The results of the study were presented at a news conference here at the American Academy of Allergy, Asthma & Immunology (AAAAI) meeting. The results were simultaneously published in the New England Journal of Medicine.
Xolair is approved for allergic asthma.
The study shows it lessens the symptoms of what's called chronic idiopathic urticaria. For people with the condition, hives can last for years. It's not clear what causes the hives, and often they don't get better with antihistamines, the only approved treatment for the condition.
The study involved 323 people who had hives for at least six months. They also didn't respond to eight weeks of antihistamines.
The participants "pretty much fit the profile that we see for these patients," says Thomas Casale, MD, from Creighton University in Omaha, Neb. "They tend to be adults, in their 40s, majority are female, and the duration of the disease can vary. One patient had it for over 60 years."
Participants were given three monthly injections of one of three doses of Xolair or a placebo. This was followed by a 16-week observation period.
Throughout the treatment and follow-up period, patients were allowed to remain on their regular antihistamine regimen. They were also allowed to take antihistamines as needed for quick relief of symptoms.
Casale says the rapid response to Xolair was "pretty amazing."
"In the high-dose group, for example, patients had a clear drop in their symptoms in a week. And that was apparent at two weeks for the [second-highest dose]. So it not only worked, but it worked fairly rapidly," he says.
At the end of treatment, 53% of patients receiving the high dose were completely free of hives. That compares with:
- 23% in the mid-dose group
- 18% in the low-dose group
- 10% in the placebo group
The participants also relied less on antihistamines. That's important "because if you can achieve good improvement and do it with less rescue [immediate-relief] antihistamine, then you know you have an even better treatment," Casale says.
During the 16-week follow-up period after people stopped using Xolair, symptoms slowly returned for most patients, he says.
"When they get off the study drug, they start developing a recurrence of symptoms, so that by the end of the 16 weeks off treatment, they were close to those patients who were treated with placebo. That would suggest that in this particular study, the duration of treatment may have to be longer. We don't know how long, to reduce hopefully a more sustained remission," Casale says.
Still, "the results of the study are significant. Previous studies suggested this treatment might work, but this study shows us a definitive dose that actually reduces symptoms. Antihistamines and steroids have been the main treatments and do not work well or have major side effects," says Wesley Burks, MD, president of AAAAI.
"The prevalence of chronic [hives] is significant, and until now, a good treatment to make the disease go away has not been available," he says.
There may be more research needed to determine how long people need to stay on Xolair to keep the hives away. But there is now hope where there used to be frustration.
"There are a lot of patients that we see with this problem, and it's one of those diseases where I walk in and tell a patient, 'Gee, I have nothing but bad news for you. You have hives, most of the time we don't find a cause, this could last for years, and we don't really have a treatment.' It's very frustrating," Burks says.
Genentech says it plans to seek FDA approval of Xolair for chronic hives.
To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals.
This study was sponsored by Xolair's manufacturers, Genentech and Novartis Pharma. A number of the study's co-authors are employees of the companies.
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