Tac and pim ifp 82 a5.qxd

NHS
National Institute for
Clinical Excellence
Tacrolimus and pimecrolimus
for atopic eczema
Understanding NICE guidance –
information for people with atopic
eczema, their families and carers,
and the public
Information about NICE Technology Appraisal 82 Tacrolimus and pimecrolimus for atopic eczema
Understanding NICE guidance – information for people with atopic
eczema, their families and carers, and the public
Issue date: August 2004
Review date: August 2007
To order copies
Copies of this booklet can be ordered from the NHS Response Line
(telephone 0870 1555 455 and quote reference number N0687). A
version in Welsh and English is also available, reference number
N0688. Mae fersiwn yn Gymraeg ac yn Saesneg ar gael hefyd, rhif
cyfeirnod N0688. The NICE technology appraisal on which this
information is based, ‘Tacrolimus and pimecrolimus for atopic
eczema’, is available from the NICE website
(www.nice.org.uk/TA082guidance). A short version of the guidance
(a ‘quick reference guide’) is available from the website
(www.nice.org.uk/TA082quickrefguide), or from the NHS Response
Line, reference number N0686.
National Institute for
Clinical Excellence
MidCity Place71 High HolbornLondonWC1V 6NA Published by the National Institute for Clinical ExcellenceAugust 2004Typeset by Icon Design, EtonPrinted by Abba Litho Sales Limited, London National Institute for Clinical Excellence, August 2004. All rightsreserved. This material may be freely reproduced for educational andnot-for-profit purposes within the NHS. No reproduction by or forcommercial organisations is permitted without the express writtenpermission of the Institute.
Contents
What is NICE guidance?
What is atopic eczema?
What are tacrolimus and pimecrolimus?
What has NICE recommended?
What should I do next?
Will NICE review its guidance?
Further information
What is NICE guidance?
The National Institute for Clinical Excellence(NICE) is part of the NHS. It produces guidance(recommendations) on the use of medicines,medical equipment, diagnostic tests and clinicaland surgical procedures within the NHS inEngland and Wales.
To produce this guidance, NICE looks at howwell the medicine, equipment or procedureworks and also how well it works in relation tohow much it costs. This process is called anappraisal. The appraisal process involves themanufacturer of the medicine or equipment forwhich guidance is being produced and theorganisations that represent the healthcareprofessionals, patients and carers who will beaffected by the guidance.
NICE was asked to look at the available evidenceon the use of tacrolimus and pimecrolimus fortreating atopic eczema. NICE was asked toprovide guidance that will help the NHS inEngland and Wales decide when tacrolimus andpimecrolimus should be used. Understanding NICE guidance – tacrolimus and pimecrolimus What is atopic eczema?
People with atopic eczema (also known as atopicdermatitis) have areas of red, inflamed, itchyskin that is often covered with fluid-filledblisters. Damage to the skin from scratching cancause bleeding, infection and thickening of theskin (also called lichenification).
Atopic eczema is the most common type ofeczema. Atopic eczema usually begins in earlychildhood, and may continue to flare up fromtime to time throughout life. Unlike other types of eczema (such as irritanteczema), the causes of atopic eczema are notfully understood. People who inherit a tendencyto allergies are most likely to get atopic eczema.
Environmental factors such as house dust mites,pollen, tobacco, air pollution and low humiditymay cause atopic eczema to start or to flare up.
Atopic eczema can be mild, moderate or severe.
Understanding NICE guidance – tacrolimus and pimecrolimus What are tacrolimus and
pimecrolimus?
Tacrolimus and pimecrolimus are non-steroidproducts that can be used to treat atopic eczema.
They work mainly by reducing inflammation(pain, heat, redness and swelling) by ‘switchingoff’ the activities of certain immune system cellsthat can cause the skin to become red andbroken. They are applied directly to the affectedareas of the skin (tacrolimus as an ointment andpimecrolimus as a cream) and are usually usedalongside creams that help keep the skinmoisturised (called emollients). Flare-ups of atopic eczema are often treated witha type of steroid, called topical corticosteroids(topical means it is applied directly to the skin).
