HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo‐controlled portion of a phase 2 adalimumab study

Abstract

BackgroundDetermining treatment response for patients with hidradenitis suppurativa (HS) can be challenging due to limitations of current disease activity evaluations.ObjectiveEvaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (HiSCR) and its utility as an outcome measure.MethodsPatients with baseline total abscess and inflammatory nodule count (AN count) of at least three and draining fistula count of 20 or fewer comprised the post hoc subpopulation analysed. HiSCR (at least a 50% reduction in total AN count, with no increase in abscess count, and no increase in draining fistula count relative to baseline) and HS‐PGA Response [Hidradenitis Suppurativa‐Physician's Global Assessment score of clear, minimal, or mild, with at least a 2‐grade improvement from baseline] were used to evaluate patient response after adalimumab treatment weekly, every other week, or placebo (1 : 1 : 1).ResultsThe subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, HiSCR was achieved by 54.5% receiving weekly adalimumab, 33.3% every other week, and 25.6% placebo and HS‐PGA Response was achieved by 20.5% receiving weekly adalimumab, 6.7% every other week and 2.3% placebo.ConclusionHiSCR was more responsive to change than HS‐PGA Response in this subpopulation.

Development of core outcome sets in hidradenitis suppurativa: systematic review of outcome measure instruments to inform the process

“…Test–retest reliability for HiSCR was adequate for both ANs and sinuses, with intraclass correlations of 0·91 and 0·95, respectively, and methodological quality was again rated ‘good’. Using the original trial data, more patients reached the threshold for improvement compared with the HS‐PGA instrument; however, a correlation coefficient was not calculated and so the sensitivity to change of HiSCR requires further evaluation.…”

Longitudinal observational study of hidradenitis suppurativa: impact of surgical intervention with adjunctive biologic therapy

“…The total number of abscesses and inflammatory nodules (AN) were assessed at baseline and each visit. AN count is associated with patient‐reported quality of life scores and pain level . The probability of achieving AN count reduction in 75% (AN75) is a validated outcome measure used in clinical trials of HS that was assessed in this study.…”

Prevalence of antinuclear antibodies in hidradenitis suppurativa

“…The total number of abscesses and inflammatory nodules, known as the active nodule (AN) count was assessed at each visit …”