Publications
Publications, Books, Book Chapters and Reviews by Prof. Marcus Maurer, MD
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Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy
Filename | 163. Kaplan et al,Omalizumab in pat. with sympt. JACI 2013.pdf |
Filesize | 728.80 KB |
Version | o.163 |
Date added | June 5, 2020 |
Downloaded | 0 times |
Category | Original Work |
Tags | Chronic idiopathic urticaria, chronic spontaneous urti- caria, H1-antihistamine, H2-antihistamines, hive, itch, leukotriene receptor antagonist, omalizumab, Pruritus, wheal |
Authors | Kaplan, A., Ledford, D., Ashby, M., Canvin, J, Zazzali, J. L., Conner, E., Veith, J., Kamath, N., Staubach, P., Jakob, T., Stirling, R. G., Kuna, P., Berger, W., Maurer, M. and Rosén, K. |
Citation | Kaplan, A., Ledford, D., Ashby, M., Canvin, J, Zazzali, J. L., Conner, E., Veith, J., Kamath, N., Staubach, P., Jakob, T., Stirling, R. G., Kuna, P., Berger, W., Maurer, M. and Rosén, K.: Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J. Allergy Clin. Immunol. 2013: 132; 101-109. |
Corresponding authors | Rosén, K. |
DocNum | O.163 |
DocType | |
Edition; Page | 132; 101-109 |
IF | 11.25 |
Publisher | J. Allergy Clin. Immunol. |
ReleaseDate | 2013 |
Background: Patients with chronic idiopathic urticaria/ chronic spontaneous urticaria (CIU/CSU) often continue to experience symptoms despite receiving standard-of-care therapy with H1-antihistamines along with 1 or more add-on therapies.
Objectives: We sought to evaluate the safety and efficacy of 24 weeks of treatment with omalizumab in patients with persistent CIU/CSU despite treatment with H -antihistamines at up to 4 times the approved dose plus H2-antihistamines, leukotriene receptor antagonists, or both.
Methods: In this phase III study patients were randomized to receive 6 subcutaneous injections at 4-week intervals of either 300 mg of omalizumab or placebo, followed by a 16-week observation period. The primary objective of the study was to evaluate the overall safety of omalizumab compared with placebo. Efficacy (itch severity, hive, and urticaria activity scores) was evaluated at weeks 12 and 24.
Results: The overall incidence and severity of adverse events and serious adverse events were similar between omalizumab and placebo recipients; the safety profile was consistent with omalizumab in patients with allergic asthma. At week 12, the mean change from baseline in weekly itch severity score was 28.6 (95% CI, 29.3 to 27.8) in the omalizumab group compared with 24.0 (95% CI, 25.3 to 22.7) in the placebo group (P < .001). Significant improvements were seen for additional efficacy end points at week 12; these benefits were sustained to week 24.
Conclusion: Omalizumab was well tolerated and reduced the signs and symptoms of CIU/CSU in patients who remained symptomatic despite the use of H1-antihistamines (up to 4 times the approved dose) plus H2-antihistamines, leukotriene receptor antagonists, or both. (J Allergy Clin Immunol 2013;132:101-9.)
(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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