Claus Bachert, PhD, Ana R. Sousa, PhD, Valerie J. Lund, MD, Glenis K

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Presentation transcript:

Reduced need for surgery in severe nasal polyposis with mepolizumab: Randomized trial Claus Bachert, PhD, Ana R. Sousa, PhD, Valerie J. Lund, MD, Glenis K. Scadding, MD, Philippe Gevaert, MD, Shuaib Nasser, MD, Stephen R. Durham, MD, Marjolein E. Cornet, MD, Harsha H. Kariyawasam, PhD, Jane Gilbert, MSc, Daren Austin, PhD, Aoife C. Maxwell, PhD, Richard P. Marshall, PhD, Wytske J. Fokkens, PhD Journal of Allergy and Clinical Immunology Volume 140, Issue 4, Pages 1024-1031.e14 (October 2017) DOI: 10.1016/j.jaci.2017.05.044 Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 1 Patient flow through the study. *One patient randomized to the mepolizumab group received placebo in error; this patient is included in the safety population for placebo. †Protocol deviations were incorrect treatment/dose (n = 3), did not meet inclusion criteria (n = 1), and smoked during the study (n = 1). ‡Before a protocol amendment that discontinued recruitment to the extension study, patients were given the option to enter the extension study. Patients were eligible to enter the extension if they were judged to no longer have a requirement for surgery according to the criteria defined in Table E2. Results from the extension phase are not presented because of low patient numbers. PP, Per-protocol. Journal of Allergy and Clinical Immunology 2017 140, 1024-1031.e14DOI: (10.1016/j.jaci.2017.05.044) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 2 Efficacy. A, Percentage of patients meeting the criteria for surgery over time (missing data imputed as nonresponders). B, Mean nasal polyposis severity VAS score for nasal polyposis. C, Least squares (LS) mean change from baseline in total endoscopic nasal polyp score (ITT population [post hoc output using last observation carried forward]). *P ≤ .05 and **P ≤ .01. Bars represent 95% CIs. VAS, 0 to 10 cm (0 = not troublesome and 10 = worst possible troublesome). Journal of Allergy and Clinical Immunology 2017 140, 1024-1031.e14DOI: (10.1016/j.jaci.2017.05.044) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig 3 Adjusted mean individual symptom VAS scores over time for rhinorrhea (A), mucus in throat (B), nasal blockage (C), and loss of smell (D; ITT population [adjusted for baseline, visit, treatment group, and visit-treatment group interaction]). Bars represent 95% CIs. *P ≤ .05, **P ≤ .01, and ***P ≤ .001. VAS, 0 to 10 cm (0 = not troublesome and 10 = worst possible troublesome). Journal of Allergy and Clinical Immunology 2017 140, 1024-1031.e14DOI: (10.1016/j.jaci.2017.05.044) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E1 Patients in the mepolizumab group achieving a 1-point or greater improvement in total endoscopic nasal polyp score at Week 25 according to baseline eosinophil count (ITT population; post hoc analysis). Journal of Allergy and Clinical Immunology 2017 140, 1024-1031.e14DOI: (10.1016/j.jaci.2017.05.044) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions

Fig E2 Adjusted means for SNOT-22 results at Week 25 (ITT population). Missing data are not imputed; bars represent SEs. *P = .005. Journal of Allergy and Clinical Immunology 2017 140, 1024-1031.e14DOI: (10.1016/j.jaci.2017.05.044) Copyright © 2017 American Academy of Allergy, Asthma & Immunology Terms and Conditions