Effects of Secukinumab on Enthesiophyte and Erosion Progression in Psoriatic Arthritis: A One-Year Double-Blind, Randomized, Placebo-Controlled Trial Using High-Resolution Peripheral Quantitative Computed Tomography.

Abstract

This study aimed to ascertain the effect of secukinumab on erosion and enthesiophyte progression in psoriatic arthritis (PsA) by using high-resolution peripheral quantitative computed tomography (HR-pQCT). This was a phase 4, double-blind, randomized, placebo-controlled trial. Patients with active PsA and ≥1 erosion in metacarpophalangeal joints (MCPJs) 2 to 4 were randomly assigned in a 1:1 ratio to subcutaneous secukinumab or placebo. HR-pQCT of MCPJs 2 to 4 were performed at baseline, week 24, and week 48. The primary outcome was the changes in the volume of erosions on MCPJs 2 to 4 measured by HR-pQCT at 24 and 48 weeks. Forty patients (mean ± SD age 51.9 ± 13.4 years, 20 [50%] male, mean ± SD disease duration 4.7 ± 6.7 years) were recruited. Thirty-four patients who completed study treatment were included in the per-protocol analysis. At baseline, week 24, and week 48, the secukinumab group showed a significant reduction in erosion volume, whereas no changes were observed in the placebo group (median change in the secukinumab group -0.1 [interquartile range -0.5 to 0.0] vs 0.0 [interquartile range -0.2 to 0.4] in the placebo group, P = 0.004). A similar trend was observed for enthesiophyte volume changes in the secukinumab group, whereas no differences were noted in the placebo group (median change in the secukinumab group -0.1 [interquartile range -0.8 to 0.0] vs 0.0 [interquartile range -0.4 to 1.3] in the placebo group, P = 0.067). Generalized estimating equations results showed that the odds ratio (OR) for enthesiophyte progression in the secukinumab group was 0.264 (95% confidence interval [CI] 0.080-0.878, P = 0.030), whereas the OR for partial erosion healing in the secukinumab group was 2.882 (95% CI 1.130-7.349, P = 0.027). Secukinumab demonstrates a potential benefit in facilitating partial erosion repair and preventing enthesiophyte progression in PsA.