Treating atopic eczema: tacrolimus seems to be effective and safe

In this blog, Sarah Chapman looks at the evidence on tacrolimus for treating children and adults with moderate-to-severe atopic eczema (atopic dermatitis) – is it an effective and safe alternative to other treatments?

Blog last updated: 16 August 2022 to reflect the latest version of the relevant NICE Clinical Knowledge Summary.

Atopic eczema (atopic dermatitis) is a common skin condition that can have a big impact on the quality of life of both children and adults. I’ve been there, managing it for myself and for my children. We’ve been through wet wraps, preparations to put in the bath and to wash with; we’ve read about animals called Itchy and Scratchy who are supposed to make my child feel better about it all; and of course we’ve been through an awful lot of different creams. There are always two pressing questions, once you get onto medicated stuff, usually steroid creams – does it work and is it safe? Possible side effects, such as skin thinning, are quick to be mentioned.

Treating atopic eczema

ointment
Is there any evidence to back concerns about the safety of tacrolimus?

Topical corticosteroids form the mainstay of treating atopic eczema. A possible alternative is tacrolimus ointment which, along with pimecrolimus, is from a class of drugs called topical calcineurin inhibitors. NICE (2022) says that “tacrolimus may be considered… as a second-line treatment option”. In other words, it may be considered when initial treatment or ‘first-line therapy’ (in this case, topical corticosteroids) doesn’t work, or stops working.

Tacrolimus comes in two strengths, 0.1% and 0.03%. Newer than corticosteroids, it is important to know about its effectiveness and safety. Concerns have been raised about an increased risk of cancers such as skin cancer and lymphomas, based on the possible risk of absorption into the bloodstream, but this is controversial, with no strong supporting evidence.

A Cochrane ReviewTopical tacrolimus for atopic dermatitis’ was updated in July 2015 with evidence from 20 randomized controlled trials with almost 6000 children and adults with moderate-to-severe atopic eczema, comparing topical tacrolimus with other active treatments. Previous research has shown that tacrolimus is likely better than placebo (a similar preparation without any drug). To find out as much as possible about side effects, the reviewers not only looked at data in the trials but also looked for other types of research, safety letters and industry warnings.

Here’s what the evidence says about tacrolimus for treating children and adults with moderate-to-severe atopic eczema:

  • Tacrolimus 0.1% is probably better than low-potency topical corticosteroids on the face and neck and moderate-potency topical corticosteroids on the trunk and extremities
  • It’s likely that tacrolimus 0.03% more than doubles the chance of improvement compared with mild topical corticosteroids or pimecrolimus 1%. In most trials, there was probably little to no difference between tacrolimus 0.03% and moderate strength topical corticosteroids, but in two studies topical corticosteroids were probably slightly better
  • Side effects:
    • Burning and itching may be more common with tacrolimus than with topical corticosteroids but symptoms may be mild and short-lived and there may be little to no difference in skin infection
    • Local side effects (side effects which affect the part of the body you’ve applied the cream to)  may be more common with tacrolimus than pimecrolimus and last longer: between 30 minutes and 12 hours compared with less than 30 minutes.
    • Serious side effects may be rare in all groups and not thought to be related to treatment
    • It may be rare to find the drug entering the bloodstream and only in diseases with severe skin barrier problems
    • No evidence was found to support the possible increased risk of skin thinning or cancer

How reliable is the evidence?

The evidence was of variable certainty. The drugs, doses and outcomes varied between studies so it was not always possible to combine the results, which is done whenever possible in a systematic review. There’s moderate-certainty evidence that tacrolimus 0.1% is probably better than the milder 0.03% preparation and mild topical corticosteroids. The evidence is less reliable when comparing both strengths of tacrolimus with moderate to potent topical corticosteroids.

The research reported objective measures of improvement and doctor’s assessments of improvement but few reported patient self-assessments; shame!

The bottom line:

The reviewers say: “Tacrolimus ointment seems to be safe and effective for the treatment of moderate to severe atopic dermatitis in both children and adults.”

Links:

Cury Martins J, Martins C, Aoki V, Gois AFT, Ishii HA, da Silva EMK. Topical tacrolimus for atopic dermatitis. Cochrane Database of Systematic Reviews 2015, Issue 7. Art. No.: CD009864. DOI: 10.1002/14651858.CD009864.pub2.

Plain language summary of this review: http://www.cochrane.org/CD009864/SKIN_topical-tacrolimus-for-atopic-dermatiti

National Institute for Health and Care Excellence. Clinical Knowledge Summary: Topical calcineurin inhibitors. London: National Institute for Health and Care Excellence; April 2022. Available from: https://cks.nice.org.uk/topics/pre-conception-advice-management/



Treating atopic eczema: tacrolimus seems to be effective and safe by Sarah Chapman

is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International

3 Comments on this post

  1. I have atopic dermatitis on my face. I was using tacrolimus 0.03%. It’s not healing my dermatitis. I am much worried. I think I should use 0.1% tacrolimus. What say?

    Snow / Reply
  2. Hi my name’s Scott i was using many steroid creams to treat mild exzema on my face , chest and behind ears for a few years and they stopped working and my face became reliant so i stopped using them. Was off the steroid creams for a month and face was itchy, sore, dry and red and i booked to see a skin specialist she gave me tacrolimus I’ve been using it for a week now and face is itchy and a little sore should i carry on or stop as i originally thought i had steroid withdrawal. Thanks

    Scott / Reply
    • Hi Scott,
      This is something you’ll need to ask your clinician or pharmacist about.
      Best wishes,
      Sarah Chapman [Editor].

      Sarah Chapman / (in reply to Scott) Reply

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