Duvakitug Shows Durable Efficacy in Ulcerative Colitis and Crohn Disease

Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn disease. These positive results from the RELIEVE UCCD (NCT05668013) long-term extension study confirmed that clinical and endoscopic efficacy could be maintained over 44 weeks in patients who initially responded to the induction phase.¹

“These results reinforce duvakitug's potential as a leading TL1A therapy and an important advancement in inflammatory bowel disease treatment with durable efficacy maintained for nearly 1 year in patients living with ulcerative colitis or Crohn disease," Houman Ashrafian, executive vice president and head of research and development at Sanofi, said in a news relewase. "With phase 3 studies underway, we're committed to advancing duvakitug for patients who need new options, and it remains a key opportunity in our pipeline."

During the maintenance period, patients were rerandomized to receive either a 450 mg or 900 mg subcutaneous dose of duvakitug every 4 weeks, totaling up to 58 weeks of therapeutic exposure. For patients with ulcerative colitis, clinical remission rates reached 58% in the 900 mg group and 47% in the 450 mg group by week 44 of the maintenance period.^1,2

Similarly, 55% of Crohn disease patients at the higher dose and 41% at the lower dose achieved the primary end point of endoscopic response. These findings represent a significant milestone for duvakitug, an investigational human IgG1-λ2 monoclonal antibody that targets tumor necrosis factor-like ligand 1A, also known as TL1A.^1,3

By targeting TL1A, duvakitug is designed to inhibit signaling that amplifies inflammation and drives the fibrosis often associated with inflammatory bowel disease (IBD). The drug binds to TL1A to prevent it from interacting with its receptor, death receptor 3 (DR3). Pharmacologically, duvakitug is unique because it is designed to preferentially inhibit TL1A-DR3 signaling while potentially reducing the inhibition of decoy receptor 3.^1,3

This durable efficacy data follows the successful 14-week RELIEVE UCCD induction phase, where duvakitug demonstrated a clinical remission rate of 48% in ulcerative colitis patients at the 900 mg dose compared to 20% for those on placebo. In the Crohn’s disease cohort of that same induction study, 48% of patients receiving the 900 mg dose achieved an endoscopic response, significantly higher than the 13% observed in the placebo group.³

Duvakitug showed benefits across diverse patient populations, including those who were either advanced therapy-naïve or had previous experience with advanced treatments. From a safety perspective, duvakitug was generally well tolerated throughout the clinical program, with no emergent safety signals or dose-dependent adverse event patterns identified.^1,3

The most frequent adverse events reported during the extension study included nasopharyngitis, upper respiratory tract infections, and hypertension, which were consistent with observations from the earlier induction phase. Managing IBD remains a complex task for the health care team, as the condition involves leukocyte-driven inflammation that can lead to permanent damage, such as strictures or fistulas, especially in Crohn disease.^1,3,4

“One of the persistent challenges in treating ulcerative colitis and Crohn disease isn’t just achieving an initial response, but sustaining it,” Eric Hughes, MD, PhD, executive vice president of global R&D and chief medical officer at Teva, said in a news release. “These phase 2b results further reinforce TL1A as a compelling target and clearly strengthen the case that duvakitug has the potential to be a best-in-class therapy. They also provide further evidence to support additional indications we anticipate announcing this year, with the goal of bringing meaningful innovation to patients.”

Pharmacists play a vital role in this management, not only in overseeing biologic therapy but also in counseling patients on medications like nonsteroidal anti-inflammatory drugs, which can potentially trigger or aggravate IBD flares. Currently, phase 3 programs for duvakitug are underway, with Sanofi leading the clinical development while collaborating with Teva on global commercialization efforts.^1,4

Although the safety and efficacy of duvakitug have not yet been reviewed by any regulatory authority, the nearly 1-year maintenance data reinforces its potential as a best-in-class therapy for patients who have long struggled with the cycle of remission and relapse.^1,3

REFERENCES

1. Sanofi and Teva’s duvakitug phase 2b maintenance data demonstrated clinically meaningful durable efficacy in ulcerative colitis and Crohn’s disease. News release. February 17, 2026. Accessed February 17, 2026. https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-17-11-00-00-3239014

2. A study to evaluate the long-term effect of TEV-48574 in moderate to severe ulcerative colitis or Crohn’s disease. ClinicalTrials.gov identification: NCT05668013. Updated February 17, 2026. Accessed February 17, 2026. https://clinicaltrials.gov/study/NCT05668013?term=duvakitug&aggFilters=phase:2&rank=1

3. ECCO 2025: new duvakitug data reinforce best-in-class potential in ulcerative colitis and Crohn’s disease. News release. February 22, 2025. Accessed February 17, 2026. https://www.sanofi.com/en/media-room/press-releases/2025/2025-02-22-07-30-00-3030764

4. Mayo Clinic. Ulcerative colitis vs Crohn’s disease. November 7, 2025. Accessed February 17, 2026. https://www.mayoclinic.org/diseases-conditions/inflammatory-bowel-disease/in-depth/ulcerative-colitis-vs-crohns-disease/art-20590269