Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Bressler, Brian; Yarur, Andrés; Silverberg, Mark S.; Bassel, Marielle; Bellaguarda, Emanuelle; Fourment, Chris; Gatopoulou, Anthia; Karatzas, Pantelis; Kopylov, Uri; Michalopoulos, George; Michopoulos, Spyridon; Navaneethan, Udayakumar; Rubin, David T.; Siffledeen, Jesse; Singh, Andrew; Soufleris, Konstantinos; Stein, Dara; Demuth, Dirk; Mantzaris, Gerassimos J.

doi:10.1093/ecco-jcc/jjab058

Cited by 74 publications

(52 citation statements)

References 19 publications

(24 reference statements)

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“… 23 Several studies have assessed endoscopic remission with VDZ; however, the timing of colonoscopic evaluation and remission rate (30–60%) varied among the studies. 24 , 25 , 26 , 27 In our study, the endoscopic remission rate at week 24 was 60.0% (21/35), similar to a previous report evaluating real‐world outcomes. 27 We observed that the cumulative VDZ administration continuation rate was significantly higher in patients who achieved endoscopic remission, and most of the patients in the non‐endoscopic remission group withdrew VDZ within the observation period.…”

Section: Discussionsupporting

confidence: 90%

“…Narula et al reported that achievement of MES of ≤1 was noted in 29% and 62% patients at week 24 and week 48, respectively, in the VICTORY study 23 . Several studies have assessed endoscopic remission with VDZ; however, the timing of colonoscopic evaluation and remission rate (30–60%) varied among the studies 24–27 . In our study, the endoscopic remission rate at week 24 was 60.0% (21/35), similar to a previous report evaluating real‐world outcomes 27 .…”

Section: Discussionsupporting

confidence: 88%

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Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

et al. 2021

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Background and Aim Vedolizumab is a humanized monoclonal antibody that selectively inhibits the migration of gut‐homing memory T cells into the intestinal submucosa by antagonizing the interaction of α 4 β 7 integrin with MAdCAM‐1. Vedolizumab is employed for ulcerative colitis with moderate to severe activity; however, predictors of its clinical efficacy have not been established in real‐world clinical practice. We investigated the clinical characteristics predicting vedolizumab efficacy. Methods This was a single‐center, retrospective, observational study that enrolled patients with ulcerative colitis at Kyorin University Hospital. Fifty‐two consecutive patients who started vedolizumab induction therapy and were tracked for minimum 14 weeks between August 2018 and February 2021 were included. Clinical and endoscopic disease activities were scored at baseline and at weeks 2, 6, and 14 with the Lichtiger index and at baseline and week 24 with the Mayo endoscopic subscore, respectively. Clinical remission, clinical response, and endoscopic remission were defined as Lichtiger index of ≤3, Lichtiger index of ≤10 with a reduction of minimum 3 points from baseline, and Mayo endoscopic subscore of ≤1, respectively. Results In these cases, clinical response/remission rates at weeks 2, 6, and 14 were 26.9%/15.3%, 50.0%/46.3%, and 57.6%/50.0%, respectively. The endoscopic remission rate at week 24 was 60%. The clinical response at week 6 was significantly associated with endoscopic remission at week 24 after starting vedolizumab. Conclusions In vedolizumab treatment for ulcerative colitis, the clinical response at week 6 can be a predictor for endoscopic remission at week 24.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 88%

Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

et al. 2021

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“…Considering vedolizumab treatment relative to other biologic treatments for CD, data from the EVOLVE study demonstrated comparable real-world MH rates in biologicnaïve patients with moderate to severe CD treated with vedolizumab or anti-TNF agents [28,61]. Cumulative MH rates at 12 months (62.5% vs. 59.7%, respectively) and over 24 months (100.0% vs. 90.1%, respectively) included in this SLR were comparable between vedolizumab-treated and anti-TNF-treated patients [28].…”

