Real-world use of ixekizumab for axial spondyloarthritis treatment in Spain (ESPADA study).

Introduction: While ixekizumab (IXE) has demonstrated efficacy in axial spondyloarthritis (axSpA) clinical trials, real-world evidence is limited. This study describes the characteristics and treatment persistence of axSpA patients receiving IXE in routine clinical practice in Spain. Methods: A retrospective study of axSpA patients treated with IXE was carried out in ten hospitals. Demographic, clinical, treatment-related characteristics, persistence and disease activity were collected at baseline, 12, 24 and 52 weeks. Descriptive analysis and Kaplan-Meier methods were used. Results: The study included 106 axSpA patients, 69.8% had r-axSpA, 58.5% were male, and 63% had overweight or obesity. Mean (SD) disease duration was 12.8 (12.3) years. 98.1% had received b/tsDMARDs and 52.5% presented normal C-reactive protein (CRP) levels at baseline. Persistence rates were 99.0, 80.5, and 56.3% at 12, 24, and 52 weeks, respectively. At week 52, 33.3% fewer patients had high/very high disease activity according to Ankylosing Spondylitis Disease Activity Index (ASDAS-CRP) scores and 18.9% showed an improvement of ≥50% in their Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Exploratory subanalyses showed IXE persistence was not influenced by gender, smoking status, BMI, axSpA clinical form, CRP levels, HLA-B27 status, prior biological (b) or targeted synthetic (ts) DMARD (b/tsDMARD) or secukinumab. IXE was discontinued by 40 (37.7%) patients during follow-up, mainly due to lack of effectiveness. Conclusion: Most axSpA patients treated with IXE had long-standing, highly active disease involving multiple domains and prior multiple domains and prior b/tsDMARDs (b/tsDMARD) exposure. Despite this, half remained on IXE at 1 year with improved disease activity, highlighting its potential as a treatment option in daily practice.