Baricitinib (3) – Olumiant®

• Clinical trials
  • In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or a placebo.

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, or are intolerant of, one or more conventional synthetic DMARDs

• For 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 conventional synthetic DMARDs or have been unable to tolerate them; the additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
• In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
• In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo. In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

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, or are intolerant of, one or more biological DMARDs

• For 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 or have been unable to tolerate them; the additional benefit is not proven.
• The pharmaceutical manufacturer has not provided any data for either patient population to assess the additional benefit of baricitinib compared with the appropriate comparator therapy.
• In agreement with the pharmaceutical manufacturer, no suitable studies could be identified for a comparison of baricitinib with the appropriate comparator therapy.
• In the pivotal I4V-MC-JAHV (JUVE-BASIS) trial, all patients initially received baricitinib for 12 weeks, followed by a double-blind treatment phase lasting up to 32 weeks, during which patients who responded were randomised to receive either further treatment with baricitinib or placebo. In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.