ATS 2021 will feature presentations of original research from accepted abstracts. Mini Symposia and Thematic Poster Sessions are abstract based sessions.
Please use the form below to browse scientific abstracts and case reports accepted for ATS 2021. Abstracts presented at the ATS 2021 will be published in the Online Abstract Issue of the American Journal of Respiratory and Critical Care Medicine, Volume 203, May 3, 2021.
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Dupilumab Provides Early and Durable Improvement of Symptoms in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the SINUS-24 and SINUS-52 Phase 3 Trials
Session Title
TP6 - TP006 CLINICAL STUDIES OF ALLERGIC AIRWAY DISEASES, LUPUS, AND EOSINOPHILIC DISEASES
Abstract
A1341 - Dupilumab Provides Early and Durable Improvement of Symptoms in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from the SINUS-24 and SINUS-52 Phase 3 Trials
Author Block: P. Gevaert1, S. E. Lee2, R. Settipane3, M. Wagenmann4, J. Msihid5, S. Siddiqui6, S. Nash6, J. A. Jacob-Nara7, A. H. Khan5, S. Kamat6, C. Chuang7; 1Ghent University, Ghent, Belgium, 2Department of Otolaryngology—Head & Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, United States, 3The Warren Alpert Medical School of Brown University, Providence, RI, United States, 4Department of Otorhinolaryngology, Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 5Sanofi, Chilly Mazarin, France, 6Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 7Sanofi, Cambridge, MA, United States.
RATIONALE: Chronic rhinosinusitis with nasal polyps (CRSwNP) is mostly a type 2 inflammatory disease, with cardinal symptoms of nasal congestion (NC), loss of smell (LoS), and rhinorrhea significantly impacting patients’ daily lives. Dupilumab, a fully human monoclonal antibody, blocks interleukin (IL)-4Rα, the shared receptor component for IL-4 and IL-13, key drivers of type 2 inflammation. We report dupilumab effect on patient-reported CRSwNP symptoms from SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies.
METHODS: In this post hoc analysis, endpoints were compared in adults with CRSwNP receiving dupilumab 300 mg or placebo every 2 weeks. Pooled SINUS-24/SINUS-52 intent-to-treat (ITT) population (N=724) data was used for assessment until Week 24 and the SINUS-52 population (N=303) for Week 52 assessment. Patients reported symptom scores (0=none; 1=mild; 2=moderate; or 3=severe) daily for NC, LoS, and rhinorrhea. The proportions of patients with symptom scores ≥2 at baseline who achieved symptom improvement (no or mild symptoms, ie, score ≤1) at Weeks 2, 24, and 52 were reported for the ITT population and for subgroups with prior nasal polyp surgery or comorbid asthma. Additionally, symptom improvement for all three symptoms was reported at Weeks 24 and 52.
RESULTS: At baseline, 86.7%, 94.1%, and 64.1% of patients had scores ≥2 for NC, LoS, and rhinorrhea, respectively, in the pooled ITT population. Of these patients, a significantly greater proportion achieved symptom improvement with dupilumab compared with placebo from Week 2 through Week 24 and continued improving until Week 52 (Figure); similar results were observed in patients with prior surgery or comorbid asthma. Among patients who did not achieve scores ≤1 at Week 24, a greater proportion of dupilumab- versus placebo-treated patients experienced symptom improvement by achieving a score of >1 to ≤2 at Week 24. Among the patients in the ITT population with baseline scores ≥2 for all three symptoms, a greater proportion of dupilumab-treated patients had improvement of all three symptoms at Weeks 24 and 52 (33.0% and 34.7%, respectively), compared with 2.2% and 4.4%, respectively, for placebo (all P <0.0001).
CONCLUSIONS: In CRSwNP patients, dupilumab significantly improved symptoms compared with placebo, regardless of prior surgery or comorbid asthma. Symptom improvement was observed as early as Week 2 and continued until Week 52, suggesting an early onset and durable treatment effect of dupilumab in reducing patient symptom burden.
Author Block: P. Gevaert1, S. E. Lee2, R. Settipane3, M. Wagenmann4, J. Msihid5, S. Siddiqui6, S. Nash6, J. A. Jacob-Nara7, A. H. Khan5, S. Kamat6, C. Chuang7; 1Ghent University, Ghent, Belgium, 2Department of Otolaryngology—Head & Neck Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, United States, 3The Warren Alpert Medical School of Brown University, Providence, RI, United States, 4Department of Otorhinolaryngology, Düsseldorf University Hospital (UKD), Düsseldorf, Germany, 5Sanofi, Chilly Mazarin, France, 6Regeneron Pharmaceuticals, Inc., Tarrytown, NY, United States, 7Sanofi, Cambridge, MA, United States.
RATIONALE: Chronic rhinosinusitis with nasal polyps (CRSwNP) is mostly a type 2 inflammatory disease, with cardinal symptoms of nasal congestion (NC), loss of smell (LoS), and rhinorrhea significantly impacting patients’ daily lives. Dupilumab, a fully human monoclonal antibody, blocks interleukin (IL)-4Rα, the shared receptor component for IL-4 and IL-13, key drivers of type 2 inflammation. We report dupilumab effect on patient-reported CRSwNP symptoms from SINUS-24 (NCT02912468) and SINUS-52 (NCT02898454) studies.
METHODS: In this post hoc analysis, endpoints were compared in adults with CRSwNP receiving dupilumab 300 mg or placebo every 2 weeks. Pooled SINUS-24/SINUS-52 intent-to-treat (ITT) population (N=724) data was used for assessment until Week 24 and the SINUS-52 population (N=303) for Week 52 assessment. Patients reported symptom scores (0=none; 1=mild; 2=moderate; or 3=severe) daily for NC, LoS, and rhinorrhea. The proportions of patients with symptom scores ≥2 at baseline who achieved symptom improvement (no or mild symptoms, ie, score ≤1) at Weeks 2, 24, and 52 were reported for the ITT population and for subgroups with prior nasal polyp surgery or comorbid asthma. Additionally, symptom improvement for all three symptoms was reported at Weeks 24 and 52.
RESULTS: At baseline, 86.7%, 94.1%, and 64.1% of patients had scores ≥2 for NC, LoS, and rhinorrhea, respectively, in the pooled ITT population. Of these patients, a significantly greater proportion achieved symptom improvement with dupilumab compared with placebo from Week 2 through Week 24 and continued improving until Week 52 (Figure); similar results were observed in patients with prior surgery or comorbid asthma. Among patients who did not achieve scores ≤1 at Week 24, a greater proportion of dupilumab- versus placebo-treated patients experienced symptom improvement by achieving a score of >1 to ≤2 at Week 24. Among the patients in the ITT population with baseline scores ≥2 for all three symptoms, a greater proportion of dupilumab-treated patients had improvement of all three symptoms at Weeks 24 and 52 (33.0% and 34.7%, respectively), compared with 2.2% and 4.4%, respectively, for placebo (all P <0.0001).
CONCLUSIONS: In CRSwNP patients, dupilumab significantly improved symptoms compared with placebo, regardless of prior surgery or comorbid asthma. Symptom improvement was observed as early as Week 2 and continued until Week 52, suggesting an early onset and durable treatment effect of dupilumab in reducing patient symptom burden.
