, based on data from more than 2,000 individuals.
The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.
In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.
The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.
Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).
Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.
Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.
Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV1 < 80% and patients with FEV1 ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).
The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).
Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.
The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.
The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.
The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.