ArticleFrontiers in medicine2025
New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug development.
Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- Interdisciplinary Clinical Practice Guidelines for patient-centred management of juvenile-onset systemic lupus erythematosus.EULAR rheumatology open · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
Childhood-onset systemic lupus erythematosus (cSLE, also known as juvenile or paediatric SLE) is a severe autoimmune disease affecting multiple organs and systems, with higher morbidity and severity compared to adult SLE (aSLE). The European Union's Paediatric Regulation No. 1901/2006 mandates the agreement of a paediatric investigation plan (PIP) for new investigational medicinal products (IMPs) to ensure reliable efficacy and safety data for paediatric indications. This study examined the experience of the Paediatric Committee (PDCO) at the European Medicines Agency (EMA) in assessing PIPs for cSLE, highlighting the challenges and potential solutions in the planning of development of novel agents in this disease and providing the academia point of view on key points of cSLE medicines development. Regulatory requirements so far have been rather consistent when a PIP is agreed, and recommend randomised controlled trials to enable a full benefit-risk assessment. However, PIPs are agreed when adult efficacy data are not yet available and as soon as the product lifecycle progresses, new methods and approaches can offer some advantages over randomised controlled trials in this setting and might provide a comparable level of evidence of efficacy in an alternative way. Extrapolation of adult efficacy data to paediatrics is one possible approach, provided that adult trials produce data that can be used for this purpose and that the degree of residual uncertainty is appropriately quantified for the medicinal product in question. The study also highlights the value of enhanced international cooperation among regulatory authorities, developers, and academic institutions in this field to support collaborative efforts among various stakeholders.
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Registered trials
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