Dermatologic and Ocular Diseases
Long-term management of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid anti-inflammatory drug,☆☆

https://doi.org/10.1067/mai.2002.126500Get rights and content

Abstract

Background: Pimecrolimus cream 1% (Elidel, SDZ ASM 981), a nonsteroid selective inhibitor of inflammatory cytokines, is effective in the treatment of atopic dermatitis (AD). In this study we compared early intervention with pimecrolimus cream with treatment with a vehicle control. Objective: The purpose of this investigation was to assess whether early treatment in infants of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares. Methods: In this 1-year, double-blind controlled study, 251 infants aged 3 to 23 months with AD were randomized 4:1 to a pimecrolimus-based regimen (n = 204) or a conventional treatment regimen (n = 47). Both groups used emollients for dry skin. Early AD signs and symptoms were treated either with pimecrolimus cream to prevent flares or, in the control group, with vehicle. Vehicle was used to maintain blinding conditions. In the event of flares, moderately potent corticosteroid was permitted in both groups. The primary efficacy end point was the incidence of flares at 6 months. Results: Pimecrolimus significantly reduced the incidence of flares compared with control treatment (P < .001), with 67.6% versus 30.4% of patients completing 6 months with no flare and 56.9% versus 28.3% completing 12 months with no flare. Overall corticosteroid use was substantially lower in the pimecrolimus group: 63.7% versus 34.8% of patients did not use corticosteroids at all during the study. Pimecrolimus was also more effective than control treatment in the long-term control of pruritus and the signs of AD. There were no clinically significant differences in incidence of adverse events between the 2 treatment groups. Conclusions: Treatment with pimecrolimus of early signs and symptoms significantly modified the disease course in infants by reducing the incidence of flares and improving overall control of AD. Pimecrolimus was safe and well tolerated. (J Allergy Clin Immunol 2002;110:277-84.)

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.

. Flow diagram of treatment outcome.

The demographic and clinical characteristics of the patients are summarized in Table II.

. Baseline demographic and clinical characteristics

Empty CellPimecrolimus (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)

  • S. Gunther

    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

    (1976)
  • CJ Hill et al.

    Adverse effects from topical steroids

    Cutis

    (1978)
  • R Ruiz-Maldonado et al.

    Cushing's syndrome after topical application of corticosteroids

    Am J Dis Child

    (1982)
  • HH. Bode

    Dwarfism following long-term topical corticosteroid therapy

    JAMA

    (1980)
  • C Queille et al.

    Efficacy versus systemic effects of six topical steroids in the treatment of atopic dermatitis of childhood

    Pediatr Dermatol

    (1984)
  • JG Meingassner et al.

    A novel anti-inflammatory drug, SDZ ASM 981, for the topical and oral treatment of skin diseases: in vivo pharmacology

    Br J Dermatol

    (1997)
  • Cited by (246)

    • Modification of electrospun PI membranes with active chlorine for antimicrobial skin patches applications

      2022, Applied Surface Science
      Citation 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].

    • Genetic 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 Immunology
      Citation 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).

    View all citing articles on Scopus

    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.

    View full text