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Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria

Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria BackgroundMany patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H1-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients.MethodsIn this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H1-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching).ResultsThe baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was −5.1±5.6 in the placebo group, −5.9±6.5 in the 75-mg group (P=0.46), −8.1±6.4 in the 150-mg group (P=0.001), and −9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each).ConclusionsOmalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H1-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The New England Journal of Medicine The New England Journal of Medicine

Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria

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References (28)

Publisher
The New England Journal of Medicine
Copyright
Copyright © 2013 Massachusetts Medical Society. All rights reserved.
ISSN
0028-4793
eISSN
1533-4406
DOI
10.1056/NEJMoa1215372
pmid
23432142
Publisher site
See Article on Publisher Site

Abstract

BackgroundMany patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H1-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients.MethodsIn this phase 3, multicenter, randomized, double-blind study, we evaluated the efficacy and safety of omalizumab in patients with moderate-to-severe chronic idiopathic urticaria who remained symptomatic despite H1-antihistamine therapy (licensed doses). We randomly assigned 323 patients to receive three subcutaneous injections, spaced 4 weeks apart, of omalizumab at doses of 75 mg, 150 mg, or 300 mg or placebo, followed by a 16-week observation period. The primary efficacy outcome was the change from baseline in a weekly itch-severity score (ranging from 0 to 21, with higher scores indicating more severe itching).ResultsThe baseline weekly itch-severity score was approximately 14 in all four study groups. At week 12, the mean (±SD) change from baseline in the weekly itch-severity score was −5.1±5.6 in the placebo group, −5.9±6.5 in the 75-mg group (P=0.46), −8.1±6.4 in the 150-mg group (P=0.001), and −9.8±6.0 in the 300-mg group (P<0.001). Most prespecified secondary outcomes at week 12 showed similar dose-dependent effects. The frequency of adverse events was similar across groups. The frequency of serious adverse events was low, although the rate was higher in the 300-mg group (6%) than in the placebo group (3%) or in either the 75-mg or 150-mg group (1% for each).ConclusionsOmalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H1-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.)

Journal

The New England Journal of Medicine – The New England Journal of Medicine

Published: Mar 7, 2013

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