Biologics frequently used in US patients with severe asthma, switching therapies uncommon
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Use of biologic therapies in patients with severe, uncontrolled asthma treated by subspecialists in the United States is common, according to data from the real-world, observational CHRONICLE study.
Switching from one biologic therapy to another was uncommon, in 10% of patients in this study, and was most commonly motivated by suboptimal effectiveness, the researchers reported.
“Biologic therapies have revolutionized the treatment of severe asthma by reducing asthma exacerbations in randomized placebo-controlled trials, but there is no real-world contemporary measurement of biologic therapy in the U.S. at this time,” Wendy C. Moore, MD, professor in the department of pulmonary, critical care, allergy and immunologic diseases at the Wake Forest School of Medicine, Winston-Salem, North Carolina, said during a presentation at the virtual CHEST Annual Meeting.
The researchers looked at patients in the ongoing, observational CHRONICLE study of U.S. adults with uncontrolled severe asthma treated by subspecialists and who meet one of three criteria: treated with an FDA-approved monoclonal antibody, receive systemic steroids for 50% or more of the year and/or use high-dose inhaled corticosteroids or other controllers with persistent and uncontrolled disease. After enrollment, patients were followed every 6 months. Researchers recorded new initiations of biologics 1 year before enrollment, switches from one biologic to another within 6 months and discontinuations of a biologic without initiation of another.
The current study focused on 1,884 patients at multiple U.S. sites who were enrolled from February 2018 to December 2019. In total, 65% of patients (mean age, 54 years; 67% women) were receiving a biologic at the time of enrollment. Commercial insurance was used by 60% of patients and Medicare insurance was used by 23%.
Most patients received biologic therapy at the specialist’s site. Type of biologic therapy use depended on date of initiation and timing of FDA approval of new therapies. Before November 2015, omalizumab (Xolair, Genentech) was the primary biologic prescribed. After November 2015, mepolizumab (Nucala, GlaxoSmithKline) use increased. After November 2017 through October 2018, benralizumab (Fasenra, AstraZeneca) and dupilumab (Dupixent, Sanofi/Regeneron) gained approval, respectively, and began taking up percentages of newly initiated biologic use.
“In this sample, the most prevalent biologic therapy was omalizumab, which was administered to approximately one-half of patients receiving biologics,” Moore said. “Following the approval of other biologics, omalizumab represented the minority of new starts, while benralizumab became the predominant biologic in those initiating therapy since December 2017.”
Researchers observed 148 biologic therapy switches among 134 patients during the study period (10% of biologic recipients). The most common switches were mepolizumab to benralizumab (n = 34), omalizumab to mepolizumab (n = 15) or benralizumab (n = 26) and benralizumab to dupilumab (n = 20), Moore said during the presentation. Dual use of two biologics was uncommon (n = 27) and represented less than 2% of biologic uses, she said.
The most common reason for switching biologics was worsening asthma control or increase in symptoms (n = 30), waning efficacy over time (n = 19) and lack of efficacy (n = 13).
Overall, 106 biologic discontinuations were reported in 101 patients (8% of biologic recipients).
“U.S. allergists/immunologists and pulmonologists frequently use biologics to treat uncontrolled, severe asthma. However, 35% of patients in CHRONICLE were not on biologics, despite being uncontrolled [or] on oral corticosteroids chronically,” Moore said. “It is not clear if those patients could not afford to get biologics, did not qualify based on biomarkers or whether or not they had a different phenotype.”
Editor's Note: On Nov. 11, we corrected the percentage of patients on commercial insurance. The Healio editors regret this error.