Rapid and Continuing Improvements in Nasal Symptoms with Dupilumab in Patients with Severe CRSwNP

Claus Bachert, Asif H. Khan, Claire Hopkins, Michael S. Blaiss, Zachary M. Soler, Scott Nash, Shahid Siddiqui, Amy Praestgaard, Yamo Deniz, Paul J. Rowe, Juby A. Jacob-Nara

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: In the phase 3 SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies in adults with severe chronic rhinosi-nusitis with nasal polyps (CRSwNP), dupilumab significantly improved the co-primary endpoints of change from baseline to Week 24 in nasal polyp score (NPS) and nasal congestion/obstruction (NC) vs placebo on background intranasal corticosteroids (standard of care [SOC]). This post hoc analysis of SINUS-24/-52 investigated the direction and magnitude of within-patient change in these endpoints over time. Methods: NPS (scale 0–8) was assessed at Weeks 4, 8, 16, 24, 40, and 52 in SINUS-52 and Weeks 8, 16, and 24 in SINUS-24. Daily patient-reported NC scores (0 [no symptoms]–3 [severe symptoms]) were averaged over 28 days. Within-patient changes from baseline were assessed through Week 24 in pooled SINUS-24/-52 (n = 438/286 dupilumab/SOC) and through Week 52 in SINUS-52 (n = 150/153). Results: In SINUS-52, NPS improved in 70.0% of dupilumab-treated patients at Week 4 vs 31.8% with SOC (odds ratio [OR] 5.2 [95% confidence interval 3.1–8.8]) and 78.7% vs 28.2% at Week 52 (OR 10.6 [6.0–18.7]) (all p < 0.0001). NC improved in 73.3% of dupilumab-treated patients at Week 4 vs 46.7% with SOC (OR 3.2 [2.0–5.3]) and 86.9% vs 50.7% at Week 52 (OR 6.4 [3.5–11.5]) (all p < 0.0001). Clinically meaningful (≥1 point) improvements in NPS occurred in 55.7% and 72.3% of dupilumab-treated patients at Weeks 4 and 52, respectively, vs 16.9% and 16.2% with SOC. Clinically meaningful (≥1 point) improvements in NC occurred in 16.7% and 67.6% of dupilumab-treated patients at Weeks 4 and 52, respectively, vs 3.9% and 20.8% with SOC. At Week 52, NPS worsening from baseline was observed in 5.7% of dupilumab-treated patients vs 40.1% with SOC and NC worsening in 2.1% vs 20.8%, respectively. Conclusion: Dupilumab provided rapid, continuing, and clinically relevant improvements over time in NPS and NC in most patients with severe CRSwNP in the SINUS studies.

Original languageEnglish
Pages (from-to)557-563
Number of pages7
JournalJournal of Asthma and Allergy
Volume15
DOIs
StatePublished - 2022
Externally publishedYes

Keywords

  • chronic rhinosinusitis with nasal polyps
  • dupilumab
  • nasal congestion
  • nasal polyp score

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