A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study

Lenti, Marco Vincenzo; Levison, Scott; Eliadou, Elena; Willert, Robert P.; Kemp, Karen; Carter, Anna; Stansfield, Catherine; Assadsangabi, Arash; Singh, Salil; Crooks, Benjamin; Tattersall, Suzanne; Fairhurst, Francesca; Kenneth, Catherine; Subramanian, Sreedhar; Probert, Chris; Storey, Daniel; Gregg, Belle; Smith, Paul M.; Liu, Eleanor; Limdi, Jimmy K.; Johnston, Alexander; Hamlin, P. J.; Selinger, Christian P.

doi:10.1016/j.dld.2018.07.007

Cited by 49 publications

(58 citation statements)

References 49 publications

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“…The same results were shown by Kopylov et al with similar rates of response and remission both for CD and UC. 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 .…”

Section: Discussionmentioning

confidence: 90%

“…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: Discussionmentioning

confidence: 90%

“…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: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 90%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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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“…These data did not bear out in remaining real-world cohorts. For example, no differences were noted with any concomitant therapy in Israeli cohorts or the VICTORY or Cross Penine cohorts (3,(17)(18)(19). Regardless of these results, it is important to remember that the appeal of the relative safety for VDZ is decreased with combination therapy with corticosteroids and/or immunomodulators (20), and there also does not appear to be the same risk of immunogenicity or benefit of increased trough levels with concomitant immunomodulators for VDZ (21,22) (Table 2).…”

Section: Concomitant Immunosuppressive Therapymentioning

confidence: 99%

Predicting Response to Vedolizumab in Inflammatory Bowel Disease

Meserve

Dulai

2020

Front. Med.

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Vedolizumab is known to be safe, well-tolerated, and effective. However, as personalization becomes an increasingly important aspect of IBD care and in lieu of guidelines to inform clinicians on positioning of biologics, there is a need to reliably predict response to inform patient preferences and shared decision-making. Recent data from clinical trials and real-world evidence have elucidated predictors of clinical and endoscopic response while providing the framework to establish predictive models. Current models are able to predict that those patients with less severe disease, without prior biologic exposure and who demonstrate early response to VDZ have the highest rates of durable clinical and endoscopic response and remission. When incorporating these models into clinical practice, clinicians will be able to identify those patients who are likely to respond before drug initiation as well as early non-responders and response latency after initiation of vedolizumab. In a shift toward personalization of medicine in IBD, the ability of predictive models for vedolizumab to aid pre-biologic and early management will inform both clinician and patient. Ideally this will provide both a personalized and more cost-effective approach, though further studies in cost-analysis in this framework are needed. Though current models are comprehensive of existing data, future research on microbial and translational biomarkers will be additive and necessary to provide full personalization of treatment.

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“…Almost half of the IBD patients respond to vedolizumab, but more than one-third of them relapse within 12-36 months from the induction phase [13][14][15][16][17][18][19][20][21][22][23]. These findings have boosted intensive research aimed at identifying predictors of response to the drug [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31]. It is now evident that prior exposure to anti-TNF α drugs associates with a reduced induction of clinical and endoscopic remission [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31].…”

Section: Introductionmentioning

confidence: 99%

Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

Scarozza

Marafini

Laudisi

et al. 2020

JCM

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Randomized controlled clinical trials and real-life observations indicate that less than 50% of patients with Crohn’s disease (CD) or ulcerative colitis (UC) respond to vedolizumab, a humanized monoclonal antibody that blocks the α4β7 integrin. Since α4β7-expressing lymphocytes mainly infiltrate the left colon, we assessed whether localization of CD and UC influences vedolizumab-induced remission. One hundred and eighty-one patients (74 CD and 107 UC) receiving vedolizumab in 3 referral centers were retrospectively evaluated for clinical remission at week 14. Demographic and clinical characteristics were compared between remitters and non-responders, and multivariable multinomial analysis was performed to identify predictors of remission. Remission was achieved in 17 CD (23%) and 34 UC (32%) patients, respectively. In CD, localization of the lesions did not influence clinical remission. In UC, the remitters had more frequently a distal/left-sided colitis (21/34, 62%) as compared to the non-responders (9/47, 19%), and extensive colitis was more frequent in the non-responders (38/47, 81%) than in the remitters (13/34, 38%). The multivariable multinomial analysis showed that distal/left-sided colitis was associated with a higher probability of clinical remission while extensive colitis was inversely associated with induction of remission. Data indicate that UC patients with distal or left-sided colitis are more likely to achieve remission than patients with extensive colitis following vedolizumab treatment.

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A real-world, long-term experience on effectiveness and safety of vedolizumab in adult patients with inflammatory bowel disease: The Cross Pennine study

Abstract: Vedolizumab is an effective therapy for inducing and maintaining remission of IBD, with better results for UC, and with a good safety profile.

Cited by 49 publications

References 49 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

Predicting Response to Vedolizumab in Inflammatory Bowel Disease

Extent of Mucosal Inflammation in Ulcerative Colitis Influences the Clinical Remission Induced by Vedolizumab

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