Dermatologic and Ocular DiseasesLong-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug☆,☆☆
Section snippets
Study conduct
This study was conducted at 41 centers in 8 countries (Belgium, Canada, France, Germany, New Zealand, South Africa, Spain, and the United Kingdom). The institutional review board at each center approved the protocol, and written informed consent was obtained from the legal guardians of all study participants.
Study population
In total, 251 infants aged 3 to 23 months with a clinical diagnosis of AD according to the criteria of Seymour et al18 were randomized to treatment. For the main inclusion and exclusion
Patients
In total, 251 patients from 39 centers were randomized, of whom 204 were randomized to the pimecrolimus-based treatment regimen and 47 to the conventional treatment control group. A flow diagram of patient accounting and treatment outcome is provided in Fig 2.
The demographic and clinical characteristics of the patients are summarized in Table II.
Empty Cell Pimecrolimus (n = 204) Control (n = 46) Age, mo (range) 12.2 (3-23)
Discussion
This study demonstrates that a treatment strategy on the basis of early intervention with pimecrolimus twice daily for preventing flares and reducing dependence on corticosteroids was safe and provided superior disease control in infants with AD compared with a conventional regimen of emollients and moderately potent corticosteroids. In particular, pimecrolimus treatment was associated with a clinically significant effect on the course of the disease over 12 months, including a lower incidence
Acknowledgements
We would like to thank the participating investigators in the Flare Reduction in Eczema with Elidel (infants) study: Belgium: A. De Moor; Canada: S. Mehra, J. Tan; France: J. P. Escande, J.-J. Bonerandi, M. Ruer-Mulard; Germany: W.-B. Schill, M. Meurer, U. Schauer, H. Hofmann, T. Scheer; New Zealand: N. Birchall, A. Oakley; South Africa: R. Green, J. A. Jacovides, A. Manjra, N. Raboobee, A. Walele, S. J. Reyneke; Spain: L. Puig; United Kingdom: A. Bingham, A. Darrah, C. McKinnon, R. Lal Sarin,
References (33)
- et al.
The prevalence of childhood atopic eczema in a general population
J Am Acad Dermatol
(1994) - et al.
Cataracts, glaucoma, and femoral avascular necrosis caused by topical corticosteroid ointment
Lancet
(1995) - et al.
Clinical effects of diaper types on the skin of normal infants and infants with atopic dermatitis
J Am Acad Dermatol
(1987) - et al.
Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents
J Am Acad Dermatol
(2002) Atopic dermatitis—the skin manifestation of atopy
Clin Exp Allergy
(1995)- et al.
Atopic dermatitis and allergic contact dermatitis
The epidemiology of atopic dermatitis
Monogr Allergy
(1993)- et al.
Prevalence of atopic eczema in children between 0 and 30 months on Avon district
Br J Dermatol
(2000) - et al.
Topical steroid treatment in infants, children, and adolescents
Adv Dermatol
(1994) Managing pediatric atopic dermatitis
Clin Pediatr
(2000)
Incidence and degree of unwanted adverse effects of corticoids in childhood: results of dermatological studies in children with chronic diseases in the age group of 1-15 years
Z Hautkr
Adverse effects from topical steroids
Cutis
Cushing's syndrome after topical application of corticosteroids
Am J Dis Child
Dwarfism following long-term topical corticosteroid therapy
JAMA
Efficacy versus systemic effects of six topical steroids in the treatment of atopic dermatitis of childhood
Pediatr Dermatol
A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology
Br J Dermatol
Cited by (246)
Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trials
2023, Journal of Allergy and Clinical ImmunologyCancer risk with topical calcineurin inhibitors, pimecrolimus and tacrolimus, for atopic dermatitis: a systematic review and meta-analysis
2023, The Lancet Child and Adolescent HealthModification of electrospun PI membranes with active chlorine for antimicrobial skin patches applications
2022, Applied Surface ScienceCitation Excerpt :Basic therapies include topical application of corticosteroids and skin hydration [7]. To decrease the bacterial load on the skin, applications of UV-radiation [8], nonsteroid anti-inflammatory drugs [9], antibiotics [10], or disinfectants have been investigated. Among positively evaluated antiseptics, we can find povidone-iodine [11], benzalkonium chloride [12], triclosan [12], or bleach (containing active chlorine) [13].
Atopic Dermatitis and Allergic Contact Dermatitis
2022, Allergy EssentialsGenetic ancestry does not explain increased atopic dermatitis susceptibility or worse disease control among African American subjects in 2 large US cohorts
2020, Journal of Allergy and Clinical ImmunologyCitation Excerpt :Inactive disease was defined as self-reported complete control without treatment. The disease control question was chosen because it is easily interpreted and comprehensive and has been shown to have good overlap with validated measures of AD severity recommended for use in clinical trials.33-35 Multivariable adjusted models included sociodemographic factors and atopic comorbidities previously shown to be related to AD: sex, history of atopy (yes/no), age at assessment (continuous), age at enrollment into the cohort (continuous), self-reported income at enrollment (3-level categorical variable), education (3-level categorical variable, GERA only), duration of follow-up (continuous, PEER only), and age at disease onset (continuous, PEER only).
Patterns and predictors of atopic dermatitis disease control past childhood: An observational cohort study
2018, Journal of Allergy and Clinical Immunology
- ☆
Sponsored by Novartis Pharma AG, Basel, Switzerland.
- ☆☆
Reprint requests: Alexander Kapp, MD, PhD, Department of Dermatology and Allergology, Hannover Medical University, Ricklingerstr. 5, D-30449 Hannover, Germany.