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Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group.
Arch Dermatol. 2000 Aug; 136(8):999-1006.AD

Abstract

OBJECTIVE

To investigate the safety and efficacy of using 0.1% tacrolimus ointment for long-term treatment of atopic dermatitis.

DESIGN

Open-label, noncomparative study with 6 to 12 months of follow-up.

SETTINGS

Outpatient departments in 30 study centers in 11 European countries.

PATIENTS

We enrolled 316 patients aged 18 years and older with moderate to severe atopic dermatitis, 200 for 6 months and 116 for 12 months; 77.5% of patients completed the study.

INTERVENTION

Twice-daily application of 0.1% tacrolimus ointment on all affected skin. Visits were scheduled on day 1; after 1, 2, and 4 weeks of treatment; and monthly thereafter.

MAIN OUTCOME MEASURES

Safety assessments included monitoring of adverse events, clinical laboratory values, and tacrolimus blood concentrations. Efficacy end points included a combined score (modified Eczema Area and Severity Index) and an investigator's global assessment.

RESULTS

Local irritation, adverse events such as burning sensation (47% of patients), pruritus (24% of patients), and erythema (12% of patients) were common but tended to occur only when initiating treatment. Laboratory values showed no marked changes over time. Systemic absorption was minimal, with the maximum tacrolimus blood concentration being less than 1 ng/mL in 76% of patients. All efficacy end points showed improvement. The mean (SD) modified Eczema Area and Severity Index score was 23.7 (12.6) at day 1, 13.5 (11.3) at week 1, 6.1 (9.2) at month 6, and 6.1 (8.1) at month 12. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively.

CONCLUSION

Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Arch Dermatol. 2000;136:999-1006

Authors+Show Affiliations

Department of Dermatology, University Hospital, Helsinki, Finland. sakari.reitamo@hus.fiNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

10926735

Citation

Reitamo, S, et al. "Safety and Efficacy of 1 Year of Tacrolimus Ointment Monotherapy in Adults With Atopic Dermatitis. the European Tacrolimus Ointment Study Group." Archives of Dermatology, vol. 136, no. 8, 2000, pp. 999-1006.
Reitamo S, Wollenberg A, Schöpf E, et al. Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Arch Dermatol. 2000;136(8):999-1006.
Reitamo, S., Wollenberg, A., Schöpf, E., Perrot, J. L., Marks, R., Ruzicka, T., Christophers, E., Kapp, A., Lahfa, M., Rubins, A., Jablonska, S., & Rustin, M. (2000). Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. Archives of Dermatology, 136(8), 999-1006.
Reitamo S, et al. Safety and Efficacy of 1 Year of Tacrolimus Ointment Monotherapy in Adults With Atopic Dermatitis. the European Tacrolimus Ointment Study Group. Arch Dermatol. 2000;136(8):999-1006. PubMed PMID: 10926735.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of 1 year of tacrolimus ointment monotherapy in adults with atopic dermatitis. The European Tacrolimus Ointment Study Group. AU - Reitamo,S, AU - Wollenberg,A, AU - Schöpf,E, AU - Perrot,J L, AU - Marks,R, AU - Ruzicka,T, AU - Christophers,E, AU - Kapp,A, AU - Lahfa,M, AU - Rubins,A, AU - Jablonska,S, AU - Rustin,M, PY - 2000/8/5/pubmed PY - 2000/9/2/medline PY - 2000/8/5/entrez SP - 999 EP - 1006 JF - Archives of dermatology JO - Arch Dermatol VL - 136 IS - 8 N2 - OBJECTIVE: To investigate the safety and efficacy of using 0.1% tacrolimus ointment for long-term treatment of atopic dermatitis. DESIGN: Open-label, noncomparative study with 6 to 12 months of follow-up. SETTINGS: Outpatient departments in 30 study centers in 11 European countries. PATIENTS: We enrolled 316 patients aged 18 years and older with moderate to severe atopic dermatitis, 200 for 6 months and 116 for 12 months; 77.5% of patients completed the study. INTERVENTION: Twice-daily application of 0.1% tacrolimus ointment on all affected skin. Visits were scheduled on day 1; after 1, 2, and 4 weeks of treatment; and monthly thereafter. MAIN OUTCOME MEASURES: Safety assessments included monitoring of adverse events, clinical laboratory values, and tacrolimus blood concentrations. Efficacy end points included a combined score (modified Eczema Area and Severity Index) and an investigator's global assessment. RESULTS: Local irritation, adverse events such as burning sensation (47% of patients), pruritus (24% of patients), and erythema (12% of patients) were common but tended to occur only when initiating treatment. Laboratory values showed no marked changes over time. Systemic absorption was minimal, with the maximum tacrolimus blood concentration being less than 1 ng/mL in 76% of patients. All efficacy end points showed improvement. The mean (SD) modified Eczema Area and Severity Index score was 23.7 (12.6) at day 1, 13.5 (11.3) at week 1, 6.1 (9.2) at month 6, and 6.1 (8.1) at month 12. Marked or excellent improvement or clearance of disease was reported in 54%, 81%, and 86% of patients at week 1, month 6, and month 12, respectively. CONCLUSION: Up to 1 year of tacrolimus ointment use was safe and effective in patients with atopic dermatitis. Arch Dermatol. 2000;136:999-1006 SN - 0003-987X UR - https://www.unboundmedicine.com/medline/citation/10926735/Safety_and_efficacy_of_1_year_of_tacrolimus_ointment_monotherapy_in_adults_with_atopic_dermatitis__The_European_Tacrolimus_Ointment_Study_Group_ L2 - https://jamanetwork.com/journals/jamadermatology/fullarticle/vol/136/pg/999 DB - PRIME DP - Unbound Medicine ER -