Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps: A Meta-Analysis of Real-World Evidence

Abstract

Dupilumab, omalizumab, mepolizumab, and benralizumab have demonstrated good efficacy and safety in the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps (CRSwNP) in phase 3 randomised controlled trials (RCTs). With recent regulatory approvals, there has been a surge in real-world studies (RWSs). This systematic review and meta-analysis aimed to summarise the efficacy and safety of these four biologics in real-world settings. Primary outcomes were nasal polyp score and sino-nasal outcome test-22 score. Secondary outcomes included smell identification test score, loss of smell score, nasal congestion score, overall nasal symptom score, treatment response, and adverse events (AEs) prompting discontinuation. Efficacy outcomes at 4, 6, 12, and over 12 months were summarised, and meta-analyses of mean changes from baseline were conducted. Sixty-four RWSs involving 3921 patients were included. Significant improvements in clinical outcomes were observed at most follow-up time points, with dupilumab showing particularly notable effects. The efficacy observed in these RWSs was superior to that demonstrated in phase 3 RCTs. All biologics exhibited low discontinuation rates due to AEs. Overall, biologic treatments for CRSwNP in real-world settings demonstrate strong efficacy and good safety. However, the limitations in current RWSs highlight the need for long-term, high-quality multicentre prospective studies and comprehensive healthcare database analyses.

Keywords: biologics; chronic rhinosinusitis with nasal polyps; dupilumab; meta‐analysis; real‐world study.

FIGURE 1

PRISMA flowchart for study identification. PRISMA, preferred reporting items for systematic reviews and meta‐analysis.

FIGURE 2

Pooled NPS and SNOT‐22 score over different time points and the matched baseline data. NA, not available; NPS, nasal polyp score; SE, standard error; SNOT‐22, sino‐nasal outcome test‐22.

FIGURE 3

Meta‐analysis forest plot of mean changes in NPS and SNOT‐22 score over different time points. CI, confidence interval; MC, mean change; NA, not available; NPS, nasal polyp score; SNOT‐22, sino‐nasal outcome test‐22.

FIGURE 4

Forest plot comparing the NPS and SNOT‐22 scores for four biologics at 6 and 12 months between RWSs and RCTs. Data was presented as MC (95% CI). CI, confidence interval; MC, mean change; NA, not available; NPS, nasal polyp score; RCT, randomised controlled trial; RWS, real‐world study; SNOT‐22, sino‐nasal outcome test‐22.