Safety and Effectiveness of Vedolizumab in Indian Patients with Inflammatory Bowel Disease: Results from a Phase 4 Study
Vedolizumab showed an acceptable safety profile and clinical effectiveness in Indian patients with moderate-to-severe inflammatory bowel disease (IBD), according to findings from a recent Indian study.
The study was published in the February 2026 issue of the Journal of Clinical and Experimental Gastroenterology, and is among the first prospective studies evaluating vedolizumab specifically in Indian patients.
Inflammatory bowel disease (IBD), comprising ulcerative colitis (UC) and Crohn’s disease (CD), is emerging as a growing healthcare burden in India. Between 1990 and 2019, the estimated number of IBD cases in India increased from 0.13 million to 0.27 million. Vedolizumab, a gut-selective monoclonal antibody targeting integrin α4β7, has shown favourable results globally in reducing gastrointestinal inflammation and maintaining remission in patients who do not respond adequately to conventional therapies or TNF-α antagonists. However, India-specific evidence has remained limited.
About the Study
To address this gap, researchers conducted an open-label, single-arm, prospective Phase 4 study across 17 centers in India involving patients with moderate-to-severe UC or CD.
A total of 150 patients with moderate-to-severe IBD were enrolled, including 102 UC and 48 CD patients, with a median age of 36 years. A total of 111 patients (76 UC and 35 CD) completed the study, baseline demographics, disease duration, and disease activity scores were evaluated to assess vedolizumab’s safety and effectiveness.
Patients received vedolizumab 300 mg intravenously at Weeks 0, 2, and 6 during the induction phase, followed by maintenance doses at weeks 14, 22, 30, 38, and 46. Patients with Crohn’s disease who showed inadequate response were eligible for an additional dose at week 10 or every four weeks during maintenance if response declined.
The primary endpoint of the study was safety, assessed through adverse events (AEs), treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse drug reactions (ADRs), and adverse events of special interest (AESIs). Secondary endpoints included clinical response, clinical remission, mucosal healing, endoscopic response, and quality-of-life improvements.
Study Graphical Abstract
The key findings from the study include:
1. Clinical response improved over time
- Overall clinical response rates increased from 60.7% at Week 14 to 65.3% at Week 30 and 72% at Week 46.
- Among UC patients, response improved from 54.9% at Week 14 to 73.5% at Week 46, while CD patients maintained consistently high response rates ranging from 72.9% at Week 14 to 68.8% at Week 46.
2. Clinical remission rates also improved
- Overall clinical remission rates increased from 42% at Week 14 to 44% at Week 30 and 53.3% at Week 46.
- Among UC patients, remission improved from 39.2% to 52%, while in CD patients, remission increased from 47.9% to 56.3% over the treatment period.
3. Mucosal healing and endoscopic response
- These were assessed in a limited number of patients at Week 46. Overall, 27 patients (18%) achieved mucosal healing, including 23 UC patients (22.5%) and 4 CD patients (8.3%).
- Similarly, 28 patients (18.7%) achieved endoscopic response, comprising 22 UC patients (21.6%) and 6 CD patients (12.5%).
- Both mucosal healing and endoscopic response were observed more frequently in UC patients than in those with CD.
4. Changes in Quality of Life
- Patient-reported quality of life, assessed using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), improved from a median increase of 5 points at Week 14 to 13 points at Week 46 in both UC and CD patients.
5. Safety profile
- 55.3% of patients experienced at least one adverse event, with a slightly higher incidence among CD patients (60.4%) compared to UC patients (52.9%).
- Most adverse events were mild, no deaths were reported, and the majority of adverse events resolved by the end of the study.
This study findings indicate positive treatment effects across multiple endpoints, with improvements in clinical response, clinical remission, mucosal healing, and quality of life among both UC and CD patients.
This Phase 4 study provides important evidence supporting the safety and effectiveness of vedolizumab in IBD among the Indian population.
Overall, the research findings suggest that vedolizumab may be considered a treatment option for patients with moderate-to-severe UC or CD in India
Abbreviations: IBD – Inflammatory Bowel Disease, UC – Ulcerative Colitis, CD – Crohn’s Disease, IV – Intravenous, AE – Adverse Event, TEAE – Treatment-Emergent Adverse Event, SAE – Serious Adverse Event, ADR – Adverse Drug Reaction, AESI – Adverse Event of Special Interest, QoL – Quality of Life, SIBDQ – Short Inflammatory Bowel Disease Questionnaire, TNF-α – Tumor Necrosis Factor-alpha, GI – Gastrointestinal
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