ROACTEMRA (tocilizumab), immunosuppressive agent
RARE DISEASE - New indication
Opinions on drugs -
Posted on
Jan 11 2019
Reason for request
Extension of indication
High clinical benefit in giant cell arteritis, combined with degressive corticotherapy, in patients requiring cortisone-sparing.
Insufficient clinical benefit in other clinical situations, particularly in the treatment of recently diagnosed or recurrent giant cell arteritis, in the absence of corticosteroid dependence and/or intolerance.
Subcutaneous ROACTEMRA has now been granted an MA for the treatment of adults suffering from giant cell arteritis (GCA).
When combined with decreasing 26-week corticotherapy, its superiority is demonstrated versus placebo in terms of remission at 52 weeks.
Its tolerance profile is characterised by infectious, haematological, hepatic and gastrointestinal adverse effects.
ROACTEMRA presents a clinical benefit only in patients requiring cortisone-sparing.
Clinical Benefit
Substantial |
- |
Insufficient |
Clinical Added Value
no clinical added value |
- |
Not applicable |