Dupilumab (8) – Dupixent®

• Clinical trials
  • The multi-part EE-1774 trial was submitted for the assessment of the additional benefit of dupilumab in the treatment of eosinophilic oesophagitis (EoE).
  • The two parts of the study, A and B, have a similar randomised, controlled, double-blind design and were conducted in parallel.

Adults and adolescents aged 12 years and over with eosinophilic oesophagitis (EoE) who are inadequately treated with conventional drug therapy, cannot tolerate such therapy, or for whom such therapy is not an option

• The additional benefit is not proven
• Overall, study EE-1774 is not suitable for assessing the additional benefit of dupilumab compared with the appropriate comparator therapy determined by the G-BA, namely treatment as prescribed by a doctor, with a choice of budesonide or a PPI.
• Accordingly, the additional benefit is not proven.
• mortality
  • The study investigated endpoints in the categories of mortality, morbidity, health-related quality of life and side effects, including the co-primary endpoints ‘proportion of patients with a peak value of ≤ 6 eos/hpf’ and ‘change in the DSQ score’.
• morbidity
  • The study investigated endpoints in the categories of mortality, morbidity, health-related quality of life and side effects, including the co-primary endpoints ‘proportion of patients with a peak value of ≤ 6 eos/hpf’ and ‘change in the DSQ score’.
• Health-related quality of life
  • The study investigated endpoints in the categories of mortality, morbidity, health-related quality of life and side effects, including the co-primary endpoints ‘proportion of patients with a peak value of ≤ 6 eos/hpf’ and ‘change in the DSQ score’.
• Side effects
  • The study investigated endpoints in the categories of mortality, morbidity, health-related quality of life and side effects.
• Overall assessment
  • In summary, based on the study presented, no conclusions can be drawn regarding the additional benefit of dupilumab compared with the appropriate comparator therapy.
  • In Parts A and B of the study, dupilumab was compared with placebo in adults and adolescents who had previously failed treatment with high-dose PPIs. It was not permitted for budesonide to be routinely available to all patients. Furthermore, participants who had failed PPI treatment during screening were required to continue their high-dose PPI therapy unchanged throughout the study. The remaining participants had no access to PPIs. The study protocol corresponds neither to the appropriate comparator therapy nor to the guideline recommendations for the treatment of EoE.

Courtesy translation only, please refer to the German original.