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




Clinical Added Value

no clinical added value


Not applicable