Effect of Secukinumab Versus Adalimumab Biosimilar on Radiographic Progression in Patients With Radiographic Axial Spondyloarthritis: Results From a Head‐to‐Head Randomized Phase IIIb Study

Abstract

IntroductionSpinal radiographic progression is an important outcome in radiographic axial spondyloarthritis (r‐axSpA). SURPASS is the first head‐to‐head phase IIIb study comparing such changes in patients with r‐axSpA treated with secukinumab (IL‐17A inhibitor) versus adalimumab biosimilar (Sandoz adalimumab [SDZ‐ADL]; TNF inhibitor).MethodsBiologic‐naïve patients with active r‐axSpA, at high risk of radiographic progression (high‐sensitivity C‐reactive protein [hsCRP] ≥5 mg/L and/or ≥1 syndesmophyte[s] on spinal radiographs) were randomized (1:1:1) to secukinumab (150/300 mg) or SDZ‐ADL (40 mg). The proportion of patients with no radiographic progression (change from baseline [CFB] in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤0.5) on secukinumab versus SDZ‐ADL at week 104 (primary endpoint), mean CFB‐mSASSS, proportion of patients with ≥1 syndesmophyte(s) at baseline with no new syndesmophytes(s), and safety were evaluated.ResultsOverall, 859 patients (78.5% male, mSASSS 16.6, BASDAI 7.1, hsCRP 20.4 mg/L, and 73.0% with ≥1 syndesmophyte[s]) received secukinumab 150 mg (n=287), 300 mg (n=286), or SDZ‐ADL (n=286). At week 104, the proportion of patients with no radiographic progression was 66.1%, 66.9%, and 65.6% (P=not significant, both secukinumab doses) and mean CFB‐mSASSS was 0.54, 0.55, and 0.72 in secukinumab 150 mg, 300 mg, and SDZ‐ADL arms, respectively. Overall, 56.9%, 53.8%, and 53.3% of patients on secukinumab 150 mg, 300 mg, and SDZ‐ADL, respectively, with ≥1 syndesmophyte(s) at baseline did not develop new syndesmophyte(s) by week 104. There were no unexpected safety findings.ConclusionsSpinal radiographic progression over 2 years was low with no significant difference between secukinumab and SDZ‐ADL arms. The safety of both treatments was consistent with previous reports.