AUGUST 30, 2004
VOLUME 1 NO. 15
 

Tacrolimus topples pimecrolimus in the battle
of topical immunomodulators

It's not a rash decision to pick tacrolimus � both drug safety profiles are comparable


Aspiring drummer, fifteen-year-old Christopher Robinson's fervent hope is that the eczema on his hands will clear up before the debut gig of his band, Screaming Lizard. In Canada, for moderate eczema like Chris's, doctors can prescribe either tacrolimus ointment or pimecrolimus cream, both nonsteroidal topical immunomodulators which are considered safer than corticosteroids. Chris wants to know which one works best. Wouldn't it be nice to have a simple answer for him? A study presented at the 2004 American Academy of Dermatology provides evidence that tacrolimus outperforms pimecrolimus on every measure of efficacy and matches it for tolerability.

"This study is the first, large, well-designed comparative trial to examine tacrolimus ointment and pimecrolimus cream in the same patient populations, including age, disease severity, length of treatment, efficacy endpoints and adverse events," said lead researcher Dr Alan Fleischer, director of the General Dermatology Clinic at the Wake Forest University Baptist Medical Center in North Carolina. "In this study, tacrolimus ointment seemed to work better for all severities of atopic dermatitis than pimecrolimus, including mild sufferers and particularly in severe patients."

Dr Fleischer's results also showed that there's no significant difference between the two medicines in terms of adverse effects such as burning or stinging. The six-week, randomized, investigator-blinded study evaluated 1,056 patients with mild to severe atopic dermatitis (AD). Patients' symptoms were measured at day one and at weeks one, three and six. As well as the physician-rated Investigator's Global Atopic Dermatitis Assessment and Body Surface Area assessment, an Eczema Area and Severity Index score was calculated, and finally, the patient's own all-important evaluation of itch was recorded.

Tacrolimus beat out pimecrolimus in treating both mild and severe pediatric AD. Forty-seven percent of children with mild AD treated with tacrolimus ointment 0.03% achieved "clear" or "almost clear" skin compared with 41% of patients using pimecrolimus cream 1%. Similarly, 32% of patients aged 2 to 15 with severe AD treated with tacrolimus ointment 0.1% saw significant improvement, while only 18% of children treated with pimecrolimus cream 1% did.

Tacrolimus also proved its superiority in the adult arm of the study. Tacrolimus ointment 0.1% was successful in clearing up skin 46% of the time compared with a success rate of 27% for pimecrolimus cream 1%.

"This study supports existing data that show that tacrolimus and pimecrolimus have the same safety profile and comparable tolerability," said Dr Fleischer. "Tacrolimus works more rapidly at the skin's surface than pimecrolimus, yet existing data indicate that neither medication showed a trend toward higher blood accumulation over time, deeming them equally safe. Patients treated with tacrolimus ointment for all degrees of severity of atopic dermatitis experienced a greater and more rapid reduction in itching symptoms, which is key to improving the quality of life for these patients."

 

 

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