A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children

M. Boguniewicz, V. C. Fiedler, Sharon Raimer, I. D. Lawrence, D. Y M Leung, J. M. Hanifin

Research output: Contribution to journalArticle

288 Citations (Scopus)

Abstract

Background: A topical formulation of tacrolimus, an immunosuppressant currently marketed for the prevention of rejection after solid organ transplant, is a potential therapeutic agent for atopic dermatitis. Objective: We sought to determine the safety and efficacy of tacrolimus ointment in pediatric patients with moderate-to-severe atopic dermatitis. Methods: In this double-blind, vehicle-controlled multicenter trial, children ages 7 to 16 years were treated with twice daily application of tacrolimus ointment at 1 of 3 concentrations (0.03% [n = 431, 0.1% [n = 49], or 0.3% [n = 44]) or vehicle (n = 44) for up to 22 days, with a 2-week follow-up period. Results: The Physician's Global Evaluation of clinical response showed that 69% (95% confidence interval: 53-82) of patients in the 0.03% tacrolimus ointment group, 67% (95% confidence interval: 52-81) in the 0.1% tacrolimus ointment group, and 70% (95% confidence interval: 54-83) in the 0.3% tacrolimus ointment group, compared with 38% (95% confidence interval: 24- 54) in the vehicle group, had a marked to excellent (≥75%) improvement or clearing of their atopic dermatitis (P = .005, .007, and .004, respectively for the 3 tacrolimus groups compared with the vehicle group). The mean percent improvement for a modified Eczema Area and Severity Index at end of treatment for each of the 3 tacrolimus groups (0.03%, 72%; 0.1%, 77%; and 0.3%, 81%) was significantly better than that of the vehicle group (26%; P < .001). The median percent reduction in pruritus was significantly greater for tacrolimus-treated patients (74% to 89%) than for vehicle-treated patients (51%, P = .027). No serious systemic adverse events were noted, and systemic absorption was minimal. Conclusion: Tacrolimus ointment appears to be safe and effective in children with atopic dermatitis.

Original languageEnglish (US)
Pages (from-to)637-644
Number of pages8
JournalJournal of Allergy and Clinical Immunology
Volume102
Issue number4 I
DOIs
StatePublished - 1998

Fingerprint

Tacrolimus
Atopic Dermatitis
Ointments
Randomized Controlled Trials
Confidence Intervals
Therapeutics
Eczema
Pruritus
Immunosuppressive Agents
Double-Blind Method
Multicenter Studies
Pediatrics
Physicians
Transplants
Safety

Keywords

  • Atopic dermatitis
  • Children/pediatric
  • Eczema
  • Ointment
  • Tacrolimus

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. / Boguniewicz, M.; Fiedler, V. C.; Raimer, Sharon; Lawrence, I. D.; Leung, D. Y M; Hanifin, J. M.

In: Journal of Allergy and Clinical Immunology, Vol. 102, No. 4 I, 1998, p. 637-644.

Research output: Contribution to journalArticle

Boguniewicz, M. ; Fiedler, V. C. ; Raimer, Sharon ; Lawrence, I. D. ; Leung, D. Y M ; Hanifin, J. M. / A randomized, vehicle-controlled trial of tacrolimus ointment for treatment of atopic dermatitis in children. In: Journal of Allergy and Clinical Immunology. 1998 ; Vol. 102, No. 4 I. pp. 637-644.
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abstract = "Background: A topical formulation of tacrolimus, an immunosuppressant currently marketed for the prevention of rejection after solid organ transplant, is a potential therapeutic agent for atopic dermatitis. Objective: We sought to determine the safety and efficacy of tacrolimus ointment in pediatric patients with moderate-to-severe atopic dermatitis. Methods: In this double-blind, vehicle-controlled multicenter trial, children ages 7 to 16 years were treated with twice daily application of tacrolimus ointment at 1 of 3 concentrations (0.03{\%} [n = 431, 0.1{\%} [n = 49], or 0.3{\%} [n = 44]) or vehicle (n = 44) for up to 22 days, with a 2-week follow-up period. Results: The Physician's Global Evaluation of clinical response showed that 69{\%} (95{\%} confidence interval: 53-82) of patients in the 0.03{\%} tacrolimus ointment group, 67{\%} (95{\%} confidence interval: 52-81) in the 0.1{\%} tacrolimus ointment group, and 70{\%} (95{\%} confidence interval: 54-83) in the 0.3{\%} tacrolimus ointment group, compared with 38{\%} (95{\%} confidence interval: 24- 54) in the vehicle group, had a marked to excellent (≥75{\%}) improvement or clearing of their atopic dermatitis (P = .005, .007, and .004, respectively for the 3 tacrolimus groups compared with the vehicle group). The mean percent improvement for a modified Eczema Area and Severity Index at end of treatment for each of the 3 tacrolimus groups (0.03{\%}, 72{\%}; 0.1{\%}, 77{\%}; and 0.3{\%}, 81{\%}) was significantly better than that of the vehicle group (26{\%}; P < .001). The median percent reduction in pruritus was significantly greater for tacrolimus-treated patients (74{\%} to 89{\%}) than for vehicle-treated patients (51{\%}, P = .027). No serious systemic adverse events were noted, and systemic absorption was minimal. Conclusion: Tacrolimus ointment appears to be safe and effective in children with atopic dermatitis.",
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AU - Fiedler, V. C.

AU - Raimer, Sharon

AU - Lawrence, I. D.

AU - Leung, D. Y M

AU - Hanifin, J. M.

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N2 - Background: A topical formulation of tacrolimus, an immunosuppressant currently marketed for the prevention of rejection after solid organ transplant, is a potential therapeutic agent for atopic dermatitis. Objective: We sought to determine the safety and efficacy of tacrolimus ointment in pediatric patients with moderate-to-severe atopic dermatitis. Methods: In this double-blind, vehicle-controlled multicenter trial, children ages 7 to 16 years were treated with twice daily application of tacrolimus ointment at 1 of 3 concentrations (0.03% [n = 431, 0.1% [n = 49], or 0.3% [n = 44]) or vehicle (n = 44) for up to 22 days, with a 2-week follow-up period. Results: The Physician's Global Evaluation of clinical response showed that 69% (95% confidence interval: 53-82) of patients in the 0.03% tacrolimus ointment group, 67% (95% confidence interval: 52-81) in the 0.1% tacrolimus ointment group, and 70% (95% confidence interval: 54-83) in the 0.3% tacrolimus ointment group, compared with 38% (95% confidence interval: 24- 54) in the vehicle group, had a marked to excellent (≥75%) improvement or clearing of their atopic dermatitis (P = .005, .007, and .004, respectively for the 3 tacrolimus groups compared with the vehicle group). The mean percent improvement for a modified Eczema Area and Severity Index at end of treatment for each of the 3 tacrolimus groups (0.03%, 72%; 0.1%, 77%; and 0.3%, 81%) was significantly better than that of the vehicle group (26%; P < .001). The median percent reduction in pruritus was significantly greater for tacrolimus-treated patients (74% to 89%) than for vehicle-treated patients (51%, P = .027). No serious systemic adverse events were noted, and systemic absorption was minimal. Conclusion: Tacrolimus ointment appears to be safe and effective in children with atopic dermatitis.

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