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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
Author(s) -
Kimball A.B.,
Sobell J.M.,
Zouboulis C.C.,
Gu Y.,
Williams D.A.,
Sundaram M.,
Teixeira H.D.,
Jemec G.B.E.
Publication year - 2016
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/jdv.13216
Subject(s) - hidradenitis suppurativa , medicine , adalimumab , placebo , post hoc analysis , clinical endpoint , surgery , clinical trial , dermatology , disease , pathology , alternative medicine
Abstract Background Determining treatment response for patients with hidradenitis suppurativa ( HS ) can be challenging due to limitations of current disease activity evaluations. Objective Evaluate the novel, validated endpoint, Hidradenitis Suppurativa Clinical Response (Hi SCR ) and its utility as an outcome measure. Methods Patients 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. Hi SCR (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). Results The subpopulation included 132 (85.7%) patients; 70.5% women and 73.5% white. At week 16, Hi SCR 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. Conclusion Hi SCR was more responsive to change than HS ‐ PGA Response in this subpopulation.