Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels

Study of Immunoadsorption to Treat Severe Atopical Dermatitis Associated With Excessively High Serum IgE Levels

The purpose of this study is to determine whether immunoadsorption is effective in the treatment of severe atopic dermatitis associated with excessively high serum IgE levels.

Inclusion Criteria:

• Atopical dermatitis
• Total serum IgE level above 5000 kU/l
• IGA score of 3 or above
• No sufficient response to topical corticosteroids/calcineurin inhibitors, UV therapy (at least 4 weeks of therapy), systemic corticosteroids and cyclosporin A (at least 8 weeks of therapy) or no possibility of a prolonged use of this therapy due to adverse events/contraindications
• 18 years of age or above
• Effective contraception during therapy
• Informed consent

Exclusion Criteria:

• Unfavorable conditions for peripheral venous access
• Known hypersensitivity or allergy towards materials used in the adsorber columns
• Adequate anticoagulation not possible (e.g. multiple allergies towards various anticoagulants)
• Extreme bleeding tendency during anticoagulation
• Hypercoagulability
• Severe cardiovascular disease forbidding extracorporeal circulation
• Severe systemic infection
• Serum IgG level below 250 mg/dl
• Severe immunodeficiency (e.g. AIDS)
• Treatment with an ACE inhibitor (discontinue drug at least 72 h before treatment)
• Pregnancy
• Lactation
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism or mental dysfunction)