Медицинские услуги
© 2017-2021 Сайт «БЕЛМЕД.БАЙ», info@belmed.by
Sept. 2, 2003 — On-going investigations show the revolutionary anti-IgE drug Omalizumab (trade name Xolair) is safe and effective long-term — for one year — in controlling severe allergic asthma in adults and children. Two reports on the results were published in this month's Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology (ACAAI).
"It was reassuring to see the longer term results scientifically proven, since we had such good feedback from patients throughout our investigation," said Bobby Q. Lanier, M.D., of the Lanier Education and Research Network in Fort Worth, Texas.
Results of the 24-week investigation were consistent with a previous 28-week clinical trial. A total of 460 patients participated in the double-blind extension phase of the study. Omalizumab-treated patients experienced significantly fewer exacerbations compared to those taking placebo despite a sustained significant reduction in their use of inhaled corticosteroids.
"Anti-IgE is now being prescribed for moderate-to-severe persistent asthma in adults and adolescents in whom asthma attacks are triggered by an allergic reaction to things like pollen, mold, dust mites and pet dander. Initially, we have had better than anticipated acceptance of this new drug by insurance companies, although it seems to vary quite a bit from region to region," Dr. Lanier said.
Overall, adverse reactions were similar in the omalizumab and placebo groups during both the extension phase and the full 52 weeks of the trial. The majority of adverse events were mild or moderate in severity. Six patients (2.4 percent) in the omalizumab group and three patients (1.4 percent) taking placebo had at least one adverse event suspected to be related to the study drug during the extension phase, most commonly headache. No adverse events indicating possible systemic immunologic reactions were reported. None of the serious adverse events experienced by three patients in each treatment group were considered to be drug related.
People with less severe asthma, asthma not triggered by allergies, or other types of allergic disease, such as hay fever and food allergies, are not yet candidates for the new treatment.
In an extended study with 202 children (ages 6 to 12 years) also published this month, investigators found long-term treatment of allergic asthma with omalizumab is safe and well tolerated. A total of 225 pediatric patients participated in the double-blind core 28-week study, and a total of 202 children participated in the open-label extension trial.
Investigators concluded there was no evidence that new or more serious adverse events occur with a longer treatment period with omalizumab. Among the patients treated for one year with omalizumab, 81.4 percent did not require other concomitant asthma medication during the extension study.
Anti-IgE is administered through an injection one or two times each month. It is the first drug to stop an allergic reaction before it starts by blocking the antibody that causes the reaction. Other therapies treat the symptoms of allergies or block reactions to specific allergens.
It's estimated that among the 17 million Americans who have asthma, half of adults and 80 percent of children have allergic asthma. An estimated 5,000 die of asthma every year.
"Since allergic asthma is the most common chronic disease in children, and a major cause of school absenteeism, this breakthrough drug may have a significant impact on the health and welfare of these children," Dr. Berger said.
Anti-IgE studies are continuing and allergists expect the treatment to be available eventually for a greater number of patients. Many patients with mild to moderate asthma who are not candidates for anti-IgE now could be doing more to control their disease according to Dr. Berger. In fact, it is often people with these milder cases who end up in the emergency room because they don't recognize the need for aggressive control of their asthma. The ACAAI recommends the following treatment guidelines to help asthma patients determine if they are getting the most effective care.
If you have asthma, your doctor should:
· Test and monitor your asthma symptoms, including taking a detailed medical history, performing a physical examination, measuring lung function with special tests and ordering additional tests as needed.
· Obtain allergy testing to identify environmental factors that might be triggering your asthma.
· Identify and take steps to control asthma triggers, like animal dander, dust mites, pollen, exercise and cigarette smoke.
· Explain treatment options, including both long-term and quick-relief drugs for asthma, and anti-allergy therapies like allergy shots.
· Provide ongoing education and support.
· Develop a written plan to monitor how well the disease is being controlled.