P1048 Vedolizumab in Indian patients with Inflammatory Bowel Disease: Final results from a prospective, multicentre, open-label, phase 4 study
Authors: Kabrawala M , Banerjee R , Ahuja V , Anumula K , Bhardwaj V , Dalal A , Ramesh Kumar B , Mukewar S , Sood A , Mohan Prasad V G , Arora S , Bahuguna G 
Published: January 2025

Abstract

Background
India has rising prevalence of Inflammatory Bowel Disease (IBD), with an estimated 1.4 million cases reported in 2010.¹ Vedolizumab (VDZ) has demonstrated safety and effectiveness internationally as an alternative for achieving clinical response and remission. 2,3 There is limited data on VDZ’s efficacy and safety for Indian patients. This study provides the first focused evaluation of VDZ in this population.

Methods
In this prospective, multicenter, open-label phase IV study (NCT04804540), patients aged 18–65 with moderate to severe ulcerative colitis (UC) or Crohn’s disease (CD) unresponsive to corticosteroids, immunomodulators or anti-TNF agents received VDZ 300 mg intravenously at weeks 0, 2, and 6 (induction) and at weeks 14, 22, 30, 38, and 46 (maintenance).
Patients had diagnosis of moderate to severe active UC or CD with a Full Mayo Score of 6-12 for UC and Harvey Bradshaw Index (HBI) of ≥8 for CD at the time of enrollment. Clinical remission was defined as Simple Clinical Colitis Activity (SCCAI) ≤2 for UC or HBI ≤4 for CD, while clinical response was defined as an SCCAI decrease of ≥3 or physician assessed response for UC and HBI decrease of ≥3 for CD.
The primary objective analyzed the safety of VDZ in Indian UC or CD patients, with a secondary objective of assessing efficacy. The final analysis included data up to Week 46 or patient discontinuation.

Results
Of 215 patients screened, 150 were enrolled (102 with UC: median age 39 years; 48 with CD: median age 31 years). The median treatment duration was 325 days for UC and 323 for CD. AEs affected 83 patients (55.3%), with mild AEs in 72 (48%). TEAEs occurred in 52 (51%) patients with UC and 29 (60.4%) with CD, while SAEs occurred in 8 (5.3%) patients, with 2 treatment- related. Additionally, 5 patients (3.3%) had at least 1 ADR, and 4 (2.7%) had AESI. Reported ADR/AESI cases included one patient each with pulmonary tuberculosis, tuberculous pleurisy, rectal adenocarcinoma, and hypertension. Anaemia was most common TEAE, and small intestinal obstruction was most frequent SAE. No AE related deaths occurred(Table 1). Overall clinical response rates were 60.7% at Week 14, 65.3% at Week 30, and 72% at Week 46. Remission rates were 42% at Week 14, 44% at Week 30, and 53.3% at Week 46(Fig 1). Mucosal healing was observed in 27/150 (18%) patients at week 46. Quality of life scores showed improvements across both UC and CD groups, with median Short Inflammatory Bowel Disease Questionnaire score 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 profile in Indian patients with moderate-to-severe UC and CD, offering well-tolerated option for achieving clinical response and remission.

References
1.Singh P, Ananthakrishnan A, Ahuja V. Pivot to Asia: inflammatory bowel disease burden. Intest Res. 2017 Jan;15(1):138-141. doi: 10.5217/ir.2017.15.1.138
2.Ooi CJ, Hilmi IN, Kim HJ, et al. Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study. Intest Res. 2021;19(1):71-82. doi:10.5217/ir.2019.09159.
3.Singh H, Grewal N, Arora E, Kumar H, Kakkar AK. Vedolizumab: A novel anti-integrin drug for treatment of inflammatory bowel disease. J Nat Sci Biol Med. 2016;7(1):4-9. doi:10.4103/0976-9668.175016.