Lead Investigator: Alexa Kimball, Beth Israel Deaconess Medical Center
Title of Proposal Research: Effects of adalimumab on inflammation-associated abnormal hematologic patterns in patients with Hidradenitis Suppurativa
Vivli Data Request: 7127
Funding Source: None
Potential Conflicts of Interest: I am a consultant and Investigator for Abbvie, Eli Lilly, Janssen, BMS, Novartis, Pfizer, UCB, Leo Pharma, Meiji Pharma, and Regeneron. Advisor to the Organization of Teratology Information Services (OTIS), Vimalan Biosciences. Fellowship funding from Janssen and Abbvie. Stockholder in Ventxy. Bioscience and Board of Directors, Almirall. BOD and Past President International Psoriasis Council. OTIS Pregnancy Registry Board Stelara, Cimzia and Otezla. These conflicts are regularly reviewed by my institution and managed via disclosure.
Summary of the Proposed Research:
Hidradenitis suppurativa (HS) is a painful and debilitating skin disease that can last for decades. Patients are affected by painful skin lumps and boils, primarily in the armpits and groin. These areas can get worse and form pockets of pus (abscesses), tunnels within the skin (fistulae), and extensive scarring. In addition to skin disease, HS patients may have abnormal blood tests, including anemia (low red blood cell counts; red blood cells carry oxygen) and elevated white blood cell counts (white blood cells fight infection so high counts can indicate infection). These abnormal blood tests can also include increases in blood markers of inflammation (when immune system cells are activated to fight infection of for some other reason) that may affect the whole body, including one called C-reactive protein (CRP). These health changes seem happen more often in people with worse skin disease suggesting that that they are related. While raised platelet levels (platelets help with clotting) have not yet been associated HS, elevated platelet levels can be seen in other diseases that also have significant inflammation.
The set of these blood test abnormalities and painful draining skin lesions can present a problem for physicians and lead to unintended consequences. A common instinct, when faced with an elevated white blood cell count and a patient who appears unwell, is to treat for infection, which for these patients, may be unnecessary. Anemia and high platelet levels can mimic blood cancer and also lead to unnecessary testing. In this work, we plan to study patients with blood abnormalities associated with HS to see if they improve with adalimumab, a medication proven to improve HS, compared to patients who receive placebo treatment.
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