STOCKHOLM — Patients with moderately to severely active ulcerative colitis (UC) treated with the investigational, once-daily, oral obefazimod (Abivax, France) reported clinically meaningful improvements in disease-specific and overall quality of life (QoL), according to pooled data from two large phase 3 induction trials, ABTECT-1 and ABTECT-2. 

“Improvements in both patient-reported outcome measures were observed as early as 8 weeks after initiation of treatment,” reported Filip Baert, MD, gastroenterologist at AZ Delta, Roeselare-Menen, Belgium, in presenting the data here at the European Crohn’s and Colitis Organisation (ECCO) Congress 2026. 

In two additional pooled analyses, presented in the same session by other speakers, obefazimod was associated with rapid reductions in inflammatory biomarkers and demonstrated consistent efficacy at week eight across baseline disease extents, including proctosigmoiditis, left-sided colitis, and extensive colitis.

Baert emphasized that the quality-of-life improvements mirrored other clinical outcomes reported in the ABTECT induction program. “The improvements that really matter to our patients are consistent with the clinical measures of treatment effect that we are used to seeing in these trials,” he said.

Quality of Life as a Key Outcome 

Obefazimod is an investigational oral small molecule that enhances expression of microRNA-124, which restores mucosal immune balance through regulation of Th17 cells and macrophages.

ABTECT-1 and ABTECT-2 were identically designed induction trials enrolling a total of 1272 patients with moderately to severely active UC with an inadequate response, loss of response, or intolerance to at least one prior therapy. Participants were randomly assigned in a 2:1:1 ratio to receive obefazimod 50 mg or 25 mg or placebo once daily for 8 weeks.

As previously reported by Medscape Medical News,  the initial results showed that obefazimod achieved the primary endpoint of clinical remission and all key secondary endpoints at 8 weeks. 

For the current analysis, QoL was assessed using two validated instruments: the Inflammatory Bowel Disease Questionnaire (IBDQ), a disease-specific tool covering bowel symptoms, emotional health, social functioning, and systemic symptoms; and the EuroQol-5D-5L (EQ-5D-5L), a generic measure of health status that includes both an index score and a visual analogue scale (VAS). A clinically meaningful change on the IBDQ was defined as an improvement of 16 points or more, while IBDQ remission was defined as a total score of at least 170. Patients who received at least one dose of study drug and had baseline IBDQ or EQ-5D-5L data were included in the analyses.

“These instruments allow us not only to assess statistical change, but also to determine what constitutes a meaningful improvement and remission from the patient’s perspective,” said Baert, noting the increasing importance of patient-centered outcomes in clinical trials. 

Response rates for the patient-reported outcome measures were high (n = 1207 for IBDQ; n = 1137 for EQ-5D-5L; n = 1180 for EQ-5D-5L VAS), with nearly all participants completing both the disease-specific and overall QoL assessments at baseline and week 8, he reported. 

At baseline, mean IBDQ total scores were approximately 110 across all treatment groups, reflecting substantial disease burden. By week 8, statistically significant differences were observed between placebo and both obefazimod doses across the IBDQ total score and all four subdomains.

Mean changes in IBDQ total score from baseline to week 8 were 50.0 points in the 50-mg group and 46.3 points in the 25-mg group, compared with 24.0 points in the placebo group (both doses, P < .0001).

Importantly, a greater proportion of obefazimod-treated patients achieved a clinically meaningful within-patient change in IBDQ score (≥ 16 points), occurring in 60.9% of patients receiving 50 mg and 56.9% receiving 25 mg, compared with 39.8% in the placebo group. 

IBDQ remission was also achieved by a greater proportion of patients in the obefazimod groups (36.7% with 50 mg; 33.2% with 25 mg) than with placebo (19.6%). 

Improvements Extend Beyond Gut Symptoms 

Benefits were also seen on general QoL measures. On the EQ-5D-5L index, patients treated with obefazimod showed significantly greater improvements from baseline than placebo, with mean increases of 0.16 and 0.15 in the 50-mg and 25-mg groups, respectively, compared with 0.06 in the placebo group (P < .0001).

A significantly higher proportion of obefazimod-treated patients also achieved a clinically meaningful improvement on the EQ-5D-5L index (41.0% with 50 mg; 38.9% with 25 mg; 28.5% with placebo). Similar patterns were observed on the EQ-5D-5L VAS, which captures patients’ overall perception of health on a 0-100 scale.

“These results show clear improvements in overall quality of life, not just disease-specific measures,” Baert said. 

Consistency With Clinical and Biomarker Outcomes 

In one of the other pooled analyses presented at the meeting, researchers examined changes in inflammatory biomarkers, which are considered important intermediate treatment targets under STRIDE-II recommendations for moderate-to-severe UC.

That analysis, presented by Britta Siegmund, MD, medical director of the Division of Gastroenterology, Infectiology and Rheumatology at Charité-Universitätsmedizin Berlin, focused on high-sensitivity C-reactive protein (hs-CRP) and fecal calprotectin (FCP). 

Compared with placebo, both obefazimod doses were associated with rapid reductions in FCP, with statistically significant differences evident by week 4, the first post-baseline assessment. Reductions in hs-CRP reached nominal significance by week 8, and a greater proportion of obefazimod-treated patients achieved biomarker normalization thresholds by the end of induction.

In the other analysis, presented by Sonja Heeren, MD, gastroenterologist at LKH-Universitätsklinikum der PMU Salzburg, Austria, investigators examined whether baseline disease extent influenced treatment response. Patients were stratified as having proctosigmoiditis, left-sided colitis, or extensive colitis, reflecting clinically relevant subgroups that often guide therapeutic decision-making.

Across all disease extents, obefazimod demonstrated consistent efficacy at week 8. Both doses were associated with significantly higher rates of clinical remission and response in patients with proctosigmoiditis and left-sided colitis, while in patients with extensive colitis, the higher 50-mg dose was associated with significantly greater improvements across multiple endpoints, including endoscopic outcomes and histo-endoscopic mucosal improvement.

The session co-moderator, Robin Dart, MD, consultant gastroenterologist at Guy’s and St Thomas’ Hospital, London, reflected on the broader implications of the findings. 

“It’s very important that quality of life is included in large studies,” he said. “We are increasingly using endpoints that matter to patients, such as urgency, and seeing these integrated into clinical trials. It’s the right thing to do.”

The study was sponsored by Abivax. Several study authors are employees of or consultants to the company, as disclosed in the abstract.

Baert reports grants from AbbVie, Amgen, and EG, among other companies, and personal fees from multiple sources including AbbVie, Abivax, and Eli Lilly. 

Siegmund reports grants from Pfizer and has acted as a consultant for AbbVie, Abivax, Boehringer Ingelheim, Bristol Myers Squibb, among other companies. 

Heeren has served as a consultant or advisory board member for Amgen, MSD, and AbbVie, among other companies, and has received speaker honoraria from multiple sources including Gilead, Janssen, and Lilly. He has also acted as a past or present Principal Investigator for studies sponsored by AbbVie, Abivax, Agomab, and other pharmaceutical companies. 

Dart has declared no relevant disclosures.