OLUMIANT (baricitinib), anti-JAK 1 and 2
RHEUMATOLOGY - New medicinal product
Opinions on drugs - Posted on Oct 04 2017
Reason for request
No clinical benefit demonstrated in the treatment of rheumatoid polyarthritis after failure of one or more disease-modifying treatments
- OLUMIANT has marketing authorisation in the treatment of rheumatoid polyarthritis (RP) after failure of one or more disease-modifying treatments.
- It is a second-line treatment after failure of conventional disease-modifying treatments such as methotrexate (MTX) or a third-line treatment (failure of biotherapy) or beyond (failure of multiple conventional disease-modifying and/or biological treatments).
- Its superiority has been demonstrated in combination with MTX compared with adalimumab in combination with MTX in second-line (MTX failure). OLUMIANT has not been compared to available third-line alternatives (in particular tocilizumab, abatacept, rituximab).
- There are concerns in terms of long-term safety, in particular in relation to risks of infection and cardiovascular and carcinogenic risks.
Clinical Added Value
|no clinical added value||
Évaluation des médicaments