The AGH study is the first to investigate the efficacy and safety of using under-the-tongue tablets to treat grass pollen-induced allergic rhinoconjunctivitis, which affects an estimated 13 to 17 percent of children, and according to some studies, as many as 42 percent. Previous studies at AGH and other centers have shown sublingual immunotherapy is safe and effective for adults, and the therapy is now commonly used in Europe.
“The standard practice of treating young allergy suffers via weekly shots can deter children and their parents from seeking treatment, due to factors that include a fear of injections and the inconvenience of having to visit a doctor’s office for treatment,” said David P. Skoner, MD, Director of AGH’s Division of Allergy, Asthma and Immunology and the study’s senior author.
“This study shows that immunotherapy treatment with tablets can be a safe and effective option, one that could become an important new addition to our arsenal of treatments,” Dr. Skoner added
The study enrolled 345 children ages 5 to 17 and randomly assigned them to receive either a once-daily tablet or a placebo.
Researchers recorded the severity of participants’ allergy symptoms, and number of adverse events. Allergy symptoms and the need for additional medication improved 26 percent in the group receiving the tablets, compared to the placebo group. In addition, those receiving the medication ranked their quality of life 18 percent higher than those who received the placebo. Mild and transient local adverse events, such as mouth itching, were commonly reported. However, only one adverse event, which did not require hospitalization, was reported.
The subjects began taking the medication about 16 weeks before the start of the 2009 grass pollen season, and continued throughout the season.
Allergic conjunctivitis is an inflammation of the membrane covering the whites of the eyes. Its symptoms include redness, itching, swelling and increased tear production.
Typically, it is treated by avoiding the allergen and taking over-the-counter antihistamines or prescription nasal corticosteroids. Allergic immunotherapy, however, modifies the disease process and can give patients long-term symptom relief even after the therapy is discontinued. Currently, injection is the only U.S. Food and Drug Administration-approved method for administering allergic immunotherapy.
“An alternative to injections is much needed in the administration of allergic immunotherapy,” Dr. Skoner said. “Sublingual tablets are convenient, safe, effective, and do not require a buildup of dosage, making them a potentially strong treatment option.”
Researchers also included Michael Blaiss, MD, of the University of Tennessee Health Science Center, Memphis; Jennifer Maloney, MD, Merck Research Laboratories, Kenilworth, NJ; Hendrik Nolte, MD, PhD, Copenhagen University Hospital; Sandra Gawchik, DO, Upland, Pa., and Ruji Yao, PhD, Drexel University College of Medicine, Philadelphia.