RINVOQ (upadacitinib) - Crohn’s disease

The Committee deems that the clinical benefit of RINVOQ (upadacitinib) 15 mg, 30 mg and 45 mg, prolonged-release tablet, is substantial in the treatment of moderate to severe active Crohn’s disease for adult patients who have had an inadequate response, loss of response or intolerance to conventional treatments and to at least one TNFα inhibitor, and where the alternatives are less suitable.

For patients failing to respond to conventional treatments (corticosteroids or immunosuppressants) and at least one TNF inhibitor, in view of:

• the methodological quality of the evidence of the efficacy of RINVOQ (upadacitinib) in three randomised controlled studies versus placebo conducted on patients mostly failing to respond to at least one TNF inhibitor, especially having a moderate form of Crohn’s disease (CD),
• the lower robustness of this evidence for the maintenance treatment,
• the clinically relevant effect size versus placebo on clinical remission and endoscopic response at W12 and W52, with an established effect on quality of life at W12 (fatigue and IBDQ score) and at W52 (IBDQ score),

but also in view of:

• the lack of established additional impact with upadacitinib (RINVOQ) on complications (fistulas, stenosis), extraintestinal manifestations of Crohn’s disease and referral for surgery,
• the efficacy and safety data currently available not allowing positioning in relation to the clinically relevant comparators (STELARA and ENTYVIO in particular),
• and the updated safety profile of janus kinase inhibitors including that of RINVOQ (upadacitinib) in CIBD (UC and CD) with a risk of serious adverse events and death,

the Committee deems that RINVOQ (upadacitinib) 15 mg, 30 mg and 45 mg, prolonged-release tablet, provides no clinical added value (CAV V) in the current therapeutic strategy.