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- Title
Dupilumab improves outcomes in patients with chronic rhinosinusitis with nasal polyps irrespective of gender: results from the SINUS‐52 trial.
- Authors
Fokkens, Wytske J; Bachert, Claus; Hopkins, Claire; Marglani, Osama; Praestgaard, Amy; Nash, Scott; Deniz, Yamo; Rowe, Paul J; Sacks, Harry; Jacob‐Nara, Juby A
- 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.
- Subjects
UNIVERSITY of Pennsylvania; NASAL polyps; DUPILUMAB; PATIENTS; SINUSITIS; OLFACTOMETRY
- Publication
Clinical & Translational Immunology, 2024, Vol 13, Issue 6, p1
- ISSN
2050-0068
- Publication type
Article
- DOI
10.1002/cti2.1511