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Novel biologic could offer ulcerative colitis symptomatic remission

Johnson & Johnson’s selective IL-23 inhibitor demonstrated clinically meaningful improvements compared to placebo in ulcerative colitis, new study data shows.

TREMFYA ulcerative colitisTREMFYA ulcerative colitis

Initial data from a Phase III maintenance study of TREMFYA ® (guselkumab) has demonstrated promising remission rates obtained from a dual-acting monoclonal antibody given to ulcerative colitis (UC) patients.

This data from Johnson & Johnson’s Phase III QUASAR study is being presented at Digestive Disease Week 2024 (Abstract #759).

Achievement of clinical remission

  • Fifty percent of patients with moderate to severe active ulcerative colitis given subcutaneous TREMFYA (guselkumab) 200mg every four weeks achieved the primary endpoint of clinical remission
  • This observation was also seen in 45.2 percent of patients given subcutaneous TREMFYA 100mg every eight weeks.

This data for the primary endpoint of clinical remission at Week 44 was achieved compared to placebo (18.9 percent).

Additional analyses showed that in the ulcerative colitis patients who achieved clinical remission, 67 percent and 71 percent, respectively, also achieved endoscopic remission at Week 44.

According to Johnson & Johnson, both TREMFYA treatment groups also met all nine major secondary endpoints with high statistical significance and clinically meaningful improvements compared to placebo .

About TREMFYA (guselkumab) for ulcerative colitis

“These data suggest the potential of guselkumab to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalisation and histologic remission”

In the trial, the selective IL-23 inhibitor was evaluated in adults with moderately to severely active ulcerative colitis with inadequate response or intolerance to conventional therapy such as corticosteroids, other biologics and/or JAK inhibitors.

Developed by Johnson & Johnson, TREMFYA is the first approved fully-human dual-acting monoclonal antibody that blocks IL-23, a key driver of pathogenesis in inflammatory diseases.

“These data suggest the potential of guselkumab to provide durable, clinical remission and improve important high-bar endpoints such as endoscopic remission to the point of normalisation and histologic remission,” stated Dr David Rubin, Chief, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago and lead study investigator.

Johnson & Johnson stated that this year, it submitted regulatory applications for the approval of TREMFYA to treat adults with moderately to severely active ulcerative colitis in countries or regions including the US and Europe. 

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