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Safety and Efficacy of 1 Year of Tacrolimus Ointment Monotherapy in Adults With Atopic Dermatitis
Sakari Reitamo, MD;
Andreas Wollenberg, MD;
Erwin Schöpf, MD;
Jean Luc Perrot, MD;
Ronald Marks, MD;
Thomas Ruzicka, MD;
Enno Christophers, MD;
Alexander Kapp, MD;
Mourad Lahfa, MD;
Andris Rubins, MD;
Stefania Jablonska, MD;
Malcolm Rustin, MD;
for the European Tacrolimus Ointment Study Group
Arch Dermatol. 2000;136:999-1006.
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.
From the Department of Dermatology, University Hospital, Helsinki, Finland (Dr Reitamo); Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians-Universität, Munich, Germany (Dr Wollenberg); Klinikum der Albert-Ludwigs-Universität, Universitäts-Hautklinik, Freiburg, Germany (Dr Schöpf); the Service de Dermatologie, Hôpital Nord, Saint Etienne, France (Dr Perrot); the Department of Dermatology, University of Wales College of Medicine, Cardiff (Dr Marks); Heinrich-Heine-Universität, Düsseldorf, Germany (Dr Ruzicka); Dermatologische Universitätsklinik Kiel, Kiel, Germany (Dr Christophers); Dermatologische Klinik und Poliklinik der Medizinischen Hochschule Hannover, Hannover, Germany (Dr Kapp); Hôpital Saint-Louis, Institut de Recherche sur la Peau, Paris, France (Dr Lahfa); the Department of Dermatology, Latvian Medical Academy, Riga, Latvia (Dr Rubins); Klinika Dermatologiczna, Akademia Medyzna, Warsaw, Poland (Dr Jablonska); and the Department of Dermatology, Royal Free Hospital, London, England (Dr Rustin).
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