Real‐world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

Kotze, Paulo Gustavo; Ma, Christopher; Almutairdi, Abdulelah; Al-Darmaki, Ahmed; Devlin, Shane; Kaplan, Gilaad G.; Seow, Cynthia H.; Novak, Kerri L.; Lu, Cathy; Ferraz, José G.; Stewart, Michael J.; Buresi, Michelle; Jijon, Humberto; Mathivanan, M; Heatherington, Joan; Martin, M; Panaccione, Remo

doi:10.1111/apt.14919

Cited by 50 publications

(57 citation statements)

References 33 publications

(43 reference statements)

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“…Other authors found no difference in CD and UC cohorts after the induction phase, while in one study a higher clinical benefit in patients with UC was seen, with a cumulative clinical remission plus response rate after 14 weeks of 91.2% in UC and 78.5% in CD ( P = 0.02). Again, at 52 weeks the trend of the response in our study was favorable to CD patients despite a lack of statistical significance; in other real‐life studies, the two groups were comparable or there were higher response rates in UC . In addition, despite the better clinical results in CD, our endoscopic remissions at 52 weeks (15% UC and 27% CD) were very low compared with the other available data (41% of UC and 63% of CD in the VICTORY studies and 25.9% of CD and 47.8% of UC patients in a large Canadian cohort).…”

Section: Discussioncontrasting

confidence: 82%

“…Again, at 52 weeks the trend of the response in our study was favorable to CD patients despite a lack of statistical significance; in other real‐life studies, the two groups were comparable or there were higher response rates in UC . In addition, despite the better clinical results in CD, our endoscopic remissions at 52 weeks (15% UC and 27% CD) were very low compared with the other available data (41% of UC and 63% of CD in the VICTORY studies and 25.9% of CD and 47.8% of UC patients in a large Canadian cohort). A possible explanation for these findings may be the high percentage of patients with severe disease and patients with anti‐TNF experience at baseline in our cohort.…”

Section: Discussioncontrasting

confidence: 82%

“…Our Kaplan‐Meier survival analysis reported lower response rates at 1 and 2 years than Kotze et al (56% vs 70% at 52 weeks, 30% vs 53.2% at 104 wks), showing that the trend of sustained remission in patients with initial response is not to be expected in all clinical scenarios. In this regard, the perfect timing for defining a primary response or non‐response to VDZ is currently unknown, as its effect may be slower than what is common in an anti‐TNF response .…”

Section: Discussioncontrasting

confidence: 74%

“…Real‐world data on VDZ effectiveness and tolerability have started to accumulate in the last 2 years. Our single‐center data collection is the third evaluation after that of Kotze et al and the VICTORY Consortium studies to analyze both a long‐term follow‐up of at least 1 year and routine endoscopic assessment.…”

Section: Discussionmentioning

confidence: 99%

“…Considering the highly selective character of trial enrollment, it is always fundamental to observe whether real‐life settings support the initially reported results of a new drug . Real‐world publications on this field are accumulating, with some conflicting results, but only a few of them include long‐term evaluation at 1 year with endoscopic assessment . Therefore, we presented an Italian single‐center study on VDZ long‐standing effectiveness and tolerability in patients with UC and CD at a tertiary referral setting.…”

Section: Introductionmentioning

confidence: 99%

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Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Dragoni

Bagnoli

Grazie

et al. 2019

J of Digest Diseases

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Objective: The study aimed to evaluate the long-term efficacy and safety of vedolizumab in a real-life cohort of patients with inflammatory bowel diseases enrolled at a tertiary referral center.The primary outcomes were clinical response and remission at 14, 24, and 52 weeks, and steroid-free remission rate (SFRR) at 52 weeks. Endoscopic response and remission rates at 52 weeks were the secondary outcomes. Results: Altogether 49 patients (22 with ulcerating colitis [UC] and 27 with Crohn'sDisease [CD]) were enrolled. The clinical response rate gradually dropped from 85% and 50% in CD and UC, respectively, at week 14 to 59% and 25% at week 52, with significantly a higher response in CD at week 14. The endoscopic response at week 52 was 55% in CD and 25% in UC (P = 0.21). CD group had a higher SFRR than UC group (41% vs 20%) at 52 weeks, although the difference was not statistically significant. Similar clinical and endoscopic rates were observed in biologic-naive and -experienced patients. We reported no discontinuation due to adverse drug reactions, and only mild to moderate events.Conclusions: In our cohort the clinical response in the induction phase was similar to those of registered trials, despite surprising better results for CD. During the maintenance phase we observed an higher drop out than in the reported literatures. Of note, its good safety profile makes vedolizumab a reliable choice in patients with contraindications to anti-tumor necrosis factor agents. K E Y W O R D Sadverse event, anti-integrin, endoscopic remission, inflammatory bowel diseases, maintenance, swap therapy

