Real-world effectiveness of dupilumab in a European cohort of chronic rhinosinusitis with nasal polyps (CHRINOSOR) - 26/11/24

Doi : 10.1016/j.jaci.2024.10.016

Sven F. Seys, PhD ^a,^⁎ , Sven Schneider, MD, PhD ^b, Joost de Kinderen, MBA, MSc, MA ^a, Sietze Reitsma, MD, PhD ^c, Carlo Cavaliere, MD, PhD ^d, Peter-Valentin Tomazic, MD, PhD ^e, Christina Morgenstern, PhD ^b, Geoffrey Mortuaire, MD, PhD ^f, Martin Wagenmann, MD, PhD ^g, Giulia Bettio, MSc ^a, Andrea Ciofalo, MD, PhD ^d, Zuzana Diamant, MD, PhD ^h,^i,^j, Julia Eckl-Dorna, MD, PhD ^b, Wytske J. Fokkens, MD, PhD ^c, Clemens Holzmeister, MD ^e, Gert Mariën, MSc ^a, Simonetta Masieri, MD, PhD ^k, Josje Otten, MD ^c, Kathrin Scheckenbach, MD ^g, Aldine Tu, MSc ^b, Claus Bachert, MD, PhD ^l,^m
and the
CHRINOSOR consortium^{^∗}
CHRINOSOR consortium members are listed in the Acknowledgments section.
Isam Alobid, MD, PhD, Alexandros Andrianakis, MD, Peter W. Hellings, MD, PhD, Claire Hopkins, MD, PhD, Valérie Hox, MD, PhD, Anette Kjeldsen, MD, PhD, Anu Laulajainen-Hongisto, MD, PhD, Valerie Lund, MD, MS, Laura Van Gerven, MD, PhD

^a Galenus Health, Hasselt, Belgium
^b Department of Otorhinolaryngology, Head and Neck Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria
^c Department of Otorhinolaryngology and Head/Neck Surgery, Amsterdam University Medical Centres, Amsterdam, The Netherlands
^d Department of Sense Organs, Sapienza University, Rome, Italy
^e Department of General ORL, Head and Neck Surgery, Medical University of Graz, Graz, Austria
^f Otorhinolaryngology–Head and Neck Department, Huriez Hospital, Centre Hospitalier Universitaire Lille, Lille, France
^g Department of Otorhinolaryngology, Universitätsklinikum Düsseldorf, Dusseldorf, Germany
^h Allergy and Clinical Immunology Research Group, Department of Microbiology, Immunology & Transplantation, Katholieke Universiteit Leuven, Leuven, Belgium
ⁱ Department of Respiratory Medicine, First Faculty of Medicine, Charles University and Thomayer Hospital, Prague, Czech Republic
^j Department of Clinical Pharmacy and Pharmacology, University Groningen, University Medical Center Groningen, Groningen, The Netherlands
^k Department of Oral and Maxillofacial Sciences, Sapienza University, Rome, Italy
^l Department of Otorhinolaryngology, Upper Airways Research Laboratory, Ghent University, Ghent, Belgium
^m Clinic for ENT diseases and Head and Neck Surgery, University Clinic Münster, Münster, Germany

^∗Corresponding author: Sven Seys, PhD, Galenus Health, Hendrik van Veldekesingel 150, 3500 Hasselt, Belgium.Galenus HealthHendrik van Veldekesingel 150Hasselt3500Belgium

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Abstract

Background

Pivotal studies with dupilumab demonstrated clinically relevant improvements in nasal polyp score, symptom score, and quality-of-life score in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Objective

We evaluated the effectiveness of dupilumab in a large-scale CRSwNP cohort from 6 European tertiary-care centers.

Methodology

Nasal polyp score, Sinonasal Outcome Test 22 score, visual analog scale for total sinus symptoms, loss of smell, and nasal blockage, and Asthma Control Test (ACT) score were collected from hospital records and assessed at baseline and again at 24 and 52 weeks’ treatment with dupilumab in CRSwNP patients. Treatment effectiveness was evaluated in relation to demographic and lifestyle factors, sinus surgery history, presence of comorbidities, and blood eosinophil counts (BEC). Treatment response was evaluated according to European Forum for Research and Education in Allergy and Airway Diseases (EUFOREA) 2021 criteria.

Results

All patient outcomes improved at 24 and 52 weeks’ treatment compared to baseline. Dupilumab showed effectiveness independent of age, sex, body mass index, smoking status, prior sinus surgery, presence of asthma, nonsteroidal anti-inflammatory drug–exacerbated respiratory disease, allergy, or baseline BEC. A total of 92.5% and 94.4% showed an improvement in at least 1 EUFOREA criterion at 24 and 52 weeks, respectively; 54.4% and 68.2% met all 4 of the more stringent EUFOREA criteria at 24 and 52 weeks, respectively.

Conclusions

Real-world evaluation of dupilumab effectiveness demonstrates a robust and sustained response in at least two thirds of patients at 52 weeks’ treatment. Favorable treatment response was independent of the number of sinus surgery procedures, major comorbidities, or baseline systemic levels of type 2 inflammation.

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Key words : Chronic rhinosinusitis, nasal polyps, biologic therapy, real-world evidence, asthma, sinus surgery, effectiveness, dupilumab

Abbreviations used : ACT, BEC, BMI, CHRINOSOR, CRS, CRSwNP, ESS, EUFOREA, IQR, LoS, NERD, NPS, QoL, SNOT-22, VAS