Efficacy and safety of tacrolimus ointment compared with that of hydrocortisone acetate ointment in children with atopic dermatitis

Reitamo, Sakari; Leent, E.J.M. van; Ho, Vincent; Harper, John; Ruzicka, Thomas; Kalimo, Kirsti; Cambazard, F.; Rustin, M.H.A.; Taı̈eb, Alain; Gratton, David; Sauder, Daniel N.; Sharpe, Graham R.; Smith, Catherine; Jünger, Michael; Prost, Y. De

doi:10.1067/mai.2002.121831

Cited by 203 publications

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“…[22][23][24][25][26][27] When tacrolimus ointment is used to treat moderate to severe AD, children generally respond to treatment within the first week with an improvement in signs and symptoms, assessment of itch and %BSA affected. [22][23][24][25][26] Transient burning and itching typically decreases after the first few days of treatment, and no increase has been reported in the incidence of infections or other adverse events when used long-term for up to 4 years. 27 Because of the limitations of topical corticosteroid therapy, a nonsteroidal treatment alternative is needed for children with mild to moderate AD.…”

Section: Discussionmentioning

confidence: 99%

“…[16][17][18][19][20][21] Tacrolimus ointment (0.03% and 0.1%) has been clinically shown to reduce the extent, severity, and symptoms of moderate to severe AD in children as young as 2 years of age and to be safe and effective for long-term use for up to 4 years. [22][23][24][25][26][27] However, it has not been evaluated for treatment of mild to moderate cases. This study was designed to investigate the safety and efficacy of tacrolimus ointment 0.03% monotherapy in pediatric patients with mild to moderate AD.…”

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confidence: 99%

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Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study

Schachner

Lamerson²,

Sheehan³

et al. 2005

Pediatrics

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ABSTRACT. Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients.Methods. A total of 317 patients (2-15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety.Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicletreated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site.Conclusion A topic dermatitis (AD) is a recurrent inflammatory skin disease, with intense pruritus as its hallmark symptom, and often follows a chronic, relapsing course. 1 It frequently affects children, with symptoms developing in 65% of patients before 1 year of age and in 90% by 5 years of age. 2 Although many children will outgrow the condition by 10 years of age, 60% remain symptomatic as adults. 2 If not outgrown in childhood, the condition progresses to adulthood, with recurrent flares that may be severe and sometimes debilitating. The prevalence of AD in the United States is projected to be between 7% and 17% of school-aged children and has increased greatly over the past 40 years. 3 Several quality-of-life issues have been reported in children with AD, including sleep disturbances, changes in activity, irritability, and self-consciousness. 4-8 AD exacts a marked toll on the children and their families through both direct and indirect financial expenses of medical care. Even more significant are the stressful impacts of sleep deprivation, missed school and work, and the time spent on the dai...

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study

Schachner

Lamerson²,

Sheehan³

et al. 2005

Pediatrics

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“…Bei erwachsenen Patienten mit mittelschwerem bis schwerem atopischem Ekzem erwies sich Protopic 0,1 % Salbe als vergleichbar gut wirksam wie Hydrokortisonbutyrat 0,1 % Salbe [26]. In einer Studie bei Kindern im Alter von 2 ± 15 Jahren war Protopic 0,03 % Salbe deutlich besser wirksam im Vergleich zu einer 1 %igen Hydrokortisonazetatsalbe [27]. Insgesamt haben diese Studien gezeigt, dass Protopic Salbe bei Erwachsenen und Kindern mit atopischem Ekzem in den meisten Fällen bereits nach einer relativ kurzen Behandlungsdauer von 3 ± 7 Tagen eine signifikante Besserung sowohl des Ekzems als auch des quälenden Juckreizes bewirkt [24,28].…”

