Dupilumab in adolescents with uncontrolled moderate-to-severe atopic dermatitis: Results from a phase IIa open-label trial and subsequent phase III open-label extension
British Journal of Dermatology Jan 13, 2020
Cork MJ, Thaçi D, Eichenfield LF, et al. - A global, multicentre, phase IIa, open-label, ascending-dose, sequential cohort study with a phase III open-label extension (OLE) was designed to demonstrate the pharmacokinetics of dupilumab, and long-term utility and safety in adolescents. In the phase IIa study, 40 adolescents received dupilumab; 36 included in the OLE. In this research, one dupilumab dose was given to the individuals and 8 weeks of pharmacokinetic sampling. Further, for 4 weeks, patients received the same dose weekly, with 8-week safety follow-up. Dupilumab's pharmacokinetic profile was similar to that in adults, in adolescents with moderate-to-severe AD. In this patient population, these 52-week utility and safety data support long-term use of dupilumab. They also suggested that the utility of dupilumab in combination with current standard of care, which was not assessed in the 16-week phase III monotherapy trial.
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