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Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies
| Filename | 245. Zazzali et al., Angioedema omalizumab CIU CSU, AAAI 2016.pdf |
| Filesize | 469,26 kB |
| Version | o.245 |
| Date added | Juli 30, 2020 |
| Downloaded | 0 times |
| Category | Original Work |
| Authors | Zazzali, J. L., Kaplan, A., Maurer, M. Raimundo, K., Trzaskoma, B., Solari, P. G., Antonova, E., Mendelson, M., and Rosén, K. |
| Citation | Zazzali, J. L., Kaplan, A., Maurer, M. Raimundo, K., Trzaskoma, B., Solari, P. G., Antonova, E., Mendelson, M., and Rosén, K.: Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann. Allergy Asthma Immunol. 2016: 117; 370-377. |
| Corresponding authors | Antonova, E. |
| DocNum | O.245 |
| DocType | |
| Edition; Page | 117; 370-377 |
| IF | 3.72 |
| Publisher | Ann. Allergy Asthma Immunol. |
| ReleaseDate | 2016 |
Background: Angioedema, present in some patients with chronic idiopathic/spontaneous urticaria (CIU/CSU), may have a negative effect on patient quality of life.
Objective :To describe patient-reported angioedema and its management in the pivotal omalizumab studies(ASTERIA I, ASTERIA II, GLACIAL).
Methods: Enrolled patients with CIU/CSU remained symptomatic despite treatment with histamine1(H1)-antihistamines at licensed doses (ASTERIA I, ASTERIA II) or H1-antihistamines at up to 4 times the approveddose plus H2-antihistamines and/or a leukotriene receptor antagonist (GLACIAL). All studies administeredomalizumab (75,150, or 300 mg in ASTERIA I and ASTERIA II; 300 mg in GLACIAL) or placebo subcutaneouslyevery 4 weeks for at least 12 weeks. Urticaria Patient Daily Diary entries were completed by patients andsummarized.
Results: At baseline, angioedema prevalence was higher in GLACIAL (53.1%) than in ASTERIA I (47.5%) orASTERIA II (40.7%). The mean proportion of angioedema-free days during weeks 4 to 12 was greater forpatients treated with 300 mg of omalizumab than placebo in ASTERIA I (96.1% vs 88.2%,P<.001), ASTERIA II(95.5% vs 89.2%,P<.001), and GLACIAL (91.0% vs 88.7%,P¼.006). Most patient-reported angioedema wasmanaged by low-intensity interventions (doing nothing or taking medication).
Conclusion: Treatment with 300 mg of omalizumab was efficacious in reducing patient-reported angioe-dema. Low-intensity interventions were generally used to manage angioedema episodes.
Trial Registration: clinicaltrials.govIdentifiers: NCT01287117 (ASTERIA I), NCT01292473 (ASTERIA II), andNCT01264939 (GLACIAL).
(Last update: 12.2023)
| Number of original publications in peer-reviewed journals: | 580 |
| Number of reviews in peer-reviewed journals: | 210 |
| Number of publications (original work and reviews) in peer-reviewed journals: | 790 |
| Cumulative IF for original publications in peer-reviewed journals: | 4196.39 |
| Cumulative IF for reviews in peer-reviewed journals: | 1409.32 |
| Cumulative IF of publications (original work & reviews) in peer-reviewed journals: | 5605.71 |
| Total number of citations: 36,836, h-index: 99 (Web of Science December 2023) | 36836 |
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