Weidinger S, et al. – A comparative scrutiny was performed of the safety and efficacy of pimecrolimus 1% cream (PIM) and low–to–medium–potency topical corticosteroids (TCS) in children with mild–to–moderate atopic dermatitis (AD). It was reported that the long–term management of mild–to–moderate AD in children with both TCS and PIM was safe. PIM exhibited similar efficacy to TCS. The yielded findings supported the use of PIM as a first–line therapy of mild–to–moderate AD in children.

Methods

• The plan of this study was a 5-year drug-company sponsored multicentre, open-label, parallel-group trial.
• The candidates were enrolled between April 2004 and October 2005. There were no details regarding the study sites.
• Infants aged ≥ 3 to < 12 months with mild-to-moderate AD were randomly assigned in a 1 : 1 ratio to receive either PIM or a low- or medium-potency TCS cream/ointment for 5 years.
• There was no information on specific TCS products used.
• The topical therapy was applied twice daily ‘until complete AD clearance or for as long as allowed by the label of the specific TCS’.
• It was reinitiated at the occurrence of first signs and symptoms of AD flares.
• The exacerbations not controlled by PIM were treated with short-term TCSs, in the PIM group.
• Outcomes included recording of the adverse events (AEs) and serious AEs (SAEs) ‘during clinic visits’.
• In a proportion of the patients, several immunological analyses were conducted, for instance, antibody titres to common vaccine antigens, immunoglobulin levels, B and T lymphocyte cell counts, and T-cell proliferation tests.
• The children's growth was determined via height and weight estimation.
• AD severity was calculated via the Investigator Global Assessment (IGA) score and the percentage of the total body surface area affected.
• No specific information was yielded in terms of the number and scheduling of study visits.
• Primary outcomes were the incidence of AEs ‘of primary clinical interest’ and those with a crude incidence of ≥ 5% in either treatment group.
• Secondary outcome comprised of ‘long-term efficacy’ defined as IGA ≤1 at week 3 and year 5.

Results

• The PIM group experienced considerably more AEs [bronchitis (P = 0·02), infected eczema (P ≤ 0·001), impetigo (P = 0·045), nasopharyngitis (P = 0·04)].
• There were no prominent variations for other AEs.
• The overall incidence of SAEs was found to be slightly higher for PIM (20·5% vs. 17·3%; P = 0·046).
• The proportion of enrollees with IGA ≤ 1 at year 5 was 88·7% for PIM and 92·3% for TCS, a success rate variation of 3·6% (95% confidence interval 0·8-6·4) favouring TCS.