Abstract
Background: The significant treatment effect of the 300IR 5-grass pollen (GP) allergen extract sublingual tablet could be translated into a relevant improvement of symptoms of allergic rhinoconjunctivitis (ARC) and/or the reduction of symptomatic medication use in patients with GP-induced ARC1 . Here we aimed at illustrating clinical trial results into a concrete treatment benefit for patients.Method: In 3 randomised, DBPC clinical trials [NCT00367640 (CT1), NCT00418379 (CT2) and NCT00409409 (CT3)], adults or paediatric patients with moderate-to-severe seasonal GP-induced ARC with or without mild asthma received the 300IR 5-grass tablet or placebo pre- and co-seasonally over a single pollen season (CT1 & CT3) or 3 consecutive seasons (CT2). The efficacy of the 5-grass tablet was evaluated through a balanced Combined Symptom and Medication Score ranging from 0 to 36 (CSMS 0-36) analysed post hoc by ANCOVA over the primary period in a modified ITT set.Results: In 864 evaluable patients, the treatment effect on the CSMS 0-36 over the primary period with the 5-grass tablet was found equal to or greater than an absolute difference vs placebo of −2.31 on average. As previously published1 , the reduction of at least 2 points reflects a calculated benefit over the pollen period in terms of symptom severity decrease of 1 class in 2 symptoms or 2 classes in 1 symptom, or medication use reduction (around 10 days less therapy/month for a patient taking antihistamines or nasal corticosteroids daily). For example, assuming a placebo patient and a patient treated with 5-grass tablet with an average CSMS 0-36 of 8.40 and 6.09, respectively, the reduction of −2.31 may apply on the severity of blocked nose, recognised as the most bothersome symptom, considering the other symptoms and use of medication stable. With such a reduction translated into a decrease in 2 severity classes, the actively treated patient may expect having no days with severe or moderate blocked nose over the pollen period as shown in the figure below. Patient cases reflecting the treatment benefit on 2 symptoms or on medication use are also displayed.Conclusion: Displayed calculated patient cases illustrating the effect of the 300IR 5-grass pollen sublingual tablet reflect the clinical meaningfulness of this treatment for patients with an average grass pollen ARC severity and presume a greater impact in more severe patients.Reference: 1. Pfaar et al. Allergy 2023;EAACI 2022 Abstract#100085