Randomized double-blind pilot study of universal, species abundant, multiallergen subcutaneous immunotherapy for moderate-severe allergic rhinitis

Background: Allergic rhinitis affects approximately 10% to 20% of people living in industrialized nations leading to significant morbidity and large health care expenditures. Individualized high-dose, single-species allergen immunotherapy has been found to be effective in treating allergic rhinitis but can be associated with significant risks including anaphylaxis. Few studies have evaluated the safety and efficacy of universal low-dose multiallergen immunotherapy (MAIT). Objective: To determine the efficacy and safety of a universal MAIT formula for the treatment of allergic rhinitis. Methods: Patients with moderate-severe perennial and seasonal allergic rhinitis were randomized in a double-blind, placebo-controlled fashion to receive a novel, subcutaneous MAIT regimen containing a unique mixture of more than 150 aeroallergens, including several cross-reactive species. All patients received the exact same universal immunotherapy formula regardless of which specific skin tests were positive. Primary outcome measures at 8 and 12 weeks of therapy included validated clinical assessments, total nasal sinus score and mini-rhinoconjunctivitis quality of life questionnaire, and the use of rescue medications. Results: A total of 31 patients (n = 31) were randomized to receive MAIT vs placebo. By week 12, MAIT resulted in a −4.6 (−58%) decrease in the combined total nasal sinus score and rescue medication score (daily combined score) compared with −1.5 (−20%) for placebo (P = .04). Likewise, MAIT resulted in a decrease in the mini-rhinoconjunctivitis quality of life questionnaire score of −34.9 (−68%) compared with −17 (−42%) for the placebo (P = .04). Mild adverse events were uncommon and with similar frequency among the groups. Conclusion: A novel, universal, and high-species abundant MAIT formula was well tolerated and resulted in significant improvement in symptoms of moderate-severe allergic rhinitis. The results of this pilot study should be considered preliminary, pending further randomized clinical trials.