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Efficacy of tacrolimus 0.03% ointment as second-line treatment for children with moderate-to-severe atopic dermatitis: evidence from a randomized, double-blind non-inferiority trial vs. fluticasone 0.005% ointment.
Pediatr Allergy Immunol. 2010 Mar; 21(2 Pt 1):321-9.PA

Abstract

Tacrolimus 0.03% ointment is licensed for second-line treatment of children with atopic dermatitis (AD). Although data are available from clinical trials, no study has enrolled only second-line patients. This double-blind, non-inferiority study compared tacrolimus 0.03% and fluticasone 0.005% ointments in children with moderate-to-severe AD, who had responded insufficiently to conventional therapies. Children (aged 2-15 yr) were randomized to tacrolimus ointment (n = 240) or fluticasone ointment (n = 239), twice daily until clearance or for a maximum of 3 wk and, if lesions remained, once daily for up to 3 wk further. Primary end-point was week 3 response rate (improvement of >or=60% in modified Eczema Area and Severity Index and not withdrawn for lack of efficacy). Secondary end-points included pruritus and sleep quality, global assessment of clinical response, incidence of new flares and safety. Response rates were 86.3% with tacrolimus ointment and 91.5% with fluticasone. Lower limit of the 95% confidence interval was -11.8%, exceeding the non-inferiority limit of -15% and meeting the primary end-point. Moderate or better improvement on the physicians' global assessment occurred in 93.6% and 92.4% of patients in the tacrolimus ointment and fluticasone arms, respectively, while median pruritus scores improved by 84.0% and 91.5%. Sleep quality improved by approximately 92% in both treatment arms. After day 21, new flare-up occurred in 5.5% and 11.3% of patients receiving tacrolimus ointment and fluticasone, respectively; mean times to new flares were 6.5 +/- 5.0 and 8.6 +/- 5.2 days. Adverse events were similar between the two arms, with the exception of application-site skin burning sensation in the tacrolimus ointment group. In conclusion, efficacy of tacrolimus 0.03% ointment as second-line treatment was not inferior to that of fluticasone 0.005% ointment, with similar benefits on global disease improvement and quality of sleep.

Authors+Show Affiliations

Department of Dermatology, Military Hospital of Tunis, Tunis, Tunisia. nejib.doss@voila.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19563466

Citation

Doss, N, et al. "Efficacy of Tacrolimus 0.03% Ointment as Second-line Treatment for Children With Moderate-to-severe Atopic Dermatitis: Evidence From a Randomized, Double-blind Non-inferiority Trial Vs. Fluticasone 0.005% Ointment." Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, vol. 21, no. 2 Pt 1, 2010, pp. 321-9.
Doss N, Kamoun MR, Dubertret L, et al. Efficacy of tacrolimus 0.03% ointment as second-line treatment for children with moderate-to-severe atopic dermatitis: evidence from a randomized, double-blind non-inferiority trial vs. fluticasone 0.005% ointment. Pediatr Allergy Immunol. 2010;21(2 Pt 1):321-9.
Doss, N., Kamoun, M. R., Dubertret, L., Cambazard, F., Remitz, A., Lahfa, M., & de Prost, Y. (2010). Efficacy of tacrolimus 0.03% ointment as second-line treatment for children with moderate-to-severe atopic dermatitis: evidence from a randomized, double-blind non-inferiority trial vs. fluticasone 0.005% ointment. Pediatric Allergy and Immunology : Official Publication of the European Society of Pediatric Allergy and Immunology, 21(2 Pt 1), 321-9. https://doi.org/10.1111/j.1399-3038.2009.00895.x
Doss N, et al. Efficacy of Tacrolimus 0.03% Ointment as Second-line Treatment for Children With Moderate-to-severe Atopic Dermatitis: Evidence From a Randomized, Double-blind Non-inferiority Trial Vs. Fluticasone 0.005% Ointment. Pediatr Allergy Immunol. 2010;21(2 Pt 1):321-9. PubMed PMID: 19563466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of tacrolimus 0.03% ointment as second-line treatment for children with moderate-to-severe atopic dermatitis: evidence from a randomized, double-blind non-inferiority trial vs. fluticasone 0.005% ointment. AU - Doss,N, AU - Kamoun,M-R, AU - Dubertret,L, AU - Cambazard,F, AU - Remitz,A, AU - Lahfa,M, AU - de Prost,Y, Y1 - 2009/06/26/ PY - 2009/7/1/entrez PY - 2009/7/1/pubmed PY - 2010/7/30/medline SP - 321 EP - 9 JF - Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology JO - Pediatr Allergy Immunol VL - 21 IS - 2 Pt 1 N2 - Tacrolimus 0.03% ointment is licensed for second-line treatment of children with atopic dermatitis (AD). Although data are available from clinical trials, no study has enrolled only second-line patients. This double-blind, non-inferiority study compared tacrolimus 0.03% and fluticasone 0.005% ointments in children with moderate-to-severe AD, who had responded insufficiently to conventional therapies. Children (aged 2-15 yr) were randomized to tacrolimus ointment (n = 240) or fluticasone ointment (n = 239), twice daily until clearance or for a maximum of 3 wk and, if lesions remained, once daily for up to 3 wk further. Primary end-point was week 3 response rate (improvement of >or=60% in modified Eczema Area and Severity Index and not withdrawn for lack of efficacy). Secondary end-points included pruritus and sleep quality, global assessment of clinical response, incidence of new flares and safety. Response rates were 86.3% with tacrolimus ointment and 91.5% with fluticasone. Lower limit of the 95% confidence interval was -11.8%, exceeding the non-inferiority limit of -15% and meeting the primary end-point. Moderate or better improvement on the physicians' global assessment occurred in 93.6% and 92.4% of patients in the tacrolimus ointment and fluticasone arms, respectively, while median pruritus scores improved by 84.0% and 91.5%. Sleep quality improved by approximately 92% in both treatment arms. After day 21, new flare-up occurred in 5.5% and 11.3% of patients receiving tacrolimus ointment and fluticasone, respectively; mean times to new flares were 6.5 +/- 5.0 and 8.6 +/- 5.2 days. Adverse events were similar between the two arms, with the exception of application-site skin burning sensation in the tacrolimus ointment group. In conclusion, efficacy of tacrolimus 0.03% ointment as second-line treatment was not inferior to that of fluticasone 0.005% ointment, with similar benefits on global disease improvement and quality of sleep. SN - 1399-3038 UR - https://www.unboundmedicine.com/medline/citation/19563466/Efficacy_of_tacrolimus_0_03_ointment_as_second_line_treatment_for_children_with_moderate_to_severe_atopic_dermatitis:_evidence_from_a_randomized_double_blind_non_inferiority_trial_vs__fluticasone_0_005_ointment_ L2 - https://doi.org/10.1111/j.1399-3038.2009.00895.x DB - PRIME DP - Unbound Medicine ER -