House dust mite (HDM) allergens are responsible for the most prevalent persistent respiratory allergies. Clinical trials in this field often use a four-component nasal symptom score (T4NSS) as a measure of efficacy.

Methods

The present observational, prospective, multinational, multicenter study determined the minimal important difference (MID) for a T4NSS in children, adolescents, and adults with physician-diagnosed HDM-induced allergic rhinoconjunctivitis (AR). Patients rated the T4NSS daily, a 15-point global rating of change scale (GRCS) and the Rhinoconjunctivitis Quality of Life Questionnaire weekly. The MID was determined primarily by using a regression method with a GRCS threshold of 2.

Results

A total of 546 patients (210 adults, 133 adolescents, and 203 children) were included; 92.6% of the patients had moderate-to-severe AR, and 30.1% had concomitant mild asthma. During the first week, the mean ± standard deviation T4NSS was 5.68 ± 2.76 in adults, 5.34 ± 2.66 in adolescents, and 5.07 ± 2.48 in children. In a GRCS regression analysis, the MID [95% confidence interval] for the T4NSS was −0.90 [−1.06;-0.75] overall (n = 509), −0.94 [−1.19;-0.69] in children (n = 187), −0.74 [−1.07;-0.41] in adolescents (n = 125), and −1.04 [−1.29;-0.79] in adults (n = 197). The MID did not differ greatly from one disease severity tertile to another. Confirmatory distribution-based analyses yielded overall MID values of −0.87 for the first week of the study and −0.93 for the week 2–week 1 difference.

Conclusion

The MID for improvement in the T4NSS is at least −0.90 units in children, adolescents, and adults suffering from HDM-induced AR This value could be rounded up to −1 unit for convenience.

Graphical Abstract

In patients with house dust mite allergic rhinoconjunctivitis, the minimal important difference for improvement in a four-item nasal symptom score was at least 0.9 units. This value was estimated in children (n=187), adolescents (n=125), and adults (n=197) by both regression analyses using anchors and distribution-based analyses using the standard deviation (SD). The anchors in the regression analyses were either a 15-point global rating of change scale or the age-specific Rhinoconjunctivitis Quality of Life Questionnaires.

CONFLICT OF INTEREST

P. Devillier has received consulting fees, honoraria for lectures, and/or research funding from GlaxoSmithKline, AstraZeneca, Chiesi, Novartis, ALK, Meda Pharma, and Stallergenes. KC. Bergmann has received consulting fees, honoraria for lectures, and/or research funding from AstraZeneca, Lofarma, ALK, Novartis, Sanofi, Bencard, HAL, Allergopharma, Stallergenes, and HAL. H. Brüning has received consulting fees, honoraria for lectures, and/or research funding from Stallergenes GmbH.

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Citing Literature

Volume74, Issue11

November 2019

Pages 2191-2198