Guselkumab Maintains Clinical and Endoscopic Remission for Ulcerative Colitis Up to 3 Years

Long-term data for guselkumab (Tremfya) reveals that the therapy maintains clinical and endoscopic remission in adults with moderately to severely active ulcerative colitis for up to 3 years. These findings, derived from the QUASAR (NCT04033445) long-term extension study and presented at the European Crohn’s and Colitis Organisation 2026 conference, demonstrate that more than 80% of patients were in clinical remission at week 140.¹

“Ulcerative colitis is a lifelong condition that can significantly impact patients’ overall health, and they need treatment options that remain effective and well-tolerated over time,” Laurent Peyrin-Biroulet, MD, PhD, said in a news release.¹ “The QUASAR long-term study shows the sustained ability of Tremfya to deliver durable results, with consistent outcomes regardless of previous biologic or JAK inhibitor treatment. With high study retention and no new safety concerns over this extended time period, the data strengthen confidence in the long-term use of Tremfya in ulcerative colitis.”

Furthermore, 53.6% of participants achieved endoscopic remission, and 78.6% reached histo-endoscopic mucosal improvement, a metric that combines visual endoscopic healing with histologic tissue normalization. The data suggests that this efficacy is sustained regardless of a patient's prior history with other biologics or Janus kinase inhibitors.¹

For pharmacists evaluating the clinical utility of this treatment, guselkumab represents the first and only approved dual-acting monoclonal antibody that blocks IL-23 while simultaneously binding to CD64, a receptor on cells that produce that specific cytokine. This mechanism targets the cellular source of inflammation associated with ulcerative colitis, a chronic inflammatory bowel disease characterized by sores and inflammation in the superficial lining of the large intestine and rectum. Because ulcerative colitis is a lifelong condition that can lead to severe complications such as anemia, bone loss, or an increased risk of colon cancer, achieving durable, long-term remission is a critical clinical objective.^1,2

Recent clinical investigations have also expanded the delivery options for this therapy, with the ASTRO (NCT05528510) study demonstrating that a fully subcutaneous induction regimen can provide clinically meaningful remission similar to intravenous induction. This flexibility in administration may allow health care providers to better tailor treatment approaches to individual patient needs.³

In the long-term QUASAR study, nearly 90% of eligible participants completed the full 140 weeks of treatment, and the vast majority of those in clinical remission remained corticosteroid-free for at least 8 weeks.¹

The safety profile of guselkumab through 3 years of treatment remains consistent with previous findings, and no new safety signals were observed in the extended study period. Pharmacists should be aware that the most frequently reported adverse events include respiratory tract infections, headaches, and injection site reactions.^1,3

Additionally, because the medication influences the immune system, patients must be monitored for serious infections and tuberculosis both before and during the course of therapy. Clinical monitoring for liver function is also required for patients being treated for inflammatory bowel disease.¹

Although there is currently no cure for ulcerative colitis, these sustained 3-year outcomes suggest that targeted therapies such as guselkumab can help patients achieve meaningful disease control and return to a more normal quality of life. The ability to maintain both clinical and endoscopic results over an extended period is particularly significant for pharmacists managing complex patient populations who have failed conventional therapies.^1-3

As the therapeutic landscape for inflammatory bowel disease continues to evolve, these long-term results strengthen the evidence for utilizing IL-23 inhibition as a durable maintenance strategy.¹

“These findings highlight the endoscopic outcomes that can be achieved with Tremfya, raising expectations for what is possible for patients with ulcerative colitis,” Esi Lamousé-Smith, MD, PhD, vice president and gastroenterology disease area lead in immunology at Johnson & Johnson, said in the news release.¹ “Patients who achieve endoscopic remission experience fewer flare-ups and are less likely to need steroids or require surgery over time.”

READ MORE: Digestive Health Resource Center

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REFERENCES

1. Tremfya (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years. News release. Johnson and Johnson. February 21, 2026. Accessed February 23, 2026. https://www.jnj.com/media-center/press-releases/tremfya-guselkumab-long-term-data-show-sustained-clinical-and-endoscopic-remission-in-ulcerative-colitis-through-3-years

2. Mayo Clinic. Ulcerative colitis. October 21, 2025. Accessed February 23, 2026. https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326

3. Gallagher A. Tremfya demonstrates sustained response up to 92 week. Drug Topics. May 8, 2025. Accessed February 23, 2026. https://www.drugtopics.com/view/tremfya-demonstrates-sustained-response-up-to-92-weeks