First experience of topical SDZ ASM 981 in children with atopic dermatitis

Harper, John; Green, A.; Scott, Graham; Gruendl, E.; Dorobek, Birgit; Cardno, M.; Burtin, P

doi:10.1046/j.1365-2133.2001.04133.x

Cited by 134 publications

(121 citation statements)

References 7 publications

(10 reference statements)

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“…20,27,[30][31][32]44 The favorable safety and tolerability profile of 1% pimecrolimus cream demonstrated in published pediatric studies 35,[37][38][39]43,44 is supported by the data summarized in this review. The combined analysis of the results from 4 pharmacokinetic studies conducted with 35 infants with AD indicated that pimecrolimus blood concentrations after topical applications were consistently low, irrespective of the level of disease severity and percentage of TBSA involved.…”

Section: Discussionmentioning

confidence: 74%

“…As shown in pediatric and adult pharmacokinetic studies, blood concentrations after treatment with pimecrolimus cream are very low or undetectable. 30,43,44 Blood concentrations display similar low values 2, 4, 6, and 12 hours after application, with no peak. Concentration ranges are similar on days 4 and 22, which indicates no systemic accumulation of pimecrolimus after topical application.…”

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confidence: 84%

“…Pimecrolimus blood concentrations were determined either with a radioimmunoassay, with a limit of quantification (LoQ) of 0.5 ng/mL, or with liquid chromatography/tandem mass spectrometry, with a LoQ of 0.1 ng/mL, as described elsewhere. 43,44 In study W206, cohort 2, 55% of the 21 blood samples contained pimecrolimus concentrations below the LoQ. The highest pimecrolimus blood concentration measured was 2 ng/mL, excluding a single isolated value of Ͼ50 ng/mL that was attributed to contamination of the blood sample with the cream during venipuncture (the patient had AD lesions treated with 1% pimecrolimus cream in the area of venipuncture).…”

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confidence: 99%

“…Among human subjects, no manifestations of toxicity were observed among adult psoriatic patients treated with orally administered pimecrolimus for up to 12 weeks, at doses associated with mean peak blood concentrations of 54 ng/mL. [42][43][44][45][46] Systemic exposure to pimecrolimus during treatment with 1% pimecrolimus cream was assessed in pharmacokinetic studies by measuring pimecrolimus blood concentrations at various times during the treatment period. A summary of the pharmacokinetic studies completed among pediatric patients with AD is reported in Table 1.…”

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confidence: 99%

“…Thirty infants were treated for 3 weeks and 5 (study 0301-E1) continued treatment for up to 1 year (Table 1). In the 3-week studies, 30,43,44 venous blood sampling for measurement of pimecrolimus blood concentrations was performed on day 4, before and at least 2 hours after the morning application of 1% pimecrolimus cream, and on the last day of the treatment period (day 22). For the 5 infants who were treated with 1% pimecrolimus cream for up to 1 year, blood sampling was also performed 2 hours after the morning application of the study drug at week 27 and at the end of the study.…”

mentioning

confidence: 99%

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Safety and Tolerability of 1% Pimecrolimus Cream Among Infants: Experience With 1133 Patients Treated for Up to 2 Years

et al. 2006

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Pimecrolimus is a calcineurin inhibitor developed for the topical treatment of atopic dermatitis. During the clinical development of 1% pimecrolimus cream, 1133 patients 3 to 23 months of age with mild to severe atopic dermatitis were treated for up to 2 years. The objective of this review is to discuss the safety and tolerability of 1% pimecrolimus cream among infants, on the basis of the combined results from all studies (4 pharmacokinetic studies and 6 clinical trials) conducted among these patients. Pimecrolimus blood concentrations measured for 35 patients were consistently low (Յ1 ng/mL in Ͼ80% of samples), irrespective of the disease severity and extent, and remained low during intermittent treatment for up to 1 year. The level of systemic exposure to pimecrolimus among infants was comparable to that observed for older pediatric patients enrolled in the same studies and treated in the same way with 1% pimecrolimus cream, which indicated that young pediatric patients are not at higher risk of significant percutaneous absorption of topically applied pimecrolimus, despite their large skin surface area/body mass ratio. The 6 clinical trials included a total of 1098 infants, who were treated for periods ranging from 4 weeks to 2 years. Most of these patients (60%) had moderate to severe disease at baseline. The most frequently reported adverse events were common childhood disorders such as nasopharyngitis, pyrexia, upper respiratory tract infections, ear infections, and bronchitis. During the double-blind (DB) studies or DB phases of studies, the incidence rates for the most frequently reported adverse events were similar for patients who received 1% pimecrolimus cream and patients who received the vehicle, except for the incidence of teething, which was higher among the pimecrolimus-treated infants (relative risk: 2.02; 95% confidence interval: 1.32-3.27). Treatment with 1% pimecrolimus cream was not associated with an increase in the overall incidence of nonskin infections, compared with the vehicle (relative risk: 1.015; 95% confidence interval: 0.88 -1.18). The incidence density (ID) rates for total bacterial, fungal, parasitic, and viral skin infections during the DB studies or DB phases of www.pediatrics.org/cgi

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