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The content on this page is not current guidance and is only for the purposes of the consultation process.

1 Recommendations

1.1 Crisaborole is not recommended, within its marketing authorisation, for treating mild to moderate atopic dermatitis in people 2 years and older when 40% or less of their body surface area is affected.

1.2 This recommendation is not intended to affect treatment with crisaborole that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop. For children and young people, this decision should be made jointly by the clinician and the child or young person, and their parents or carers.

Why the committee made these recommendations

Mild to moderate atopic dermatitis is usually controlled using emollients and topical corticosteroids. Sometimes topical calcineurin inhibitors are used for moderate atopic dermatitis to treat flares and on delicate areas such as the face and neck. Crisaborole is likely to be used for moderate atopic dermatitis, after emollients and topical corticosteroids, or when these cannot be used.

Evidence from clinical trials shows that crisaborole ointment improves the severity of atopic dermatitis compared with unmedicated ointment. However, this is based on assessing atopic dermatitis in a way that:

  • is not used in UK clinical practice

  • does not capture outcomes that are important to patients

  • is a subjective and unreliable way of assessing atopic dermatitis severity.

So, it is not possible to determine whether crisaborole is clinically effective and whether the small improvements seen are clinically relevant. Also, there are no trials directly comparing crisaborole with topical calcineurin inhibitors, and the results from indirect comparisons are inconsistent and difficult to interpret. So, the efficacy of crisaborole compared with topical calcineurin inhibitors is uncertain.

The cost-effectiveness analysis is unreliable because of the uncertainty about any clinical benefits with crisaborole. Therefore, crisaborole cannot be recommended for mild to moderate atopic dermatitis.