Development and initial validation of the HS-IGA: a novel hidradenitis suppurativa-specific investigator global assessment for use in interventional trials

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  • Amit Garg
  • Carla Zema
  • Katherine Kim
  • Weihua Gao
  • Naijun Chen
  • Jemec, Gregor
  • Joslyn Kirby
  • Linnea Thorlacius
  • Bente Villumsen
  • John R. Ingram

Background: Few validated instruments exist for use in hidradenitis suppurativa (HS) trials. Objectives: To develop a novel HS Investigator Global Assessment (HS-IGA) and to validate its psychometric properties. Methods: Development of HS-IGA involved discussion among stakeholders, including patients, within HISTORIC. Data from replicate phase III randomized controlled trials evaluating HS treatment were utilized. Multivariate models identified lesion type and body region as variables of importance. Classification and regression trees for ordinal responses were built. Validation included assessment of test–retest reliability, predictive validity, responsiveness and clinical meaningfulness. Results: There were 3024 unique measurements available in PIONEER I. Mean and median lesion counts by region were largely <10 and were highest in axillary and inguinal regions. The mean and median number of regions involved were ≤ 3 for individual lesions and combinations. Regardless of lesion type, axillary and inguinal regions most influenced the HS-IGA score. Accordingly, regions were combined into a six-point IGA based on the maximum lesion number in either upper or lower body regions with a score of 0 (0–1 lesions), 1 (2–5), 2 (6–10), 3 (11–15), 4 (16–20) and 5 (≥ 20 lesions). The intraclass correlation coefficient for test–retest reliability was 0·91 (95% confidence interval 0·87–0·94). Spearman’s rank order correlations (SROCs) with HS-PGA and Hidradenitis Suppurativa Clinical Response (HiSCR) were 0·73 and 0·51, respectively (P < 0·001 for both comparisons). SROCs with Dermatology Life Quality Index (DLQI), pain numerical rating scale and HS-QoL were 0·42, 0·34 and –0·25, respectively (P < 0·001 for all comparisons). HS-IGA was responsive at weeks 12 and 36. Predictive convergent validity was very good with HS-PGA (area under the curve = 0·89) and with HiSCR (area under the curve = 0·82). Predictive divergent validity was low with DLQI and HS-QoL. Conclusions: HS-IGA has moderate-to-strong psychometric properties and is simple to calculate.

OriginalsprogEngelsk
TidsskriftBritish Journal of Dermatology
Vol/bind187
Udgave nummer2
Sider (fra-til)203-210
Antal sider8
ISSN0007-0963
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
sources Financial support was provided by AbbVie, Inc. AbbVie participated in the interpretation of data, and review and approval of the manuscript. All authors contributed to the development of the manuscript and maintained control over the final content. No honoraria or payments were made for authorship.

Funding Information:
A.G. is a consultant for AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, InflaRx, Insmed, Janssen, Novartis, Pfizer, UCB and Viela Biosciences and receives honoraria. He has grants from AbbVie and the National Psoriasis Foundation. He is a joint copyright holder of the HiSQoL. C.Z., K.K. and W.G. were previously employees of AbbVie for a portion of this study and may own AbbVie stock or stock options. N.C. is an employee of AbbVie and may own AbbVie stock or stock options. G.B.E.J. is Editor in Chief of and reports grants and personal fees from AbbVie, personal fees from Coloplast, personal fees from Chemocentryx, personal fees from LEO Pharma, grants from LEO Foundation, grants from Afyx, personal fees from Incyte, grants and personal fees from InflaRx, grants from Janssen‐Cilag, grants and personal fees from Novartis, grants and personal fees from UCB, grants from CSL Behring, grants from Regeneron, grants from Sanofi, personal fees from Kymera, and personal fees from Viela Bio. He is a joint copyright holder of the HiSQoL and Patient Global Assessment instruments for hidradenitis suppurativa. J.K. is a consultant for AbbVie, ChemoCentryx, Incyte, InflaRx, Janssen, Novartis, UCB and Viela Bio and receives honoraria. She is a speaker for AbbVie. She is a joint copyright holder of the HiSQoL and Patient Global Assessment instruments for hidradenitis suppurativa. L.T. has received speaker honoraria from UCB, had travel expenses covered by AbbVie and Janssen, and been an investigator for Regeneron. She is a joint copyright holder of the HiSQoL and Patient Global Assessment instruments for hidradenitis suppurativa. B.V. is a consultant for Boehringer Ingelheim and a joint copyright holder of the HiSQoL and Patient Global Assessment instruments for hidradenitis suppurativa. J.R.I. is Editor in Chief of the and receives an author honorarium from UpToDate. He is a consultant for UCB Pharma, Novartis, Boehringer Ingelheim and ChemoCentryx and has participated in advisory boards for Kymera Therapeutics and Viela Bio, all in the field of hidradenitis suppurativa. He is a joint copyright holder of the HiSQoL and Patient Global Assessment instruments for hidradenitis suppurativa. Dermatology British Journal of Dermatology

Publisher Copyright:
© 2022 The Authors. British Journal of Dermatology published by John Wiley & Sons Ltd on behalf of British Association of Dermatologists.

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