Drug persistence of omalizumab, cyclosporine, and hydroxychloroquine in antihistamine-refractory chronic spontaneous urticaria: A biomarker-stratified real-world study

Heh-Shiang Sheu, Yi-Ming Chen, Jun-Peng Chen, Chao-Kuei Juan, Wen-Nan Huang, Yi-Hsing Chen, Kuo-Tung Tang

Affiliations:
¹ Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
² Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan
³ Department of Dermatology, Taichung Veterans General Hospital, Taichung, Taiwan
⁴ School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan
⁵ Department of Post-Baccalaureate Medicine, College of Medicine, National Chung Hsing University, Taichung, Taiwan
⁶ Rong Hsing Research Center for Translational Medicine & Ph.D. Program in Translational Medicine, National Chung Hsing University, Taichung, Taiwan
⁷ Department of Pharmacy, Taichung Veterans General Hospital, Taichung, Taiwan
⁸ Department of Medical Education, Taichung Veterans General Hospital, Taichung, Taiwan
⁹ College of Business and Management, Ling Tung University, Taichung, Taiwan
¹⁰ Rheumatology and Immunology Center, China Medical University Hospital, Taichung, Taiwan
¹¹ College of Medicine, China Medical University, Taichung, Taiwan
¹² Ph.D. Program in Translational Medicine, National Chung Hsing University, Taiwan

Abstract

Background: Real-world comparative data on alternatives to omalizumab for antihistamine-refractory chronic spontaneous urticaria (CSU) are limited, particularly in resource-constrained Asia-Pacific settings.
Objective: To compare drug survival among patients treated with omalizumab, cyclosporine, or hydroxychloroquine and evaluate associations between biomarkers and treatment persistence.
Methods: This retrospective single-center cohort of 409 patients (omalizumab n = 97, cyclosporine n = 85, hydroxychloroquine n = 227) analyzed drug survival using Kaplan-Meier analysis and Cox regression. Patients were stratified by total IgE and autoimmune biomarkers (antinuclear antibodies [ANA], thyroid autoantibodies).
Results: Omalizumab showed significantly longer drug survival than hydroxychloroquine (hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.50–0.85), while cyclosporine did not retain significance after multivariable adjustment. After stratification by potential biomarkers, omalizumab demonstrated significantly longer drug survival than hydroxychloroquine in patients with elevated total IgE (HR 0.48, 95%CI 0.32–0.72), negative ANA (HR 0.63, 95%CI 0.45–0.88), or negative IgG thyroid autoantibodies (HR 0.58, 95%CI 0.37–0.93). In patients with normal total IgE levels, no significant differences in drug survival were observed among the three treatments (p = 0.795). Hydroxychloroquine showed drug survival comparable to cyclosporine irrespective of ANA status and among patients with IgG thyroid autoantibodies.
Conclusions: While omalizumab demonstrated longer overall drug survival, our findings suggest that in patients with normal total IgE or positive autoimmune biomarkers, hydroxychloroquine and cyclosporine may offer comparable drug persistence. These observations warrant prospective validation and suggest the potential value of biomarker-informed treatment approaches in resource-limited Asia-Pacific settings.
Key words: autoimmune markers, biomarkers, chronic spontaneous urticaria, cyclosporine, drug survival,
hydroxychloroquine, omalizumab, total IgE, treatment persistence