J&J reports three-year Crohn’s remission data for Tremfya

what happened

Seeking Alpha reported that long-term findings from two Phase 3 trials showed clinical remission rates of as much as 94% after three years among adults with Crohn’s disease treated with Tremfya (guselkumab). In GALAXI 2 and GALAXI 3, patients first received induction treatment and were then assigned either 100 mg at eight-week intervals or 200 mg on a four-week schedule. Remission reached 94% and 91%, respectively.

Endoscopic remission was recorded in 52% of patients receiving treatment every eight weeks and 61% of those treated every four weeks. In both dosing groups, 88% achieved clinical remission without corticosteroids over a 90-day period.

J&J separately said Phase 3 FUZION results showed consistent fistula remission in certain Crohn’s subgroups. At week 24, the combined fistula-remission endpoint was reached by 28% of patients on the q8w regimen and 27% on q4w, compared with 10% for placebo. Among participants with higher baseline luminal disease activity, the rates were 30% and 21%, respectively, versus 0% with placebo. Fistula remission was also seen in patients with prior biologic exposure and in those with or without baseline proctitis.

why it matters

The findings add longer-term efficacy data for Tremfya in Crohn’s disease and may matter for how investors assess J&J’s position in this treatment market.

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