The Minimal Clinically Important Difference in Allergen Immunotherapy: An Evidence-Based Approach.

ABSTRACT:

Background

Regulatory authorities recommend a combination of symptom and medication scores during the grass pollen season as a primary endpoint for Phase III allergen immunotherapy (AIT) trials targeting allergic rhinoconjunctivitis. However, many composite primary endpoint scales exist; none are validated, nor do they have a well-justified minimal clinically important difference (MCID).

Methods

Direct patient feedback from 1071 grass-allergic patients was obtained to determine the minimally relevant improvement in allergic symptoms and translated into an MCID for the EAACI recommended CSMS_0-6. Additionally, a clinically relevant threshold for the validated Rhinitis Quality of Life Questionnaire (RQLQ(S)) was determined from studies of registered SLIT products and

SUBMITTER: Pfaar O 

PROVIDER: S-EPMC12666754 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature