Pre-seasonal, subcutaneous immunotherapy: a double-blinded, placebo-controlled study in elderly patients with an allergy to grass

Abstract

Background: There is limited evidence indicating that specific immunotherapy in elderly patients is safe and effective.

Objective: To evaluate the safety and efficacy of pre-seasonal specific subcutaneous immunotherapy (SCIT) against grass pollen allergens in patients older than 65 years with seasonal allergic rhinitis and to measure the prime outcome of area under the curve for the combined symptoms and medication score during grass pollen season after 3 years of SCIT in a double-blinded, placebo-controlled trial.

Methods: This study included 60 65- to 75-year-old patients with seasonal allergic rhinitis and grass pollen allergy. Patients were individually randomized to the active or placebo group. Thirty-three subjects in the SCIT group and 27 subjects in the placebo group were monitored for 3 years. Patients were required to record each use of anti-allergy medication.

Results: Thirty-one patients completed 3 years of pre-seasonal SCIT and 24 subjects finished placebo treatment. The median area under the curve for the combined symptoms and medication score after the third grass pollen season after SCIT was significantly decreased from 7.85 (range 3.67-8.98) to 4.63 (range 3.56-7.80) in the active group and did not significantly change in the placebo group. In the active group, the combined symptoms and medication score was decreased by 41%, the symptoms score was decreased by 55%, and the medication score was decreased by 64% after 3 years of immunotherapy.

Conclusion: Pre-seasonal SCIT in the elderly is safe and efficacious and elicits an immune response comparable to what is found in studies of younger patients.

Trial registration: ClinicalTrials.gov NCT02440243.