Patients with asthma who received biologic therapy experienced reduced exacerbations and were able to reduce their dosages of oral corticosteroids in the real-world setting, according to recently published findings. Further, researchers identified patients with acid reflux disease, high eosinophil counts and greater baseline FEV1 as most likely to respond to biologics.

“The heterogeneity in severe asthma has become increasingly relevant as several biologic treatments targeting specific asthma phenotypes have recently become available,” Farrukh Abbas, MD, FACP, of the University of Rochester School of Medicine and Dentistry, and colleagues wrote. “While data from randomized controlled trials (RCTs) are essential to confirm safety and efficacy, RCTs have strict inclusion and exclusion criteria as well as close monitoring of participants for adherence and adverse effects. Confirmation of effectiveness of these therapies in the real-world setting is desirable, as patient characteristics and experiences may differ from those included in RCTs. Real-world studies can also help reveal responder profile as well as impact of comorbidities that may have been excluded in RCTs. “

Abbas and colleagues conducted a retrospective study of 112 patients with asthma who received treatment with biologic therapies. All patients were treated at the University of Rochester Mary Parkes Asthma Center. The main outcome of the study was the change in clinically significant exacerbation incidents at the 1-year mark after the patient started biologics compared with 1 year before starting the drugs. There were several secondary outcomes: Asthma Control Test scores, FEV1 measurements, changes in the incidence of severe exacerbations and patients’ dosage of oral corticosteroids for asthma maintenance.

The patients were a mean age of 57 years old and most (55%) were women. The researchers considered patients to be responsive to biologic therapy if they experienced any of the following: reductions of at least 50% in maintenance corticosteroid dose or clinically significant exacerbations, improvement of ACT score by 3 points or more, or an FEV1 increase of 120 mL or greater.

Biologics reduced exacerbations by 59%, the researchers reported (P < 0.0001), while severe exacerbations fell by nearly two-thirds (65%; P < 0.0001). Biologics were also linked with a 54% reduction in corticosteroid dosage (P = 0.0003). Patients experienced improvements in both asthma control and FEV1.

Abbas and colleagues wrote that patients who responded to biologics were more likely to have a history gastro-esophageal reflux disease, though only “marginally (OR = 4.55, P = 0.06).” Responders were also more likely to have eosinophils counts of more than 500 cells/uL (OR=1.24; P = 0.02) ), and less likely to have ever been smokers (odds ratio for ever-smokers, OR=0.01; P = 0.01). Those with higher baseline FEV1 measurements were also more likely to be responsive.

“In summary, we conclude that asthma biologics can significantly improve disease control in a real-world clinic setting,” the researchers wrote. “Further study of the determinants of response to individual biologics will help in targeting the right drug to the right subjects with severe asthma.”