Pediatric Atopic Dermatitis: Pimecrolimus Safe, Effective

Lara C. Pullen, PhD

March 24, 2015

Pimecrolimus 1% cream (PIM) or topical corticosteroids (TCS) are safe for the long-term management of mild to moderate atopic dermatitis (AD) in infants. Neither treatment affects the systemic immune system. Moreover, data suggest that PIM and TCS are similarly effective and that PIM should be considered as a first-line treatment for mild to moderate AD in infants and children because it has a significant steroid-sparing effect.

Bardur Sigurgeirsson, MD, PhD, from the University of Iceland in Reykjavik, and colleagues published the results of their intervention study online March 23 in Pediatrics. The study included a large population (n = 2418) of infants with AD and extended through the first 5 to 6 years of their lives. The study was noteworthy because it included the most comprehensive immunologic investigations yet performed to evaluate the effect of real-life AD treatment on the maturation of the immune system.

The researchers randomly assigned patients to PIM (n = 1205; with short-term TCSs for disease flares) or TCSs (n = 1213) alone.

By week 3, more than half of patients treated with either PIM or TCS achieved treatment success. After 5 years of treatment, more than 85% (PIM) and 95% (TCS) of patients achieved overall and facial treatment success. The investigators identified no safety concerns associated with real-life use of PIM or TCSs. These results should reassure parents, who are often reluctant to use topical steroids.

"Pediatricians will be pleased at the safety data and age studied. These are very young infants (3 - 12 months), which is exactly when steroid fear is most acute amongst providers and parents alike, and the parameters examined (vaccine responsiveness, growth, immune function, cancer rates) are all big concerns for pediatricians in considering this medication class in this group," Robert Sidbury, MD, MPH, from Seattle Children's in Washington, told Medscape Medical News. Dr Sidbury was not affiliated with the study.

"The concern for topical steroid safety is greatest in, in descending order, parents, pediatricians, and dermatologists," Dr Sidbury added.

Dr Sidbury also emphasized that the PIM was associated with impressive steroid sparing. The PIM group required only 7 steroid days compared with 178 steroid days in the TCS group. These results suggest PIM is a safe and effective nonsteroidal alternative for infantile AD.

The investigators also report that children receiving PIM tended to have a lower risk for rhinorrhea, wheezing, viral rash, and lower respiratory tract infection, relative to TCSs, although the difference did not reach statistical significance.

The results serve as a response to the recommendations from the Topical Calcineurin Inhibitor Task Force of the American College of Allergy, Asthma, and Immunology that more studies are needed to address the issues of the safety and efficacy of topical immunosuppressive medications.

The study was funded by Novartis Pharmaceuticals Corporation. Dr Sigurgeirsson has received research grants from or lectured/consulted for Novartis, Galderma, Amgen, Topica, Viamet, Prostrakan, and Stiefel. Several coauthors have various financial relationships with Novartis, Astellas, Meda, and Valeant. The other authors and Dr Sidbury have disclosed no relevant financial relationships.

Pediatrics. Published online March 23, 2015. Abstract


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