Low Rate of Drug Discontinuation, Frequent Need for Dose Adjustment, and No Association with Development of New Arthralgia in Patients Treated with Vedolizumab: Results from a Tertiary Referral IBD Center

Reinglas, Jason; Gönczi, Lóránt; Verdon, Christine; Bessissow, Talat; Afif, Waqqas; Wild, Gary; Seidman, Ernest G.; Bitton, Alain; Lakatos, László

doi:10.1007/s10620-019-05982-z

“…Over the last four years, several real‐world experiences on VDZ in inflammatory bowel disease (IBD) were published 8–27 . Overall, all of these studies confirmed the efficacy and safety demonstrated by VDZ in clinical trials, even if the majority of the patients enrolled had at least one previous failure to anti‐TNFs, while the proportion of patients who were naïve to biologicals was low.…”

Section: Introductionmentioning

confidence: 82%

Effectiveness and safety of vedolizumab in biologically naïve patients: A real‐world multi‐centre study

Macaluso

¹

,

Fries

²

,

Renna

³

et al. 2020

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Background Biologically naïve patients with inflammatory bowel disease treated with vedolizumab (VDZ) are largely underrepresented in real-world cohorts. A multi-centre, observational cohort study was performed on the effectiveness and safety of VDZ in biologically naïve subjects with Crohn’s disease (CD) and ulcerative colitis (UC). Methods Data of consecutive biologically naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease. Results A total of 172 consecutive patients (CD: N = 88; UC: N = 84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. Conclusions This study demonstrates the effectiveness and safety of VDZ as a first-line biological, particularly among elderly patients.

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“…Rates of endoscopic remission (absence of ulcers/erosions and SES-CD scores of < 4) were reported in seven studies [52][53][54][55][56][57][58]. Rates of endoscopic remission in vedolizumabtreated patients were 15%-33% at/within 6 months (two studies [54,57,58]) and 27%-38% at or within 12 months (four studies [53,[56][57][58]), with two studies contributing cumulative data over 6 months [54] and 6-12 months [58], respectively.…”

Section: Statistical Analysesmentioning

confidence: 99%

“…Rates of endoscopic remission (absence of ulcers/erosions and SES-CD scores of < 4) were reported in seven studies [52][53][54][55][56][57][58]. Rates of endoscopic remission in vedolizumabtreated patients were 15%-33% at/within 6 months (two studies [54,57,58]) and 27%-38% at or within 12 months (four studies [53,[56][57][58]), with two studies contributing cumulative data over 6 months [54] and 6-12 months [58], respectively. The first of these [54] reported a significantly higher 3 GastroHep cumulative rate of endoscopic remission with early-versus late-stage CD at 6 months: 29% (n = 62) in patients with a disease duration of ≤ 2 years, versus 13% (n = 588) for disease duration of > 2 years.…”

Section: Statistical Analysesmentioning

confidence: 99%

“…anti-TNF: antitumour necrosis factor; GI: gastrointestinal; SES-CD: Simple Endoscopic Score for Crohn's Disease. † Four studies (Kotze et al[39]; Ylisaukko-Oja et al[46]; Perin et al[42]; Reinglas et al[58]) reported mean age and standard deviation. ‡ Three studies (Kotze et al[39]; Amiot et al[70]; Wang et al[71]) reported mean age at diagnosis and standard deviation.…”

mentioning

confidence: 99%

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

Danese

¹

,

Kamble

²

,

Yang

³

et al. 2022

GastroHep

1

0

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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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“…In this issue of Digestive Diseases and Sciences, Reinglas et al [10] seek to add to the growing body of real-world data addressing VDZ treatment of IBD patients. In their single-center retrospective study evaluating 130 patients (75 CD, 55 UC), the median duration of VDZ therapy was 65 weeks.…”

mentioning

confidence: 99%

Vedolizumab (VDZ) for UC and CD: Still Safe and Effective After All These Years

Bach

¹

,

Taleban

²

2020

Dig Dis Sci

1

0

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Low Rate of Drug Discontinuation, Frequent Need for Dose Adjustment, and No Association with Development of New Arthralgia in Patients Treated with Vedolizumab: Results from a Tertiary Referral IBD Center

Cited by 11 publications

References 31 publications

Effectiveness and safety of vedolizumab in biologically naïve patients: A real‐world multi‐centre study

Effectiveness and safety of vedolizumab in biologically naïve patients: A real‐world multi‐centre study

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

Vedolizumab (VDZ) for UC and CD: Still Safe and Effective After All These Years

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