PREVENT: Secukinumab improves non-radiographic axial SpA symptoms across sexes, subgroups
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Secukinumab improves non-radiographic axial spondyloarthritis signs and symptoms across patients grouped by C-reactive protein level, MRI score, HLA-B27 status and sex, according to data published in Arthritis Research & Therapy.
“Axial spondyloarthritis (axSpA) is categorized into radiographic axSpA (r-axSpA) or ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA) based on the presence of structural changes on radiographs of the sacroiliac joints (SIJs),” Jürgen Braun, MD, PhD, of Ruhr-University Bochum, in Germany, told Healio Rheumatology.
“Elevated C-reactive protein (CRP), MRI evidence of SIJ inflammation, HLA-B27 positivity, and male sex are known predictors of better treatment response to biologic disease-modifying anti-rheumatic drugs (bDMARDs) in patients with axSpA,” he added. “This manuscript is important because it reports the results of the efficacy of secukinumab in patients with nr-axSpA in these important subgroups.”
To assess the efficacy of secukinumab (Cosentyx, Novartis) in patients with non-radiographic axial SpA grouped by CRP level, MRI score, HLA-B27 status and sex, Braun and colleagues conducted a post hoc analysis of the phase-3 PREVENT study. In that study, 555 patients with active non-radiographic axial SpA were randomized 1:1:1 to receive subcutaneous secukinumab 150mg either with or without a loading dose, or placebo. Doses were then administered weekly, starting at week 4, every 4 weeks.
For this analysis, Braun and colleagues reported on the efficacy outcomes of all participants who received secukinumab up to 16 weeks, based on CRP, MRI, HLA-B27 and sex.
According to the researchers, efficacy differences between the secukinumab groups and those who received placebo were highest in the CRP-positive, MRI-positive, HLA-B27-positive and male subgroups. This was particularly true for the Ankylosing Spondylitis Disease Activity Score-CRP inactive disease and the Assessment of SpondyloArthritis international Society (ASAS) partial remission outcomes. ASAS40 response rates at week 16 among those who were CRP- and MRI-positive were 52.3% for the pooled secukinumab group and 21.8% for placebo (P < .0001).
ASAS40 response rates in the HLA-B27-positive subgroup were 43.9% among those treated with secukinumab, compared with 32.6% in those who received a placebo. Additional ASAS40 response rates were 32.7% and 16.4% in the HLA-B27-negative subgroup, 51.2% versus 30.8% in males, and 31.7% versus 25.3% in female patients, respectively.
“The results reported in this manuscript provide additional evidence supporting the efficacy of secukinumab in the treatment of patients with nr-axSpA,” Braun said. “Results have previously been published showing that secukinumab provides sustained improvement in the signs and symptoms of AS over 5years. Taken together, the clinical significance of this publication is that it provides additional evidence supporting the efficacy of secukinumab in the treatment of patients across the spectrum of axSpA.”