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

Oliver Pfaar1, Ralph Mösges2,3, Michael S Blaiss4

  • 1Section of Rhinology and Allergy, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Marburg, Philipps-Universität Marburg, Marburg, Germany.

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|July 18, 2025
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Summary
This summary is machine-generated.

Determining the minimal clinically important difference (MCID) for allergic rhinoconjunctivitis trials is crucial. This study established an MCID for the CSMS0-6 scale, providing a benchmark for grass allergen immunotherapy efficacy.

Keywords:
EAACI CSMS0–6allergic rhinoconjunctivitisgrass pollen allergypivotal phase III clinical trialsubcutaneous immunotherapy

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Symptom Assessment of Patients with Allergic Rhinitis Using an Allergen Exposure Chamber
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Area of Science:

  • Allergy and Immunology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • Regulatory bodies recommend symptom and medication scores for allergic rhinoconjunctivitis trials.
  • Existing composite endpoint scales lack validation and a defined minimal clinically important difference (MCID).

Purpose of the Study:

  • To determine the MCID for the EAACI-recommended Combined Symptom and Medication Score (CSMS0-6).
  • To establish clinically meaningful thresholds for grass allergen immunotherapy (AIT) trials.

Main Methods:

  • Collected patient feedback from 1071 grass-allergic individuals to define minimally relevant symptom improvement.
  • Utilized the Rhinitis Quality of Life Questionnaire (RQLQ(S)) as an anchor, referencing data from registered sublingual immunotherapy (SLIT) products.
  • Derived the MCID for CSMS0-6 using data from a Phase III trial (RESONATE) of PQ Grass 27,600 SU.

Main Results:

  • 69% of patients found a 1-point symptom improvement satisfactory, translating to an MCID range of -0.23 to -0.21 for CSMS0-6 (-17% to -16%).
  • A -0.34 point difference in RQLQ(S) was deemed clinically meaningful, based on SLIT grass tablet data.
  • The RESONATE trial data anchored an MCID of -0.21 points (-16%) for CSMS0-6.

Conclusions:

  • Patient feedback and RESONATE trial results support an average MCID of -0.22 points (-16%) for the CSMS0-6 scale.
  • This provides essential minimal thresholds for concluding positive Phase III AIT trial outcomes compared to placebo.