TREMFYA® (Guselkumab) is the first IL-23 inhibitor to demonstrate robust results with a fully subcutaneous regimen in both induction and maintenance in Crohn’s disease

A greater number of patients treated with subcutaneous guselkumab induction and maintenance vs placebo achieved clinical remission and endoscopic response at 48 weeks in the Phase 3 GRAVITI study1

Guselkumab shows potential to become the first IL-23 treatment to offer both a subcutaneous and intravenous induction regimen for patients living with Crohn’s disease1

High Wycombe, UK (29 October 2024) – Johnson & Johnson today announced results from the Phase 3 GRAVITI study of TREMFYA® (guselkumab), the first IL-23 inhibitor, demonstrating robust results in subcutaneous (SC) induction and maintenance therapy. The findings demonstrated significant clinical remission and endoscopic response at 48 weeks vs placebo in adults with moderately to severely active Crohn’s disease (CD).1 These results are among the 14 Johnson & Johnson abstracts presented at the American College of Gastroenterology (ACG) 2024, 25th – 30th October 2024.

“The results from the GRAVITI study indicate that guselkumab has the potential to make a positive difference for individuals with Crohn’s disease," said Professor Ailsa Hart, Consultant Gastroenterologist and Director Inflammatory Bowel Disease Research, St Mark's Hospital & Imperial College, London, UK. "Subcutaneous induction therapy with guselkumab could help people living with Crohn's disease to actively manage their symptoms and provides choice and flexibility for them and healthcare providers.”

GRAVITI SC Induction Week 12 Results:

More than half of patients treated with guselkumab (400 mg administered subcutaneously at Weeks 0, 4, and 8) achieved clinical remission versus those in the placebo group (56.1 percent versus 21.4 percent; p<0.001).1

Endoscopic response was achieved in 41.3 percent of patients treated with guselkumab SC induction therapy versus 21.4 percent in the placebo group (p<0.001).1

Greater improvements in clinical remission were seen as early as Week 4 with guselkumab compared with placebo, demonstrating rapid onset of action.2

GRAVITI SC Induction Week 48 Results:

The number of patients achieving clinical remission was more than three times higher with both maintenance doses of guselkumab versus placebo at week 48 (60.0 percent for 100 mg SC every eight weeks (q8w) and 66.1 percent for 200 mg SC every four weeks (q4w) versus 17.1 percent in the placebo group; p<0.001).1

Endoscopic response at week 48 was achieved in 44.3 percent and 51.3 percent of patients in the guselkumab 100 mg SC q8w group and 200 mg SC q4w group respectively, versus 6.8 percent in the placebo group (p<0.001).1

Endoscopic remission was achieved in 30.4 percent and 38.3 percent of patients in the guselkumab 100 mg SC q8w group and 200 mg SC q4w group respectively, versus 6.0 percent in the placebo group.2

The co-primary endpoint of clinical remission and endoscopic response at week 12 and all multiplicity-controlled endpoints were met.1 Safety findings were consistent with the known safety profile of guselkumab in approved indications.1,a

“These results show that guselkumab could become the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options,” stated Dr. John Fleming, Country Medical Director, UK at Johnson & Johnson Innovative Medicine. “The one-year results of this study suggest that subcutaneous induction with guselkumab is a promising approach to help people with Crohn’s disease manage their symptoms and achieve meaningful endoscopic improvements.”

Johnson & Johnson submitted a regulatory application seeking the approval of guselkumab for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and for the treatment of adults with moderately to severely active CD in the United Kingdom.