TREMFYA (guselkumab) - Crohn’s disease

The clinical benefit of TREMFYA (guselkumab) is substantial only 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-TNF agent, or who have a medical contraindication to these treatments.

Considering:

• the methodological quality of the evidence of efficacy of TREMFYA (guselkumab) in three placebo-controlled, randomised, double-blind studies, with a study design without re-randomisation between induction and maintenance, conducted in patients who mostly had previous failure to at least on anti-TNF agent,
• a clinically relevant effect size compared to placebo for relevant clinical and endoscopic endpoints, in induction therapy (12 weeks) and maintenance therapy (48 weeks) in these studies,
• the results of the direct comparison between ustekinumab and guselkumab, which do not provide robust evidence of the superiority of guselkumab in the overall population and in the subgroup (exploratory) in patients with no prior second-line therapy,
• the absence of an established additional impact with guselkumab on complications (fistula, stenosis), extraintestinal manifestations of Crohn’s disease and recourse to surgery,
• the favourable safety profile of TREMFYA (guselkumab) in Crohn’s disease,

the Committee deems that TREMFYA (guselkumab) provides no clinical added value (CAV V) compared to ustekinumab (STELARA) at an optimised dosage (SC injection every 8 weeks) 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.