A recently published study in Pragmatic and Observational Research, “Real-world biologic use patterns in severe asthma, 2015–2021: the CLEAR study”, shows that biologic initiation was associated with improved clinical outcomes compared with non-initiation. Among biologic initiators, switching or stopping biologic therapy was associated with worse clinical outcomes than continuing the initial therapy; however, there remained a need for improvements in outcomes among continuers. These findings call for collaborative efforts among policymakers, clinicians and researchers to increase access to biologic therapies and initiate biologic therapy earlier in eligible patients. As the biologics in this study target immunoglobulin E (omalizumab), interleukin (IL)-4/IL-13 (dupilumab) or IL-5 signalling (mepolizumab, reslizumab or benralizumab), ongoing research on how to predict patient response to these biologics is needed to inform clinical decision-making on selecting the ‘right’ initial biologic for the ‘right’ patient, to reduce the need for switching or stopping. Additionally, further research on new biologic therapies (e.g., the anti-thymic stromal lymphopoietin biologic tezepelumab) that have less restrictive eligibility criteria would be of value.
Biologic initiators had fewer exacerbations, were less likely to have uncontrolled asthma and had a greater reduction in daily long-term oral corticosteroid (LTOCS) dose than non-initiators during the follow-up period. Approximately 54.1% of initiators and 66.5% of non-initiators experienced ≥1 exacerbations (annualized count; Figure 1A); 35.6% of initiators and 41.0% of non-initiators had uncontrolled asthma at last assessment (Figure 1B). Initiators had a greater reduction in daily LTOCS dose than non-initiators (adjusted β: −2.73 mg [95% CI: −4.77, −0.68]).
After biologic initiation, continuers had fewer exacerbations, were less likely to have uncontrolled asthma and had a greater reduction in daily LTOCS dose than switchers or stoppers at follow-up. The proportion of patients who experienced ≥1 exacerbations was 52.7% for continuers, 84.0% for switchers and 61.4% for stoppers (Figure 2A). The proportion of patients with uncontrolled asthma at last assessment was 33.3% for continuers, 67.1% for switchers and 50.1% for stoppers (Figure 2B). The reduction in daily LTOCS dose was smaller for switchers and stoppers than for continuers (adjusted β: 3.77 mg [95% CI: 1.71, 4.37] and 3.09 mg [95% CI: −0.27, 6.45] for switchers and stoppers, respectively, versus continuers). Nevertheless, it should be noted that among continuers, >50% had ≥1 exacerbation (Figure 2A) and one-third had uncontrolled asthma (Figure 2B).
The CLEAR study was a multicentre, observational study of patients enrolled in the International Severe Asthma Registry (ISAR), using data collected between December 2015 and August 2021. 3,404 patients with severe asthma from 23 countries were included.
To learn more about the study, please read the full publication in Pragmatic and Observational Research, as well as the accompanying slide deck.
The CLEAR study was funded by AstraZeneca. The International Severe Asthma Registry (ISAR) is operated by Optimum Patient Care Global Ltd. (OPCG) and co-funded by OPCG and AstraZeneca.
To learn more please visit our website: www.isar.opcglobal.org.