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. Bonerandi & 68 others J. 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: Contribution to journalArticle

26 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

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Atopic Dermatitis
Pediatrics
Adrenal Cortex Hormones
Emollients
pimecrolimus
Body Surface Area
Switzerland
Caregivers
Multicenter Studies
Signs and Symptoms
Cytokines
Control Groups
Skin
Therapeutics
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Dermatology

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Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis. / Papp, Kim; Staab, Doris; Harper, John; Potter, Paul; Puig, Lluis; Ortonne, J. P.; Molloy, Stephen; Barbier, Nathalie; Paul, Carle; Stevens, R.; Varigos, G.; Stingl, G.; De Moor, A.; Gulliver, W.; Mehra, S.; Patel, P.; Tan, J.; Buckova, H.; Salavec, M.; Bonerandi, S.; Escande, J. P.; Guiller, G.; Khemis, A.; Ruer-Mulard, M.; Taieb, A.; de Prost, Y.; Amon, U.; Czech, W.; Fölster-Holst, R.; Hoffman, H.; Kapp, A.; Kaufmann, R.; Luger, T.; Meurer, M.; Reibel, S.; Rohr, C.; Schauer, U.; Scheer, T.; Schill, W. B.; Wahn, U.; Dobozy, A.; Horváth, A.; Károlyi, Z.; Török, É; Andreassi, L.; Bonifazi, E.; Caputo, R.; Gelmetti, C.; Birchall, N.; Oakley, A.; Cilliers, J.; Davis, M.; Docrat, M.; Gongypp, L.; Green, R.; Jacovides, J. A.; Manjra, A.; Raboobee, N.; Reyneke, S.; Walele, A.; Webster, I.; Wüthrich, B.; Bessens, P. J M J; Bos, J. D.; de Groot, L. J.; Kuiters, G. R R; Van Leent, E. J M; Oranje, A. P.; Stoof, T. J.; van der Valk, P. G M; Allamby, P.; Barnard, S.; Bingham, A.; Darrah, A.; Garala, M.; Goodfield, M.; Gooding, T.; Graham-Brown, R.; Green, A.; Lal Sarin, R.; Marazzi, P.; Martin, R.; McKinnon, C.; Smith, C.; Thompson, R.; Weaver, A.; Young, K.; Ling, M.

In: International Journal of Dermatology, Vol. 43, No. 12, 12.2004, p. 978-983.

