A Milder Form of Protopic?

[Guest guest]

Hi,

Here's another article from Skin & Allergy News' November 2001 issue.

I know that some people have used Protopic for their rosacea and/or

seb derm, but it caused much irritation. There's supposed to be a

milder form of this med, called Elidel, that causes less

irritation. However, it isn't as effective as Protopic.

Take care,

Matija

Pimecrolimus vs. tacrolimus

New Macrolide Agents Hold Different Advantages

F. Kirn

Sacramento Bureau

PORTLAND, ORE. — When it comes to the new macrolide immunomodulators,

tacrolimus and pimecrolimus, one causes less discomfort, but the

other may be slightly more effective, leading researchers reported at

an international symposium on atopic dermatitis.

Roughly half of patients who use tacrolimus for atopic dermatitis

will experience a burning sensation and pruritis that can last for

hours after application, according to the researchers. For most of

those patients, the discomfort wanes with continued use over weeks.

But it can be intense enough that a subset of patients will refuse to

use it, said Dr. Lawrence F. Eichenfield, chief of the division of

pediatric and adolescent dermatology at Children's Hospital, San

Diego, and the University of California.

On the other hand, tacrolimus may be somewhat more effective,

according to one comparison presented at the meeting, sponsored by

the National Eczema Association and the National Institute of

Arthritis and Musculoskeletal and Skin Diseases.

Tacrolimus ointment (Protopic, manufactured by Fujisawa Healthcare

Inc.) was approved last December for use in atopic dermatitis in two

concentrations, 0.1% for adults and 0.03% for adults and children at

least 2 years old. Pimecrolimus ointment (Elidel, manufactured by

Novartis Pharmaceuticals Inc.) is expected to be introduced early

next year.

Forty-seven percent of adult patients using tacrolimus ointment

experienced intense burning, while 26% of those who used pimecrolimus

did, said Dr. Edwin J. Van Leent, in a poster presentation comparing

two multicenter studies conducted in the Netherlands.

Combined data from the studies showed better results with tacrolimus,

however, said Dr. Van Leent of the University of Amsterdam. According

to investigators' assessment, 81% of 237 patients using tacrolimus

had total, or excellent or marked improvement at 6 months and 86% of

66 patients had total, or excellent or marked improvement when 12

months. In comparison, 54% of 163 patients using pimecrolimus had

cleared, almost cleared, or markedly improved at 6 months, and 69% of

135 patients had cleared, almost cleared, or markedly improved at 12

months.

In another presentation, Dr. Eichenfield compared published results

from the trials in children. Both drugs were found to be effective

and well tolerated in children over 2 years of age, according to 10

studies (3 of tacrolimus and 7 of pimecrolimus). " But, the incidence

of application site ... warmth or burning was higher with both forms

of Protopic than with Elidel, " he said.

In one 12-week study of tacrolimus in children aged 2-15 years, the

investigators reported incidence of burning at the application site

was 43% for the 0.03% ointment and 34% for the 0.1% ointment.

In contrast, data from two 6-week studies of patients in the same age

group indicated a burning incidence of only 10% with pimecrolimus.

Dr. Eichenfield said that the studies involved patients of different

ages and disease severity, which could influence reporting of side

effects.

Dr. Eichenfield's comparisons found less of a difference in efficacy

than Dr. Van Leent's. The results of a 6-week study with pimecrolimus

used twice a day showed that it reduced Eczema Area Severity Index

scores by 59% in children aged 2-17 years with mild to severe atopic

dermatitis. In a study of tacrolimus in children aged 2-15 years with

moderate or severe atopic dermatitis, the mean reduction in Eczema

Area Severity Index score at 3 months was 61%. A third 3-month study

of patients with moderate or severe disease reported a success rate

of 36% for the 0.03% ointment and 41% for the 0.1% ointment.