Section: Discussionmentioning

confidence: 99%

Systematic Literature Review and Meta-analysis: Real-World Mucosal Healing in Vedolizumab-Treated Patients with Crohn’s Disease

et al. 2022

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Background. Vedolizumab is a gut-selective monoclonal anti-α4β7-integrin antibody approved for the treatment of adults with moderately to severely active Crohn’s disease (CD). Aim. To conduct a systematic literature review and meta-analysis of published real-world studies examining mucosal healing (MH) rates in patients with CD treated with vedolizumab in routine clinical practice. Methods. MEDLINE-, Cochrane-, and EMBASE-indexed publications from January 2014 to January 2020 and 2018-2019 conference abstracts were searched for real-world studies reporting MH-related outcomes in vedolizumab-treated adults with CD. A meta-analysis was conducted in R to generate pooled estimates of MH. The primary analysis included studies reporting point estimates of MH/endoscopic remission as absence of ulcers/erosions and/or Simple Endoscopic Score for CD (SES-CD) cut − points < 4 , at 6 and 12 months. Results. The systematic literature review included 36 studies, predominantly of antitumour necrosis factor-experienced patients. MH and endoscopic remission were the most frequently reported endpoints. MH rates were 10.1%-46.0% at 6 months (ten studies) and 21.2%-62.5% at 12 months (eight studies). Fifteen studies defining MH as absence of ulcers/erosions and/or SES-CD cut − points < 4 were included for meta-analysis. Pooled MH rates for the primary analysis were 31.8% at 6 months (95% confidence interval (CI): 25.6-38.3; five studies, N = 223 ) and 33.4% at 12 months (95% CI: 25.9-41.4; three studies, N = 151 ). Conclusion. Approximately one-third of vedolizumab-treated patients with CD achieved MH at both 6 and 12 months in real-world clinical settings, despite utilisation in largely biologic-refractory patients. These findings confirm the effectiveness of vedolizumab for achieving MH in patients with CD.

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“…Real-world evidence from the West has suggested that early initiation of vedolizumab may offer additional outcomes benefits. 29 , 30 Unfortunately, local data in Asia for this category of patients remain limited. Further effort should be invested to examine the potential benefits of vedolizumab among anti-TNF-naïve patients in Korea and Asia.…”

Section: Discussionmentioning

confidence: 99%

The real-world outcomes of vedolizumab in patients with ulcerative colitis in Korea: a multicenter retrospective study

Cheon

Song³

et al. 2021

Therap Adv Gastroenterol

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Aim: This study examined the real-world effectiveness and safety outcomes of vedolizumab in ulcerative colitis (UC) patients who had failed anti-tumor necrosis factor (anti-TNF) therapy in Korea. Methods: A retrospective chart review study was conducted in adults with moderate to severely active UC who had failed anti-TNF agents and subsequently received vedolizumab. Clinical response and clinical remission at week 6 and 14 after vedolizumab initiation was evaluated. Safety outcomes were also reported. Outcome rates were compared with a matched sub-cohort derived from the open-label sub-cohort of the GEMINI 1 trial using the optimal matching method. Results: A total of 105 patients (mean age, 45.3 years; 63.8% male) were included. At week 6, 55.8% ( n = 43/77) achieved a clinical response and 18.2% ( n = 14/77) achieved clinical remission. At week 14, 73.2% ( n = 52/71) achieved a clinical response and 39.4% ( n = 28/71) achieved clinical remission. When non-response imputation was used, the clinical response rate at week 6 and week 14 were 40.1% ( n = 43/105) and 49.5% ( n = 52/105) respectively. Of the 105 patients, 16 (15.2%) experienced at least one adverse event. The matched analysis showed that the clinical response rate at week 6 was higher in the matched sub-cohort of this study (24/47, 51.1%) versus the matched sub-cohort from the GEMINI 1 open-label cohort (12/47, 34.3%, p = 0.019). The clinical remission rates at week 6 were similar (7/47, 14.9% versus 9/47, 19.1%, p = 0.785). Conclusions: In the real-world setting, vedolizumab is effective and well tolerated within the first 14 weeks of use in Korea. The proportion of patients experiencing clinical response and clinical remission at 6 and 14 weeks appeared to be largely consistent with that observed in real-world studies from other regions and populations.

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Vedolizumab and Anti-Tumour Necrosis Factor α Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study

Cited by 74 publications

References 19 publications

Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

Clinical response of vedolizumab at week 6 predicted endoscopic remission at week 24 in ulcerative colitis

Systematic Literature Review and Meta-analysis: Real-World Mucosal Healing in Vedolizumab-Treated Patients with Crohn’s Disease

The real-world outcomes of vedolizumab in patients with ulcerative colitis in Korea: a multicenter retrospective study

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