Patients With Asthma May Move Too Quickly to Biologics, Researchers Say

Two-thirds of patients with asthma who started biologic treatment had suboptimal adherence to their medications and one-third had mild disease, which researchers said are signs that they may have been escalated to biologics contrary to guidelines, according to a recent study.

The retrospective claims database analysis looked at patients in the United States, where it is estimated that costs related to asthma are more than $80 billion annually.

About 10% of people with asthma do not respond to standard treatments and are considered to have severe asthma. The researchers acknowledged that for patients with severe asthma, biologics, although costly, have been life-changing. In addition, they noted that there are many reasons why patients may not be adherent to their medication, including issues of cost and affordability, inhaler technique, beliefs about health, or the ability to understand complex regimens.

The study, published in The Journal of Allergy and Clinical Immunology: In Practice, examined an IQVIA claims database for adults with asthma who were escalated to biologics (omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab) between January 2016 and June 2020. They were excluded from the analysis if they had 2 or more claims separated by at least 60 days, with a diagnosis of chronic obstructive pulmonary disease (COPD), chronic idiopathic urticaria, eczema, or nasal polyps at any time during the study period.

Researchers analyzed exacerbations and control status as well as maintenance medication adherence during the 12 months before biologics were started. Adherence was defined as the proportion of days covered (PDC) by maintenance medication claims.

Current Global Initiative for Asthma (GINA) guidelines recommend a stepwise approach to asthma treatment, beginning at the lowest step that both prevents and controls symptoms, and it defines severe asthma as asthma that is not controlled by correct use of high-dose inhaled corticosteroids and long-acting beta-agonists or that worsens when high doses are lowered. The GINA step was inferred by using recorded prescription claims before biologics began.

Asthma control was assessed using both the European Respiratory Society/American Thoracic Society (ERS/ATS) and Stempel criteria.

Of 1786 patients escalated to biologics, 506 were included for analysis. During the 12 months before escalation, 346 patients had confirmed exacerbations. A majority of the patients had uncontrolled asthma: 55% using ERS/ATS criteria and 70% using Stempel criteria.

Furthermore, most of the patients were on the lower GINA step levels, according to the inferred data, and had not progressed through them before starting a biologic: 154 were at step 2, 11 at step 3, 104 at step 4, and 126 at step 5.

In addition, 63% of 403 patients with maintenance medication claims had poor medication adherence (PDC <80%).

These results suggest that many patients are being escalated to biologic therapy inappropriately, said the authors, who noted that a 2018 report from the Institute for Clinical and Economic Review suggested a 50% price decrease would be needed in order to make the treatments cost effective for severe asthma.

"Because of the high cost of biologic therapy, inappropriate escalation to biologics may have tremendous economic consequences at the population health level, particularly due to the high prevalence of asthma," they wrote.

Electronic monitoring of inhaled therapies could assist clinicians with understanding how patients are using asthma treatments at home before deciding whether a move to a biologic is needed, the authors noted.

Reference

Bender B, Oppenheimer J, George M, et al. Assessment of real-world escalation to biologics in US patients with asthma. J Allergy Clin Immunol Pract. Published online August 2, 2022. doi:10.1016/j.jaip.2022.07.016