OBJECTIVES: Biologic therapies represent transformative interventions for severe asthma; however, comprehensive integration of clinical effectiveness with economic evidence across real-world populations remains incomplete. This systematic review synthesizes both domains to support clinical and policy decisions. METHODS: Systematic literature search (PubMed, Scopus; 2014-2024) following PRISMA 2020 guidelines with prospective PROSPERO registration (CRD420251153385). Eligible studies evaluated biologic therapies in real-world asthma populations, reporting clinical outcomes (exacerbations, lung function, asthma control, quality of life) and economic measures (costs, ICER, healthcare resource utilization). GRADE methodology assessed evidence certainty; risk of bias evaluated using RoB 2 (RCTs) and ROBINS-I (observational studies). RESULTS: Twenty-seven studies (25 observational, 2 RCTs; 59,958 patients) evaluated omalizumab (n = 11), mepolizumab (n = 5), benralizumab (n = 4), dupilumab (n = 1), tezepelumab (n = 1), reslizumab (n = 1) and multiple biologic drugs comparatively (n = 4). All agents showed exacerbation reductions (46-86%), with 48-81% of previously exacerbating patients achieving exacerbation-free status. Hospitalizations decreased 57-85% and emergency department visits reduced 52-72%. Oral corticosteroid-dependent patients decreased 53-67%, representing substantial safety and quality-of-life benefits. Healthcare resource utilization reductions generated cost offsets of €1,181-2469 per patient annually, achieving favorable cost-effectiveness (€602-2244 per exacerbation avoided). High treatment persistence (51-54 months) and adherence (70-94.6%) exceeded conventional therapies. Significant methodological limitations were evident: 80.8% observational studies had serious bias risk. CONCLUSIONS: Biologic therapies achieve substantial clinical benefits and favorable economic value through healthcare cost offsets. Precision medicine approaches and early response assessment optimize patient selection and clinical outcomes in severe asthma management.
Procacci et al. (Tue,) studied this question.