Research output: Contribution to journalArticle

Papp, K, Staab, D, Harper, J, Potter, P, Puig, L, Ortonne, JP, 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, Bonerandi, S, Escande, JP, Guiller, G, Khemis, A, Ruer-Mulard, M, Taieb, A, de Prost, Y, Amon, U, Czech, W, Fölster-Holst, R, Hoffman, H, Kapp, A, Kaufmann, R, Luger, T, Meurer, M, Reibel, S, Rohr, C, Schauer, U, Scheer, T, Schill, WB, Wahn, U, Dobozy, A, Horváth, A, Károlyi, Z, Török, É, Andreassi, L, Bonifazi, E, Caputo, R, Gelmetti, C, Birchall, N, Oakley, A, Cilliers, J, Davis, M, Docrat, M, Gongypp, L, Green, R, Jacovides, JA, Manjra, A, Raboobee, N, Reyneke, S, Walele, A, Webster, I, Wüthrich, B, Bessens, PJMJ, Bos, JD, de Groot, LJ, Kuiters, GRR, Van Leent, EJM, Oranje, AP, Stoof, TJ, van der Valk, PGM, Allamby, P, Barnard, S, Bingham, A, Darrah, A, Garala, M, Goodfield, M, Gooding, T, Graham-Brown, R, Green, A, Lal Sarin, R, Marazzi, P, Martin, R, McKinnon, C, Smith, C, Thompson, R, Weaver, A, Young, K & Ling, M 2004, 'Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis', International Journal of Dermatology, vol. 43, no. 12, pp. 978-983. https://doi.org/10.1111/j.1365-4632.2004.02121.x
Papp, Kim ; Staab, Doris ; Harper, John ; Potter, Paul ; Puig, Lluis ; Ortonne, J. P. ; Molloy, Stephen ; Barbier, Nathalie ; Paul, Carle ; Stevens, R. ; Varigos, G. ; Stingl, G. ; De Moor, A. ; Gulliver, W. ; Mehra, S. ; Patel, P. ; Tan, J. ; Buckova, H. ; Salavec, M. ; Bonerandi, S. ; Escande, J. P. ; Guiller, G. ; Khemis, A. ; Ruer-Mulard, M. ; Taieb, A. ; de Prost, Y. ; Amon, U. ; Czech, W. ; Fölster-Holst, R. ; Hoffman, H. ; Kapp, A. ; Kaufmann, R. ; Luger, T. ; Meurer, M. ; Reibel, S. ; Rohr, C. ; Schauer, U. ; Scheer, T. ; Schill, W. B. ; Wahn, U. ; Dobozy, A. ; Horváth, A. ; Károlyi, Z. ; Török, É ; Andreassi, L. ; Bonifazi, E. ; Caputo, R. ; Gelmetti, C. ; Birchall, N. ; Oakley, A. ; Cilliers, J. ; Davis, M. ; Docrat, M. ; Gongypp, L. ; Green, R. ; Jacovides, J. A. ; Manjra, A. ; Raboobee, N. ; Reyneke, S. ; Walele, A. ; Webster, I. ; Wüthrich, B. ; Bessens, P. J M J ; Bos, J. D. ; de Groot, L. J. ; Kuiters, G. R R ; Van Leent, E. J M ; Oranje, A. P. ; Stoof, T. J. ; van der Valk, P. G M ; Allamby, P. ; Barnard, S. ; Bingham, A. ; Darrah, A. ; Garala, M. ; Goodfield, M. ; Gooding, T. ; Graham-Brown, R. ; Green, A. ; Lal Sarin, R. ; Marazzi, P. ; Martin, R. ; McKinnon, C. ; Smith, C. ; Thompson, R. ; Weaver, A. ; Young, K. ; Ling, M. / Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis. In: International Journal of Dermatology. 2004 ; Vol. 43, No. 12. pp. 978-983.
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title = "Effect of pimecrolimus cream 1{\%} on the long-term course of pediatric atopic dermatitis",
abstract = "Background. This report investigates the effect of pimecrolimus cream 1{\%} (Elidel{\circledR}, 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.",
author = "Kim Papp and Doris Staab and John Harper and Paul Potter and Lluis Puig and Ortonne, {J. P.} and Stephen Molloy and Nathalie Barbier and Carle Paul and R. Stevens and G. Varigos and G. Stingl and {De Moor}, A. and W. Gulliver and S. Mehra and P. Patel and J. Tan and H. Buckova and M. Salavec and S. Bonerandi and Escande, {J. P.} and G. Guiller and A. Khemis and M. Ruer-Mulard and A. Taieb and {de Prost}, Y. and U. Amon and W. Czech and R. F{\"o}lster-Holst and H. Hoffman and A. Kapp and R. Kaufmann and T. Luger and M. Meurer and S. Reibel and C. Rohr and U. Schauer and T. Scheer and Schill, {W. B.} and U. Wahn and A. Dobozy and A. Horv{\'a}th and Z. K{\'a}rolyi and {\'E} T{\"o}r{\"o}k and L. Andreassi and E. Bonifazi and R. Caputo and C. Gelmetti and N. Birchall and A. Oakley and J. Cilliers and M. Davis and M. Docrat and L. Gongypp and R. Green and Jacovides, {J. A.} and A. Manjra and N. Raboobee and S. Reyneke and A. Walele and I. Webster and B. W{\"u}thrich and Bessens, {P. J M J} and Bos, {J. D.} and {de Groot}, {L. J.} and Kuiters, {G. R R} and {Van Leent}, {E. J M} and Oranje, {A. P.} and Stoof, {T. J.} and {van der Valk}, {P. G M} and P. Allamby and S. Barnard and A. Bingham and A. Darrah and M. Garala and M. Goodfield and T. Gooding and R. Graham-Brown and A. Green and {Lal Sarin}, R. and P. Marazzi and R. Martin and C. McKinnon and C. Smith and R. Thompson and A. Weaver and K. Young and M. Ling",
year = "2004",
month = "12",
doi = "10.1111/j.1365-4632.2004.02121.x",
language = "English",
volume = "43",
pages = "978--983",
journal = "International Journal of Dermatology",
issn = "0011-9059",
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TY - JOUR

