February 25, 2013
Asthma Drug Found Effective In Treatment Of Chronic Hives, Itchiness
Lawrence LeBlond for redOrbit.com - Your Universe Online
Though not the most common occurrence, researchers do sometimes discover drugs marketed for one particular disease, disorder or illness can work well in treating a totally different condition. One recent discovery was that of a popular diabetes drug that showed promise in treating ovarian cancer. Another--not so recent--discovery was of the antidepressant drug Wellbutrin that proved to be effective in helping smokers kick the habit.Now, an international team of scientists has found an asthma drug is showing promise in relieving itchiness in patients who have chronic hives. The drug in question, omalizumab (Xolair), which was first released to treat allergic asthma in 2003, has been found in a Phase 3 clinical trial to significantly reduce hives and itchiness with a monthly high-dose injection.
Specifically, the drug has shown promise in treating teens and adults chronically afflicted with hives and severe, itchy rash, who have not responded well to traditional antihistamine treatment.
Results of the study have been published online Sunday (Feb 24) in the New England Journal of Medicine (NEJM). The released paper coincides with a presentation of findings at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio, Texas.
For the study, carried out at a total of 55 medical centers, omalizumab was tested on 323 people whom antihistamine therapy failed to treat their allergic asthma, known as chronic idiopathic urticaria or chronic spontaneous uticaria.
The study participants were randomly assigned to receive monthly injections of 75, 150 or 300 milligrams of omalizumab or a placebo for 12 weeks. The participants were also followed for four months after treatment stopped.
For those treated with the highest dosage -- 300 mg -- a 71-percent reduction in the amount of itchiness was recorded. For those taking the second-highest allotment -- 150 mg -- a 57-percent reduction was observed. A 41-percent reduction was recorded in those taking the lowest dosage, only slightly higher than the placebo group, who had a 37-percent reduction in itchiness.
The researchers found those taking the two highest dosages also experienced less swelling and less severity of hives.
The study ran from 2009 to 2011 and included mostly women between the ages of 12 and 75. All study patients had chronic hives and rash for at least six months at the beginning of the study, with many having suffered for more than five years. All participants also had persistent hives, rash and itchiness while being treated with antihistamines.
For those who were on the highest dosage of omalizumab during the study, initial relief from symptoms was relatively quick, occurring within a week. By the study´s end, more than half (53 percent) of the patients in that group experienced a total elimination of all hives and 44 percent had no further incidents of hives, rash or itch.
“This is the magic bullet that patients have been waiting for for the last 40 years,” lead author Dr. Marcus Maurer, professor of dermatology and allergy at CharitÃ©-UniversitÃ¤tsmedizin in Berlin, said in a New York Times interview.
Dr. Jonathan Bernstein, an allergy specialist at the University of Cincinnati, said the study was well designed and the results were encouraging. He said omalizumab, while not a cure, will “advance our ability to manage these patients.”
If approved, it could bring much relief to those who suffer from the chronic hives, rash and itchiness. It could also help in the reduction of swelling of the lips, tongue and other soft tissues.
The drug is believed to deactivate Immunoglobulin E (IgE), an antibody that plays a critical role in allergic response. It is possible patients suffering from chronic hives may have higher levels of IgE, which binds to immune cells, signaling them to release proteins that cause allergic inflammation, according to Dr. Karin Rosen, a study coauthor and medical director of Genentech, a biotechnology and human genetics company and part funder of the study.
Study coauthor Sarbjit (Romi) Saini, MD, a Johns Hopkins allergist and immunologist, said, "Physicians and patients may now have a fast, safe and well-tolerated treatment option to consider before prescribing even more antihistamines, which can be highly sedating.
“Patients suffering with this condition need more and better treatment options because chronic hives and rash are profoundly hard to treat and can be very debilitating," he said in a statement. He has been studying omalizumab since 2005 and pointed out fewer than half of those treated with the asthma-marketed drug responded to traditional antihistamines.
He added the new study results offer significant evidence omalizumab not only works for treating hives and itchiness, but does so more safely than other drugs, which can carry potentially severe and toxic side effects. With omalizumab, the most common side effect observed was headache. No study participants died or suffered anaphylactic shock, or had to withdraw due to adverse reactions during the study, he noted.
Chronic idiopathic urticarial affects some 3 million Americans, according to Saini. He said many of these cases may or may not involve swelling, but most cases seen do involve more than twice as many women than men. Some patients with severe cases have swelling of the eyes, hands, face, lips, and throat and can have extreme difficulty breathing. The symptoms can be so overpowering that many will not leave the house, losing several days of work at a time when severe flare-ups occur.
Saini said the research will continue with the goal of understanding the relationship between omalizumab and the IgE antibody, as well as the underlying mechanism of chronic idiopathic urticaria and to explain why omalizumab is so effective.
Along with funding from Genentech, the study also received monetary support from Novartis and several other pharmaceutical manufacturers.