Randomized Double Blind Pilot Study of Universal, Species Abundant, Multi-Allergen Subcutaneous Immunotherapy for Moderate-Severe Allergic Rhinitis.

BACKGROUND: Allergic rhinitis affects approximately 10-20% of people living in industrialized nations leading to significant morbidity and large health care expenditures. Individualized high-dose, single species allergen immunotherapy has been shown to be effective in treating allergic rhinitis but can be associated with significant risks including anaphylaxis. Few studies have examined the safety and efficacy of universal low-dose multi-allergen immunotherapy.

OBJECTIVE: To determine the efficacy and safety of a universal, multi-allergen immunotherapy 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 multi-allergen immunotherapy (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; TNSS and mini-RQLQ, and the use of rescue medications.

RESULTS: Thirty-one subjects (n=31) were randomized to receive multi-allergen immunotherapy (MAIT) versus placebo. By week twelve, MAIT resulted in a -4.6 (-58%) decrease in the combined TNSS and rescue medication score (DCS) compared to -1.5 (-20%) for placebo (P = 0.037). Likewise, MAIT resulted in a mini-RQLQ decrease of -34.9 (-68%) compared to -17 (-42%) for placebo (P = 0.039). Mild adverse events were uncommon and with similar frequency among the groups.

CONCLUSION: A novel and universal, high species abundance, multi-allergen immunotherapy 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.