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Dupilumab efficacy in patients with chronic rhinosinusitis with nasal polyps with and without allergic rhinitis.
Peters, Anju T; Wagenmann, Martin; Bernstein, Jonathan A; Khan, Asif H; Nash, Scott; Jacob-Nara, Juby A; Siddiqui, Shahid; Rowe, Paul J; Deniz, Yamo.
Afiliación
  • Peters AT; From the Allergy-Immunology Division and the Sinus and Allergy Center, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
  • Wagenmann M; Department of Otorhinolaryngology, Düsseldorf University Hospital, Düsseldorf, Germany.
  • Bernstein JA; Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.
  • Khan AH; Global Medical Affairs, Sanofi, Chilly-Mazarin, France.
  • Nash S; Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, New York, and.
  • Jacob-Nara JA; Global Medical Affairs, Sanofi, Bridgewater, New Jersey.
  • Siddiqui S; Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, New York, and.
  • Rowe PJ; Global Medical Affairs, Sanofi, Bridgewater, New Jersey.
  • Deniz Y; Medical Affairs, Regeneron Pharmaceuticals Inc., Tarrytown, New York, and.
Allergy Asthma Proc ; 44(4): 265-274, 2023 07 01.
Article en En | MEDLINE | ID: mdl-37480206
Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a predominantly type 2 inflammatory disease, which often coexists with allergic rhinitis (AR). Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and interleukin-13, key and central drivers of type 2 inflammation. Objective: This post hoc analysis investigated the efficacy and safety of dupilumab in patients with severe CRSwNP with or without coexisting AR in the pooled phase III SINUS-24/SINUS-52 studies. Methods: Patients randomized to subcutaneous dupilumab 300 mg (n = 438) or placebo (n = 286) every 2 weeks for 24 (SINUS-24) or 52 weeks (SINUS-52) were analyzed. Pooled data from the first 24 weeks of treatment are presented. Changes from baseline in disease outcome measures and biomarker levels were analyzed by the patient-reported history of AR status. Results: Overall, 338 of 724 patients (46.7%) had AR. Baseline characteristics were generally similar between patients with and those without AR. Dupilumab significantly improved objective and patient-reported measures of CRSwNP, including loss of smell, and reduced systemic and nasal biomarker levels versus placebo at week 24, with no significant treatment difference between patients with and those without AR. Use of systemic corticosteroids and/or sinonasal surgery during treatment was significantly reduced with dupilumab versus placebo, irrespective of AR status (p ≤ 0.0029). The safety profile of dupilumab was similar in patients with and in patients without AR. Conclusion: Dupilumab demonstrated significant improvements in both clinical end points and symptom scores versus placebo in patients with severe CRSwNP, irrespective of comorbid AR status, a common subgroup of patients often associated with poorer CRSwNP outcomes. Clinical trials NCT02912468 (SINUS-24) and NCT02898454 (SINUS-52), www.clinicaltrials.gov.
Asunto(s)

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Sinusitis / Rinitis / Pólipos Nasales / Rinitis Alérgica Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Allergy Asthma Proc Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2023 Tipo del documento: Article

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Sinusitis / Rinitis / Pólipos Nasales / Rinitis Alérgica Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Allergy Asthma Proc Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2023 Tipo del documento: Article