Publications
Publications, Books, Book Chapters and Reviews by Prof. Marcus Maurer, MD
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Effect of omalizumab on angioedema in H1-antihistamine resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial
Filename | 261. Staubach et al., Omalizumab AE CSU X-ACT, Allergy 2016.pdf |
Filesize | 1,001.32 KB |
Version | o.261 |
Date added | July 30, 2020 |
Downloaded | 3 times |
Category | Original Work |
Tags | angioedema, chronic spontaneous urticaria, Chronic Urticaria Quality of Life Questionnaire, omalizumab, Quality of life |
Authors | Staubach, P., Metz, M., Chapman-Rothe, N., Sieder, C., Bräutigam, M., Canvin, J., and Maurer, M. |
Citation | Staubach, P., Metz, M., Chapman-Rothe, N., Sieder, C., Bräutigam, M., Canvin, J., and Maurer, M.: Effect of omalizumab on angioedema in H1-antihistamine resistant chronic spontaneous urticaria patients: results from X-ACT, a randomized controlled trial. Allergy 2016: 71; 1135-1144. |
Corresponding authors | Maurer, M. |
DocNum | O.261 |
DocType | |
Edition; Page | 71; 1135-1144 |
IF | 7.36 |
Publisher | Allergy |
ReleaseDate | 2016 |
Background: Chronic spontaneous urticaria (CSU) severely impacts quality of life(QoL), especially in patients with wheals and angioedema. Omalizumab is approved as add-on therapy for CSU patients; however, its effect on patients who are double-positive for wheals and angioedema has not been systematically studied.
Objective: The primary objective was to evaluate the efficacy of omalizumab vs placebo at week 28 using the Chronic Urticaria Quality of Life (CU-Q2oL) questionnaire. Number of angioedema-burdened days, time interval between successive angioedema episodes, disease activity, angioedema-specific and overall QoL impairment were secondary objectives.
Methods: X-ACT was a phase III, randomized, double-blind study conducted in24 centres (Germany), which selectively included CSU patients with angioedema and wheals. Patients were randomized (1 : 1) to omalizumab 300 mg or placebo(every 4 weeks up to week 24) (ClinicalTrials.gov number: NCT01723072).
Results: Of the 91 patients randomized to omalizumab (n=44) or placebo(n=47) at baseline, 68 completed the 28-week treatment phase (omalizumab, 35;placebo, 33). Omalizumab was superior to placebo in improving CU-Q2oL scoresat week 28 (P<0.001). There was a threefold improvement in angioedema-burdened days/week with omalizumab (0.3) vs placebo (1.1). The median time to firstrecurrence of angioedema was 57–63 days with omalizumab and<5 days withplacebo. Omalizumab significantly improved angioedema-specific QoL(P<0.001). The adverse events reported are in line with the established safety profile of omalizumab.
Conclusion: Omalizumab was an effective treatment option for patients with moderate-to-severe CSU symptoms and angioedema unresponsive to high doses of antihistamine treatment.
(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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