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OLUMIANT (baricitinib), anti-JAK 1 and 2

RHEUMATOLOGY - New medicinal product
Opinions on drugs - Posted on Oct 04 2017

Reason for request

Inclusion

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 Benefit

Substantial

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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