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Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis

Authors

  • Kim Papp MD,

    Corresponding author
    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
      Kim Papp Probity Medical Research Waterloo Canada E-mail: kapapp@probitymedical.com
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  • Doris Staab MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • John Harper MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • Paul Potter MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • Lluis Puig MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • J.-P. Ortonne MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • Stephen Molloy PhD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • Nathalie Barbier PhD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • Carle Paul MD,

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • for the Multicentre Investigator Study Group

    1. From the Probity Medical Research, Waterloo, Canada; Charité Campus Virchow, Department for Pediatric Pneumology and Immunology, Charité, Berlin, Germany; Department of Paediatric Dermatology, Great Ormond Street Hospital for Children, London, UK; Allergology Unit, Department of Immunology, Groote Schuur Hospital, Cape Town, South Africa; Department of Dermatology, Hospital Santa Creu i Sant Pau, Barcelona, Spain; Hôpital l’Archet 2, Nice, France; and Novartis Pharma AG, Basel, Switzerland
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  • This work was sponsored by Novartis Pharma AG, Basel, Switzerland.

Kim Papp Probity Medical Research Waterloo Canada E-mail: kapapp@probitymedical.com

Abstract

Background  This report investigates the effect of pimecrolimus cream 1% (Elidel®, Novartis pharma AG, Basel, Switzerland), a nonsteroid, cell-selective, cytokine inhibitor on the course of atopic dermatitis (AD), as assessed by changes in body surface involvement and pattern of drug use over time.

Methods  Data from 961 patients in two 1-year double-blind, multicenter, pediatric studies of similar design were analyzed: 250 infants (aged 3–23 months) were randomized 4 : 1 and 711 children (aged 2–17 years) were randomized 2 : 1 to receive pimecrolimus cream 1% or vehicle, respectively. Emollients were used by all patients to alleviate dry skin and, at the first signs or symptoms of AD, pimecrolimus or vehicle was applied twice daily to prevent progression to flares. If flares occurred in either group, moderately potent topical corticosteroids were mandated.

Results  Pimecrolimus was applied for 68.4% (infants) and 53.8% (children) of study days, and frequency of use of pimecrolimus decreased over time, reflecting improvement in disease control. The mean total body surface area affected decreased continuously over time. Significantly more patients in the pimecrolimus than control groups were maintained without corticosteroid therapy (infants: 63.7% vs. 34.8%, P < 0.001; children: 57.4% vs. 31.6%, P < 0.001, respectively).

Conclusion  The need for pimecrolimus therapy decreases over time as the patients’ disease improves. Hence, once long-term management of AD with pimecrolimus is established, the burden of disease for both the patient and the caregiver decreases significantly and disease-free periods become more frequent.

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