Long-term efficacy and safety of omalizumab for nasal polyposis in an open-label extension study
| Autor: | Joaquim Mullol, Joseph K. Han, Rui Zhao, Kit Wong, Randall A. Ow, Monet Howard, L. Islam, Claus Bachert, Monica Ligueros-Saylan, Theodore A. Omachi, Stella E. Lee, Jonathan Corren, R. Saenz, Philippe Gevaert |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Adult
medicine.medical_specialty Immunology Nasal Congestion Score nasal obstruction Omalizumab Nasal congestion Placebo nasal corticosteroids Nasal Polyps Internal medicine Medicine and Health Sciences otorhinolaryngologic diseases Humans Immunology and Allergy Medicine Nasal polyps Sinusitis Adverse effect Rhinitis Asthma business.industry Minimal clinically important difference asthma medicine.disease Discontinuation Treatment Outcome quality of life Chronic Disease omalizumab IgE medicine.symptom business medicine.drug |
| Zdroj: | JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY |
| ISSN: | 0091-6749 1097-6825 |
| DOI: | 10.1016/j.jaci.2021.07.045 |
| Popis: | Background: Chronic rhinosinusitis with nasal polyps (CRSwNP) frequently remains uncontrolled despite maximal medical therapy and sinonasal surgery, presenting several unmet needs and challenges. Omalizumab previously demonstrated efficacy in CRSwNP in duplicate phase 3, randomized, placebo-controlled trials (POLYP 1, POLYP 2). Objective: This open-label extension evaluated the continued efficacy, safety, and durability of response of omalizumab in adults with CRSwNP who completed POLYP 1 or 2. Methods: After 24 weeks of omalizumab or placebo in POLYP 1 and 2, patients (n = 249) received open-label omalizumab plus background nasal mometasone therapy for 28 weeks and were subsequently followed for 24 weeks after omalizumab discontinuation. Efficacy end points assessed change from baseline for the coprimary end points, Nasal Polyp Score and Nasal Congestion Score, and the secondary end points of Sino-Nasal Outcome Test 22, Total Nasal Symptom Score and its components, and University of Pennsylvania Smell Identification Test scores. Safety objectives included incidence of adverse events and adverse events leading to omalizumab discontinuation. Results: Patients who continued omalizumab experienced further improvements across coprimary end points and secondary end points through 52 weeks. Patients who switched from placebo to omalizumab experienced favorable responses across end points through week 52 that were similar to POLYP 1 and 2 at week 24. After omalizumab discontinuation, scores gradually worsened over the 24-week follow-up, but remained improved from pretreatment levels for both groups. The safety profile was similar to previous reports. Conclusions: The efficacy and safety profile from this study supports extended omalizumab treatment up to 1 year for CRSwNP with inadequate response to nasal corticosteroids. |
| Databáze: | OpenAIRE |
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