Dupilumab Efficacy on Asthma Functional, Inflammatory, and Patient-Reported Outcomes across Different Disease Phenotypes and Severity: A Real-Life Perspective

Author:

Caminati Marco12ORCID,Maule Matteo12,Benoni Roberto3ORCID,Bagnasco Diego4ORCID,Beghè Bianca5,Braido Fulvio4,Brussino Luisa6ORCID,Cameli Paolo7ORCID,Candeliere Maria Giulia4,Carpagnano Giovanna Elisiana8,Costanzo Giulia9ORCID,Crimi Claudia1011ORCID,D’Amato Mariella12,Del Giacco Stefano9,Guarnieri Gabriella13ORCID,Yacoub Mona-Rita14ORCID,Micheletto Claudio15ORCID,Nicola Stefania6,Olivieri Bianca2ORCID,Pini Laura16ORCID,Schiappoli Michele2ORCID,Vaia Rachele12,Vianello Andrea12,Visca Dina17,Spanevello Antonio17,Senna Gianenrico12ORCID

Affiliation:

1. Department of Medicine, University of Verona, Piazzale L.A. Scuro, 37134 Verona, Italy

2. Allergy Unit and Asthma Center, Verona Integrated University Hospital, 37126 Verona, Italy

3. Department of Diagnostics and Public Health, University of Verona, 37129 Verona, Italy

4. Allergy and Respiratory Diseases Clinic, IRCCS Policlinico San Martino, University of Genoa, 16132 Genoa, Italy

5. AOU of Modena, University of Modena and Reggio Emilia, 41125 Modena, Italy

6. SCDU Immunologia e Allergologia, AO Ordine Mauriziano di Torino, 10137 Torino, Italy

7. Respiratory Diseases and Lung Transplantation Unit, Department of Medicine, Surgery and Neuroscience, University of Siena, 53100 Siena, Italy

8. Institute of Respiratory Disease, Department Translational Biomedicine and Neuroscience, University “Aldo Moro”, 70121 Bari, Italy

9. Department of Medical Sciences and Public Health, University of Cagliari, 09124 Cagliari, Italy

10. Department of Clinical and Experimental Medicine, University of Catania, 95124 Catania, Italy

11. Respiratory Medicine Unit, AOU Policlinico “G. Rodolico—San Marco”, 95123 Catania, Italy

12. Respiratory Department, Monaldi Hospital AO Dei Colli, Federico II University, 80131 Naples, Italy

13. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35122 Padova, Italy

14. Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy

15. Pulmonology Unit, Verona Integrated University Hospital, 37126 Verona, Italy

16. Respiratory Medicine Unit, ASST—“Spedali Civili” of Brescia, 25123 Brescia, Italy

17. Division of Pulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri, IRCCS, 21049 Tradate, Italy

Abstract

Dupilumab is currently approved for the treatment of Type 2 severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies have specifically reported on dupilumab efficacy on asthma outcomes as a primary objective in a real-life setting, in patients with and without CRSwNP. Our study aimed to explore the efficacy of dupilumab on functional, inflammatory, and patient-reported outcomes in asthma patients across different disease phenotypes and severity, including mild-to-moderate asthma coexisting with CRSwNP. Data from 3, 6, and 12 months follow-up were analyzed. Asthma (FEV1%, Tiffeneau%, ACT, FeNO, oral steroid use, exacerbation rate, and blood eosinophilia) and polyposis (SNOT22, VAS, NPS) outcomes showed a rapid (3 months) and sustained (6 and 12 months) significant change from baseline, despite most of the patients achieving oral steroid withdrawal. According to the sensitivity analysis, the improvement was not conditioned by either the presence of polyposis or severity of asthma at baseline. Of note, even in the case of milder asthma forms, a significant further improvement was recorded during dupilumab treatment course. Our report provides short-, medium-, and long-term follow-up data on asthma outcomes across different diseases phenotypes and severity, contributing to the real-world evidence related to dupilumab efficacy on upper and lower airways T2 inflammation.

Publisher

MDPI AG

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