Efficacy and safety of biologic therapies for chronic rhinosinusitis with nasal polyps: a systematic review and meta-analysis

Abstract

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous, type 2-inflammation-driven disease of the sinonasal mucosa that is frequently refractory to intranasal and systemic corticosteroids and often recurs after endoscopic sinus surgery. Biologic agents targeting distinct upstream and downstream type 2 inflammatory mediators have been evaluated in phase 3 randomized controlled trials (RCTs) as add-on therapy to standard of care. This study aimed to systematically review and meta-analyze randomized, placebo-controlled trials of biologic therapies for CRSwNP, and to quantify their effect on nasal polyp size, sinonasal symptom burden, and the need for surgery or systemic corticosteroids. Databases were searched from inception to 15 August 2026, together with ClinicalTrials.gov and the WHO ICTRP. Five trial comparisons from four publications (62â€"413 randomized patients per trial) had verified extractable data and were pooled quantitatively. All five reported statistically significant improvement in total NPS versus placebo at their respective primary endpoints (24â€"52 weeks); the pooled random-effects mean/median difference was âˆ'1.02 points (95% CI âˆ'1.64 to âˆ'0.41; I² ≤ 92.8%). SNOT-22 total score also improved across trials (pooled difference âˆ'16.10 points, 95% CI âˆ'23.57 to âˆ'8.62; I² ≤ 87.4%), although the effect in OSTRO (benralizumab) did not reach statistical significance. Biologic therapies targeting IgE, IL-5/IL-5Rα, and TSLP produce clinically meaningful, statistically significant improvements in nasal polyp size and sinonasal quality of life compared with placebo in patients with CRSwNP, although the magnitude of effect varies substantially by mechanism and population, and cross-trial pooling should be interpreted cautiously given the very high statistical heterogeneity.