Johnson & Johnson's Tremfya Seeks Expanded Use Approval After It Shares Encouraging Late-Stage Study Data In Crohn's Disease

On Monday, Johnson & Johnson JNJ announced results from the Phase 3 GRAVITI study of Tremfya (guselkumab) for Crohn’s disease.

The findings demonstrated significant clinical remission and endoscopic response at 48 weeks in adults with moderately to severely active Crohn’s disease.

These results are among the 14 Johnson & Johnson abstracts presented at the American College of Gastroenterology 2024.

Also Read: Johnson & Johnson’s Blockbuster Drug Tremfya Clears Plaque Psoriasis With Lesions Covering Body’s Smaller Areas.

GRAVITI  Subcutaneous Induction Week 12 Results:

• More than half of patients treated with Tremfya (400 mg administered subcutaneously at Weeks 0, 4, and 8) achieved clinical remission versus those in the placebo group (56.1% versus 21.4%).
• Endoscopic response was achieved in 41.3% of patients treated with Tremfya SC induction therapy versus 21.4% in the placebo group.
• Greater improvements in clinical remission were seen as early as Week 4 with Tremfya compared with placebo, demonstrating rapid onset of action.

GRAVITI SC Induction Week 48 Results:

• The rate of clinical remission was more than three times higher with both maintenance doses of Tremfya versus placebo (60% for 100 mg SC every eight weeks (q8w) and 66.1% for 200 mg SC every four weeks (q4w) versus 17.1%.
• The endoscopic response was achieved in 44.3% and 51.3% of patients in the Tremfya 100 mg SC q8w group and 200 mg SC q4w group, respectively, versus 6.8% in the placebo group.
• Endoscopic remission was achieved in 30.4% and 38.3% of patients in the Tremfya 100 mg SC q8w group and 200 mg SC q4w group, respectively, versus 6.0 percent in the placebo group.

The FDA approved Tremfya in September 2024 for moderately to severely active ulcerative colitis (UC), and an application for moderately to severely active Crohn’s disease is currently under FDA review.

Regulatory applications seeking approval of Tremfya for moderately to severely active ulcerative colitis and Crohn’s disease have been submitted in Europe.

Price Action: JNJ stock is up 0.29% at $161.34 at the last check on Monday.

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