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IL-1β Pathway Inhibition in Asthma and COPD: Strong Biological Rationale, Disappointing Clinical Trials, and Emerging
Mario Cazzola1, Clive P Page2, Maria Gabriella Matera3
1Unit of Respiratory Medicine, Department of Experimental Medicine, University of Rome 'Tor Vergata', Rome, Italy. mario.cazzola@uniroma2.it.
Lung
|May 21, 2026
Summary
Interleukin-1β (IL-1β) drives airway inflammation in asthma and COPD. Targeting IL-1β has shown limited success due to disease complexity, necessitating precision medicine and biomarker-guided strategies for future therapies.
Area of Science:
- Immunology
- Pulmonology
- Pharmacology
Background:
- Interleukin-1β (IL-1β) is a critical mediator of innate immunity and a primary driver of airway inflammation in asthma and chronic obstructive pulmonary disease (COPD).
- Elevated IL-1β levels are associated with neutrophilic inflammation, increased exacerbations, airflow limitation, and corticosteroid resistance in these respiratory diseases.
- IL-1β promotes key inflammatory processes including epithelial activation, neutrophil recruitment, and immune cell plasticity, contributing to disease pathogenesis.
Purpose of the Study:
- To review the role of IL-1β in asthma and COPD pathogenesis.
- To analyze the reasons for limited clinical success of IL-1 signaling blockade.
- To explore emerging therapeutic strategies for IL-1β-driven airway inflammation.
Main Methods:
- Literature review and synthesis of existing research on IL-1β in respiratory diseases.
- Analysis of clinical trial outcomes and reasons for therapeutic failure.
- Discussion of novel therapeutic approaches and future research directions.
Main Results:
- IL-1β plays a significant role in airway inflammation, epithelial-mesenchymal transition, and immune cell dysfunction in asthma and COPD.
- Clinical trials targeting IL-1 signaling have shown limited efficacy, attributed to disease heterogeneity and pathway redundancy.
- Emerging strategies focus on precision medicine, upstream inhibition (e.g., NLRP3 inflammasome), and combination therapies.
Conclusions:
- Despite its central role, direct IL-1β targeting has faced challenges in clinical application for asthma and COPD.
- Future therapeutic success may depend on biomarker-guided patient stratification, targeting upstream pathways, and personalized treatment approaches.
- Adaptive trial designs incorporating multi-omics and endotyping are crucial for validating novel IL-1-targeted interventions in specific patient subgroups.
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