinumab 150 mg subcutaneously with loading dose (Induction: 150 mg Secukinumab subcutaneously weekly for four weeks, then maintenance with 150 mg secukinumab monthly); secukinumab 150 mg no loading dose (150 mg Secukinumab subcutaneously monthly), or placebo (induction of subcutaneously weekly for four weeks, followed by maintenance of once-monthly).

The primary endpoint was a proportion of biologic-naïve patients achieving an ASAS40 response with secukinumab 150 mg at 16 and 52 weeks. The secondary endpoint included change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).

At week 16, patients showed improvements in health-related quality of life as compared to the placebo group. The treatment group also showed greater improvement from baseline in the SF-36 physical component summary (PCS) score and in the mental component summary (MCS) score. No new safety signals were detected.

“There is a need for additional treatment options. Having a new treatment option for the axSpA community is truly encouraging," said Cassie Shafer, chief executive officer of the Spondylitis Association of America. “Helping reduce the burden on people living with non-radiographic axial spondyloarthritis by improving symptoms that affect their daily lives remains a critical focus for the SAA.”

Secukinumab was approved in April by European Medicines Agency for the treatment of nr-axSpA.