Efficacy of a short course of specific immunotherapy in patients with allergic rhinoconjunctivitis to ragweed pollen

Abstract

Background: Specific immunotherapy acts to modify the underlying cause of allergic rhinoconjunctivitis. Addition of adjuvants, such as monophosphoryl lipid A (MPL), might allow for efficacious and safe treatment with only 4 injections administered preseasonally, which is in contrast to most available schedules requiring long injection courses.

Objective: The primary objective was to assess the clinical efficacy of Ragweed MATA MPL (short ragweed pollen allergoid adsorbed to L-Tyrosine + MPL) versus placebo in reducing allergic rhinoconjunctivitis symptoms caused by ragweed pollen in an environmental exposure chamber (EEC) 3 weeks after treatment.

Methods: This was a randomized, double-blind, placebo-controlled phase IIb study to evaluate the clinical efficacy and safety of Ragweed MATA MPL compared with placebo by using controlled ragweed pollen exposure in an EEC. Two hundred twenty-eight patients with a history of ragweed allergy and positive skin prick test responses to ragweed were randomized and received 4 weekly injections of active treatment or placebo. Total nasal and nonnasal symptom scores were obtained in the EEC before and after treatment.

Results: Mean improvement in total symptom scores in the Ragweed MATA MPL group was statistically significantly greater than in the placebo group (relative mean improvement of active vs placebo, 48%; P < .05; median improvement, 82%). The majority of adverse events (AEs) experienced by subjects were mild injection-site reactions. No severe systemic AEs or serious AEs occurred during the study.

Conclusion: This study demonstrated that an ultrashort course of Ragweed MATA MPL is efficacious in reducing allergy symptoms in patients with seasonal allergic rhinitis and that it is well tolerated.

Keywords: AE; AR; Adverse event; Allergic rhinoconjunctivitis; EEC; Environmental exposure chamber; ITT; Intention to treat; MPL; Monophosphoryl lipid A; PP; Per protocol; RQLQ; Rhinoconjunctivitis Quality of Life Questionnaire; SAR; SIT; SU; Seasonal allergic rhinitis; Specific immunotherapy; Standardized units; TSS; Total symptom score; environmental exposure chamber; ragweed; specific immunotherapy; ultrashort course.