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
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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