Role of Anti-IgE in Severe Childhood Eczema

To address the value of anti-IgE in children with severe eczema.

Inclusion criteria

• Children between the ages of 4-19 years
• Severe eczema
• Raised SpIgE or SPT to at least 1 food allergen or 1 aeroallergen AND/OR
• Clinical impression that allergic exposures cause worsening eczema.
• Total IgE level >300 kU/l
• Clinically proven IgE-mediated allergic disease.
• Written informed consent to participate.

Exclusion criteria

• Inability to comply with 2-4 weekly injections and clinic visits
• Evidence of underlying immune compromise, autoimmune disease, immune complex mediated conditions.
• Uncontrolled infection or unstable eczema.
• Malignancy or a history of malignancy.
• Pre-existing hepatic or renal impairment
• Known cardiovascular or ischaemic cerebrovascular abnormality.
• Other serious or uncontrolled systemic disease.
• Pregnancy or lactation.
• Known history of hypersensitivity or anaphylaxis to anti-IgE injections or its constituents.
• Insufficient understanding of the trial assessments.
• Participation in a CTIMP in the previous 60 days or (if known) 4 half-lives of the relevant medication, whichever is the greater.
• Investigator feels that there is a good clinical reason why the child would be unsuitable.