Abstract
ObjectiveTo evaluate the efficacy and safety of pimecrolimus cream 1% in the treatment of AD in the pediatric population.MethodsPubMed, EMBASE, Web of Science and Cochrane library databases were searched till July 2013. The randomized and nonrandomized blinded studies of pimecrolimus cream 1% applied twice daily with Jaded score ≥3 in pediatric patients with AD were included. The efficacy outcomes included investigator global assessment (IGA), eczema area and severity index (EASI) scores, pruritus and care giver's assessments and flares free period. Adverse events were reviewed to assess the safety.ResultsOut of 81 studies, 7 were selected that enrolled 2,170 pediatric patients. The pooled analysis reported that pimecrolimus was no better to vehicle reducing eczema at day-8, day-26 and six weeks (OR 4.95, 95% CI 2.79–8.80), (OR 9.69, 95% CI 4.12–22.83) and (OR 3.83. 95% CI 1.94–7.56), respectively in children. Similarly, pimecrolimus did not show beneficial effects when analyzed for mild or absent pruritus at day 4 (OR 8.29, 95% CI 3.88–17.72 favoring vehicle), day 43 (OR 1.81 95% CI 1.13–2.89 favoring vehicle) and 1 week (OR 2.29, 95%CI 1.45 to 3.60 favoring vehicle) as compared with vehicle. One study comparing pimecrolimus with tacrolimus found no significant difference in achieving mild or absent pruritus (OR 0.94, 95% CI 0.44–1.99). More patients showed an improvement in overall disease in vehicle group at day 8 (OR 3.30, 95% CI 2.03–5.35), day 29 (OR 14.14, 95% CI 6.87–29.13) and day 43 (OR 4.11, 95% CI 2.59–6.52) as compared with pimecrolimus 1% group, as assessed by caregivers. No significant difference was seen between the total AEs in both groups (pimecrolimus vs vehicle/tacrolimus) (OR 1.19, 95% CI 0.85, 1.65)ConclusionThe results of the present meta-analysis showed that pimecrolimus cream 1% was not significantly better to vehicle for AD in pediatrics population.
Highlights
Atopic dermatitis (AD) known as atopic eczema, is an inflammatory, chronic and relapsing skin disorder [1] affecting 10% to 15% of the children worldwide [2]
The treatment of AD with pimecrolimus cream 1% is an important alternative to topical corticosteroids without the associated adverse events (AE) [23,24]
We have investigated heterogeneity by splitting the studies into subgroups and looking at the forest plot and calculated chi2 value
Summary
Atopic dermatitis (AD) known as atopic eczema, is an inflammatory, chronic and relapsing skin disorder [1] affecting 10% to 15% of the children worldwide [2]. AD is considered as the first symptom of the ‘atopic march’ [8] and is characterized by itching, redness and skin creases [9] It has a significant social, personal, emotional and economic impact on the life of patients and their family [10]. Pimecrolimus cream 1% is an anti-inflammatory compound that blocks the T-cells proliferation and inhibits the production and release of numerous inflammatory mediators from mast cells [12,13]. It has a unique skin-selective pharmacologic profile [14,15]. The treatment of AD with pimecrolimus cream 1% is an important alternative to topical corticosteroids without the associated adverse events (AE) [23,24]
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