A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis

This is an interventional treatment trial for Anakinra focused on measuring Kineret, Anakinra, Atopic Dermatitis, Eczema, Allergic Disease Read More

• INCLUSION CRITERIA:

To be eligible for enrollment in this protocol, participants must fulfill all of the following criteria:

1. Must be 10 years to 30 years of age
2. Patient or legal guardian must be able to give informed consent
3. Must have evidence of severe atopic dermatitis as determined by the investigators and a SCORAD score >40 performed within 90 days of study entry
4. Must have report from primary physician documenting lack of sufficient response to topical corticosteroids for > 6 months
5. Must have skin test or radioallergosorbent test (RAST) showing sensitivity to greater than or equal to 3 food and/or airborne allergens

6. Must have a baseline CBC that demonstrates:

   • White Blood Cell Count (WBC) greater than or equal to lower limit of normal for age

   • Absolute Neutrophil Count (ANC) greater than or equal to lower limit of normal for age

     c. Platelet Count greater than or equal to lower limit of normal for age

7. Must not be pregnant or breastfeeding

8. If subject is a female that has begun menstruation, and is sexually active, she must agree to consistently use contraception throughout study participation. Acceptable forms of contraception are:

   • Condoms, male or female, with spermicide
   • Diaphragm or cervical cap with spermicide
   • Intrauterine device
   • Contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method
   • Male partner has previously undergone a vasectomy for which there is documentation of aspermatogenic sterility
   • Abstinence
9. Must have a primary care physician
10. Must be willing to submit blood and skin tissue for storage

EXCLUSION CRITERIA:

A patient will be ineligible to participate in this protocol if any of the following criteria are fulfilled:

1. Patient is taking oral or injectable immunomodulators (such as methotrexate, imuran, and cyclosporine) or biologics (such as etanercept or omalizumab).
2. Patient requires systemic immunosuppression at any time during the study
3. Patient has known diseases of immunodysregulation or immunodeficiency.
4. Any chronic medical condition other than atopic dermatitis, allergy/asthma and infection, such as heart disease, diabetes and autoimmunity that, in the investigator s opinion, places the patient at undue risk by participating in the study.
5. History of anaphylactic reaction or hypersensitivity to anakinra.
6. The presence of certain types of acquired abnormalities of immunity such as human immunodeficiency virus (HIV), cytotoxic chemotherapy for malignancy could be grounds for possible exclusion if, in the opinion of the investigator, the presence of such disease process interferes with evaluating a coexisting abnormality of immunity that is a subject of study under this protocol.
7. The presence of any dermatologic diagnosis which, in the investigator's opinion, is not consistent with atopic dermatitis and would impair the ability to assess drug response.
8. Has a diagnosis of active tuberculosis with consistent findings from a PPD skin test, computerized tomography (CT) scan or Chest x-ray. Those subjects found to have a positive PPD will be referred back to their primary care physician for appropriate management.
9. Has received a live vaccine within 4 weeks prior to therapy or potential need for a live vaccine during the study.
10. Is unwilling to undergo testing or procedures associated with this protocol.
11. The patient or guardian is unable or unwilling to give daily injections.