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Omalizumab effective for refractory urticaria.

BERLIN -- Omalizumab proved effective and safe in patients with moderate to severe chronic urticaria refractory to antihistamines in a double-blind, placebo-controlled, multicenter trial.

Of the omalizumab-treated participants, 70% were free of all symptoms at 27 weeks, compared with 4.5% of placebo-treated controls.

"For those of you who know urticaria and know how well drugs do in urticaria patients, I think this is absolutely amazing. There's no other drug that can do this. Your favorite antihistamine can't achieve these levels. Plus, these are patients who have already been on pretty much everything else and didn't respond," Dr. Marcus Maurer commented at the annual congress of the European Academy of Dermatology and Venereology.

"This is definitely a drug to consider when you have patients who do not respond to your standard urticaria treatment," added Dr. Maurer, of Charite University Hospital, Berlin.

Omalizumab (Xolair) is a monoclonal antibody directed against IgE that is approved for treatment of severe allergic asthma. It binds to IgE, preventing it from binding to the IgE receptor on mast cells.

For their proof-of-concept study, Dr. Maurer and his coworkers restricted eligibility to patients who had one specific subtype of urticaria, autoallergic. These are patients with IgE antibodies directed to thyroid peroxidase as an autoantigen.

A total of 27 patients were randomized to omalizumab and 22 to placebo. Two subjects in the omalizumab arm dropped out during the study period, as did five in the control group, mainly due to lack of response.

The mean baseline score on an urticaria assessment scale was 25 out of a possible 42. At 6 months the score in the omalizumab group had dropped to 6, but the score remained unchanged in the control group. The omalizumab group also made significantly less use of rescue antihistamines.

Response to omalizumab occurred rapidly, within the first several weeks. "It's very different from asthma patients, who take a couple of months to respond," Dr. Maurer said.

"We're in desperate need of new therapies for patients who are resistant to nonsedating antihistamines," he said.

Questions that remain to be answered before omalizumab can earn an indication for urticaria include its efficacy in types other than autoallergic urticaria, the drug's mechanism of action, and optimal dosing.

Anecdotally, Dr. Maurer said that he and his colleagues have successfully treated patients with antihistamine-refractory spontaneous urticaria, cold urticaria, physical urticaria, cholinergic urticaria, solar urticaria, pressure urticaria, and other forms of the disease.

"It doesn't seem to matter what type of urticaria you suffer from. The benefit from Xolair is tremendous," Dr. Maurer said.

Audience members were quick to ask about the cost, which is high.

"It's about 500 euro [about $750] per injection, and these patients typically need one or two injections per month," Dr. Maurer replied. "But remember, these patients suffer tremendously, they miss work, and the other drugs are not cheap either."

Also in the developmental pipeline are small-molecule IgE inhibitors that are far less expensive to produce than biotech agents and are suitable for oral administration, he noted.

In a congress highlights lecture devoted to new developments in skin allergy, Dr. Torsten Zuberbier singled out the omalizumab study for mention, noting that its symptom-free rate of 70% is "fascinating."

"This is beautiful. Now the biologies are coming to dermatological allergy, and we're really going to start to learn more about the mechanisms of our dermatological diseases," said Dr. Zuberbier, professor of dermatology and head of the allergy branch at Charite University Hospital. He was not involved in Dr. Maurer's study.

The omalizumab study was funded by Genentech and Novartis, makers of Xolair. Dr. Maurer has served as a consultant to the companies.
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Title Annotation:DERMATOLOGY
Author:Jancin, Bruce
Publication:Internal Medicine News
Geographic Code:4EUGE
Date:Dec 1, 2009
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