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

Kim Papp, Doris Staab, John Harper, Paul Potter, Lluis Puig, J. P. Ortonne, Stephen Molloy, Nathalie Barbier, Carle Paul, R. Stevens, G. Varigos, G. Stingl, A. De Moor, W. Gulliver, S. Mehra, P. Patel, J. Tan, H. Buckova, M. Salavec, S. BonerandiJ. P. Escande, G. Guiller, A. Khemis, M. Ruer-Mulard, A. Taieb, Y. de Prost, U. Amon, W. Czech, R. Fölster-Holst, H. Hoffman, A. Kapp, R. Kaufmann, T. Luger, M. Meurer, S. Reibel, C. Rohr, U. Schauer, T. Scheer, W. B. Schill, U. Wahn, A. Dobozy, A. Horváth, Z. Károlyi, É Török, L. Andreassi, E. Bonifazi, R. Caputo, C. Gelmetti, N. Birchall, A. Oakley, J. Cilliers, M. Davis, M. Docrat, L. Gongypp, R. Green, J. A. Jacovides, A. Manjra, N. Raboobee, S. Reyneke, A. Walele, I. Webster, B. Wüthrich, P. J.M.J. Bessens, J. D. Bos, L. J. de Groot, G. R.R. Kuiters, E. J.M. Van Leent, A. P. Oranje, T. J. Stoof, P. G.M. van der Valk, P. Allamby, S. Barnard, A. Bingham, A. Darrah, M. Garala, M. Goodfield, T. Gooding, R. Graham-Brown, A. Green, R. Lal Sarin, P. Marazzi, R. Martin, C. McKinnon, C. Smith, R. Thompson, A. Weaver, K. Young, M. Ling

Research output: Article

27 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)978-983
Number of pages6
JournalInternational journal of dermatology
Volume43
Issue number12
DOIs
Publication statusPublished - dec. 2004

ASJC Scopus subject areas

  • Dermatology

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    Papp, K., Staab, D., Harper, J., Potter, P., Puig, L., Ortonne, J. P., Molloy, S., Barbier, N., Paul, C., Stevens, R., Varigos, G., Stingl, G., De Moor, A., Gulliver, W., Mehra, S., Patel, P., Tan, J., Buckova, H., Salavec, M., ... Ling, M. (2004). Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis. International journal of dermatology, 43(12), 978-983. https://doi.org/10.1111/j.1365-4632.2004.02121.x