Study drug also recently showed promise in treating psoriatic arthritis.
Denis Poddubnyy, MD
Patients with axial spondyloarthritis often suffer from spinal inflammation that causes back pain by affecting the sacroiliac joints and spine, causing substantial functional limitations and impairment of health-related quality of life.
However, a team led by Denis Poddubnyy, MD, Charité University Medicine Berlin, evaluated the efficacy and safety of secukinumab in reducing spinal pain for patients with axial spondyloarthritis patients who had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs) in a study presented at the European Congress of Rheumatology (EULAR) 2020 virtual meeting.
The SKIPPAIN trial was a 24-week, randomized, double-blind, multi-center study involving 380 adult patients with axial spondyloarthritis with active disease defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥4 and average spinal pain numerical rating scale (NRS) score >4 at baseline and inadequate response to ≥2 NSAIDs ≥4 weeks.
The study population included 269 ankylosing spondylitis patients (70.8%) and 111 non-radiographic axial spondyloarthritis (nr-AxSpA) patients (29.2%).
The trial also included a placebo-controlled period from baseline to week 8, as well as a secukinumab 150/300 mg period from week 8-24.
A total of 285 patients were randomized to the study drug, with 96 individuals in the placebo arm.
The investigators sought primary and key secondary endpoints of the superiority of secukinumab 150mg compared to placebo in achieving average spinal pain score of less than 4 on a 0-10 NRS and BASDAI less than 4 at week 8, respectively.
The proportion of responders measured by average spinal pain was 31.9% in the study drug group and 20.0% for the placebo group (P <0.05) at week 8. The proportion of patients with BASDAI scores of less than 4 was 33.3% for the secukinumab group and 23.2% in the placebo group (P <0.05) at week 8.
After week 8, the responder rates in the treatment group increased. Also, there were no unexpected safety events reported in the study.
“Secukinumab provided significant improvement of spinal pain in patients with axSpA,” the authors wrote. “SEC was well tolerated with a safety profile consistent with previous reports.”
Earlier this year, researchers found multiple doses of secukinumab provided sustained improvement of the signs and symptoms of psoriatic arthritis.
Findings from the phase 3 FUTURE 2 study highlighted the clinical benefit and safety of long-term treatment with the interleukin-17A (IL-17A) inhibitor.
Iain McInnes, MD, PhD, and a team of investigators aimed to assess and describe the five-year results on the efficacy and safety of secukinumab 300 mg and 150 mg doses, along with dose escalation, from the FUTURE 2 study. The FUTURE 2 study was a phase 3, double-blind, placebo-controlled study done at 76 centers across Asia, Australia, Canada, Europe, and the US.
ACR responses at 5 years were 71 (74%; ACR20), 50 (52%; ACR50), and 31 (32%; ACR70) of the 96 evaluable patients in the 300 mg cohort, and 67 (70%; ACR20), 41 (43%; ACR50), and 28 (29%; ACR70) of 96 evaluable patients in the secukinumab 150 mg group.
The study, “Secukinumab Provides Significant Improvement of Spinal Pain in Patients with Axial Spondyloarthritis: Results from the 24-Week Phase 3 SKIPPAIN Study,” was published online by EULAR.