Different topical corticosteroids vary in potency(how much they reduce inflammation). They aredescribed as mild, moderately potent, potent orvery potent. Different preparations of a steroidmay also vary in strength (how much of thesteroid they contain). A possible long-term side effect of topicalcorticosteroids is that the skin becomes thin andeasily bruised (this is called skin atrophy). This ismost likely to happen in areas where the skin isalready thin, such as the face or inside the bendsof the joints, and can be a particular problem inchildren. The skin may recover gradually when Understanding NICE guidance – tacrolimus and pimecrolimus treatment is stopped, but it may never recovercompletely. Permanent skin damage is more likelyif potent or very potent steroids are usedexcessively, or for long periods. Tacrolimus andpimecrolimus can be used on all parts of the bodyand do not cause skin atrophy, although theymay have other long-term side effects that arenot yet known.
What has NICE recommended on
using tacrolimus and pimecrolimus
for atopic eczema?
During the appraisal, NICE’s Appraisal Committeeread and heard evidence from: • high-quality studies of tacrolimus and • doctors with specialist knowledge of atopic • individuals with specialist knowledge of the issues affecting people with atopic eczema • organisations representing the views of people who will be affected by the guidance (becausethey have, or care for someone with, thecondition or because they work in the NHS andare involved in providing care for people withthe condition) Understanding NICE guidance – tacrolimus and pimecrolimus The evidence is summarised in the full guidance(see page 10 for details). More informationabout the studies is provided in the AssessmentReport for this appraisal (see page 10 for details).
NICE has made the following recommendationsabout the use of tacrolimus and pimecrolimus totreat atopic eczema within the NHS in Englandand Wales.
Tacrolimus and pimecrolimus should not be usedto treat mild atopic eczema. When atopiceczema is moderate or severe, tacrolimus andpimecrolimus should not be used as ‘first-line’treatments – that is, they should not be usedbefore other treatments have been tried. But,they may be considered in the circumstancesbelow.
• Tacrolimus may be considered to treat moderate or severe atopic eczema for adults,or children aged 2 years or older, if themaximum strength and potency of topicalcorticosteroid that is appropriate for thepatient’s age and the area being treated hasbeen adequately tried and hasn’t worked,where there is serious risk of important sideeffects from further use of topicalcorticosteroids (particularly permanentdamage to the skin).
Understanding NICE guidance – tacrolimus and pimecrolimus • Pimecrolimus may be considered to treat moderate atopic eczema on the face and neckfor children aged between 2 and 16 years ifthe maximum strength and potency of topicalcorticosteroid that is appropriate for thepatient’s age and the area being treated hasbeen adequately tried and hasn’t worked,where there is serious risk of important sideeffects from further use of topicalcorticosteroids (particularly permanentdamage to the skin).
Treatment with either tacrolimus or pimecrolimusshould only be started by doctors with a specialinterest and experience in skin diseases (this caninclude your GP), and only after the pros and consof these and other appropriate treatment optionshave been discussed.
What should I do next?
If you or someone you care for has atopiceczema, you should discuss this guidance withyour doctor or specialist.
Understanding NICE guidance – tacrolimus and pimecrolimus Will NICE review its guidance?
Yes. The guidance will be reviewed in August2007.
Further information
The NICE website (www.nice.org.uk) has furtherinformation about NICE and the full guidance onthe use of tacrolimus and pimecrolimus foratopic eczema that has been issued to the NHS.
The Assessment Report, which contains details ofthe studies that were looked at, is also availablefrom the NICE website. A short version of theguidance (a ‘quick reference guide’) is availableon the website and from the NHS Response Line(reference number N0686). NICE has published guidance on topicalcorticosteroids for treating atopic eczema.
'Information for the public' is available fromwww.nice.org.uk/TA081publicinfo or from theNHS Response Line, quote reference N0617 for aversion in English, or N0618 for a version inEnglish and Welsh.
If you have access to the Internet, you can findmore information about atopic eczema on theNHS Direct website (www.nhsdirect.nhs.uk). Youcan also phone NHS Direct on 0845 46 47. Understanding NICE guidance – tacrolimus and pimecrolimus NHS
National Institute for
Clinical Excellence
National Institute for
Clinical Excellence

Source: http://www.epgpatientdirect.org/docs/eczema/nice_patient_info.pdf