The approval by the U.S. Food and Drug Administration (FDA) follows a similar decision by the European Commission in April. In both the U.S. and European Union, the therapy is also indicated for the treatment of ankylosing spondylitis, the other form of axSpA.
Cosentyx is a monoclonal antibody that blocks interleukin-17a, a pro-inflammatory molecule, to lower inflammation and immune reactions in chronic inflammatory diseases.
The FDA’s decision was based on the results of the Phase 3 PREVENT trial (NCT02696031), which tested the safety and efficacy of Cosentyx in 555 adults with active nr-axSpA previously treated with a minimum of two non-steroidal anti-inflammatory drugs for up to four weeks. Participants had failed to show a good response to a TNF inhibitor therapy. Most (90.3%) had not undergone any biologic treatments.
Patients were randomly assigned either to receive Cosentyx given subcutaneously (under the skin) as a 150 mg monthly dose, with or without an induction phase of 150 mg administered weekly for four weeks, or to a placebo.
The study’s main goal was to assess Cosentyx’s efficacy, as measured by the proportion of patients who met the Assessment of Spondyloarthritis International Society (ASAS) 40 response criteria at weeks 16 and 52 (one year). Meeting ASAS40 means an improvement or reduction of at least 40% in a minimum of three of the following domains: patient global assessment, pain assessment, function — assessed with the Bath Ankylosing Spondylitis Functional Index — and inflammation.
Additional goals included reductions in disease activity as measured by other tools, including the Bath AS Disease Activity Index, or BASDAI. This test measures fatigue, spinal pain, joint pain or swelling, inflammation of the entheses — where tendons or ligaments insert into the bone — and morning stiffness. Other parameters included health-related quality of life, as measured by the Ankylosing Spondylitis Quality of Life questionnaire, and general health and quality of life assessed by the Short Form health survey (SF-36).
In line with prior reports, full 52-week results showed that the trial met its main goal, with significantly more patients who received Cosentyx after an induction phase achieving ASAS40 compared with the placebo group (41.5% vs. 29.2%) at week 16. The significant improvements with Cosentyx were still seen at one year (35.4% vs. 19.9%).
Cosentyx also led to significant benefits in secondary outcomes, with treated patients showing significant improvements by week 16 in health-related quality of life, and in both physical and mental health parameters of the SF-36.
“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, MD, an investigator in the trial and medical director of Rheumatology Clinics at Oregon Health & Science University.
“This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis,” he added.
Safety results were consistent with previous data, and no new safety concerns were identified. Three cases of serious infections and one of Crohn’s disease in participants treated with Cosentyx had already been reported.
The results were recently presented at the Annual European Congress of Rheumatology (EULAR) e-congress 2020 in a poster titled “Secukinumab 150 mg significantly improved signs and symptoms of non-radiographic axial spondyloarthritis: 52-week results from the Phase III Prevent Study” (OP0106).
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