期刊
BRITISH JOURNAL OF DERMATOLOGY
卷 171, 期 6, 页码 1434-1442出版社
WILEY
DOI: 10.1111/bjd.13270
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- AbbVie
Background Quantification of disease severity supports the development of evidence-based treatments. Assessments to capture clinical improvement in hidradenitis suppurativa (HS) can be improved. Objectives This study aimed to validate the Hidradenitis Suppurativa Clinical Response (HiSCR), which is defined as a >= 50% reduction in inflammatory lesion count (sum of abscesses and inflammatory nodules, AN), and no increase in abscesses or draining fistulas in HS when compared with baseline as a meaningful clinical endpoint for HS treatment. Methods Patients with >= 3 ANs at baseline in a Phase II adalimumab trial for HS were included for analysis. HiSCR achievers vs. nonachievers were assessed at week 16 and week 52. Criteria measures included physician-rated assessments [Hurley stage, modified Sartorius score (MSS), and HS Physician's Global Assessment] and patient-reported outcomes (PROs: visual analogue pain scale, Dermatology Life Quality Index, and Work Productivity and Activity Impairment questionnaire). Test-retest reliability, convergent validity, responsiveness and predictive validity of HiSCR, and its meaningfulness to patients were assessed. Results Among 138 eligible study participants, the majority were female (69.6%) with a mean age of 36.7 years. The mean (median) MSS was 125.2 (85.5) at baseline. Test-retest reliability of the AN count was 0.91. HiSCR was significantly correlated with improvements in all physician-rated and PRO measures (Spearman's rho between -0.61 and.0.27, all P < 0.001). Improvements of all PROs in HiSCR achievers exceeded the respective meaningful improvement thresholds. Conclusions In patients with HS with >= 3 ANs, HiSCR achievers had significant improvements in physician-rated and patient-reported HS disease severity and impact. HiSCR is a valid and meaningful endpoint for assessing HS treatment effectiveness in controlling inflammatory manifestations in this population.
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