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Three Part Question

IN [infants with atopic dermatitis] IS [there any treatment] THAT [significantly reduces pruritus]?

Clinical Scenario

An 8 month old boy with atopic dermatitis attends the Paediatric Emergency Department. His mother's main concern is his itching which is causing him to become distressed and areas of skin to become broken down despite the use of emollients.

You know that in older children the use of sedating antihistamines is recommended. You wonder if there is anything available to treat this infant's pruritus.

Search Strategy

Cochrane, OVID Medline <1950 to June Week 1 2010, EMBASE <1980 to 2010 Week 23, CINAHL.
Cochrane: 'atopic dermatitis' OR 'eczema'
OVID Medline/EMBASE/CINAHL: (exp dermatitis,atopic OR exp eczema) AND (exp pruritus OR itch$.mp.) LIMIT to infant < 23 months AND humans AND English language.

Search Outcome

Cochrane: 37 found. 0 relevant.
OVID Medline: 32 found. 3 relevant.
EMBASE: 330 found. 1 relevant.
CINAHL: 79 found. 1 relevant.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Boguniewicz et al June 2008 United States	139 children aged from 6 months to 12 years with mild to moderate atopic dermatitis.	Randomised double-blinded control trial. Children were randomised to either Atopiclair or 'vehicle' which they applied 3 times a day.	Complete itch relief (Visual Analogue Scale (VAS): carer or child depending on age)	90 (65%)
			Reduction in pruritus (VAS)	Atopiclair group decreased from baseline value 60mm to 13mm on the VAS compared to 66mm to 57mm in the control group (p < 0.0001).
Patrizi et al November 2008 Italy	60 children aged between between 2 and 17 years with atopic dermatitis recruited from 2 dermatological sites in Italy.	Randomised double-blinded control trial. Children were randomised to either Atopiclair or 'vehicle' cream which they applied 3 times a day.	Reduction of pruritus (Visual Analogue Scale by carer or patient depending upon age, 0-100 mm)	p < 0.05 when compared to vehicle (baseline value of 42.5mm decreased to 16.8mm by day 43 compared with decrease to 44.7mm in vehicle group)
Kapp et al August 2002 Europe, Canada and South Africa	251 infants aged 3 to 23 months with atopic dermatitis were recruited from 41 centres in 8 countries including Belgium, Canada, France, Germany, New Zealand, South Africa, Spain and the United Kingdom.	Randomised double-blinded controlled trial. Children were randomised to either Pimecrolimus 1% cream or a 'vehicle' cream applied twice a day in addition to standard therapy.	Reduction in pruritus to 1 or less (primary caregiver scale, 0-3)	p = 0.008 on day 43 (76.5%)	Pruritus score based on caregiver scale of 0-3 is quite basic. Doesn't allow a range of results or impact on child to be assessed. The score may vary between caregivers due to their previous experience of disease.
Kaufmann et al November 2004 Germany	196 infants aged 3 to 23 months with atopic dermatitis from 19 centres in Germany.	Randomised double-blinded controlled trial. Children were randomised to Pimecrolimus 1% cream or 'vehicle' cream which they applied twice daily.	Reduction in pruritus (primary caregiver visual analog scale, 0-10)	p < 0.001 (baseline mean was 5.1 decreased to 2.1 compared to vehicle which increased from 4.5 to 5.2)	Children were randomised with ratio of 2:1, Pimecrolimus:vehicle. This could cause negative effects to be amplified in the control group and reduced in the interventional group.
Ring et al February 2008 Europe, Asia and South America	2014 infants aged 3 months to 17 years were recruited from 248 centres in 28 countries in Europe, Asia and South America.	Prospective naturalistic cohort study	Reduction in pruritus (primary caregiver or child score depending on age, 0-3)	1510 (75%) scored pruritus at 1 or absent after 1 month	No attempt to blind or randomise patients. Short time period of only 3 months. Pruritus assessment was basic. Treatment was not standardised or controlled and was given only when it may have been of benefit.

Comment(s)

Papers were also excluded if they were not published within last ten years and not considered to be high quality evidence following critical appraisal. The papers show that Pimecrolimus and Atopiclair can effectively reduce pruritus in those with atopic dermatitis. Pimecrolimus is currently not licensed for use for those under two years of age. It is recommended that it only be prescribed by those with dermatological interest (Association of Dermatologists' guidelines 2009). Atopiclair however is licensed for use in those of 1 month of age plus. Therefore it is clinically useful in this age group when the major complaint is pruritus.

Clinical Bottom Line

Atopiclair is a useful adjunct to standard emollient therapy in those who are under two years of age with pruritus caused by atopic dermatitis.

References

1. Mark Bouguniewicz, Joshua A. Zeichner, Lawrence F. Eichenfield, Adelaide A. Herbert, Michael Jarratt, Anne W. Lucky and Amy S. Paller MAS063DP is Effective Monotherapy for Mild to Moderate Atopic Dermatitis in Infants and Children: A Multicenter, Randomised Vehicle-Controlled Study Journal of Paediatrics June 2008;152(6):854-9
2. Patrizi A, Captianio B, Neri I, Giacomini F, Sinagra JL, Raone B, Berardesca E. A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIR) in the management of atopic dermatitis in paediatric patients. Paediatric Allergy & Immunology November 2008;19(7):619-25.
3. Kapp A, Papp K, Bingham A, Folster-Holst R, Ortonne JP, Potter PC, Gulliver W, Paul C, Molloy S, Barbier N, Thurston M and de Prost Y Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug. Journal of Allergy & Clinical Immunology August 2002;110(2):277-84.
4. Kaufmann R, Folster-Holst R, Hoger P, Thaci D, Loffler H, Staab D and Brautigam M Onset of action of pimecrolimus cream 1% in the treatment of atopic eczema in infants. Journal of Allergy & Clinical Immunology November 2004;114(5):1183-8.
5. Ring J, Abraham A, de Cuyper C, Kim K, Langeland T, Parra V, P Pigatto, Reunala T, Szczepanski R, Mohrenschlager M, Brautigam M, Rossi AB, Meents-Kopecky E and Schneider D. Control of atopic eczema with pimecrolimus cream 1% under daily practice conditions: results of a > 2000 patient study Journal of European Academy of Dermatology and Venerology February 2008;22(2):195-203.