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How do Asian patients with ulcerative colitis choose treatment options? See what the latest real-world research has to say! Ulcerative colitis (UC) is a chronic, relapsing intestinal inflammatory disease of unknown etiology, with persistent or recurrent disease progression [1]
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The incidence of UC in China is on the rise [2], which seriously affects people's health and quality of life
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Among the many treatment options, how to choose a drug with definite curative effect and less adverse reactions is a problem that both clinicians and patients are concerned about
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Traditional treatments such as hormones, immunosuppressants, and biological agents have problems such as many side effects and unresponsiveness
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The anti-integrin drug vedolizumab is a novel gut-selective biological agent, its efficacy and safety have been confirmed by a large number of clinical evidence-based evidence and real-world studies, and it has been increasingly used in clinical practice , which is recommended by the consensus of authoritative guidelines at home and abroad [1,3]
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However, compared with European and American patients, there is relatively little evidence from studies focusing on Asian populations
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Differences in genetic and environmental factors may affect treatment response and complication rates, and data from Asian populations are also important for clinical decision-making [4]
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This article summarizes the recently published real-world research evidence on the application of vedelizumab in Asian UC patients, in order to provide a reference for guiding the clinical practice of UC patients in China
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Inventory of evidence-based evidence for vedolizumab in Asian UC patients The VARSITY post hoc analysis presented at the 2021 European Congress of Crohn's and Colitis Organization (ECCO) included 45 patients with moderate-to-severe disease in Hong Kong, Taiwan, and South Korea In patients with active UC [5], at week 52, the clinical response rate (28.
6% vs.
16.
7%) in patients receiving vedelizumab (n=21) compared with patients receiving adalimumab (n=24) %), histological remission rate (33.
3% vs.
16.
7%), hormone-free remission rate (33.
3% vs.
20.
0%), and endoscopic improvement rate were higher (42.
9% vs.
20.
8%)
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A post hoc analysis of another multicenter, double-blind, randomized, parallel-controlled phase 3 study evaluated the speed of onset of symptomatic response to vedolizumab in Japanese patients with moderate-to-severe UC [6]
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Patients were randomized 2:1 to receive vedolizumab 300 mg intravenously (n=164) and placebo (n=82) at weeks 0, 2, and 6, respectively Stratified by anti-TNF-α treatment
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The results showed rapid improvement of symptoms in the second week of vedolizumab treatment
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At Weeks 2, 6, and 10, the vedolizumab group met the composite endpoint compared with placebo in patients with a baseline stool frequency (SF) subscore ≥2 and a rectal bleeding (RB) subscore ≥1 (SB sub-score ≤ 1 and RB sub-score = 0) were significantly higher, and also in the anti-TNF-α-naïve group
.

Figure 1 Results of symptom improvement in the vedolizumab group compared to the placebo group.
In addition, among patients receiving vedolizumab, patients with SB subscore ≤1 and RB subscore = 0 at week 2 were significantly more Clinical response rate (82.
6% vs.
33.
1%), clinical remission rate (65.
2% vs.
10.
8%), and mucosal healing rate (87.
0% vs.
28.
8) at 10 weeks for overall patients with subscore ≥2 and RB subscore ≥1 %) were significantly higher, also in the anti-TNF-α-naïve group, suggesting that early symptom improvement with its treatment could predict efficacy at 10 weeks
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Real-World Study in Taiwan: Demonstrating Good Efficacy and Safety of Vedelizumab in UC Efficacy and safety of induction therapy with Zizumab [7]
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The study included 37 patients with UC who received and completed induction therapy with vedelizumab from October 2017 to May 2021.
The patients received vedelizumab intravenously at weeks 0, 2, and 6, respectively.
300 mg of induction therapy was injected, followed by dosing every 8 weeks until treatment cessation or the end of the 52-week follow-up, of which 81.
8% were biologics naïve patients
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The results showed that at weeks 8-10, 56.
8%, 32.
4% and 58.
3% of patients who received vedelizumab induction therapy achieved clinical response, clinical remission and endoscopic remission, respectively
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At week 8, 54.
1% of patients could be gradually discontinued
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Subgroup analysis showed that the clinical response rate and endoscopic remission rate after induction therapy were 63.
3% vs.
28.
6% and 62.
5% vs.
50 in the anti-TNF-α-naïve and treatment failure groups, respectively, at weeks 8-10.
%
.

Figure 2.
Efficacy results of vedelizumab treatment only 10.
8% of patients were initially non-responders during the induction phase
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58.
9% of patients relapsed after vedolizumab discontinuation, and the relapse rates within 6 months and 1 year after discontinuation were 42.
1% and 52.
6%, respectively
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In terms of safety, 16.
2% of patients experienced mild adverse events related to vedelizumab treatment, no serious adverse events related to vedalizumab treatment were found, and no patients discontinued due to treatment-related adverse reactions
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In conclusion, this Taiwanese real-world study demonstrated good efficacy and safety of vedelizumab induction therapy in Asian UC patients, especially in anti-TNF-α-naïve patients.

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Conclusion: The disease burden of patients with UC is severe, and the selection of appropriate treatment options is critical
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As vedolizumab is more and more widely used in clinical practice, a number of clinical evidences on Asian populations are also accumulating [5,6]
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The newly published real-world study results in Taiwan, China [7] show that vedolizumab is effective and safe in the treatment of UC patients, and the anti-TNF-α untreated group has better efficacy than the treatment failure group, which is the highest in Asian UC.
Treatment of patients with vedolizumab provides new clinical evidence
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References: [1] Inflammatory Bowel Disease Group, Digestive Disease Branch of Chinese Medical Association.
Chinese Journal of Digestive Medicine.
2021.
41(6):366-378.
[2] Windsor JW, et al.
Curr Gastroenterol Rep.
2019 Jul 23; 21(8):40.
[3]Rubin DT, et al.
Am J Gastroenterol.
2019;114(3):384-413.
[4]Leung WK.
Intest Res 2015;13(3):208e12.
[5 ]Kim JS, et al.
J Crohns Colitis.
2021,15(Supplement_1):S431-S432.
[6]Nagahori M,et al.
Digestion.
2021;102(5):742-752.
[7]Kuo CJ, et al.
J Formos Med Assoc.
2021 Dec 16;S0929-6646(21)00532-5.
Approval number: VV-MEDMAT-60460 Approval date: January 2022 Statement: This content is only for Chinese medical and health professionals, It is intended to provide scientific information, and only to healthcare professionals, for personal study and reference
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If you are not a healthcare professional, please do not participate or spread
.

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