XELJANZ (tofacitinib), anti-JAK 1 and 3
RHEUMATOLOGY - New medicinal product
Opinions on drugs - Posted on Jan 18 2018
Reason for request
No clinical benefit demonstrated in the treatment of rheumatoid arthritis (RA) after failure of one or more disease-modifying antirheumatic drugs (DMARD)
- XELJANZ has a Marketing Authorisation in the treatment of rheumatoid arthritis (RA) after failure of one or more DMARDs. It is administered orally, twice a day.
- It is a second-line treatment after failure of conventional DMARDs such as methotrexate (MTX), as a third-line treatment (after failure of a biological DMARD) or beyond (failure of multiple conventional and/or biological DMARDs).
- Its non-inferiority has been demonstrated in combination with MTX compared with adalimumab in second-line (after MTX failure); its superiority has not been demonstrated. XELJANZ 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.
Improvement in actual benefit
Évaluation des médicaments