Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria
2013/02/24 by Marcus Maurer, Karin Rosén, Hsin-Ju Hsieh +13 · 1,087 citations
Immunology and Microbiology · Medicine · #Adverse effect #Anesthesia #Antibody #Antihistamine #Coagulation, Bradykinin, Polyphosphates, and Angioedema #Gastroenterology #Immunoglobulin E #Immunology #Internal medicine #Itching #Mast cells and histamine #Medicine #Omalizumab #Pathology #Placebo #Randomized controlled trial #Surgery #Urticaria and Related Conditions
paper · pdf · doi:10.1056/nejmoa1215372
published in New England Journal of Medicine 368(10), 924-935 (Massachusetts Medical Society)
openalex publication_date 2013/02/24 · openalex created_date 2025/10/10 · openalex updated_date 2026/08/05
Abstract
BACKGROUND: Many patients with chronic idiopathic urticaria (also called chronic spontaneous urticaria) do not have a response to therapy with H-antihistamines, even at high doses. In phase 2 trials, omalizumab, an anti-IgE monoclonal antibody [corrected] 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 H-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 (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). CONCLUSIONS: Omalizumab diminished clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of approved doses of H-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.).
Cited by
- The International Guideline for the Definition, Classification, Diagnosis and Management of Urticaria
- The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria
- Type‐2‐Inflammatory‐Diseases Share Comorbidities, Molecular Signatures, IL4/IL13 Genetics, and Response to IL4/IL13 Blockade
- Real‐life effectiveness of omalizumab in severe allergic asthma above the recommended dosing range criteria
- Basophils and allergic inflammation
- Unveiling chronic spontaneous urticaria pathophysiology through systems biology
- European Guideline on Chronic Pruritus. In cooperation with the European Dermatology Forum (EDF)
- Spectrum and Impact of Reported Side Effects of Omalizumab in Patients With Chronic Urticaria: A Long‐Term Multicentre Real‐World Study
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