REFERENCES
- Brunner, H. I., A. Martini, D. J. Lovell, and N. Ruperto. 2019. Clinical trials in children and adolescents with systemic lupus erythematosus: Methodological aspects, regulatory landscape and future opportunities. Annals of the Rheumatic Diseases 78(2):162–170. doi: 10.1136/annrheumdis-2018-213198.
- ClinicalTrials.gov. 2019. Identifier NCT02955615, ILT-101 in Patients with Active Moderate to Severe Systemic Lupus Erythematosus (SLE) (LUPIL-2). National Library of Medicine (US). https://clinicaltrials.gov/ct2/show/NCT02955615 (accessed December 30, 2019)
- Committee for Medicinal Products for Human Use (CHMP). 2019. Assessment report: Benlysta (Procedure No. EMEA/H/C/002015/II/0062). Amsterdam, The Netherlands: European Medicines Agency. https://www.ema.europa.eu/en/documents/variation-report/benlysta-h-c-2015-ii-0062-epar-assessment-report-variation_en.pdf. (accessed December 30, 2019)
- Division of Pulmonary Allergy and Rheumatology Products (CDER). 2019. BLA 125370/s-064 and BLA 761043/s-007 Multi-disciplinary Review and Evaluation, Benlysta® (belimumab) for Intravenous Infusion in Children 5–17 Years of Age with SLE. Silver Spring, MD: Food and Drug Administration. https://www.fda.gov/media/127912/download (accessed December 30, 2019)
- Food and Drug Administration (FDA). 2019. 21 CFR Part 312.42. Clinical holds and request for modification. Revised 1 April 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.42 (accessed December 30, 2019)
- Gamalo-Siebers, M., L. Hampson, K. Kordy, S. Weber, R. M. Nelson, and R. Portman. 2019. Incorporating innovative techniques toward extrapolation and efficient pediatric drug development. Therapeutic Innovation and Regulatory Science 53(5):567–578. doi: 10.1177/2168479019842541.
- He, J., X. Zhang, Y. Wei, et al. 2016. Low-dose interleukin-2 treatment selectively modulates CD4(+) T cell subsets in patients with systemic lupus erythematosus. Nature Medicine 22(9):991–993. doi: 10.1038/nm.4148.
- Johnson, L., D. Duenas, and B. S. Wilfond. 2020. Ethical drug development for rare childhood diseases: When there are limited but promising data in adults, how to choose between safety or efficacy studies? The American Journal of Bioethics 20(4):102–103.
- Rosenzwajg, M., R. Lorenzon, P. Cacoub, H. P. Pham, F. Pitoiset, K. E. Soufi, C. RIbet, C. Bernard, S. Aractingi, B. Banneville, et al. 2019. Immunological and clinical effects of low-dose interleukin-2 across 11 autoimmune diseases in a single, open clinical trial. Annals of the Rheumatic Diseases 78(2):209–217. doi: 10.1136/annrheumdis-2018-214229.
- Roth-Cline, M., and R. Nelson. 2014. The ethical principle of scientific necessity in pediatric research. The American Journal of Bioethics 14 (12):14–15. doi: 10.1080/15265161.2014.964874.
- Roth-Cline, M., J. Gerson, P. Bright, C. S. Lee, and R. M. Nelson. 2011. Ethical considerations in conducting pediatric research. Handbook of Experimental Pharmacology 205:219–244. doi: 10.1007/978-3-642-20195-0_11.
- von Spee-Mayer, C., E. Siegert, D. Abdirama, A. Rose, A. Klaus, T. Alexander, P. Enghard, B. Sawitzki, F. Hiepe, A. Radbruch, et al. 2016. Low-dose interleukin-2 selectively corrects regulatory T cell defects in patients with systemic lupus erythematosus. Annals of the Rheumatic Diseases 75(7):1407–1415. doi: 10.1136/annrheumdis-2015-207776.
- Yang, N., M.C. Xu, and Z. Yao. 2019. Evaluation of weight thresholds for pediatric patients to use adult dosage of therapeutic monoclonal antibodies. Journal of Clinical Pharmacology 59(10):1309–1318. doi: 10.1002/jcph.1434.