Dupilumab (6) – Dupixent®

Children aged 6 to 11 years with severe asthma characterised by type 2 inflammation, as indicated by an elevated eosinophil count in the blood and/or an elevated fraction of exhaled nitric oxide (FeNO), which is inadequately controlled despite treatment with medium- to high-dose inhaled corticosteroids (ICS) plus an additional medicinal product used for maintenance therapy

• For the treatment of children aged 6 to 11 years with severe asthma involving type 2 inflammation, characterised by an elevated eosinophil count in the blood and/or an elevated fraction of exhaled nitric oxide (FeNO), which is inadequately controlled despite treatment with medium- to high-dose inhaled corticosteroids (ICS) plus another medicinal product used for maintenance therapy, additional benefit is not proven.
• An additional benefit is therefore not proven.
• In the VOYAGE study, in the control arm, the inadequate treatment at the start of the study was continued unchanged throughout the study in all children, even though, in accordance with the appropriate comparator therapy determined by the G-BA, further options for treatment escalation were available.
• An escalation of the existing maintenance therapy was not permitted at the start of the study; during the course of the study, it was only possible for a small proportion of the study population after at least two severe asthma exacerbations.
• It therefore remains unclear for how many patients in the study a trial of LAMA, an increase in the ICS dose or a trial of omalizumab would have been appropriate.
• In summary, the results of the VOYAGE study cannot be taken into account for the benefit assessment due to the high level of uncertainty regarding the implementation of the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.