Section: Tacrolimus (Protopic)unclassified

Behandlung des atopischen Ekzems mit topischen Calcineurininhibitoren

Luger¹

2003

Akt Dermatol

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ZusammenfassungIn den letzten Jahren hat es wie noch nie zuvor in der gesamten Medizin und damit auch in der Dermatologie derart spannende und viel versprechende Entwicklungen in der Therapie gegeben. Ein entscheidender Fortschritt im therapeutischen Arsenal bei der Behandlung des atopischen Ekzems stellen die neuen topischen Calcineurininhibitoren wie Tacrolimus und Pimecrolimus dar. Beide Therapeutika Tacrolimus Salbe (Protopic) und Pimecrolimus Creme (Elidel) sind für die Behandlung des atopischen Ekzems zugelassen. Seit Einführung der topischen Kortikosteroide vor mehr als 50 Jahren stellt dies die erste wirkliche Innovation in der topischen Therapie dar und füllt damit eine groûe therapeutische Lücke. Beide Substanzen sind entzündungshem-mend wirksam und insbesondere Pimecrolimus besitzt nur ein schwaches immunsuppressives Potenzial. Beide Lokaltherapeutika sind bis auf ein vor allem bei Protopic auftretendes kurzfristiges Brennen gut verträglich und auch bei langfristiger Anwendung frei von kortikosteroidtypischen Nebenwirkungen wie Hautatrophie. Die nach lokaler Anwendung mögliche systemische Exposition ist relativ gering und insbesondere bei Pimecrolimus konnten in keinem Fall potenziell toxische Konzentrationen im Blut gemessen werden. Sowohl Protopic Salbe als Elidel Creme haben sich in Kurzzeit-und Langzeitstudien als sehr wirkungsvoll bei der Behandlung des atopischen Ekzems von Kindern und Erwachsenen erwiesen. Im Allgemeinen kommt es innerhalb von wenigen Tagen zu einer deutlichen Besserung der klinischen Symptomatik wie Juckreiz und Ekzem. Erste Beobachtungen belegen auch eine gute Wirksamkeit von topischen Calcineurininhibitoren bei der Behandlung von anderen entzündli-chen Dermatosen. Inwieweit bei Patienten mit atopischen Ekzem eine prophylaktische Anwendung von Protopic oder Elidel und damit die Vermeidung eines chronischen Krankheitsverlaufes möglich ist, werden weitere klinische Studien zeigen. AbstractDuring the last years the enormous progress in the understanding of the complex pathomechanisms underlying immune-mediated and inflammatory skin diseases has allowed for the development of novel therapeutic strategies. Among several drugs and biologics being investigated for dermatological use currently calcineurin inhibitors such as tacrolimus and pimecrolimus appear to be the most promising. Recently topical preparations of both tacrolimus (Protopic) and pimecrolimus (Elidel) have been developed and are available for the treatment of atopic dermatitis. Since the introduction of topical corticosteroids more than 50 years ago these novel compounds are the first major development in the topical treatment of inflammatory skin diseases. Both drugs exert a potent antiinflammatory activity and the immunosuppressive potential of pimecrolimus in particular is minimal. Both compounds are well tolerated, do not cause skin atrophy and are safe during long-term application. Application site adverse events mainly consist of a transient sensation of burning which more frequently has been observed after the...

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“…) Adverse effects of these two agents are similar. The most common adverse reactions are mild to moderate transient burning, stinging, itching, and erythema at the application site, which tends to resolve after the first few days of treatment (Bekersky, et al 2001;Kang, et al 2001;Paller, et al 2001;Reitamo, et al 2002;Soter, et al 2001). They are, however, contraindicated in pregnant or breast feeding women.…”

Section: Topical Calcineurin Inhibitorsmentioning

confidence: 99%

“…Studies also show that the calcineurin inhibitors are more effective that topical cortical steroids. In a multicenter, randomized, double-blind, parallel-group comparison of tacrolimus ointment 0.03% and 0.1% with hydrocortisone acetate ointment 1% involved 560 children 2 to 15 years of age (Reitamo, et al 2002). Both concentrations of tacrolimus were significantly more effective than hydrocortisone acetate.…”

Section: Topical Calcineurin Inhibitorsmentioning

confidence: 99%