Favourable opinion for reimbursement in the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy (corticosteroids or immunosuppressants) and at least one anti-TNFα agent, or who have a medical contraindication to these treatments.
Unfavourable opinion for reimbursement in the treatment of adult patients with moderately to severely active Crohn's disease with previous failure to conventional therapy and with no prior anti-TNFα agent therapy.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of SKYRIZI (risankizumab) 360 mg solution for injection in cartridge and SKYRIZI 600 mg concentrate for solution for infusion remains substantial in the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy (corticosteroids or immunosuppressants) and at least one anti-TNFα agent, or who have a medical contraindication to these treatments.
Clinical Added Value
minor
Considering:
the methodological quality of the evidence of the efficacy of SKYRIZI (risankizumab) in three randomised, placebo-controlled studies, conducted in patients who mostly had previous failure to at least one TNF inhibitor and predominantly had a moderate form of Crohn’s disease (CD);
the clinically relevant effect size versus placebo on clinical remission and endoscopic response at W12 and W52, and a demonstrated effect on fatigue at W12;
the lower robustness of this evidence for the maintenance treatment;
the results of the direct comparison between ustekinumab and risankizumab in a study of good methodological quality (randomised although single-blind, versus ustekinumab, a clinically relevant comparator and prescribed at an optimised dosage) having demonstrated the superiority of risankizumab, with an effect size deemed to be moderate;
the absence of an established additional impact with risankizumab on complications (fistula, stenosis), extraintestinal manifestations of Crohn’s disease and recourse to surgery;
the known safety profile of SKYRIZI (risankizumab) in Crohn’s disease;
the Committee deems that SKYRIZI 360 mg and 600 mg solution for injection in cartridge (360 mg strength) and concentrate for solution for infusion (600 mg strength) provide a minor clinical added value (CAV IV) compared to STELARA (ustekinumab) at an optimised dosage (SC injection every 8 weeks) in the third-line treatment of adult patients with moderately to severely active Crohn’s disease, i.e. after previous failure to conventional therapy including an immunosuppressant (such as azathioprine or 6-mercaptopurine) or a corticosteroid and at least one TNF inhibitor (adalimumab, infliximab).
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