Safety and efficacy of Pimecrolimus in atopic dermatitis among Chinese infants: a sub-group analysis of a five-year open-label study

Abstract

Introduction

Atopic dermatitis (AD) exhibits difference in immune polarization between Caucasians and Asian races due to which an evaluation of the efficacy and safety of Pimecrolimus (PIM) in Asian population is called for. The current study addresses the need via a sub-group analysis of the PETITE study (NCT00120523) to evaluate the safety and efficacy of PIM in Chinese infants.

Materials and methods

Patients with AD (≥3 months–<12 months of age) were randomized in a 1:1 ratio to either PIM 1% cream or topical corticosteroids (TCS). The primary endpoint was safety. The secondary endpoint was efficacy.

Results

120 patients were randomized to either PIM 1% or TCS (n = 61 for PIM, n = 59 for TCS). The most often reported adverse events were reported by similar proportions of patients treated with PIM or TCS. There was a progressive increase in overall IGA treatment success in infants treated with PIM (82.9%, p < .05, 95% CI: 70.4, 95.3) after 26 weeks which was comparable to the TCS group (88.5%, p < .05, 95% CI: 79.8, 97.1).

Conclusion

PIM showed an early and sustained efficacy in the Chinese sub-population with a substantial corticosteroid-sparing effect in patients with AD.

Keywords:

• Atopic dermatitis
• Pimecrolimus
• topical corticosteroids
• topical calcineurin inhibitors
• China

Acknowledgements

The authors appreciate the editorial support from Arghya Bhattacharya, PhD of Viatris.

Author contributions

All the authors were involved in the planning, execution, and reporting of the study. The manuscript was reviewed by all the authors and consent was given for the publication of the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

Raw data were generated at Viatris. Derived data supporting the findings of this study are available from the corresponding author X.D. on request.

Additional information

Funding

This study was funded by Viatris.