T1 - Effect of pimecrolimus cream 1% on the long-term course of pediatric atopic dermatitis

AU - Papp, Kim

AU - Staab, Doris

AU - Harper, John

AU - Potter, Paul

AU - Puig, Lluis

AU - Ortonne, J. P.

AU - Molloy, Stephen

AU - Barbier, Nathalie

AU - Paul, Carle

AU - Stevens, R.

AU - Varigos, G.

AU - Stingl, G.

AU - De Moor, A.

AU - Gulliver, W.

AU - Mehra, S.

AU - Patel, P.

AU - Tan, J.

AU - Buckova, H.

AU - Salavec, M.

AU - Bonerandi, S.

AU - Escande, J. P.

AU - Guiller, G.

AU - Khemis, A.

AU - Ruer-Mulard, M.

AU - Taieb, A.

AU - de Prost, Y.

AU - Amon, U.

AU - Czech, W.

AU - Fölster-Holst, R.

AU - Hoffman, H.

AU - Kapp, A.

AU - Kaufmann, R.

AU - Luger, T.

AU - Meurer, M.

AU - Reibel, S.

AU - Rohr, C.

AU - Schauer, U.

AU - Scheer, T.

AU - Schill, W. B.

AU - Wahn, U.

AU - Dobozy, A.

AU - Horváth, A.

AU - Károlyi, Z.

AU - Török, É

AU - Andreassi, L.

AU - Bonifazi, E.

AU - Caputo, R.

AU - Gelmetti, C.

AU - Birchall, N.

AU - Oakley, A.

AU - Cilliers, J.

AU - Davis, M.

AU - Docrat, M.

AU - Gongypp, L.

AU - Green, R.

AU - Jacovides, J. A.

AU - Manjra, A.

AU - Raboobee, N.

AU - Reyneke, S.

AU - Walele, A.

AU - Webster, I.

AU - Wüthrich, B.

AU - Bessens, P. J M J

AU - Bos, J. D.

AU - de Groot, L. J.

AU - Kuiters, G. R R

AU - Van Leent, E. J M

AU - Oranje, A. P.

AU - Stoof, T. J.

AU - van der Valk, P. G M

AU - Allamby, P.

AU - Barnard, S.

AU - Bingham, A.

AU - Darrah, A.

AU - Garala, M.

AU - Goodfield, M.

AU - Gooding, T.

AU - Graham-Brown, R.

AU - Green, A.

AU - Lal Sarin, R.

AU - Marazzi, P.

AU - Martin, R.

AU - McKinnon, C.

AU - Smith, C.

AU - Thompson, R.

AU - Weaver, A.

AU - Young, K.

AU - Ling, M.

PY - 2004/12

Y1 - 2004/12

N2 - 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.

AB - 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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U2 - 10.1111/j.1365-4632.2004.02121.x

DO - 10.1111/j.1365-4632.2004.02121.x

M3 - Article

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SP - 978

EP - 983

JO - International Journal of Dermatology

JF - International Journal of Dermatology

SN - 0011-9059

IS - 12

ER -