Efficacy and safety of omalizumab in nasal polyposis: 2 randomized phase 3 trials
Autor: | Theodore A. Omachi, L. Islam, Claus Bachert, Rui Zhu, Philippe Gevaert, Jonathan Corren, Monica Ligueros-Saylan, Joseph K. Han, Joaquim Mullol, Kit Wong, Ryan Owen, Derrick Kaufman, Monet Howard, Stella E. Lee |
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Rok vydání: | 2020 |
Předmět: |
Male
SURGERY nasal Omalizumab THERAPY 0302 clinical medicine Adrenal Cortex Hormones Anti-Allergic Agents Medicine and Health Sciences Nasal polyps Immunology and Allergy 030223 otorhinolaryngology ADULT CHRONIC RHINOSINUSITIS Nose Rhinitis Minimal clinically important difference Middle Aged obstruction Treatment Outcome medicine.anatomical_structure Drug Therapy Combination Female IgE medicine.symptom medicine.drug Adult medicine.medical_specialty Immunology Nasal congestion Placebo 03 medical and health sciences Nasal Polyps Double-Blind Method Internal medicine otorhinolaryngologic diseases medicine Humans Sinusitis rhinosinusitis Asthma business.industry Functional endoscopic sinus surgery asthma allergy medicine.disease LIFE quality of life 030228 respiratory system Chronic Disease omalizumab business Mometasone Furoate |
Zdroj: | JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY |
ISSN: | 0091-6749 1097-6825 |
Popis: | 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. |
Databáze: | OpenAIRE |
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