Real-world drug survival and treatment outcome of ixekizumab in patients with spondyloarthropathies.

BACKGROUND

Chronic inflammatory rheumatic diseases, such as ankylosing spondylitis, psoriatic arthritis, reactive arthritis, and enteropathic arthritis, are collectively referred to as spondyloarthropathies (SpA). However, Real-world evidence on the effectiveness and safety of ixekizumab in spondyloarthropathies remains limited, particularly in diverse populations outside clinical trial settings.

AIM: This study aimed to evaluate patient demographics, treatment outcomes, drug survival, and safety profile of ixekizumab in patients with SpA in a real-world clinical setting.

METHODS

We conducted a retrospective cohort study at a tertiary care hospital in Riyadh, Saudi Arabia, from January 2018 to December 2024. Patients aged ≥14 years with SpA who received ixekizumab were included. The primary outcomes included drug survival, treatment discontinuation rates, and reasons for discontinuation. Kaplan-Meier survival analysis and Cox proportional hazards regression were performed to identify the predictors of treatment discontinuation.

RESULTS

Among 93 patients (mean age 44.2 ± 13.2 years, 60.2% female), psoriatic arthritis spectrum disorders predominated (71.0%), followed by ankylosing spondylitis (23.7%). Most patients (87.1%) had prior biologic exposure, with ixekizumab used predominantly as a second-line therapy (59.1%). Drug survival rates were 69.9% at 12 months and 43.0% at 24 months, with a median survival of 23.0 months (95% CI: 19.5-26.5). The overall discontinuation rate was 34.4%, primarily due to lack of efficacy (59.4%) and adverse events (18.8%). Treatment-emergent adverse events occurred in 7.5% of patients, with no serious adverse events reported. Disease type significantly influenced drug survival (p = 0.018), with psoriatic arthritis showing superior retention compared with ankylosing spondylitis (77.8% vs. 60.0% at 12 months). Multivariate analysis identified third-line or later therapy (HR 2.58, 95% CI 1.04-6.40, p = 0.041) and the presence of treatment-emergent adverse events (HR 9.86, 95% CI 3.42-28.41, p < 0.001) as independent predictors of discontinuation.

CONCLUSION

Ixekizumab demonstrated acceptable drug survival and safety profiles in real-world patients with spondyloarthritis, with differential effectiveness across disease subtypes. Earlier treatment initiation and proactive management of adverse events may optimize treatment outcomes, supporting personalized therapeutic approaches for spondyloarthropathy management.