Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials - 05/09/20
, Jonathan Corren, MD c, Joaquim Mullol, MD, PhD d, Joseph Han, MD e, Stella E. Lee, MD f, Derrick Kaufman, PhD b, Monica Ligueros-Saylan, MD g, Monet Howard, MSc b, Rui Zhu, PhD b, Ryan Owen, PhD b, Kit Wong, PhD b, Lutaf Islam, DVM, MSc h, Claus Bachert, MD, PhD a, iAbstract |
Background |
Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by IgE hyperproduction and eosinophilic inflammation. The anti-IgE antibody, omalizumab, has demonstrated efficacy in patients with CRSwNP and comorbid asthma previously.
Objective |
Our aim was to determine omalizumab safety and efficacy in CRSwNP in phase 3 trials (POLYP 1 and POLYP 2).
Methods |
Adults with CRSwNP with inadequate response to intranasal corticosteroids were randomized (1:1) to omalizumab or placebo and intranasal mometasone for 24 weeks. Coprimary end points included change from baseline to week 24 in Nasal Polyp Score (NPS) and Nasal Congestion Score. Secondary end points included change from baseline to week 24 in Sino-Nasal Outcome Test-22 (SNOT-22) score, University of Pennsylvania Smell Identification Test, sense of smell, postnasal drip, runny nose, and adverse events.
Results |
Patients in POLYP 1 (n = 138) and POLYP 2 (n = 127) exhibited severe CRSwNP and substantial quality of life impairment evidenced by a mean NPS higher than 6 and SNOT-22 score of approximately 60. Both studies met both the coprimary end points. SNOT-22 score, University of Pennsylvania Smell Identification Test score, sense of smell, postnasal drip, and runny nose were also significantly improved for omalizumab versus placebo. In POLYP 1 and POLYP 2, the mean changes from baseline at week 24 for omalizumab versus placebo were as follows: NPS, –1.08 versus 0.06 (P < .0001) and –0.90 versus –0.31 (P = .0140); Nasal Congestion Score, –0.89 versus –0.35 (P = .0004) and –0.70 versus –0.20 (P = .0017); and SNOT-22 score, –24.7 versus –8.6 (P < .0001) and –21.6 versus –6.6 (P < .0001). Adverse events were similar between groups.
Conclusion |
Omalizumab significantly improved endoscopic, clinical, and patient-reported outcomes in severe CRSwNP with inadequate response to intranasal corticosteroids, and it was well tolerated.
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Key words : Nasal polyps, rhinosinusitis, omalizumab, quality of life, nasal obstruction, IgE, allergy, asthma
Abbreviations used : AE, AQLQ, CRS, CRSwNP, FAS, FESS, HRQoL, INCS, LSM, MCID, NCS, NPS, NSAID, OR, QoL, SCS, SNOT-22, TNSS, UPSIT
Plan
| This study was funded by Genentech, Inc, a member of the Roche Group, and Novartis Pharma AG. Third-party writing assistance was provided by Mark Snape, MBBS, CMPP, and Nicole Tom, PhD, of Envision Pharma Inc, and funded by Genentech, Inc, a member of the Roche Group, and Novartis Pharmaceuticals Corporation. |
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| Disclosure of potential conflict of interest: P. Gevaert is a speaker and advisory board member for Ablynx, ALK, Argenx, Genentech, Inc, Hal Allergy, Novartis, Regeneron, Roche, Sanofi, and Stallergenes. T. A. Omachi, D. Kaufman, M. Howard, R. Zhu, R. Owen, and K. Wong are employees of Genentech, Inc, a member of the Roche Group. J. Corren is a consultant for AstraZeneca, Genentech, Inc, Novartis, Regeneron, and Sanofi and a speaker bureau member for AstraZeneca and Genentech, Inc, and he has received grants to his institution from Genentech, Inc, Regeneron, and Sanofi. J. Mullol is a speaker, advisory board member, and recipient of research grants from ALK-Abelló, AstraZeneca, Genentech, Inc, GlaxoSmithKline, Menarini, Mitsubishi-Tanabe, MSD, Mylan, Novartis, Sanofi-Regeneron, and the Uriach Group. J. Han is an advisory board member for Genentech, Inc, and Sanofi-Regeneron, and an investigator for Amgen, AstraZeneca, GlaxoSmithKline, Novartis, and Sanofi-Regeneron. S.E. Lee has been an investigator for AstraZeneca, Genentech, Inc, GlaxoSmithKline, Regeneron, and Sanofi, and an advisory board member for AstraZeneca, Genentech, Inc, GlaxoSmithKline, Sanofi, and Regeneron. M. Ligueros-Saylan is an employee of Novartis Pharmaceuticals Corporation. L. Islam is an employee of Roche. C. Bachert is a speaker and advisory board member for ALK, ASIT Biotech, AstraZeneca, GlaxoSmithKline, Mylan, Novartis, Sanofi, and Stallergenes. |
Vol 146 - N° 3
P. 595-605 - septembre 2020 Retour au numéro
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