A study has shown the importance of Elidel ( Pimecrolimus ) cream 1% as an alternative to topical corticosteroids.
Elidel cleared eczema from the faces of patients allergic to or intolerant of steroids.

The study found 46.5% of patients treated with Elidel after six weeks were clear or almost clear of facial eczema compared to 16.2% of the group treated with unmedicated placebo "vehicle cream" ( p<0.001 ).

Topical steroids have been the mainstay of therapy for up to half-a-century, but their long-term use has been associated with a range of harmful side effects.

Of the 200 patients enrolled in the study, a total of 45.9% had previously experienced potentially irreversible consequences such as rosacea, atrophy or telangiectasias .
Some were allergic to steroids ( 21.5% ) or had eczema in areas where steroid use is inadvisable, such as around the eyes ( 17.5% ) or on the eyelids ( 10.5% ).

A special concern was that 82.5% of participants were dependent on steroids to reduce the painful and distressing symptoms of atopic eczema and were using them so frequently that there was an unacceptable risk of side effects ( i.e. for an average of 17 days within the previous month ).

Elidel, one of a class of drugs called topical calcineurin inhibitors, does not contain steroids and acts more selectively to reduce the inflammatory symptoms of atopic eczema.

Patients age 12 and above with a history of mild or moderate atopic eczema were enrolled at 29 centers in five countries.
They were randomised into two groups for treatment with either Elidel or vehicle cream during a six-week double-blind phase, followed by six weeks of open label therapy.
Efficacy was assessed using standard measures of disease severity such as the Investigator's Global Assessment ( IGA ).

As early as eight days after starting treatment, patients treated with Elidel began to show a significantly greater improvement than those using vehicle cream, with 20.8% of those on Elidel being clear or almost clear of facial eczema compared to 7.1% of those on vehicle ( p<0.01 ).
When the double-blind phase ended on day 43, the difference between the groups was even more pronounced ( 46.5% vs. 16.2% being clear or almost clear ).
Elidel patients maintained their improvement during the open label phase.

Reduction of itching, one of the most troubling symptoms of eczema, was significantly greater in Elidel patients, with 69.3% achieving a pruritis score at day 43 of <=1 ( where 1 is defined as mild ), compared to 34.5% of those on vehicle ( p<0.001 ).

In addition, the study showed that Elidel helped to reverse the effects of skin thinning.
After six weeks, 46% of Elidel patients who had skin atrophy at the start of the study experienced an improvement ( p<0.01 ), compared to 19% of patients treated with vehicle cream.

Elidel was well-tolerated, and safety results were consistent with other studies using the drug.

Atopic eczema has traditionally been treated reactively, using topical steroids to manage periodic flare-ups in which the skin becomes abnormally dry, itchy and inflamed, and scratching leads to broken, oozing and bleeding skin.
With the availability of calcineurin inhibitors such as Elidel, physicians have been able to progress from reactive treatment to earlier proactive intervention to control the disease.

Results from two associated clinical trials also presented at the EADV congress, called the Pimecrolimus in Eczema: Prevention of Progression ( PEP ) studies, demonstrated that early intervention with Elidel at the first signs or symptoms of disease reduced the number and severity of flare-ups in children and adults.

The two 26-week, multi-center, double-blind, vehicle-controlled studies involved 521 children and adolescents ( age 2-17 years ) and 543 adults ( age 18 or above ) respectively, with a history of mild to moderate atopic eczema.
Flare-ups were defined as a worsening of symptoms despite study treatment, requiring the use of topical steroids.

In the paediatric study, the mean number of flares-ups was halved in the Elidel group compared to the vehicle group ( 0.84 vs. 1.68 flare-ups ), while the adult study showed a 30% reduction ( 0.97 vs. 1.39 ). Elidel-treated patients remained flare-free for longer, with a median time to first flare of more than 190 days in both studies, compared to 59 days for children and 67 days for adults treated with vehicle cream ( both p<0.0001 ).

Children treated with Elidel at the first signs and symptoms of disease were able to shorten their use of topical steroids by 41% compared to those using vehicle ( mean duration of steroid use: 12.9 vs. 21.9 days ), while adults achieved a 21% reduction ( 17.7 vs. 22.5 days ). Furthermore, patients using Elidel made at least one-third fewer unscheduled visits to their physician than those using vehicle ( 87 vs. 246 visits for children, 156 vs. 223 for adults ). Elidel was well-tolerated and safety results were consistent with other studies using the drug.

Source: Novartis, 2005


XagenaMedicine2005