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Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial
Bardur Sigurgeirsson1, Andrzej Boznanski2, Gail Todd3
1Faculty of Medicine, Department of Dermatology, University of Iceland, Reykjavik, Iceland; bsig@hudlaeknastodin.is.
Insights
Pimecrolimus cream (PIM) and topical corticosteroids (TCSs) are safe for infants with mild-to-moderate atopic dermatitis (AD). PIM demonstrated steroid-sparing efficacy, supporting its use as a first-line treatment for pediatric AD.
Area of Science:
- Pediatric Dermatology
- Immunology
- Dermatology
Background:
- Atopic dermatitis (AD) is common in infants and young children.
- Topical corticosteroids (TCSs) are frequently prescribed but have poor compliance due to side effect concerns.
- Non-corticosteroid alternatives are needed for managing pediatric AD.
Purpose of the Study:
- To compare the safety and long-term efficacy of pimecrolimus 1% cream (PIM) versus TCSs in infants with mild-to-moderate AD.
- To assess PIM as a potential first-line treatment option.
Main Methods:
- A 5-year open-label study involving 2418 infants with mild-to-moderate AD.
- Randomization to PIM (n=1205) with short-term TCSs for flares or TCSs (n=1213).
- Primary safety comparison; secondary efficacy assessment using Investigator's Global Assessment (IGA) score (0=clear, 1=almost clear).
Main Results:
- Both PIM and TCSs showed rapid onset of action, with over 50% achieving success by week 3.
- After 5 years, overall and facial treatment success rates were >85% and >95%, respectively.
- The PIM group used significantly fewer steroid days (7 vs. 178), with similar adverse event profiles and no impact on humoral or cellular immunity.
Conclusions:
- Long-term management of mild-to-moderate AD in infants with PIM or TCSs is safe and does not affect the immune system.
- PIM is a steroid-sparing agent with efficacy comparable to TCSs.
- PIM is supported as a first-line treatment for mild-to-moderate AD in infants and children.
Background And Objectives:
Atopic dermatitis (AD) primarily affects infants and young children. Although topical corticosteroids (TCSs) are often prescribed, noncorticosteroid treatments are needed because compliance with TCSs is poor due to concerns about their side effects. In this longest and largest intervention study ever conducted in infants with mild-to-moderate AD, pimecrolimus 1% cream (PIM) was compared with TCSs.
Methods:
A total of 2418 infants were enrolled in this 5-year open-label study. Infants were randomized to PIM (n = 1205; with short-term TCSs for disease flares) or TCSs (n = 1213). The primary objective was to compare safety; the secondary objective was to document PIM's long-term efficacy. Treatment success was defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear).
Results:
Both PIM and TCSs had a rapid onset of action with >50% of patients achieving treatment success by week 3. After 5 years, >85% and 95% of patients in each group achieved overall and facial treatment success, respectively. The PIM group required substantially fewer steroid days than the TCS group (7 vs 178). The profile and frequency of adverse events was similar in the 2 groups; in both groups, there was no evidence for impairment of humoral or cellular immunity.
Conclusions:
Long-term management of mild-to-moderate AD in infants with PIM or TCSs was safe without any effect on the immune system. PIM was steroid-sparing. The data suggest PIM had similar efficacy to TCS and support the use of PIM as a first-line treatment of mild-to-moderate AD in infants and children.
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