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.).





Polls results
1

On a scale of 1 to 10, rate how much this article will change your clinical practice?

NO change
BIG change
0% Article relates to my practice (0/0)
0% Article does not relate to my practice (0/0)
0% Undecided (0/0)
2

Will this article lead to more cost-effective healthcare?

0% Yes (0/0)
0% No (0/0)
0% Undecided (0/0)
3

Was this article biased? (commercial or personal)

0% Yes (0/0)
0% No (0/0)
0% Undecided (0/0)
4

What level of evidence do you think this article is?

0% Level 1 (0/0)
0% Level 2 (0/0)
0% Level 3 (0/0)
0% Level 4 (0/0)
0% Level 5 (0/0)