Concomitant treatment with omalizumab and cyclosporine for chronic spontaneous urticaria

Abstract

Abstract Background Severe asthma (SA) often requires subspecialist management and treatment with biologic therapies and/or maintenance systemic corticosteroids (mSCS). Objective: To describe contemporary, real-world biologic and mSCS use among U.S., subspecialist-treated patients with SA. Methods CHRONICLE is an ongoing, noninterventional study of U.S. adults with SA treated by allergists/immunologists or pulmonologists. Eligible patients are receiving biologics and/or mSCS or are uncontrolled on high-dosage inhaled corticosteroids with additional controllers (HD ICS+). Biologic and mSCS use patterns and patient characteristics were summarized for patients enrolled between February 2018 and February 2019. Results Among protocol-eligible patients, 58% and 12% were receiving biologics and mSCS respectively, with 7% receiving both. Among 796 enrolled, most were female (67%), non-Hispanic white (71%), of suburban residence (50%), and had elevated body mass index (median 31). Respiratory and nonrespiratory comorbidities were highly prevalent. With biologics (n=557), 51% were anti-IgE and 48% were anti–IL5/IL-5Rα; from May 2018, 76% of initiations were anti–IL-5/IL-5Rα. In patients receiving mSCS, median prednisone-equivalent daily dose was 10 mg. Multivariate logistic regression demonstrated patients of hospital clinics, sites with fewer nonphysician staff, and with a recorded concurrent chronic obstructive pulmonary disease diagnosis were less likely to receive biologics and more likely to receive mSCS. Conclusion In this real-world sample of U.S., subspecialist-treated patients with SA not controlled by HD ICS+, mSCS use was infrequent and biologic use was common, with similar prevalence of anti-IgE and anti–IL-5/IL-5Rα biologics. Treatment differences associated with patient and site characteristics should be investigated to ensure equitable access to biologics and minimize mSCS use.