MAXIMISE: Secukinumab significantly improves signs, symptoms of axial disease in PsA
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Secukinumab in doses of 300 and 150 mg significantly improves signs and symptoms of axial disease, compared with placebo, in patients with psoriatic arthritis with axial manifestations, according to data.
“To the best of our knowledge, none of the randomized clinical trials performed to date that assessed the effect of biologics in PsA included a targeted assessment of axial disease,” Xenofon Baraliakos, MD, of Ruhr-University Bochum, in Germany, and colleagues wrote in the Annals of the Rheumatic Diseases. “The only existing evidence comes from two observational studies based on clinical practice settings. Therefore, data from randomized controlled trials are lacking on the efficacy of biological treatment for the management of axial manifestations in patients with PsA.”
“Secukinumab, a fully human monoclonal antibody that directly inhibits IL-17A, has provided significant and sustained improvement in the signs and symptoms of active PsA and axSpA,” they added.
To analyze the efficacy of secukinumab (Cosentyx, Novartis) in the management of axial manifestations in PsA, Baraliakos and colleagues conducted the “Managing Axial Manifestations in Psoriatic Arthritis with Secukinumab” (MAXIMISE) trial. According to the researchers, MAXIMISE was a phase 3, double-blind, placebo-controlled, multicenter, 52-week trial of 498 adults with PsA and spinal pain. Participants were required to have a Visual Analogue Score of at least 40 out of 100, and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4, despite use of at least two NSAIDs.
Participants were randomly assigned to one of three treatment groups, with 167 treated with 300 mg of secukinumab, 165 treated with 150 mg of secukinumab, and 166 receiving a placebo. Treatments were administered weekly for 4 weeks, then once every 4 weeks thereafter. Participants in the placebo group were rerandomized to either of the 300 mg or 150 mg secukinumab group at week 12. The primary endpoint was Assessment of Spondyloarthritis International Society (ASAS20) response with secukinumab 300 mg at week 12.
According to the researchers, patients in both the 300 mg and 150 mg secukinumab groups demonstrated significantly improved ASAS20 response, compared with placebo, at week 12. In all, 63% of those in the 300 mg group achieved the response, compared with and 66% in the 150 mg cohort and 31% in the placebo group. The odds ratios comparing the 300 mg and 150 mg groups with placebo — using a logistic regression model after multiple imputation — were 3.8 (95% CI, 2.4-6.1) and 4.4 (95% CI, 2.7-7), respectively.
“Secukinumab provided significant improvement in the signs and symptoms and objective signs of inflammation of axial disease in patients with psoriatic arthritis and inadequate response to NSAIDs,” Baraliakos and colleagues wrote. “The clinical and imaging results from MAXIMISE provide valuable data that will support deepen the clinical understanding of axial PsA.”
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