WASHINGTON — The FDA approved secukinumab (Cosentyx) for a new indication to treat adults with active non-radiographic axial spondyloarthritis (nr-axSpA).
Secukinumab, an interleukin-17A inhibitor, was originally approved January 2015 and has previously accumulated indications for adults with moderate to severe plaque psoriasis, psoriatic arthritis, and active ankylosing spondyloarthritis. This latest approval was based on the results of the two-year randomized, double-blind, placebo-controlled phase III PREVENT trial, according to a press release from Novartis, the drug’s manufacturer.
“The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with [secukinumab] versus placebo,” said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the PREVENT clinical trial, in a statement. “This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”
The PREVENT trial assessed the safety and efficacy of secukinumab in a cohort of 555 adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) who had been taking at least two non-steroidal anti-inflammatory at the highest dose up to 4 weeks prior to the start of study. Study participants had disease onset before 45 years of age, rated their spinal pain as ≥40 out of 100 on a visual analog scale (VAS), and had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4. Of the 555 participants, 501 (90%) were biologic naive.
“Patients were allocated to one of three treatment groups: [secukinumab] 150 mg subcutaneously with loading dose (Induction: 150 mg secukinumab subcutaneously weekly for 4 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 4 weeks, followed by maintenance of once-monthly),” the manufacturer explained.
Secukinumab met the study’s primary endpoint — “statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-naïve individuals at week 52,” the manufacturer wrote.
The ” nr-axSpA patients treated with [secukinumab] showed improvement in both load and without load arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire (Least Squares mean change: Week 16: -3.5 and -3.6 vs -1.8, respectively),” the manufacturer continued. “General health status and quality of life was assessed by the Short Form health survey (SF-36). At Week 16, patients treated with [secukinumab] showed greater improvement from baseline in the SF-36 physical component summary (PCS) score and in the mental component summary (MCS) score. The safety profile of [secukinumab] in the PREVENT trial was shown to be consistent with previous clinical trials. No new safety signals were detected.”
The prescribing information for secukinumab states that the most common adverse reactions are nasopharyngitis, diarrhea, and upper respiratory tract infection. Secukinumab also has the potential to cause serious infections in patients who have a chronic infection or a history of recurrent infection — treatment should be discontinued immediately if a serious infection develops. Patients should not receive live vaccines while taking the drug.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 158
Topic ID: 90,158,730,192,158,68