Severe Asthma: Patient Pathway to Biologics and the Role of Guideline-Directed Medical Therapy in Outpatient Care – A Real-World Analysis from Regional KV Data
Abstract
Background: Severe uncontrolled asthma is associated with high morbidity and healthcare utilization. Biologic therapies (Bx) may offer substantial benefit, yet real-world evidence on outpatient care trajectories prior to Bx initiation is limited. Guideline-directed medical therapy recommends Bx for patients uncontrolled despite high-dose inhaled corticosteroids (ICS) and add-on therapies, but implementation in routine practice is unclear. Objectives: To characterize outpatient care pathways of asthma patients aged≥12 years, focusing on treatment escalation and prescribing before and after Bx initiation. Secondary aims were to assess escalation timing, healthcare resource utilization (HCRU), and comorbidity profiles in relation to guideline-conform Bx use. Methods: Retrospective cohort study using outpatient claims from KV Westphalia-Lippe (2016–2023). The study population comprised prevalent asthma patients aged≥12 years. Outcomes were analyzed descriptively and stratified by sex and age. Annual prescription patterns were assessed for ICS, systemic corticosteroids (OCS), bronchodilators (SABA, LABA, LAMA), fixed-dose combinations, leukotriene receptor antagonists, and Bx. Analyses examined escalation dynamics, time to escalation, HCRU (general practitioner, pulmonologist, ENT, DMP participation), and comorbidity prevalence. Follow-up continued until death, disenrollment, or December 31, 2023. Results: 490,000 prevalent asthma cases were identified, including 125,000 in DMP-Asthma. Comorbidities were frequent: arterial hypertension (>40%), dyslipidemia (~25%), diabetes (15%). Multimorbidity (≥3 comorbidities) affected ~5% of patients20%≥60 years, more often in men. Within the DMP subgroup, 63% received long-term ICS and 3.2% long-term OCS. Data processing is ongoing; forthcoming analyses will detail prescribing frequencies and volume, escalation transitions, time to Bx initiation, and sex- and age-specific care patterns. Conclusion: This study provides real-world evidence on outpatient asthma trajectories, escalation toward biologics, and HCRU in Germany. Findings will support guideline implementation and highlight opportunities to optimize severe asthma management in daily practice. This study was supported by AstraZeneca GmbH Hamburg. Publication History Article published online: 04 March 2026 © 2026. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
Fields of Study & Subjects
Asthma and respiratory diseases
Chronic Obstructive Pulmonary Disease (COPD) Research
Clinical practice guidelines implementation
Publication details
- Journal / source
- Pneumologie
- Volume
- 80
- Publication date
- 1 March 2026
- Language
- EN