Therapeutics Development in Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): Extrapolation, Dose Selection and Clinical Trial Design; Workshop Proceedings and Recent Updates.
Laura Eve SchanbergLily Yeruk MulugetaBolanle AkinladeHermine I BrunnerJianmeng ChenRobert A ColbertVincent DelgaizoMarc R GastonguayRachel GlaserLisa ImundoDaniel J LovellJocelyn H LeuNael M MostafaRobert M NelsonPeter A NigrovicNikolay P NikolovLisa G RiderRebecca ChiuChandrahas SahajwallaRenu SinghVikram SinhaCarolyn L YanceyLynne YaoPublished in: Arthritis & rheumatology (Hoboken, N.J.) (2023)
This report summarizes key aspects of the workshop including the appropriate use of innovative approaches to pJIA therapeutics development and pediatric extrapolation to address current challenges and provide timely access to newer safe and effective treatments. Long-term safety assessment is of pressing concern to stakeholders and cannot be fully extrapolated from adult studies, but requires consistent post-marketing long-term follow up.