Lead Investigator: Joseph Merola, The International Dermatology Outcome Measures Group (IDEOM)
Title of Proposal Research: Musculoskeletal Symptoms in Hidradenitis Suppurativa
Vivli Data Request: 9390
Funding Source: The IDEOM group is a 501c3 non-profit organization that conducts research into outcome measure development and utility across a breadth of inflammatory dermatoses. Statistical support for this study will be funded by the IDEOM group.
Potential Conflicts of Interest: J. F. Merola is a consultant and/or investigator for Amgen, Bristol-Myers Squibb, Abbvie, Dermavant, Eli Lilly, Novartis, Janssen, UCB, Sanofi, Regeneron, Sun Pharma, Biogen, Pfizer and Leo Pharma.
There will be NO funding support from the data contributor, AbbVie, or any other pharmaceutical company for this project
Any conflicts of interest will be mitigated by following strict conflict of interest reporting and ICJME (International Journal of Medical Journal Editors) criteria for academic output.
A.B. Gottlieb has received honoraria as an advisory board member and consultant for: Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol-Myers Squibb Co., Incyte, Janssen, LEO Pharma, Eli Lilly, Novartis, Sun Pharmaceutical Industries, Inc., UCB, Anaptysbio and Xbiotech. A.B. Gottlieb has received research/educational grants from: Boehringer Ingelheim, Incyte, Janssen, Novartis, UCB, Xbiotech, and Sun Pharma.
Any conflicts of interest will be mitigated by following strict conflict of interest reporting and ICJME (International Journal of Medical Journal Editors) criteria for academic output.
Summary of the Proposed Research:
Hidradenitis Suppurative (HS) is a painful, chronic skin disease that is characterized by the formation of skin abscesses and scarring at areas of friction such as the armpits and groin. It is estimated that approximately 1 in 100 U.S. patients are affected by HS. Researchers now believe that there may be an association between having HS and developing musculoskeletal (MSK) symptoms, such as joint pain and arthritis caused by excess inflammation. However, MSK symptoms are not specifically routinely measured in the conduct of clinical trials for inflammatory skin conditions such as HS, thus understanding of this potential aspect of disease is poorly understood.
The International Dermatology Outcome Measures group (IDEOM) has an MSK symptoms workgroup which is focused on the measurement of MSK symptoms in the conduct clinical trials in inflammatory skin conditions such as HS. This group has hypothesized that some outcome measures that are already being used in a majority of clinical trials might in fact have a component that captures improvement of MSK symptoms during intervention. We would like to conduct sub-analysis of clinical trial results to better-understand the potential impact of MSK symptoms on HS patients, which may allow us to eventually design instruments that better-capture effects of treatment on disease burden for patients with HS. This in turn may help us to develop more patient-centered therapies for HS.
Several HS clinical trials have been conducted to study the effectiveness of adalimumab, a drug targeting a protein thought to cause excessive inflammation in HS. Our research plan is to look at the number of patients who score highly on MSK-related questions from the outcome measure instrument, 36-item Short Form Health Survey (SF-36), who do and don’t receive treatment with adalimumab in HS clinical trials. We will perform statistical analysis to see if HS patients rate their MSK symptoms higher than the general population, and whether or not treatment with adalimumab affects their MSK symptoms score. We will also perform analysis to see whether patients reporting improvement in their MSK symptoms show more improvement in their health-related quality of life scores compared to patients who only report improvement in skin symptoms. We have selected this cost-efficient research method because it may allow us to improve our understanding of the disease by using already-generated high-quality data.
Requested Studies:
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
A Phase 2 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Hidradenitis Suppurativa
Data Contributor: AbbVie
Study ID: NCT00918255
Sponsor ID: M10-467
A Phase 3, Open-Label Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa – PIONEER (Open-Label Extension)
Data Contributor: AbbVie
Study ID: NCT01635764
Sponsor ID: M12-555