TREMFYA shows promise in ulcerative colitis study

SAN DIEGO - Johnson & Johnson (NYSE: JNJ) announced today that its Phase 3 ASTRO study of TREMFYA® (guselkumab) demonstrated significant clinical remission and endoscopic improvement in adults with moderately to severely active ulcerative colitis (UC) at Week 24. These results build on the success of the drug’s FDA-approved intravenous (IV) induction regimen and offer a new subcutaneous (SC) option for patients. With a healthy gross profit margin of 68.9% and substantial revenue of $89.33 billion in the last twelve months, Johnson & Johnson maintains a strong position to advance its pharmaceutical pipeline.

The study found that patients treated with TREMFYA® 400 mg SC induction followed by maintenance doses of either 100 mg every eight weeks or 200 mg every four weeks showed statistically significant improvements in clinical remission and endoscopic measures compared to those receiving a placebo. Specifically, 35.3% of patients on the 100 mg regimen and 36.4% on the 200 mg regimen achieved clinical remission, versus 9.4% for the placebo group.

Additionally, symptomatic remission rates were 54.7% and 50.0% for the 100 mg and 200 mg regimens, respectively, compared to 25.2% for the placebo. Endoscopic improvement was observed in 40.3% of patients on the 100 mg dose and 45.0% on the 200 mg dose, in contrast to 12.2% for the placebo group.

Dr. Millie Long, a study investigator from the University of North Carolina at Chapel Hill, highlighted the clinical significance of the findings, noting the potential for TREMFYA® to offer greater treatment flexibility for physicians and patients through both SC and IV induction options.

The safety profile of TREMFYA® in the ASTRO study was consistent with previous findings, reinforcing its established safety in treating UC. Esi Lamousé-Smith, MD, PhD, of Johnson & Johnson, emphasized the drug’s potential to redefine UC care with its fully subcutaneous regimen, allowing for the possibility of patient self-administration from the onset of treatment.

TREMFYA® is notable as the first and only IL-23 inhibitor approved by the FDA for the treatment of adult patients with moderately to severely active UC and Crohn’s disease. The drug works by blocking IL-23, a cytokine implicated in immune-mediated diseases, and binds to CD64, a receptor on cells that produce IL-23.

These findings were part of 24 abstracts presented by the company at Digestive Disease Week (DDW) 2025. The information in this article is based on a press release statement from Johnson & Johnson.

In other recent news, Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) approved IMAAVY™ for treating generalized myasthenia gravis in specific patient groups. This approval is based on clinical trial data showing significant disease control and symptom relief. Additionally, S&P Global Ratings has reaffirmed Johnson & Johnson’s ’AAA’ credit rating with a stable outlook following its acquisition of Intra-Cellular Therapies for $14.6 billion. The company’s strong financial position is noted, despite ongoing talcum powder litigation concerns.

Moreover, Johnson & Johnson presented promising data for its bladder cancer treatment, TAR-200, at the American Urological Association Annual Meeting. The treatment showed potential for complete response in patients unresponsive to standard therapy. Analysts at TD Cowen and UBS have maintained a Buy rating on Johnson & Johnson stock, with price targets of $185 and $180, respectively. TD Cowen highlighted the company’s ability to manage tariff costs and a strong start to 2025, while UBS emphasized robust sales growth and resilience in the MedTech business. These developments underscore Johnson & Johnson’s strategic growth initiatives and financial health amidst economic challenges.

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