Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Samaan, Mark A; Pavlidis, Polychronis; Johnston, Emma L.; Warner, Ben; Digby-Bell, Jonathan; Koumoutsos, Ioannis; Fong, Steven; Goldberg, Rimma; Patel, Kamal; Gulati, Shraddha; Medcalf, Lucy; Sastrillo, M; Brown-Clarke, C; Bidewell-Sullivan, Johanna; Forsyth, Katrina; Lee, Emma; Stanton, Anna; Duncan, Julie; Carrault, Guy; Dubois, P; Powell, Nick; Anderson, Simon; Sanderson, Jeremy; Hayee, Bu’Hussain; Irving, Peter M

doi:10.1136/flgastro-2016-100720

Cited by 44 publications

(42 citation statements)

References 24 publications

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“…Our own previously reported experience of vedolizumab for UC demonstrated similar effectiveness to those described here for golimumab (response rates of 55% and 52%, respectively and remission rates of 39% and 34%, respectively) 47. With NICE-approval of vedolizumab coming at a similar time to the approval of anti-TNF agents, clinicians now have a broader range of treatments for UC than ever before.…”

Section: Discussionsupporting

confidence: 73%

Golimumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Samaan

Pavlidis

Digby-Bell

et al. 2017

Frontline Gastroenterol

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Section: Discussionsupporting

confidence: 73%

Golimumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Samaan

Pavlidis

Digby-Bell

et al. 2017

Frontline Gastroenterol

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“…In patients ≥60 years, 28 (64%) had a clinical response at week 14. Of these, 21 (48%) were in clinical remission (Table 3), a higher rate than those reported in the majority of observational studies from age-unstratified populations [19][20][21]23,24,29,30] ( Fig. 1A,B).…”

Section: Clinical Effectivenessmentioning

confidence: 73%

“…Clinical and safety outcomes have been corroborated in observational studies of "real-world" practice [4,17,[19][20][21][22][23][24][25]. The gut-selective mechanism of action of vedolizumab is an especially attractive property in high-risk groups such as those with advanced age, or a history of malignancy or immunosuppression.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience

Ibraheim

Samaan

Srinivasan

et al. 2020

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Background The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort. Methods A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age. Results Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn's disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts. Conclusion Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age.

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“…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%

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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Vedolizumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Abstract: Our early experience with vedolizumab demonstrates a clear benefit in terms of disease control as well as a steroid-sparing effect in a cohort, which included patients with complex and previously refractory disease.

Cited by 44 publications

References 24 publications

Golimumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Golimumab: early experience and medium-term outcomes from two UK tertiary IBD centres

Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience

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

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