TREMFYA (guselkumab) - Active ulcerative colitis (UC)

The clinical benefit of TREMFYA (guselkumab) is moderate only in the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional therapy, at least one prior TNFα antagonist and vedolizumab.

Considering:

• the methodological quality of the two pivotal studies (controlled, randomised, double-blind, relevant choices of outcome measures including quality of life, sample size), but given that the choice of placebo is regrettable, particularly in patients with no prior biologic therapy, and that the efficacy was assessed in a heterogeneous population including biologic therapy-naive and non-naive patients;
• evidence of superiority of guselkumab versus placebo, with an effect size that is at best moderate on clinical remission in the overall study population; the lack of evidence of an effect on referral for colectomy;
• the lack of comparative data versus TNFα antagonists in patients having responded inadequately to a conventional disease-modifying therapy and with no prior TNFα antagonist therapy, and versus vedolizumab (ENTYVIO), despite these comparisons

being possible;

• and the good safety profile of guselkumab.