Real-World Effectiveness and Safety of Secukinumab in Giant Cell Arteritis: An Italian Multicenter Cohort Study.

Abstract

Objective: The objective of this study was to evaluate the real-world effectiveness and safety of secukinumab in patients with giant cell arteritis (GCA).

Methods: This multicenter retrospective study included patients with GCA who received secukinumab at 14 Italian centers with at least six months of follow-up. Outcomes included clinical, complete, and glucocorticoid (GC)-free remission, GC dose reduction, drug retention rate, and adverse events.

Results: Thirty-six patients were included (66.7% women); median age at secukinumab initiation was 74 (interquartile range [IQR] 70-80) years. Overall, 32 of 36 patients (88.9%) had previously relapsed and 26 of 36 (72.2%) had received tocilizumab. Clinical remission was observed in 85.2%, 80.6%, and 83.3% at 3, 6, and 12 months, respectively. Complete remission occurred in 55.6%, 52.8%, and 63.3%, whereas GC-free remission increased progressively, reaching 14.8%, 27.8%, and 40.0% at 3, 6, and 12 months, respectively (P = 0.012). Median daily GC dose decreased from 8.7 (IQR 4.0-21.2) mg at baseline to 0 (0-5.0) mg at 12 months (P < 0.001); GCs were discontinued in 12 of 28 patients (42.9%). The 12-month retention rate was 77.0%. Adverse events occurred in 20 of 36 patients (55.6%); infections occurred in 18 of 36 patients (50.0%), accounting for 21 infectious episodes.

Conclusion: In this multicenter, real-world cohort of patients with GCA, including those with relapsing disease and previous biologic exposure, secukinumab was associated with high observed remission rates, progressive GC dose reduction, and increasing GC-free remission. Although the phase III GCAptAIN trial did not meet its primary endpoint, these findings suggest that interleukin-17A inhibition may warrant further evaluation in patients with GCA.