Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Eriksson, Carl; Marsal, Jan; Bergemalm, Daniel; Vigren, Lina; Björk, Jan; Eberhardson, Michael; Karling, Pontus; Söderman, Charlotte; Myrelid, Pär; Cao, Yang; Sjöberg, Daniel; Thörn, Magnus; Karlén, Per; Hertervig, Erik; Strid, Hans; Ludvigsson, Jonas F.; Almér, Sven; Halfvarson, Jonas

doi:10.1080/00365521.2017.1304987

Cited by 107 publications

(97 citation statements)

References 30 publications

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“…To date, limited information on the effectiveness and safety of this drug in clinical practice is available (Table ). Furthermore, the long‐term benefit of vedolizumab in clinical practice is barely known, as there are only three studies that have evaluated the effectiveness of this agent after approximately 1 year follow‐up .…”

Section: Introductionmentioning

confidence: 99%

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Chaparro¹,

Garre²,

Ricart³

et al. 2018

Aliment Pharmacol Ther

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Summary Background Effectiveness of vedolizumab in real world clinical practice is unknown. Aim To evaluate the short and long‐term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD). Methods Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey‐Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short‐term response was assessed at week 14. Variables associated with short‐term remission were identified by logistic regression analysis. The Kaplan‐Meier method was used to evaluate the long‐term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response. Results 521 patients were included (median follow‐up 10 months [interquartile range 5‐18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient‐year of follow‐up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent. Conclusions Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short‐ and long‐term response. Vedolizumab seems to be safe in clinical practice.

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Section: Introductionmentioning

confidence: 99%

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Chaparro¹,

Garre²,

Ricart³

et al. 2018

Aliment Pharmacol Ther

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“…Analyzing the data of 246 patients, the authors found that at the end of follow-up, 54% of Crohn's disease patients and 64% of ulcerative colitis patients were in clinical remission [19]. In comparison, our data show response rates of 60.7% in Crohn's disease patients and 52% in ulcerative colitis patients.…”

Section: Discussionmentioning

confidence: 60%

“…In comparison, our data show response rates of 60.7% in Crohn's disease patients and 52% in ulcerative colitis patients. In the Swedish study, 58% of the patients remained on vedolizumab after a median follow-up of 17 months [19]. In our cohort, after a median follow-up of 30 weeks plus 6.5 months, 54% of Crohn's disease patients remained on vedolizumab; after a median follow-up of 30 weeks plus [20].…”

Section: Discussionmentioning

confidence: 79%

“…Further real-world data on vedolizumab were published by the Swedish National Quality Registry for IBD [19]. Analyzing the data of 246 patients, the authors found that at the end of follow-up, 54% of Crohn's disease patients and 64% of ulcerative colitis patients were in clinical remission [19].…”

Section: Discussionmentioning

confidence: 99%

“…Seven patients discontinued vedolizumab therapy due to lack of response before week 30 (median week 15, range [6][7][8][9][10][11][12][13][14][15][16][17][18][19]. Three of these underwent colectomy (2 at week 6 and 1 at week 15).…”

Section: Secondary Endpoints In Ulcerative Colitismentioning

confidence: 99%

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Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn’s Disease at a Tertiary Referral Center

Hoffmann

Krisam

Stremmel

et al. 2018

Dig Dis

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Background: Vedolizumab was approved for the therapy of ulcerative colitis and Crohn’s disease in mid-2014. Real-world treatment data are necessary for a balanced assessment of its position among other therapeutic options. Summary: Patients with ulcerative colitis or Crohn’s disease, initiating vedolizumab therapy at the outpatient clinic for inflammatory bowel diseases at the University Hospital Heidelberg between June 1, 2014 and August 31, 2016, were recruited based on electronic medical records. The primary study endpoint was response at week 30, while the secondary endpoints were the need for surgery and discontinuation of therapy due to inadequate response, or adverse events. Twenty-five patients with ulcerative colitis (40% anti-tumor necrosis factor α [TNFα] naive) and 28 patients with Crohn’s disease (10.7% anti-TNFα naive, 53.6% having undergone at least one intestinal surgery) were enrolled. Among the ulcerative colitis patients, 20% achieved remission, 32% partial response, and 48% were non-responders to vedolizumab. In Crohn’s disease, 14.3% of the patients achieved remission, 46.4% partial response, and 39.4% were non-responders. Two patients discontinued vedolizumab therapy due to suspected side effects. Key Message: In a relatively treatment-refractory cohort of inflammatory bowel disease patients, vedolizumab was efficacious in achieving response. However, the majority of the patients were not satisfactorily treated, as they did not reach remission.

