Posted by Michael Wonder on 14 May 2020
Belimumab in active systemic lupus erythematosus: additional benefit for children and adolescents
14 May 2020 - Addendum with a new summary; subsequent information enables the benefits to be assessed.
The monoclonal antibody belimumab has been approved as an add-on therapy for adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have high disease activity despite standard therapy. In 2019, the admission was extended to children from the age of five and adolescents. In an early benefit assessment, the Institute for Quality and Efficiency in Health Care (IQWiG) therefore examined whether the active substance offers these younger patients an added benefit. However, the data submitted with the dossier was incomplete.
In the comment procedure, the manufacturer supplied information that the IQWiG has now been recognized as part of an addendum. There is therefore a hint of an unquantifiable additional benefit.
