Both secukinumab and adalimumab biosimilar have comparable efficacy in treating radiographic progression in axial spondyloarthritis (axSpA), according to research results presented at the American College of Rheumatology (ACR) Convergence 2022, held from November 10to 14, in Philadelphia, Pennsylvania.
Patients with active radiographic axSpA with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4; spinal pain score of at least 4 (range, 0-10); total back pain score of at least 40 mm (range, 0-100 mm); and high-sensitivity C-reactive protein level of at least 5 mg/L or at least 1 syndesmophyte(s) on spinal radiograph, were included in the phase 3 study. Eligible patients also had no prior exposure to biologics. Participants were randomly assigned 1:1:1 to receive secukinumab 150 mg, secukinumab 300 mg, or adalimumab biosimilar 40 mg, for 104 weeks.
The primary endpoint was the percentage of patients with no radiographic progression, defined as a change from baseline in modified Stoke AS Spinal Score (mSASSS) of 0.5 and lesser, at week 104.
A total of 859 patients were included in the study (287 receiving secukinumab 150 mg; 286 receiving secukinumab 300 mg; and 286 receiving adalimumab biosimilar). Baseline characteristics were comparable across study arms, with 78.5% being men; mean age being 42.1 years; and mean baseline mSASSS and BASDAI scores being 16.6 and 7.1, respectively.
At week 104, the percentage of patients with no radiographic progression was 66.1%, 66.9%, and 65.6%, respectively. The between-arm differences were not significant. In addition, 56.9%, 53.8%, and 53.3% of patients, respectively, with at least 1 syndesmophyte(s) at baseline did not develop new syndesmophytes during the trial.
No new safety signals were observed. The rate of serious adverse events was 14.0%, 10.2%, and 11.2%, respectively.
Overall, the study authors concluded, “Spinal radiographic progression over 2 years was low with no significant difference between [secukinumab] and [adalimumab biosimilar] arms. Safety was consistent with the well-established safety profiles of [secukinumab] and [adalimumab biosimilar].”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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Baraliakos X, Østergaard M, Poddubnyy D, et al. Effect of secukinumab versus adalimumab biosimilar on radiographic progression in patients with radiographic axial spondyloarthritis: a randomized phase IIIb study. Presented at: ACR Convergence 2022; November 10-14; Philadelphia, PA. Abstract #L15.