Dupilumab (11) – Dupixent®

• Clinical trials
  • The EE-1877 study was submitted for the assessment of the additional benefit of dupilumab in the treatment of eosinophilic oesophagitis (EoE) in children aged 1 to 11 years.
  • Study EE-1877 consists of three parts. In Part A of the study, a randomised, double-blind comparison of dupilumab versus placebo was conducted.

Children aged 1 to 11 years with eosinophilic oesophagitis (EoE) who have not responded adequately to conventional drug therapy, who cannot tolerate such therapy, or for whom such therapy is not an option

• The additional benefit is not proven.
• Overall, it is concluded that the appropriate comparator therapy was not implemented in the EE-1877 study.
• None of the children in the control arm received budenoside. Treatment with PPIs was only possible to a limited extent.
• The approach taken in the study therefore does not correspond to the implementation of the appropriate comparator therapy.
• Furthermore, the comparative treatment duration of 16 weeks is not, on its own, sufficient to assess the long-term effects of dupilumab on the treatment of EoE in children.
• Furthermore, a potentially significant proportion of children were not treated in accordance with the summary of product characteristics (SmPC) and were therefore not treated in line with the marketing authorisation.
• In summary, based on the data presented, no conclusions can be drawn regarding the additional benefit of dupilumab compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.