Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study.
Summary of "Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study."
Backgroundâ€‚ Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged â‰¥2â€ƒyears (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2â€ƒyears at start of treatment. Methodsâ€‚ Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24-month open-label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment. Resultsâ€‚ Meanâ€ƒÂ±â€ƒSD Eczema Area and Severity Index (EASI) score improved, from 11.2â€ƒÂ±â€ƒ10.5 baseline to 2.6â€ƒÂ±â€ƒ4.1 at endpoint (24â€ƒmonths); mean affected body surface area decreased from 25.2â€ƒÂ±â€ƒ21.1% to 5.1â€ƒÂ±â€ƒ9.0%, with improvement on all items of the Physicians' Assessment of Individual Signs. The Physicians' Global Evaluation of Clinical Response showed a result of "cleared"/"excellent" for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as "much better." Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application-site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0â€ƒng/ml; >40% showed concentrations below the lower limit of quantification (0.0250â€ƒng/ml). Conclusionsâ€‚ Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2â€ƒyears. Treatment tolerability was similar to that seen in older children.
Skin and Allergy Hospital, University of Helsinki, Helsinki, Finland Latvian Dermatological Institute, Riga, Latvia Clinical Pharmacology, Astellas Pharma Europe BV, Leiderdorp, The Netherlands Clinical Trials, Skin Care Centre, Vancouver, Canada Departme
This article was published in the following journal.
Name: International journal of dermatology
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21923693
- DOI: http://dx.doi.org/10.1111/j.1365-4632.2011.05015.x
Medical and Biotech [MESH] Definitions
A persistent increase in synaptic efficacy, usually induced by appropriate activation of the same synapses. The phenomenological properties of long-term potentiation suggest that it may be a cellular mechanism of learning and memory.
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The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
To assess the long-term safety of tacrolimus ointment
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