Publications
Publications, Books, Book Chapters and Reviews by Prof. Marcus Maurer, MD
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A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine– refractory chronic idiopathic urticaria
Filename | 117. Saini et al, Randomized, single-dose omalizumab, 2011 JACI.pdf |
Filesize | 597.90 KB |
Version | o.117 |
Date added | May 30, 2020 |
Downloaded | 0 times |
Category | Original Work |
Authors | Saini, S., Rosen, K. E., Hsieh, H. J., Wong, D., Conner, E., Kaplan, A., Spector, S., and Maurer, M. |
Citation | Saini, S., Rosen, K. E., Hsieh, H. J., Wong, D., Conner, E., Kaplan, A., Spector, S., and Maurer, M.: A randomized, placebo-controlled, dose-ranging study of single-dose omalizumab in patients with H1-antihistamine-refractory chronic idiopathic urticaria. J. Allergy Clin. Immunol. 2011: 128; 567-573. IF: 11.00 |
Corresponding authors | Saini, S. |
DocNum | o.117 |
DocType | |
Edition; Page | 128; 567-573 |
IF | 11.00 |
Publisher | J. Allergy Clin. Immunol. |
ReleaseDate | 2011 |
Background: Proof-of-concept studies with omalizumab in patients with chronic idiopathic urticaria (CIU) have shown significant decreases in mean urticaria activity scores (UASs).
Objective: We sought to evaluate the efficacy and safety of omalizumab in patients with CIU who remain symptomatic despite concomitant H1-antihistamine therapy.
Methods: This phase II, prospective, double-blind, placebocontrolled, dose-ranging study investigated omalizumab in patients aged 12 to 75 years in the United States and 18 to 75 years in Germany with a UAS over 7 days (UAS7) of 12 or greater despite antihistamine therapy. Patients were randomized 1:1:1:1 to receive a single subcutaneous dose of 75, 300, or 600 mg of omalizumab or placebo added to a stable dose of H1-antihistamine. The primary efficacy outcome was change from baseline to week 4 in UAS7. Patients were followed for an
additional 12 weeks to monitor safety. Results: Ninety patients from the United States or Germany were enrolled. Both the 300-mg omalizumab group (219.9 vs 26.9, P < .001) and the 600-mg omalizumab group (214.6 vs 26.9, P 5 .047) showed greater improvement versus the placebogroup in UAS7. No meaningful difference was observed for the 75-mg omalizumab group. Similar results were seen for key secondary end points of weekly hive and itch scores. Onset of effect occurred after 1 to 2 weeks. Omalizumab was welltolerated, and the incidence of adverse events was similar across treatment groups.
Conclusion: This study demonstrated that a fixed dose of 300 or 600 mg of omalizumab provides rapid and effective treatment of CIU in patients who are symptomatic despite treatment with H1- antihistamines.
(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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