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Vedolizumab for induction and maintenance of remission in Crohn's disease

Hui

Sinopoulou

Gordon

et al. 2023

Cochrane Database of Systematic Reviews

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Background Vedolizumab blocks inflammatory activity within the gastrointestinal tract. Systematic reviews have demonstrated the efficacy of vedolizumab in ulcerative colitis and inflammatory bowel disease in general. This systematic review and meta‐analysis summarises the current evidence of vedolizumab in the induction and maintenance of remission in Crohn's disease. Objectives To evaluate the benefits and harms of vedolizumab versus placebo for the induction and maintenance of remission in people with Crohn's disease. Search methods We used standard, extensive Cochrane search methods. The latest search date was 30 November 2022. Selection criteria We included randomised controlled trials (RCTs) and quasi‐RCTs comparing vedolizumab to placebo for the induction or maintenance of remission in people with Crohn's disease. Data collection and analysis We used standard Cochrane methods. For induction studies, the primary outcome was 1. clinical remission, and secondary outcomes were rates of 2. clinical response, 3. adverse events, 4. serious adverse events, 5. surgery, 6. endoscopic remission and 7. endoscopic response. For maintenance studies, the primary outcome was 1. maintenance of clinical remission, and secondary outcomes were rates of 2. adverse events, 3. serious adverse events, 4. surgery, 5. endoscopic remission and 6. endoscopic response. We used GRADE to assess certainty of evidence. Main results We analysed induction (4 trials, 1126 participants) and maintenance (3 trials, 894 participants) studies representing people across North America, Europe, Asia and Australasia separately. One maintenance trial administered subcutaneous vedolizumab whilst the other studies used the intravenous form. The mean age ranged between 32.6 and 38.6 years. Vedolizumab was superior to placebo for the induction of clinical remission (71 more per 1000 with clinical remission with vedolizumab; risk ratio (RR) 1.61, 95% confidence interval (CI) 1.20 to 2.17; number needed to treat for an additional beneficial outcome (NNTB) 13; 4 studies; high‐certainty evidence) and superior to placebo for inducing clinical response (105 more per 1000 with clinical response with vedolizumab; RR 1.43, 95% CI 1.19 to 1.71; NNTB 8; 4 studies; high‐certainty evidence). For the induction phase, vedolizumab may be equivalent to placebo for the development of serious adverse events (9 fewer serious adverse events per 1000 with vedolizumab; RR 0.91, 95% CI 0.62 to 1.33; 4 studies; low‐certainty evidence) and probably equivalent to placebo for overall adverse events (6 fewer adverse events per 1000 with vedolizumab; RR 1.01, 95% CI 0.93 to 1.11; 4 studies; moderate‐certainty evidence). Vedolizumab was superior to placebo for the maintenance of clinical remission (141 more per 1000 with maintenance of clinical remission with vedolizumab; RR 1.52, 95...

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Long-term effectiveness of vedolizumab in inflammatory bowel disease: a national study based on the Swedish National Quality Registry for Inflammatory Bowel Disease (SWIBREG)

Abstract: Vedolizumab-treated patients represent a treatment-refractory group. A long-term effect can be achieved, even beyond 1 year of treatment.

Cited by 107 publications

References 30 publications

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Short and long‐term effectiveness and safety of vedolizumab in inflammatory bowel disease: results from the ENEIDA registry

Real-World Outcomes of Vedolizumab Therapy in Ulcerative Colitis and Crohn’s Disease at a Tertiary Referral Center

Vedolizumab for induction and maintenance of remission in Crohn's disease

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