EASI, (objective) SCORAD and POEM for atopic eczema: responsiveness and minimal clinically important difference

Abstract

The objective SCORAD and SCORAD showed a fair responsiveness. The MCIDs are an important prerequisite for the interpretation of published eczema trials and for the planning/sample size estimation of future trials.

Oral and Topical Antibiotics for Clinically Infected Eczema in Children: A Pragmatic Randomized Controlled Trial in Ambulatory Care

“…The study did not meet its recruitment target, but the lower bands of the confidence intervals for treatment effects (-1.4 and -1.6) are less than the published minimal clinically important difference for POEM, suggesting that these results are not due to chance and that the conclusion that antibiotics offered no meaningful benefit would have been unlikely to change even if the sample size had been achieved. 13,14 Secondary analyses were all consistent and in the same direction, showing small effect sizes and confidence intervals that included zero.…”

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis

“…The EASI score assesses the severity and extent of erythema; induration, papulation, and edema; excoriations; and lichenification. 21,22 EASI scores range from 0 to 72, with higher scores indicating greater severity and extent of atopic dermatitis. (End-point descriptions are provided in Table S1 in the Supplementary Appendix.…”

“…Additional secondary end points in the hierarchy were the mean percent change from baseline to week 16 on the EASI score, the Scoring Atopic Dermatitis (SCORAD) score, 25 and the Global Individual Signs Score (GISS) and the mean percent change from baseline to week 2 on the pruritus numerical rating scale; the proportion of patients with an improvement on the EASI of at least 50% (EASI-50) or at least 90% (EASI-90) at week 16; and the mean change from baseline to week 16 on the pruritus numerical rating scale, percent body-surface area affected, the score on the Dermatology Life Quality Index (DLQI), 26,27 the score on the Patient-Oriented Eczema Measure (POEM), 22,28 and the total score on the Hospital Anxiety and Depression Scale (HADS). 29,30 Additional prespecified end points were the proportion of patients with an improvement of at least 4 points (i.e., the minimal clinically important difference) from baseline to week 16 in the scores on the DLQI (scores range from 0 to 30, with higher scores indicating greater effect on quality of life) and the POEM (scores range from 0 to 28, with higher scores indicating a greater symptom burden) and the proportion of patients with HADS anxiety (HADS-A) and depression (HADS-D) subscores of less than 8 (on a scale from 0 to 21, with higher scores indicating a greater burden of anxiety or depression symptoms) at week 16 among patients who had had a baseline HADS-A or HADS-D subscore of 8 or more, which is the cutoff for identifying patients with anxiety or depression.…”

Randomised controlled trial of silk therapeutic garments for the management of atopic eczema in children: the CLOTHES trial

“…However, the observed differences in POEM and PGA were small, making them unlikely to be clinically meaningful for patients. 40 These effects appeared to be most prominent during the first 3 months of the trial, when belief in the effectiveness of the garments was most likely to influence responses. It is possible that these effects occurred by chance, as many secondary outcome variables were assessed.…”

“…Although this between-group difference is approximately half the published minimum clinically important difference for EASI that was suggested from one study in adults, 40 we wanted to be sure that a clinically important difference to patients was not missed as a result of our focus on an objective outcome for the primary outcome. Sample size was based on repeated measures analysis of covariance, assuming a standard deviation (SD) of 13, a correlation between EASI scores at different time points of 0.6 and loss to follow-up of 10%.…”