Real-world Data Show Biologics Use Common, Effective in Severe Asthma

The expanding availability of biologics to treat severe asthma has resulted in a significant reduction in asthma exacerbations, according to newly published real-world data. This report also shows that 16% of patients who used biologics had switched therapies.

The study was published in Annals of Allergy, Asthma & Immunology.

Patients with severe asthma require high-dose corticosteroids and a second inhaler to control their asthma. In some cases, however, they cannot control their disease even with those therapies. About 5% to 10% of patients with asthma have severe asthma, according to the authors.

In recent years, a wide range of biologics has been developed and approved to treat this patient population, with clinical trial data suggesting these treatments can reduce exacerbations and improve disease control.

The ongoing CHRONICLE (Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United States) study was launched to prospectively track adult patients with severe asthma. In the new report, investigators used data from the trial to track the use of biologics and their impact on patients in a real-world setting.

The study covers patients who enrolled in CHRONICLE between February 2018 and February 2021. Among a total study population of 2793 patients, the investigators found that two-thirds (1832) were receiving biologics as part of their therapy.

Forty-seven percent of those patients were prescribed omalizumab (Xolair), which targets immunoglobulin E (IgE). The next most used biologics were the interleukin 5 (IL-5) alpha receptor–targeting benralizumab (Fasenra; 27%) and mepolizumab (Nucala; 26%), which targets IL-5. Another 18% of patients were taking dupilumab (Dupixent), which targets the IL-4 alpha receptor. Three percent of patients were taking reslizumab (Cinqair), another therapy targeting IL-5. Nearly 9 in 10 patients (89%) who started taking biologics reported ongoing usage.

Alhough the data showed patients were using a variety of biologics, the study authors said it was striking that one-third of patients were not using any biologic therapy.

“Given these benefits of biologic use, it is notable that a high number of patients with confirmed uncontrolled [severe asthma] were not receiving biologic therapy due to not being considered clinically eligible by their treating subspecialists; the exact reason for this discrepancy warrants further study,” they said.

Sixteen percent of the patients in the database had switched biologics, and 13% had stopped. In the study, a stop was defined as having stopped taking a prescribed biologic and then not re-starting it or another biologic for at least 6 months. Worsening asthma (13%) and lack of effectiveness (6%) were the most common reasons for stopping.

However, the investigators noted that patients who stopped were more likely than other subgroups to be on Medicaid, “suggesting that for some patients, biologic stops may have been related to affordability concerns.”

Among those who switched biologics, the median time between the 2 biologics was 19 days, the authors said.

The investigators said patients who started on biologics experienced a 58% reduction in exacerbations, and those who switched experienced a 49% reduction. Starting a non–anti-IgE therapy tended to lead to a greater reduction in exacerbations compared with IgE-targeting therapies.

The authors concluded by noting that the data suggest many subspecialists are not using comprehensive biomarker testing of patients with severe asthma, even though they said this would help physicians make more personalized medication recommendations.

“With multiple biologic options available, a personalized approach to biologic treatment and switching may improve outcomes in patients with [severe asthma],” the investigators concluded.

Reference

Panettieri RA, Ledford DK, Chipps BE, et al. Biologic use and outcomes among adults with severe asthma treated by United States subspecialists. Ann Allergy Asthma Immunol. June 2022. doi:10.1016/j.anai.2022.06.012