TREMFYA® (guselkumab) shows strong efficacy in biologic-naïve and biologic-refractory Crohn's and ulcerative colitis patients

VIENNA, Austria, Oct. 10, 2024 - Johnson & Johnson has announced significant findings regarding TREMFYA® (guselkumab) in the treatment of Crohn's disease (CD) and ulcerative colitis (UC). These results demonstrate high rates of endoscopic remission in both biologic-naïve and biologic-refractory patients, indicating a normalized appearance of intestinal mucosa. The data is derived from pooled analyses of the Phase 3 GALAXI 2 & 3 studies for CD and the Phase 3 QUASAR maintenance study for UC. These findings were presented at the United European Gastroenterology (UEG) Week 2024.

TREMFYA® is the only IL-23 inhibitor to show superiority to ustekinumab in the overall population of patients with Crohn's disease, including those who are biologic-naïve and those who are biologic-refractory. Ninety percent more biologic-naïve patients and three times more biologic-refractory patients with ulcerative colitis achieved endoscopic remission with TREMFYA®.

Endoscopic remission was notably higher in biologic-naïve patients treated with TREMFYA® compared to those treated with ustekinumab or placebo. In the pooled Phase 3 GALAXI 2 & 3 studies, 44% of biologic-naïve CD patients treated with TREMFYA® 100 mg every eight weeks (q8w) and 46.1% treated with TREMFYA® 200 mg every four weeks (q4w) achieved endoscopic remission, compared to 29.8% with ustekinumab. In the Phase 3 QUASAR study, 38.1% of UC patients treated with TREMFYA® 100 mg q8w and 41.7% with TREMFYA® 200 mg q4w achieved remission, compared to 20.4% with placebo.

Similarly, endoscopic remission in biologic-refractory patients also favored TREMFYA®. In the pooled GALAXI 2 & 3 dataset, 28.1% and 28.6% of CD patients treated with TREMFYA® 100 mg q8w and 200 mg q4w, respectively, achieved remission, compared to 20.5% with ustekinumab. In the QUASAR study, 31.2% of UC patients treated with TREMFYA® 100 mg q8w and 23.9% with TREMFYA® 200 mg q4w achieved remission, compared to 8% with placebo.

These results highlight TREMFYA®'s potential as a differentiated treatment option for CD and UC patients, particularly those who are either starting on a biologic for the first time or have failed prior biologic treatments. This marks a significant advancement in inflammatory bowel disease (IBD) therapy, building upon Johnson & Johnson's longstanding leadership in this area.

TREMFYA® received U.S. FDA approval in September 2024 for the treatment of adults with moderately to severely active UC, and an application for the treatment of CD is currently under review. The European Medicines Agency (EMA) is also reviewing TREMFYA® for the treatment of both UC and CD.

The GALAXI program is a comprehensive Phase 2/3 study evaluating the efficacy and safety of guselkumab in CD patients with inadequate response or intolerance to conventional therapies or biologics. Pooled data from GALAXI 2 & 3 demonstrated TREMFYA®'s superiority to ustekinumab in achieving endoscopic remission. The QUASAR study similarly assessed guselkumab in UC patients with inadequate response to conventional therapies or biologics.

Crohn's disease and ulcerative colitis are chronic inflammatory conditions of the gastrointestinal tract, affecting millions of people globally. Symptoms can include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever for Crohn's disease, and loose bowel movements, rectal bleeding, and abdominal pain for ulcerative colitis.

TREMFYA® is a dual-acting monoclonal antibody that targets inflammation at its cellular source by blocking IL-23 and binding to CD64. It is approved in various countries for treating moderate-to-severe plaque psoriasis and active psoriatic arthritis, and now for moderately to severely active ulcerative colitis. Johnson & Johnson holds exclusive worldwide marketing rights to TREMFYA®.

These findings underscore TREMFYA®'s potential in offering significant improvements and sustained remission for patients with Crohn's disease and ulcerative colitis, marking a milestone in IBD treatment advancements.