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Elidel (pimecrolimus)


Elidel cream is the second of two new products for the treatment of atopic dermatitis. Its efficacy has primarily been demonstrated in placebo-controlled studies. Elidel exhibited poorer efficacy than steroids in the studies, but Elidel can be used for longer continuous periods of time. The most frequently occurring adverse effect is a transient burning sensation at the application site. Elidel therapy costs roughly 5-10 times more than steroid therapy, but about the same as treatment with the other new product (Protopic).


Treatment with Elidel may be attempted in steroid-intolerant patients or for the treatment of sensitive areas (e.g. the face) on which (Class I) steroids have had an inadequate effect.



Elidel 1% cream (pimecrolimus) was marketed on Monday, 19 August 2002, and is thus the second of two new macrolide creams for the treatment of atopic dermatitis. The first was Protopic ointment (tacrolimus).


Elidel is applied twice daily at the first sign of symptoms, and therapy is continued until symptoms resolve. Elidel can be applied to any skin area, but not to the mucous membranes, and it may be used concomitantly with moisturising creams. Clothing or sunscreen should be used to minimise exposure of the skin to sun or other forms of ultraviolet light while treatment is ongoing.


Differences between Protopic and Elidel

Elidel is indicated for mild to moderate atopic dermatitis; Protopic for moderate to severe atopic dermatitis. Both therapies can be used for adults and children above two years of age (but not between three months and two years of age. Since authorisation in Denmark will also be valid in other countries, the decision was made that more studies with children between three months and two years old must be conducted before Elidel can be authorised for this age group.) The immunomodulatory potential of Elidel is less than that of Protopic, so the former may be prescribed by all physicians but the latter only by specialists in certain fields. The efficacy and adverse drug effects of Elidel and Protopic are not directly comparable. Unlike Elidel, Protopic has demonstrated the same level of efficacy as low- and medium-potency steroids (Classes I and II, but not Class III).



Placebo-controlled studies have shown that Elidel has both an acute and a prophylactic effect on flares in patients with mild to moderate atopic dermatitis. However, it exhibited poorer efficacy when compared with steroids in the following studies.


A three-week dose-response study of patients with moderate atopic dermatitis found Elidel 1% less efficacious than betamethasone valerate (a Class III steriod). The median change in EASI (Eczema Area and Severity Index) was 37.9% and 64.1% respectively for the two products.


In a one-year study of 658 patients with moderate to severe atopic dermatitis, Elidel exhibited significantly poorer efficacy than a combination therapy of triamicinolone (a Class II steriod for areas on the body and the extremities) and hydrocortisone (a Class I for the face, neck and other sensitive areas). The average change in EASI was 3.85% for Elidel and 9.57% for the steroid combination treatment.


Adverse drug reactions

Elidel does not elicit skin atrophy. Adverse events are local and short-term burning or itching, but their incidence in the above-mentioned one-year study was significantly higher than in the steroid group. 


Drug interactions

Elidel should not be used concomitantly with topical steriods on the same area of skin, but other steroid therapy (oral, nasal, inhalation) may be used. There is a theoretical possibility that Elidel may weaken the efficacy of vaccinations, so vaccinations should be administered during treatment-free intervals.



Elidel costs roughly the same as Protopic, but about 5-10 times more per gram than other therapies, e.g. the steroids it was compared with in studies (examples are prices at 2 September 2002). General reimbursement is currently not granted for Elidel.


Product  Contents  Cost (DKK)  Price per gram (DKK)
Betnovat 0.1% cream 50g  betamethasone (Class III)  84.15  1.68
Elidel 1% cream 30g  pimecrolimus  331.25  11.04
Hydrocortisone 1% cream 30ml  hydrocortisone (Class I)  72.80  2.43
Mildison Lipid 1% cream 30g  hydrocortisone (Class I)  48.90  1.63
Kenalog ointment 0.1% 50g  triamcinolone (Class II)  106.5  2.14
Protopic 0.03% ointment 30g tacrolimus 352.35 11.5
Protopic 0.1% ointment 30g  tacrolimus 390.65  13.02
Uniderm 1% ointment 50g  hydrocortisone (Class I)  60.05  1.20


Additional information can be found in the summary of product characteristics published by the Danish Medicines Agency (Danish only).
Last modified: August 19th 2002

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