Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria

Marcus Maurer, Karin Roseń, Hsin Ju Hsieh, Sarbjit S Saini, Clive Grattan, Ana Gimeneź-Arnau, Sunil Agarwal, Ramona Doyle, Janice Canvin, Allen Kaplan, Thomas Casale

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H 1-antihistamines, even at high doses. In phase 2 trials, omalizumab, an IgE monoclonal antibody that targets IgE and affects mast-cell and basophil function, has shown efficacy in such patients. METHODS: In 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). RESULTS: The 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 (P1-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.)

Original languageEnglish (US)
Pages (from-to)924-935
Number of pages12
JournalNew England Journal of Medicine
Volume368
Issue number10
DOIs
StatePublished - Mar 7 2013

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Urticaria
Histamine Antagonists
Immunoglobulin E
Placebos
Basophils
Subcutaneous Injections
Therapeutics
Pruritus
Double-Blind Method
Mast Cells
Monoclonal Antibodies
Observation
Safety
Omalizumab

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Maurer, M., Roseń, K., Hsieh, H. J., Saini, S. S., Grattan, C., Gimeneź-Arnau, A., ... Casale, T. (2013). Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. New England Journal of Medicine, 368(10), 924-935. https://doi.org/10.1056/NEJMoa1215372

Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. / Maurer, Marcus; Roseń, Karin; Hsieh, Hsin Ju; Saini, Sarbjit S; Grattan, Clive; Gimeneź-Arnau, Ana; Agarwal, Sunil; Doyle, Ramona; Canvin, Janice; Kaplan, Allen; Casale, Thomas.

In: New England Journal of Medicine, Vol. 368, No. 10, 07.03.2013, p. 924-935.

Research output: Contribution to journalArticle

Maurer, M, Roseń, K, Hsieh, HJ, Saini, SS, Grattan, C, Gimeneź-Arnau, A, Agarwal, S, Doyle, R, Canvin, J, Kaplan, A & Casale, T 2013, 'Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria', New England Journal of Medicine, vol. 368, no. 10, pp. 924-935. https://doi.org/10.1056/NEJMoa1215372
Maurer, Marcus ; Roseń, Karin ; Hsieh, Hsin Ju ; Saini, Sarbjit S ; Grattan, Clive ; Gimeneź-Arnau, Ana ; Agarwal, Sunil ; Doyle, Ramona ; Canvin, Janice ; Kaplan, Allen ; Casale, Thomas. / Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. In: New England Journal of Medicine. 2013 ; Vol. 368, No. 10. pp. 924-935.
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