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Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients
  1. B R Allen1,
  2. M Lakhanpaul1,
  3. A Morris1,
  4. S Lateo1,
  5. T Davies1,
  6. G Scott2,
  7. M Cardno2,
  8. M-E Ebelin3,
  9. P Burtin3,
  10. T J Stephenson1
  1. 1Departments of Dermatology and Child Health, University Hospital, Nottingham, UK
  2. 2Novartis Pharmaceuticals, Horsham, UK
  3. 3Novartis Pharma AG, Basel, Switzerland
  1. Correspondence to:
    Dr M E Ebelin
    Novartis Pharma AG, WSJ-210-340, CH-4002 Basel, Switzerland; marieeve.ebelinpharma.novartis.com

Abstract

Aims: To measure pimecrolimus blood concentrations and to evaluate tolerability and efficacy in children and infants treated topically for atopic dermatitis with pimecrolimus cream 1% for three weeks.

Methods: Three open label, non-controlled, multiple topical dose studies were conducted in children aged 8–14 years (study A, ten patients), and in infants aged 8–30 months (study B, eight patients) and 4–11 months (study C, eight patients). Pimecrolimus blood concentrations were determined on days 4 and 22 of treatment, and at end of study. Efficacy was assessed using the Eczema Area and Severity Index (EASI).

Results: Pimecrolimus blood concentrations were consistently low, typically (81%) below 1 ng/ml, with more than half of the measurements below the assay limit of quantitation (0.5 ng/ml) in studies A and B. The highest blood concentration measured throughout the three studies was 2.6 ng/ml. The cream was well tolerated, locally and systemically. The most common adverse event suspected to be related to study medication was a transient mild to moderate stinging sensation at the application site in 5/26 patients. There was no indication of any systemic adverse effect. The patients responded well to therapy with a rapid onset of action, usually within four days. Median reductions of EASI from baseline at day 22 were 55% (study A), 63% (study B), and 83% (study C).

Conclusion: Three weeks treatment of children and infants with extensive atopic dermatitis, using pimecrolimus cream 1% twice daily, is well tolerated and results in minimal systemic exposure, at which no systemic effect is expected.

  • pimecrolimus
  • SDZ ASM 981
  • elidel
  • atopic dermatitis
  • blood concentrations
  • AUC, area under the blood concentration–time curve
  • BSA, body surface area
  • EASI, Eczema Area and Severity Index
  • LoQ, limit of quantitation
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