Dupilumab improves outcomes in patients with chronic rhinosinusitis with nasal polyps irrespective of gender: results from the SINUS-52 trial

Abstract

Objectives: This post hoc analysis assessed disease characteristics and response to dupilumab treatment in male and female patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) (SINUS-52 study; NCT02898454).

Methods: Patients received dupilumab 300 mg or placebo every 2 weeks for 52 weeks on background intranasal corticosteroids. Efficacy was assessed through Week 52 using nasal polyp score (NPS), nasal congestion/obstruction score, loss of smell score and University of Pennsylvania Smell Identification Test score. Disease-specific health-related quality of life (HRQoL) was assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22).

Results: The analysis included 192 male and 111 female patients. Female patients had higher mean SNOT-22 total score (56.6 vs. 49.1, P < 0.01) and more coexisting asthma (78.4% vs. 46.4%, P < 0.0001) and non-steroidal anti-inflammatory drug-exacerbated respiratory disease (NSAID-ERD) (38.7% vs. 18.8%, P = 0.0001) than male patients, but other baseline characteristics were similar. Dupilumab significantly improved CRSwNP outcomes vs. placebo at Week 52, regardless of gender: least squares mean differences (95% confidence interval) for NPS were -2.33 (-2.80, -1.86) in male and -2.54 (-3.18, -1.90) in female patients (both P < 0.0001 vs. placebo), and for SNOT-22 were -19.2 (-24.1, -14.2) in male and -24.4 (-31.5, -17.3) in female patients (both P < 0.0001 vs. placebo). There were no significant efficacy-by-gender interactions.

Conclusion: Female patients had greater asthma, NSAID-ERD and HRQoL burden at baseline than male patients. Dupilumab treatment significantly improved objective and subjective outcomes compared with placebo, irrespective of gender.

Keywords: chronic rhinosinusitis; health‐related quality of life; patient‐reported outcomes; post hoc analysis.

Figure 1

LS mean differences (95% CI) for dupilumab vs. placebo in change from baseline through Week 52 in (a) NPS, (b) NC, (c) LoS, (d) UPSIT and (e) SNOT‐22 by gender. Male patients, n = 95/97 (placebo/dupilumab); female patients, n = 58/53 (placebo/dupilumab). *P < 0.05, **P < 0.01, ***P < 0.0001 vs. placebo. CI, confidence interval; LoS, loss of smell; LS, least squares; NC, nasal congestion/obstruction; NPS, nasal polyp score; SNOT‐22, 22‐item Sino‐Nasal Outcome Test; UPSIT, University of Pennsylvania Smell Identification Test.

Figure 2

LS mean differences for dupilumab vs. placebo in change from baseline at Week 52 in SNOT‐22 total and domain scores by gender. ***P < 0.0001 vs. placebo. LS, least squares; SNOT‐22, 22‐item Sino‐Nasal Outcome Test.