San Antonio, TX (PRWEB) February 24, 2013
Omalizumab is an immunomodulator medication, which means it acts by directly changing the behavior of the immune system. While it is currently used to treat severe allergic asthma in those who are 12 years of age and older, a late-breaking abstract presented at the 2013 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) found that omalizumab also appears safe and effective in the treatment of patients suffering from chronic hives who are not successfully treated with antihistamines. Further data from the clinical trial is also being published in The New England Journal of Medicine.
“Many times the treatment of hives is successful with oral antihistamines that control the itch and recurrence of the rash. Yet there are patients with hives that last for long periods of time and are idiopathic, or without an identifiable cause,” said first author and AAAAI Executive Vice President Thomas B. Casale, MD, FAAAAI. “In some of these chronic hives patients, antihistamines are not successful, but from our clinical trials we’re seeing that omalizumab is safely able to provide relief when compared with a placebo.”
To assess the safety and effectiveness of this use of omalizumab, a total of 323 patients were enrolled in a global, 28-week, multicenter, randomized, double-blind, placebo-controlled study. Patients were between the ages of 12 and 75 with moderate to severe chronic idiopathic or spontaneous hives and also were not adequately treated with antihistamines.
At twelve weeks, the average change in weekly itch severity score from the baseline measurement was significantly greater for those patients who received 150 milligram (mg) and 300 mg doses of omalizumab versus the placebo group. However, this was not the case with the patients who received the lowest dose, 75 mg, of omalizumab.
Following this trend, significant differences in the change from baseline measures of average weekly hives activity scores were observed for the 150 and 300 mg omalizumab groups versus the placebo but not for the group given an omalizumab dose of 75 mg.
Further looking at effectiveness, the researchers found that the median time to a minimally important difference in weekly itch severity score occurred at week one for the 300 mg omalizumab dose group, week two for the 75 and 150 mg dose groups and week four for those who received the placebo. In regards to safety, the frequency and severity of any adverse events were similar across the groups.
“From the trial results, omalizumab appears rapidly effective and well-tolerated in patients with chronic hives that don’t respond to licensed doses of antihistamines,” said Dr. Casale. “The results of two other Phase III trials should be available later this year and will help in defining the ultimate efficacy and safety of omalizumab for chronic hives, as well as the most appropriate dosing regimen.”
The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,700 members in the United States, Canada and 60 other countries.