Biological therapy for chronic obstructive pulmonary disease (COPD): Effectiveness and safety

Patients with chronic obstructive pulmonary disease (COPD) continue to experience exacerbations and hospitalizations despite optimal management. Biologic therapies targeting type 2 inflammatory pathways may improve clinical outcomes. We conducted a living evidence synthesis to provide a continuously updated evaluation of the effects of biologic therapies in COPD.

We systematically identified randomized controlled trials (RCT) evaluating biologic therapies in COPD patients at increased risk of exacerbations, particularly those with elevated blood eosinophil counts. Primary outcomes included annual exacerbation rate, exacerbation risk at 52 weeks, lung function, quality of life, and adverse events. Evidence was synthesized using meta-analysis, and certainty was assessed with GRADE.

Eleven RCTs including 7359 participants were identified up to November 2025. Biologic therapy reduced the mean annual rate of COPD exacerbations (MD -0.16, 95% CI -0.23 to -0.08; high certainty) but probably did not affect exacerbation risk at 52 weeks (4241 participants; RR 1.00, 95% CI 0.94 to 1.07; moderate certainty). Effects on FEV₁, quality of life, and total adverse events were not clinically important. Biologics slightly reduced serious adverse events (RR 0.87, 95% CI 0.81 to 0.94; high certainty). Subgroup analyses showed that dupilumab and mepolizumab reduced annual exacerbations, and dupilumab improved SGRQ scores.

This living evidence synthesis provides so far high-certainty evidence of biologic therapies reduce annual exacerbation rates in COPD, with a favorable safety profile. However, benefits on lung function and quality of life appear limited.