The Frequency and Intensity of Topical Pimecrolimus Treatment in Children with Physician‐Confirmed Mild to Moderate Atopic Dermatitis

Abstract

Atopic dermatitis (AD) is often treated with multiple modalities, including topical medications such as corticosteroids and topical calcineurin inhibitors (TCIs). The aim of this study was to describe the natural history of the utilization characteristics of topical treatment in those with AD. We conducted a longitudinal study of the first 4,105 children with physician-confirmed mild to moderate AD enrolled in an ongoing postmarketing safety study of pimecrolimus. Information was obtained from participants every six months using a questionnaire. Drug utilization was solely determined by the physician and patient. Over the three years of our study, an increasing number of individuals reported at least 6 months of complete control of their disease, without the continued use of a topical medication. While all study participants used pimecrolimus at the start of the study less than 40% continued to use it after 3 years of study participation. If an individual was still using a topical medication after three years of follow-up, it was most likely a topical corticosteroid. For those who continued to use pimecrolimus, the use was limited to about 60 grams of pimecrolimus in 6 months. Community-based use of topical pimecrolimus to treat AD is limited both with respect to the duration of exposure and amount or total dose of the exposure. If a topical therapy is persistent, it is most likely to a topical corticosteroid.

Association Between Malignancy and Topical Use of Pimecrolimus

“…About 8 years ago, due to concerns about the theoretical increased risk of malignancy, the FDA revised the labeling for the TCI class of medication to include a boxed warning addressing this concern 3;10 . Our current report was based on more than 25,000 person-years of follow-up from a post-marketing cohort study designed to evaluate the risk of malignancy in children exposed to pimecrolimus.…”

“…Eligible subjects were ≥ 2 and < 18 years of age at the date of enrollment. All subjects had a diagnosis of AD by a treating physician, the majority of who were pediatricians, allergists, or dermatologists 8–10 . The enrollment diagnosis was confirmed by the Working Party Diagnostic Criteria 12 .…”

“…Participants were excluded if at the time of enrollment they had a previous or current history of lymphoproliferative disease, systemic malignancy, skin malignancy, and/or history of the use of oral immunosuppressive therapy. As noted, children were not required to continue to use pimecrolimus once they were enrolled in PEER 10 . Our research protocol was approved by the IRB at the University of Pennsylvania.…”

Atopic dermatitis disease control and age: A cohort study

“…(8) After enrollment, subjects were not required to continue to use pimecrolimus, and in fact most stopped. (2) It is possible that the use of pimecrolimus reflects more about the prescribing tendencies of providers than the patient’s disease characteristics.…”

“…It is a cohort study designed to test whether there is an increased risk of malignancy associated with the use of pimecrolimus, and includes a patient-reported measure of disease control every 6 months. (2, 3) To enroll, patients must have AD diagnosed by a physician and used 1% topical pimecrolimus cream for at least 42 out of the last 180 days.…”