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Section: Discussioncontrasting

confidence: 82%

Section: Discussioncontrasting

confidence: 82%

Section: Discussioncontrasting

confidence: 74%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Dragoni

Bagnoli

Grazie

et al. 2019

J of Digest Diseases

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Standard and modified vedolizumab dosing is effective in achieving clinical and endoscopic remission in moderate‐severe Crohn’s disease

2021

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Background/Aims Vedolizumab is effective for moderate‐severe Crohn's disease. Dose optimisation may improve outcomes. We evaluated the safety and effectiveness of standard and modified maintenance vedolizumab dosing in patients with Crohn's disease. Methods We retrospectively assessed clinical, laboratory and endoscopic endpoints prior to and following standard vedolizumab dosing. In non‐remitters to standard dosing who received modified vedolizumab maintenance dosing, we assessed disease measures prior to and following modified dosing. We documented adverse events. Results We identified 226 eligible patients, mean age 41.5 years, 55.3% female, median disease duration 10 years and 88.9% with prior biologic exposure. Mean treatment duration was 28.0 months. After standard dosing, 61.7% and 41.7% of patients achieved clinical response and remission respectively. In 50.0%, C. reactive protein (CRP) normalised. Respectively, 52.9%, 42.3% and 26.0% achieved endoscopic improvement, endoscopic remission and endoscopic healing. Seventy non‐remitters to standard dosing received 300 mg IV every 4 or 6 weeks. After modified dosing, 50.0% and 44.1% achieved clinical response and remission respectively. In 52.6%, CRP normalised. Of patients with Simple Endoscopic Score ≥3 prior to dose modification, 27.8% achieved endoscopic improvement and 22.2% achieved endoscopic healing. About 60.6% of patients reported ≥1 adverse event, most commonly infection and worsening bowel symptoms. No new safety signals observed. Conclusions Standard vedolizumab dosing resulted in clinical and endoscopic improvement in Crohn's disease patients with a significant inflammatory burden and prior failure of multiple advanced therapies. For non‐remitters to standard dosing, modified maintenance dosing improved clinical disease activity in 50% and endoscopic disease activity in greater than 20% of patients.

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Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events

Lie

Paulides

Woude

2020

Int J Colorectal Dis

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Purpose Biological therapies are currently the mainstay in the treatment of patients with inflammatory bowel diseases (IBD). Several factors are known to influence the efficacy and tolerability of biologicals, such as CRP levels or previous biological use. Whether patient sex affects the efficacy or tolerability is unclear but would help with better risk and benefit stratification. This systematic review assesses patient sex on the efficacy and tolerability of biological therapies in IBD patients. Methods A systematic literature review was performed using Embase (including MEDLINE), MEDLINE OvidSP, Cochrane Central Register of Controlled Trials, Web of Science and PubMed. The primary outcome was the influence of patient sex on endoscopic outcomes in IBD patients treated with biologicals. The secondary outcome was the influence of patient sex on adverse events. Studies were included in the assessment regardless of study type or setting. Results The search yielded 19,461 citations; after review, 55 studies were included in the study, involving 28,465 patients treated with adalimumab, certolizumab pegol, infliximab, or vedolizumab. There was no significant association between patient sex and endoscopic efficacy in 41 relevant studies. Increased adverse events were associated with female sex in 7 out of 14 relevant studies. Conclusions There is no evidence for a sex difference in endoscopically measured response to biological therapies in IBD patients. However, there is an influence of sex on the occurrence of adverse events.

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Real‐world clinical, endoscopic and radiographic efficacy of vedolizumab for the treatment of inflammatory bowel disease

Abstract: Vedolizumab was effective for induction and maintenance of clinical and objective remission, both in Crohn's disease and ulcerative colitis.

Cited by 50 publications

References 33 publications

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Long‐term efficacy and safety of vedolizumab in patients with inflammatory bowel diseases: A real‐life experience from a tertiary referral center

Standard and modified vedolizumab dosing is effective in achieving clinical and endoscopic remission in moderate‐severe Crohn’s disease

Patient sex does not affect endoscopic outcomes of biologicals in inflammatory bowel disease but is associated with adverse events

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