Lead Investigator: Amit Garg, Northwell Health
Title of Proposal Research: Association between skin-related quality of life and race in patients with hidradenitis suppurativa, and Repeatability/Intra-rater agreement of lesion counts in hidradenitis suppurativa
Vivli Data Request: 9241
Funding Source: None
Potential Conflicts of Interest: Dr. Garg has received personal fees from AbbVie, Aclaris Therapeutics, Anaptys Bio, Aristea Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Incyte, InflaRx, Insmed, Janssen, Novartis, Pfizer, Sonoma Biosciences, UCB, Union Therapeutics, and Viela Biosciences, and receives honoraria. Dr. Garg receives research grants from Abbvie, Pfizer, UCB, and National Psoriasis Foundation. He is co-copyright holder of the HS-IGA and HiSQOL instruments.
Interests will be disclosed when the research is published and presented.
Summary of the Proposed Research:
Study 1: Association between skin-related quality of life and race in patients with hidradenitis suppurativa
Hidradenitis suppurativa (HS) is a chronic inflammatory disorder that affects approximately 0.1 to 1.0% of the population worldwide. HS is characterized by inflamed nodules (lumps of tissue), abscesses (swollen areas containing pus), and tunnels which result from skin wounds that have created pathways underneath the skin. Additionally, HS can cause significant scarring in the breast folds, axillary and groin regions.
HS typically occurs in the second to fourth decades of life, and disproportionately affects women and black patients. Patients with HS experience a significant decrease in quality of life due to pain, drainage, odor, disfigurement, embarrassment, and shame. No singular treatment is uniformly effective for the management of the disease and its consequences on patient quality of life.
The life impact of other common inflammatory diseases of the skin has been shown to have disparate racial outcomes. A recent study evaluating the disease burden of psoriasis showed that Black patients suffer from more severe disease with greater psychological impact and impaired quality of life compared to White patients. We will compare patient-reported quality of life at baseline between White and Black patients in two clinical trials of HS patients using the validated Dermatology Life Quality Index. Our evaluation of life impact is critical to understand potential differences in HS disease burden based on race, considering 1 in 3 HS patients in the United States is African American. Additionally, understanding these differences will foster a patient-centered approach and aid in establishing appropriate goals of treatment.
Study 2: Repeatability/Intra-rater agreement of lesion counts in Hidradenitis Suppurativa
Measurement of disease outcomes and assessment of treatment effectiveness in HS are often based on counts of distinct lesion types reported by clinicians. The standard for efficacy in HS trials has been the Hidradenitis Suppurativa Clinical Response (HiSCR), defined as > 50% reduction in total abscess (swollen areas containing pus) and inflammatory nodule (lumps of tissue) count (AN) relative to baseline and no increase in abscess or draining tunnel (pathway underneath the skin created by skin wounds) count. Using this outcome, clinical trials for HS drug development frequently result in high placebo (treatment/substance with no therapeutic effect) group response rates. Potential explanations for this high placebo response rate include natural variation in disease activity as well as poor repeatability of clinicians’ lesion counts (differences in clinicians’ counts of lesions on separate occasions when the true lesion count has not changed). While the statistical reliability of repeated lesion counts by the same rater has been investigated, reliability is a relative measure and does not describe the absolute differences in lesion counts across repeated assessments. These absolute differences are most relevant when evaluating change over time, as in a clinical trial. We aim to characterize the repeatability and intra-rater agreement of clinician reported lesion counts using measurements recorded at screening and baseline visits in two clinical trials in HS patients. The results of this study may indicate a need to improve the training of clinicians when evaluating lesion counts in the clinical trial setting. Alternatively, our results may demonstrate the adequacy of current practices.
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa – PIONEER I
Data Contributor: AbbVie
Study ID: NCT01468207
Sponsor ID: M11-313
A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa – PIONEER II
Data Contributor: AbbVie
Study ID: NCT01468233
Sponsor ID: M11-810