Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy.
Mostra el registre complet Registre parcial de l'ítem
- dc.contributor.author Casale, Thomas B.ca
- dc.contributor.author Bernstein, Jonathan A.ca
- dc.contributor.author Maurer, Marcusca
- dc.contributor.author Saini, Sarbjit S.ca
- dc.contributor.author Trzaskoma, Benjaminca
- dc.contributor.author Chen, Hubertca
- dc.contributor.author Clive, Grattanca
- dc.contributor.author Giménez Arnau, Anna Mariaca
- dc.contributor.author Kaplan, Allen P.ca
- dc.contributor.author Rosén, Karinca
- dc.date.accessioned 2015-11-09T07:56:13Z
- dc.date.available 2015-11-09T07:56:13Z
- dc.date.issued 2015
- dc.description.abstract BACKGROUND: Data from the 3 omalizumab pivotal trials in patients with chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU) represent the largest database of patients reported to date with refractory disease (omalizumab, n = 733; placebo, n = 242). OBJECTIVE: The objective of this study was to compare results from ASTERIA I and II, which included only approved doses of H1-antihistamine as background therapy based on regulatory authority requirements, to those from GLACIAL, which permitted higher doses of H1-antihistamines as well as other types of background therapy, in a post hoc analysis. METHODS: Efficacy data from the placebo, omalizumab 150-mg, and omalizumab 300-mg treatment arms of ASTERIA I and II were pooled and analyzed (n = 162 and n = 160, respectively). The 300-mg treatment arm analyses were compared with the analysis of data from GLACIAL (n = 252) using analysis of covariance models. The key efficacy endpoint was change from baseline to week 12 in mean weekly itch severity score (ISS); other endpoints were also evaluated. Safety data were pooled from all 3 studies. RESULTS: Mean ISS was significantly reduced from baseline at week 12 in the pooled ASTERIA I and II omalizumab 150- and 300-mg treatment arms and in the GLACIAL omalizumab 300-mg arm. The weekly ISS reduction magnitude at week 12 was similar between the omalizumab 300-mg groups in the ASTERIA I and II pooled and GLACIAL studies. Similar treatment effect sizes were observed across multiple endpoints. Omalizumab was well tolerated and the adverse-event profile was similar regardless of background therapy for CIU/CSU. The overall safety profile was generally consistent with omalizumab therapy in allergic asthma. CONCLUSION: Omalizumab 300 mg was safe and effective in reducing CIU/CSU symptoms regardless of background therapy.ca
- dc.description.sponsorship the study design was funded by Genentech, Inc., and Novartis Pharmaceuticals Corporation
- dc.format.mimetype application/pdfca
- dc.identifier.citation Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H. et al. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-750.e1. doi: 10.1016/j.jaip.2015.04.015.ca
- dc.identifier.doi http://dx.doi.org/10.1016/j.jaip.2015.04.015
- dc.identifier.issn 2213-2201
- dc.identifier.uri http://hdl.handle.net/10230/25020
- dc.language.iso engca
- dc.publisher Elsevierca
- dc.relation.ispartof The Journal of Allergy and Clinical Immunology: In Practice. 2015 Sep-Oct;3(5):743-50
- dc.rights 2015 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). http://dx.doi.org/10.1016/j.jaip.2015.04.015ca
- dc.rights.accessRights info:eu-repo/semantics/openAccessca
- dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/)ca
- dc.subject.other Urticàriaca
- dc.subject.other Antihistamínicsca
- dc.title Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy.ca
- dc.type info:eu-repo/semantics/articleca
- dc.type.version info:eu-repo/semantics/publishedVersionca