[HTML][HTML] Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria
New England Journal of Medicine, 2013•Mass Medical Soc
Background Many 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. 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 …
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. 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 …
Background
Many 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.
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 (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 H1-antihistamines. (Funded by Genentech and Novartis Pharma; ClinicalTrials.gov number, NCT01292473.)
The New England Journal Of Medicine