Anakinra as a Treatment for Hydradenitis Suppurativa
This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa|
- Change in Modified Sartorius Score [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
At each study visit, the same physician examined patients, and the modified Sartorius score was calculated. The following are recorded by the dermatologist: (i) the anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) the numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) the longest distance between two relevant lesions (or size of lesion if single) in each region: < 5 cm, 1 point; 5-10 cm, 3 points; > 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores are added and summed up to the patient's total score. The upper limit of the scale is open.
A supplementary subjective scoring by the patient is also recommended: soreness or pain of the most symptomatic lesion at the time of consultation, by using a visual analogue scale (VAS), graded 0-10. This value is not included in the score.
- Change in Quality of Life Assessments [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable).
The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked "What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit?" with a scale of 0=no acitivity to 100=maximal activity.
- Change in Dermatology Quality of Life Index (DLQI) [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life
- Change in C-reactive Protein [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]Change assessed from baseline to end of treatment phase.
|Study Start Date:||October 2012|
|Study Completion Date:||July 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Other Name: Kineret[TM]
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516749
|United States, California|
|San Francisco General Hospital|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Kieron S Leslie, M.D.||University of California, San Francisco - Department of Dermatology|