Dupilumab (2) – Dupixent®

• Clinical trials
  • The DRI12544 trial was a randomised, double-blind, placebo-controlled Phase IIb trial involving 776 adult patients with uncontrolled moderate to severe asthma.
  • The VENTURE trial is a randomised, double-blind Phase IIIstudy comparing dupilumab with placebo in 210 patients aged 12 years and over with uncontrolled severe asthma, who were receiving existing asthma treatment comprising high-dose ICS and 1 to 2 other controller medications at a stable dose, as well as regular OCS treatment.

a) Adolescents aged 12 to 17 years with severe asthma characterised by type 2 inflammation, as indicated by an elevated eosinophil count in the blood and/or elevated FeNO, which is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus one further medicinal product used for maintenance therapy

• An additional benefit is not proven.
• Overall, very little data was submitted for the benefit assessment from adolescent patients with inadequately controlled severe asthma with type 2 inflammation.
• There are therefore no relevant data available for the benefit assessment to evaluate the additional benefit of dupilumab as an add-on maintenance therapy in adolescents aged 12 to 17 years with inadequately controlled severe asthma with type 2 inflammation, who are already receiving high-dose ICS and at least one other medicinal product as maintenance therapy, compared with the appropriate comparator therapy.
• Overall, an additional benefit is not proven.

b) Adults with severe asthma with type 2 inflammation, characterised by an elevated eosinophil count in the blood and/or elevated FeNO, which is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus one further medicinal product used for maintenance therapy

• An additional benefit is not proven.
• The results of the VENTURE study, as well as the results from the patient populations of the DRI12544 and QUEST studies relevant to the benefit assessment, cannot be taken into account for the benefit assessment due to the high level of uncertainty regarding the implementation of the appropriate comparator therapy.
• Overall, therefore, an additional benefit is not proven.

Courtesy translation only, please refer to the German original.