TY - JOUR
T1 - Rapid and Continuing Improvements in Nasal Symptoms with Dupilumab in Patients with Severe CRSwNP
AU - Bachert, Claus
AU - Khan, Asif H.
AU - Hopkins, Claire
AU - Blaiss, Michael S.
AU - Soler, Zachary M.
AU - Nash, Scott
AU - Siddiqui, Shahid
AU - Praestgaard, Amy
AU - Deniz, Yamo
AU - Rowe, Paul J.
AU - Jacob-Nara, Juby A.
N1 - Funding Information:
Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ClinicalTrials.gov Identifiers: NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52). The authors thank Nadia Daizadeh, PhD (formerly of Sanofi), for statistical analyses and Neil Anderson, PhD, of Adelphi Group, Macclesfield, UK, for medical writing/editorial assistance funded by Sanofi and Regeneron Pharmaceuticals, Inc. in accordance with Good Publications Practice.
Publisher Copyright:
© 2022.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - chronic rhinosinusitis with nasal polyps
KW - dupilumab
KW - nasal congestion
KW - nasal polyp score
UR - http://www.scopus.com/inward/record.url?scp=85130644845&partnerID=8YFLogxK
U2 - 10.2147/JAA.S355391
DO - 10.2147/JAA.S355391
M3 - Article
AN - SCOPUS:85130644845
SN - 1178-6965
VL - 15
SP - 557
EP - 563
JO - Journal of Asthma and Allergy
JF - Journal of Asthma and Allergy
ER -