Anakinra as a Treatment for Hydradenitis Suppurativa

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

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.

Inclusion Criteria:

1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity

Exclusion Criteria:

1. Use of the following therapies:

   • Etanercept in the 4 weeks prior to the baseline visit (Day 1)
   • Adalimumab in the 8 weeks prior to the baseline visit (Day 1)
   • Infliximab in the 12 weeks prior to the baseline visit (Day 1)
   • Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1)
   • Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1)
   • Cyclosporine in the 4 weeks prior to the baseline visit (Day 1)
   • I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1)
   • 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1)
   • Colchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1)
   • Corticosteroids "20mg/day or >0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1)

2. history of immunocompromise including HIV infection

3. positive Hep B surface antigen -