Sarilumab (2) – Kevzara®

a) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to previous treatment with conventional synthetic DMARDs

• An additional benefit is not proven.
• The pharmaceutical manufacturer does not present any relevant study in its dossier for the assessment of the additional benefit of sarilumab compared with the appropriate comparator therapy.
• Overall, the additional benefit of sarilumab compared with the appropriate comparator therapy is not proven for this patient group.

b) Children and adolescents aged 2 years and over with active polyarticular juvenile idiopathic arthritis (rheumatoid factor-positive [RF+] or -negative [RF-] polyarthritis and extended oligoarthritis) who have responded inadequately to one or more biological DMARDs

• The additional benefit is not proven.
• The pharmaceutical manufacturer does not present any relevant study in its dossier for the assessment of the additional benefit of sarilumab compared with the appropriate comparator therapy.
• Overall, for this patient group, the additional benefit of sarilumab compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.