TREMFYA® Solidifies Its Place in UC Treatment with Two-Year Data: A Breakthrough for Inflammatory Bowel Disease?

Ulcerative colitis (UC), a chronic inflammatory bowel disease affecting millions worldwide, has long been a therapeutic challenge. Patients often cycle through medications, seeking treatments that balance efficacy, safety, and convenience. Enter TREMFYA® (guselkumab), a drug that’s been gaining attention for its potential to provide long-term relief. Recent data through two years of follow-up suggest it could be a game-changer. Here’s why investors should take note.

The Case for TREMFYA® in UC: Sustained Efficacy Over Time

The Phase 3 ASTRO and QUASAR studies, completed through 2025, highlight TREMFYA®’s durability. In the QUASAR long-term extension (LTE) trial, 72% of UC patients achieved clinical remission at Week 92 (nearly two years), with 43% attaining endoscopic remission—a critical marker of mucosal healing. Even more striking, 84% of patients who saw endoscopic improvement at Week 44 maintained that improvement through Week 92. These results are significant because many UC therapies lose steam over time, leaving patients in a cycle of flares and hospitalizations.

The data also show consistency across subgroups, including those who previously failed biologics or JAK inhibitors. This positions TREMFYA® as a viable option for patients with prior treatment resistance, a growing population in an era of rising treatment resistance.

Regulatory Momentum and Market Potential

The FDA approved TREMFYA® for UC in September 2024, but the journey isn’t over. A supplemental application for subcutaneous (SC) induction—eliminating the need for IV infusions—is pending review. If approved, this could expand the drug’s appeal by reducing the logistical burden on patients and healthcare systems.

Current sales are driven by the IV induction regimen, but the SC option could accelerate adoption. For context, J&J’s (JNJ) Stelara (another IL-23/IL-12 inhibitor) generated $6.8 billion in 2023 sales, primarily for psoriasis and Crohn’s disease. The UC market, though smaller, could add hundreds of millions in annual revenue if TREMFYA® captures a significant share.

Mechanism and Competitive Edge

TREMFYA®’s unique dual-action mechanism sets it apart. Unlike other IL-23 inhibitors, it binds to both IL-23 and the CD64 receptor on IL-23-producing cells, potentially amplifying its anti-inflammatory effects. This dual targeting may explain its sustained efficacy, which competitors like AbbVie’s Skyrizi (which targets IL-23/IL-17) or Pfizer’s RINVOQ (a JAK inhibitor) have yet to demonstrate over such an extended period.

Risks and Considerations

While the data are promising, challenges remain. The pending SC induction approval is critical—denial could limit uptake. Additionally, UC’s heterogeneous nature means not all patients will respond, and long-term safety data beyond two years are still emerging. Competition is fierce: new agents like Galapagos’ filgotinib (a selective JAK1 inhibitor) and AbbVie’s risankizumab (an IL-23 inhibitor) are also vying for market share.

Conclusion: A Strong Investment Thesis, Backed by Data

TREMFYA®’s two-year data represent a milestone in UC treatment. With 72% clinical remission and 43% endoscopic remission sustained over 92 weeks—alongside a mechanism that targets both IL-23 and its cellular source—this drug is well-positioned to carve out a durable niche. The pending SC approval could further solidify its appeal, reducing the need for IV infusions and broadening its patient base.

For Johnson & Johnson, TREMFYA®’s UC franchise could become a meaningful revenue driver. The global UC market is projected to reach $4.5 billion by 2028, and with Stelara’s success in other indications, J&J has the infrastructure to capitalize.

Investors should also consider the broader implications: TREMFYA®’s sustained efficacy and differentiated mechanism suggest it could redefine standards of care in UC. In a market where unmet needs persist, this drug has the potential to deliver both clinical and financial returns—a rare dual win in biotech.

As the FDA reviews the SC induction application and long-term data mature, TREMFYA®’s story is far from over. For now, the data speak for themselves: this drug is a contender to lead the next wave of UC therapies.