Rapid and sustained effects of dupilumab in severe chronic rhinosinusitis with nasal polyps

Peter W Hellings, Anju T Peters, Adam M Chaker, Enrico Heffler, Haixin Zhang, Amy Praestgaard, Scott Nash, Asif H Khan, Shahid Siddiqui, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz, Peter W Hellings, Anju T Peters, Adam M Chaker, Enrico Heffler, Haixin Zhang, Amy Praestgaard, Scott Nash, Asif H Khan, Shahid Siddiqui, Juby A Jacob-Nara, Paul J Rowe, Yamo Deniz

No abstract available

Keywords: medical therapy of chronic rhinosinusitis; olfaction; quality of life.

Conflict of interest statement

Peter W. Hellings: Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member. Anju T. Peters: Regeneron Pharmaceuticals, Inc., Sanofi – advisory board member; AstraZeneca – research support and advisory board member; Optinose – consultant and research support. Adam M. Chaker: Technical University Munich (TUM) – research/clinical study grants: ALK Abello, Allergopharma, ASIT Biotech, AstraZeneca, Bencard/Allergen Therapeutics, European Institute of Technology (EIT), GlaxoSmithKline, LETI, Roche; ALK Abello, AstraZeneca, Bencart/Allergen Therapeutics, GlaxoSmithKline, Immunotek, LETI, Lofarma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi‐Genzyme, Zeller advisory board member and/or speaker – all via TUM. Enrico Heffler: AstraZeneca, GlaxoSmithKline, Novartis, Sanofi – advisory board member. Yamo Deniz, Scott Nash, Shahid Siddiqui, and Haixin Zhang: Regeneron Pharmaceuticals, Inc. – employees, may hold stock and/or stock options in the company. Asif H. Khan, Juby A. Jacob‐Nara, Amy Praestgaard, and Paul J. Rowe: Sanofi – employees, may hold stock and/or stock options in the company.

Figures

FIGURE 1

Treatment effect of dupilumab versus placebo in daily‐assessed symptoms of CRSwNP over the first dosage interval (2 weeks; SINUS‐24 and SINUS‐52 pooled). Nominal p value versus placebo: *p <0.05, **p <0.01, ***p <0.001. LoS and NC were scored on a scale of 0−3 with 0 = no symptom and 3 = severe symptom. TSS was the sum of symptom scores for LoS, NC, and rhinorrhea. Each of the imputed complete data were analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, asthma/NSAID‐ERD status, prior surgery history, region, and study indicator as covariates. Abbreviations: ANCOVA, analysis of covariance; CRSwNP, chronic rhinosinusitis with nasal polyps; LoS, loss of smell; NC, nasal congestion; NSAID‐ERD, nonsteroidal anti‐inflammatory drug‐exacerbated respiratory disease; PNIF, peak nasal inspiratory flow; TSS, total symptom score

FIGURE 2

LS mean change in CRSwNP disease measures to week 52 in SINUS‐52 in all patients and in subgroups with prior surgery, asthma, NSAID‐ERD, and allergic rhinitis: (A) LoS†, (B) NC†, (C) TSS†, (D) PNIF†, (E) NPS, (F) UPSIT, and (G) SNOT‐22 total score. †Data points are monthly averages (mean of the previous 28 days). Each of the imputed complete data was analyzed by fitting an ANCOVA model with the corresponding baseline value, treatment group, asthma/NSAID‐ERD status, prior surgery history, region, and study indicator as covariates. Abbreviations: ANCOVA, analysis of covariance; CRSwNP, chronic rhinosinusitis with nasal polyps; LoS, loss of smell; LS, least squares; NC, nasal congestion; NSAID‐ERD, nonsteroidal anti‐inflammatory drug‐exacerbated respiratory disease; PNIF, peak nasal inspiratory flow; SNOT‐22, 22‐item Sino‐Nasal Outcome Test; TSS, total symptom score