ReviewPediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology2015
Pimecrolimus in atopic dermatitis: consensus on safety and the need to allow use in infants.
Review in Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 96 citations in OpenAlex.
- European S2k Guideline on Chronic PruritusActa dermato-venereologica · 2025Guideline
- Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a consensus statement.Annals of the rheumatic diseases · 2021Guideline
- Effect of Oral Administration of a Mixture of Probiotic Strains on SCORAD Index and Use of Topical Steroids in Young Patients With Moderate Atopic Dermatitis: A Randomized Clinical Trial.JAMA dermatology · 2018Trial
- Risk of melanocytic nevi and nonmelanoma skin cancer in children after allogeneic hematopoietic stem cell transplantation.Bone marrow transplantation · 2017Trial
- Atopic dermatitis management: integrating disease mechanisms with precision medicine and nanotechnology-based targeted therapies.Irish journal of medical science · 2026Review
- Exploring the Therapeutic Potential of Crisaborole Gel in Atopic Dermatitis: A Review.Recent advances in drug delivery and formulation · 2026Review
- Evaluating the Neuroprotective and Acetylcholinesterase Inhibitory Properties of Four Calcineurin Inhibitor Drugs: Tacrolimus, Pimecrolimus, Cyclosporin A, and Voclosporin.Molecular neurobiology · 2025Article
- Therapeutic effect of long-interval repeated subcutaneous administration of canine amniotic membrane-derived mesenchymal stem cells in atopic dermatitis mouse model.BMC veterinary research · 2025Article
- Atopic Dermatitis: A Review of Diagnosis and Treatment.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Topical calcineurin and mammalian target of rapamycin inhibitors in inflammatory dermatoses: Current challenges and nanotechnology‑based prospects (Review).International journal of molecular medicine · 2024Review
- Comparison of Old and New Systemic Treatments for Moderate to Severe Atopic Dermatitis.Current allergy and asthma reports · 2024Review
- Pimecrolimus for the Treatment of Atopic Dermatitis in Infants: An Asian Perspective.Dermatology and therapy · 2023Review
- Shedding light on key pharmacological knowledge and strategies for pediatric atopic dermatitis.Expert review of clinical pharmacology · 2023Review
- Experts' Consensus on the Use of Pimecrolimus in Atopic Dermatitis in China: A TCS-Sparing Practical Approach.Dermatology and therapy · 2022Article
- Changes in Gut Microbiota Correlates with Response to Treatment with Probiotics in Patients with Atopic Dermatitis. A Post Hoc Analysis of a Clinical Trial.Microorganisms · 2021Article
- Practical Recommendations for the Topical Treatment of Atopic Dermatitis in South and East Asia.Dermatology and therapy · 2021Article
- Successful Treatment of Recalcitrant Granuloma Gluteale Infantum with Topical Tacrolimus 0.03% Ointment.Case reports in pediatrics · 2021Article
- Atopic dermatitis. Interdisciplinary diagnostic and therapeutic recommendations of the Polish Dermatological Society, Polish Society of Allergology, Polish Pediatric Society and Polish Society of Family Medicine. Part I. Prophylaxis, topical treatment and phototherapy.Postepy dermatologii i alergologii · 2020Article
- Current Perspectives on the Management of Infantile Atopic Dermatitis.Journal of asthma and allergy · 2020Review
- Vitiligo: Focus on Clinical Aspects, Immunopathogenesis, and Therapy.Clinical reviews in allergy & immunology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors at 20 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Atopic dermatitis (AD) is a distressing dermatological disease, which is highly prevalent during infancy, can persist into later life and requires long-term management with anti-inflammatory compounds. The introduction of the topical calcineurin inhibitors (TCIs), tacrolimus and pimecrolimus, more than 10 yr ago was a major breakthrough for the topical anti-inflammatory treatment of AD. Pimecrolimus 1% is approved for second-line use in children (≥2 yr old) and adults with mild-to-moderate AD. The age restriction was emphasized in a boxed warning added by the FDA in January 2006, which also highlights the lack of long-term safety data and the theoretical risk of skin malignancy and lymphoma. Since then, pimecrolimus has been extensively investigated in short- and long-term studies including over 4000 infants (<2 yr old). These studies showed that pimecrolimus effectively treats AD in infants, with sustained improvement with long-term intermittent use. Unlike topical corticosteroids, long-term TCI use does not carry the risks of skin atrophy, impaired epidermal barrier function or enhanced percutaneous absorption, and so is suitable for AD treatment especially in sensitive skin areas. Most importantly, the studies of pimecrolimus in infants provided no evidence for systemic immunosuppression, and a comprehensive body of evidence from clinical studies, post-marketing surveillance and epidemiological investigations does not support potential safety concerns. In conclusion, the authors consider that the labelling restrictions regarding the use of pimecrolimus in infants are no longer justified and recommend that the validity of the boxed warning for TCIs should be reconsidered.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.