Asthma biologic response is high in patients with severe asthma, yet few of these patients have their severe disease under control, according to study findings published in Therapeutic Advances in Respiratory Disease.
Investigators sought to characterize asthma control and health care consumption in patients with severe asthma treated with biologics. Severe asthma was defined as disease requiring high doses of inhaled steroid and another controller, or long-term oral corticosteroids (OCSs).
The investigators conducted a real-world prospective observational study (Second Souffle; ClinicalTrials.gov Identifier: NCT04438408) between July 2020 and July 2021 that included 431 patients with severe asthma documented for at least 12 months, recruited from 12 asthma research sites and 19 public or private hospitals in France. Patients (at least 18 years of age) completed a self-administered Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), and a compliance evaluation test questionnaire. Notably, the ACQ was specifically developed and validated to measure asthma control; the AQLQ was developed to measure the functional impairments most troublesome to adult patients with asthma; the compliance evaluation test questionnaire assesses treatment compliance.
Physicians indicated whether patients (63% women; 59% with overweight/obesity) receiving biologics responded or did not respond to treatment (measured subjectively). The investigators noted one-quarter of the patients experienced at least 10 years between asthma symptom onset and the first visit with a pulmonologist. About one-quarter of the patients received maintenance OCS. Non-compliance was noted in 11% of patients overall (9% of patients receiving biologics; 16% of those not). Among all patients, 88% had at least 1 comorbidity. Long-term illness was more common in patients receiving biologics (97%) vs those not (77%).
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GERD and OSA seem to be independent factors associated with uncontrolled asthma.
Overall, 95% of patients (n=409) presented asthma with a type 2 inflammation (ie, T2 high) profile. Among the patients with T2 high, 73% (n=297) were treated with biologics (mean duration of biologic treatment [SD], 34.6 [35.4] months). Among all T2 high patients (receiving/not receiving biologics), the investigators noted similar characteristics in terms of sex, age, and smoking status.
According to physician estimates, 88% of patients responded to biologics; however, only a quarter of these patients achieved asthma control as defined by the ACQ (ie, ACQ >0.75). Thus, according to ACQ scores, three-quarters of those responding to biologics did not achieve asthma control. Likewise, among patients who reported that they responded to biologics, 77.8% still had uncontrolled asthma based on their ACQ score.
Oral corticosteroids were used by one-quarter of the patients more than 3 times a year for at least 3 consecutive days; an equal number of patients used the oral corticosteroids daily.
The investigators noted obstructive sleep apnea syndrome (OSA) and gastro-esophageal reflux disease (GERD) are independently associated with uncontrolled asthma.
Study limitations include undocumented type of biological therapy used, and patients were not assessed over time.
“Although a high proportion (88.2%) of patients with severe asthma responded to biological therapies, our study highlights that only 25.3% achieved asthma control at the time of evaluation,” the study authors concluded. The investigators stated there are probably multiple reasons why patients who respond to biological treatment continue to experience uncontrolled asthma, and added, “GERD and OSA seem to be independent factors associated with uncontrolled asthma.”
Disclosure: This research was supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
