Download opinion
Add to my selection
Quote this publication Print

SKYRIZI (risankizumab) - Crohn’s Disease

Opinions on drugs - Posted on Apr 12 2023

Reason for request

Indication extension

New indication(s).

 

Key points

Favourable opinion on the inclusion of SKYRIZI (risankizumab) 360 mg, solution for injection in cartridge and of SKYRIZI 600 mg, concentrate for solution for infusion in the treatment of moderately to severely active Crohn’s Disease in adult patients in whom a conventional treatment (corticosteroids or immunosuppressants) and at least one anti-TNFα agent have failed (insufficient response, loss of response or intolerance) or who have a medical contraindication to these treatments.

Unfavourable opinion on the inclusion of SKYRIZI (risankizumab) 360 mg, solution for injection in cartridge and of SKYRIZI 600 mg, concentrate for solution for infusion in the treatment of moderately to severely active Crohn’s Disease in adult patients in whom a conventional treatment has failed and who are anti-TNF naive.

 

Role in the care pathway?

Within the area of reimbursement:

In the treatment of moderately to severely active Crohn’s Disease in adult patients in whom a conventional treatment (corticosteroids or immunosuppressants) and at least one anti-TNFα agent have failed (insufficient response, loss of response or intolerance) or who present with a medical contraindication to these treatments: the role of SKYRIZI in the management of Crohn’s Disease is, like that of vedolizumab and ustekinumab, a third-line treatment, that is after failure of a conventional treatment including an immunosuppressant (including azathioprine and 6-mercaptopurine) or a corticosteroid and at least one anti-TNF (adalimumab, infliximab).

 

Within the area included in the MA but not selected for reimbursement:

After failure of a conventional treatment including an immunosuppressant (including azathioprine and 6-mercaptopurine) or a corticosteroid but in anti-TNF naive patients: SKYRIZI (risankizumab) does not have an established role.


Clinical Benefit
Substantial

The clinical benefit provided by SKYRIZI (risankizumab) 360 mg, solution for injection in cartridge and by SKYRIZI 600 mg, concentrate for solution for infusion is significant solely in the treatment of moderately to severely active Crohn’s Disease in adult patients in whom a conventional treatment (corticosteroids or immunosuppressants) and at least one anti-TNFα agent has failed (insufficient response, loss of response or intolerance) or who have a medical contraindication to these treatments.

Clinical Added Value
no clinical added value

In patients in whom conventional treatments (corticosteroids or immunosuppressants) and at least one anti-TNFα agent have failed in view of:

  • the methodological quality of the demonstration of efficacy of SKYRIZI (risankizumab) in three controlled randomised studies versus placebo conducted in patients in most of whom at least one anti-TNF agent had failed, and who had above all a moderate form of Crohn’s Disease (CD),
  • the size of the clinically relevant effect compared to placebo on clinical remission and the endoscopic response at W12 and W52 and a proven effect on fatigue at W12,
  • the reduced robustness of this demonstration for maintenance therapy,
  • the absence of additional established impact with risankizumab on the complications (fistulae, stenoses), the extraintestinal manifestations of Crohn’s Disease and recourse to surgery,
  • the known tolerance profile of SKYRIZI (risankizumab) in Crohn’s Disease,
  • the data on efficacy and tolerance currently available to locate it relative to clinically relevant comparators, (STELARA and ENTYVIO), and while waiting for the full results of the direct comparison of ustekinumab vs risankizumab, particularly in maintenance therapy,

 the Committee considers that SKYRIZI 360 (SC route) and 600 mg (IV infusion) (risankizumab), provides no clinical added value (CAV V) in the current therapeutic strategy which includes relevant comparators (see 5.2).

The benefit relative to risankizumab (SKYRIZI) in comparison to ustekinumab (STELARA) in patients in whom anti-TNF treatment has failed may be reassessed on the basis of the expected and definitive results of the SEQUENCE study.

Documents

English version

Contact Us

Évaluation des médicaments
All our publications