Singapore, [25 June 2024] – A new analysis of data from the International Severe Asthma Registry (ISAR) has revealed a spectrum of responsiveness among real-world patients with severe asthma who initiated biologic asthma therapies, most of whom were ineligible to participate in randomized controlled trials. Although many biologic initiators responded well, with higher proportions achieving super-responses than responses, around 40–50% did not meet the response criteria (Figure 1).
The study, "Real-world biologics response and super-response in the International Severe Asthma Registry cohort (LUMINANT)", was conducted by the Observational and Pragmatic Research Institute (OPRI), partially funded by Optimum Patient Care Global Ltd. and AstraZeneca, and is published in Allergy (European Journal of Allergy and Clinical Immunology). [1]
Figure 1. Proportions of super-responders, responders, and non-responders across single domains among patients who did or did not initiate a biologic asthma therapy
Abbreviation: FEV1, Forced expiratory volume in 1 second.
“Until now, there have been limited data on the outcomes of biologic asthma therapies outside of selected randomized controlled trial cohorts”, said Professor David Price, corresponding author, and Director of OPRI. “The LUMINANT study gives new insights affirming the effectiveness of biologic asthma therapies in the broader real-world severe asthma population, which is much more heterogenous. However, unmet treatment needs clearly remain, as half of the patients who initiated biologic therapies responded sub-optimally.”
ISAR Includes electronic medical records from 20,000 patients with severe asthma in 28 countries worldwide. This study grouped 8446 eligible adults with ≥24 weeks of follow-up into those who did or did not initiate biologic asthma therapies, and examined their treatment responses across four single outcome domains: forced expiratory volume in 1 second (FEV1) increase by ≥100 mL, improved asthma control, annualized exacerbation rate reduction ≥50%, and any reduction in use of long-term oral corticosteroids (LTOCS). The corresponding criteria defining super-responses were: FEV1 increase by ≥500 mL, new well-controlled asthma, no exacerbations, and LTOCS cessation or tapering to ≤5 mg/day.
Only 5.3% of patients in this study met standard randomized controlled trial inclusion criteria. Proportionally more biologic initiators had super-responses than responses (except for FEV1) and responses/super-responses were more frequent in biologic initiators than in non-initiators; nevertheless, ~40–50% of initiators did not meet response criteria (Figure 1).
“It is encouraging to affirm that biologic therapies can improve outcomes for many patients with severe asthma in real-world settings”, said the lead investigator Professor Eve Denton. “However, there were no complete responses to the biologics used in these patients, highlighting persisting unmet treatment needs. Our findings justify research to determine whether initiating biologics earlier may increase the likelihood of achieving a treatment response.”
To learn more about the study, please read the full publication in Allergy (Official journal of the European Academy of Allergy and Clinical Immunology), as well as the accompanying slide deck.
The Observational and Pragmatic Research Institute (OPRI) is an independent, internationally recognised research organisation which conducts studies that provide real-world evidence to support best practices for chronic disease management in primary care and make a difference to patients. https://www.opri.org.uk/
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.
Reference
1. Denton E, Hew M, Peters MJ, Upham JW, Bulathsinhala L, Tran TN, et al. Real-world biologics response and super-response in the International Severe Asthma Registry cohort. Allergy 2024: http://doi.org/10.1111/all.16178