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Journal of Clinical and Experimental Gastroenterology

ISSN: 2833-1133

Original Research Open Access

Vedolizumab in Indian patients with inflammatory bowel disease: final results from a prospective, multicenter, open-label, phase 4 study

Mayank Kabrawala1, Rupa Banerjee2,*, Vineet Ahuja3, Anumula Kavitha4, Vaishali Bharadwaj5, Ashok Dalal6, B Ramesh Kumar7, Shrikant Mukewar8, Ajit Sood9, VG Mohan Prasad10, Sandeep Arora11, Gaurav Bahuguna12, Avi Sharma12
  • 1Department of Gastroenterology, Surat Institute of Digestive Science, SIDS Hospital, Surat, Gujarat, India
  • 2IBD Centre, Asian Institute of Gastroenterology, Hyderabad, Telangana, India
  • 3Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, New Delhi, India
  • 4Department of Gastroenterology, Government General Hospital, Guntur, Andhra Pradesh, India
  • 5Department of Gastroenterology, Dr Ram Manohar Lohia Hospital, New Delhi, New Delhi, India
  • 6Department of Gastroenterology, Maulana Azad Medical College & Associated G B Pant Hospital, New Delhi, New Delhi, India
  • 7Department of Gastroenterology, Osmania Medical College & General Hospital, Hyderabad, Telangana, India
  • 8Department of Gastroenterology, Midas Multi-Specialty Hospital, Nagpur, Maharashtra, India
  • 9Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India
  • 10Institute of Gastroenterology, VGM Hospital, Coimbatore, Tamil Nadu, India
  • 11Erstwhile Head, Medical Affairs, Takeda Biopharmaceuticals India Private Limited, Gurgaon, Haryana, India
  • 12Medical Affairs, Takeda Biopharmaceuticals India Private Limited, Gurgaon, Haryana, India
+ Affiliations - Affiliations

Corresponding Author

Rupa Banerjee, dr_rupa_banerjee@hotmail.com

Received Date: November 12, 2025

Accepted Date: February 04, 2026

Citation:

Kabrawala M, Banerjee R, Ahuja V, Kavitha A, Bharadwaj V, Dalal A, et al. Vedolizumab in Indian patients with inflammatory bowel disease: final results from a prospective, multicenter, open-label, phase 4 study. J Clin Exp Gastroenterol. 2026;5(1):7–14.


Copyright: © 2026 Kabrawala M, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Abstract

Background: There is limited data on the effectiveness and safety of vedolizumab for Indian patients, making this study the first focused evaluation of its use in this population.

Methods: This prospective, multicenter, open-label phase IV study enrolled patients aged 18–65 with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), who received vedolizumab 300 mg IV at weeks 0, 2, and 6 (induction) and at weeks 14, 22, 30, 38, and 46 (maintenance). The primary objective was safety; the secondary, effectiveness. Descriptive statistics were used to summarize demographic, baseline disease characteristics, prior/concomitant medications, and treatment outcomes.

Results: A total of 150 patients were enrolled (102 with UC; 48 with CD). Adverse Events (AE) affected 83 patients (55.3%), with mild AE in 72 (48%). Treatment related adverse events (TEAE) occurred in 52 (51%) patients with UC and 29 (60.4%) with CD, Serious adverse events (SAE) occurred in 8 (5.3%) patients. Additionally, 3.3% had at least 1 Adverse drug reaction (ADR), and 2.7% had adverse events of special interest (AESI). Reported ADR/AESI cases included one patient each with pulmonary tuberculosis, tuberculous pleurisy, rectal adenocarcinoma, and hypertension. Overall clinical response rates for weeks 14, 30 and 46 were 60.7%, 65.3%, and 72% and remission rates were 42%, 44%, and 53.3% respectively. Mucosal healing was observed in 18% patients at week 46 (23 (22.5%) with UC; 4 (8.3%) with CD). Quality of life scores showed improvements across both UC and CD groups, with increases noted from baseline of 5 at week 14 to 13 at week 46 in both groups.

Conclusion: This study demonstrates that vedolizumab has a good safety and effectiveness profile in Indian patients with moderate-to-severe UC or CD.

Keywords

Vedolizumab, Safety, Effectiveness, Inflammatory Bowel Disease, India, Ulcerative colitis, Crohn's disease

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