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

Dragoni, Gabriele; Bagnoli, Siro; Grazie, Marco Le; Campani, Claudia; Rogai, Francesca; Manetti, Natalia; Bensi, Carolina Games; Macrì, Giuseppe; Galli, Andrea; Milla, Mónica

doi:10.1111/1751-2980.12748

Cited by 14 publications

(19 citation statements)

References 46 publications

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“…Canadian and Hungarian real-world cohorts also showed signi cantly greater clinical remission and response rate for UC compared with CD [31,32]. However, opposite results reported by Gabriele et al, cohort in Italy showed better results for CD patients, with higher clinical response and remission rate compared with UC at 14 weeks (85% and 69% vs. 52% and 30%), 24 weeks (84% and 61% vs. 56% and 26%) and 52 weeks (59% and 45% vs. 25% and 20%) [33]. The difference in clinical response and remission rate could be attributed to quite small sample size and differences in patients baseline characteristics variability: the characteristic of patients involved varied in IBD phenotype, disease severity at vedolizumab initiation, disease duration.…”

Section: Discussionmentioning

confidence: 74%

Efficacy and Safety of Vedolizumab for Pediatrics With Inflammatory Bowel Disease: a Systematic Review

Fang

Song

Wang

2021

Preprint

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Background: Vedolizumab use in pediatrics is still off-label and the data are limited. We conducted a systematic review evaluating the efficacy and safety of vedolizumab in children and adolescents with inflammatory bowel disease (IBD). Methods: PubMed, EMBASE and Cochrane databases were systematically searched for studies of vedolizumab in children and adolescents with IBD reporting clinical remission, response, corticosteroid-free (CS-free) remission, mucosal healing, or safety up to November 21 2020. Results: 7 studies, comprising 238 patients were included. For CD, the pooled clinical remission rates were 25% (19/75) at 6 weeks, 28% (19/67) at 14 weeks, 32% (17/53) at 22 weeks, and 25% (1/4) at 1 year. For UC/IBD-U, the pooled clinical remission rates were 36% (25/70) at 6 weeks, 52% (32/61) at 14 weeks, 53% (24/45) at 22 weeks, and 60% (6/10) at 1 year. Mucosal healing was found in 17%-39% of CD and 15%-34% of UC/IBD-U respectively. Six percent of patients reported serious adverse events.Conclusions: According to low-quality evidence based on case series, approximately one-third and one-half of patients for CD and UC/IBD-U respectively achieved remission within 22 weeks. Long-term benefit profile data and high quality evidence are still needed.

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Section: Discussionmentioning

confidence: 74%

Efficacy and Safety of Vedolizumab for Pediatrics With Inflammatory Bowel Disease: a Systematic Review

Fang

Song

Wang

2021

Preprint

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“…Those rates are substantially higher than in the regulatory GEMINI 1 trial [7]. In other real-world studies, remission rates vary widely between 20 and 82.5% [15][16][17][18][19][20][21][22][23][24]. Differences in the characteristics of study populations and/or definitions of outcomes may underlie these discrepancies.…”

Section: Discussionmentioning

confidence: 90%

“…Differences in the characteristics of study populations and/or definitions of outcomes may underlie these discrepancies. Indeed, the lowest rates were reported in studies with the smallest numbers of patients, which may have skewed results toward worse outcomes [17,18,20]. Enrichment with patients reporting multiple anti-TNF failures may be another reason.…”

Section: Discussionmentioning

confidence: 99%

Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort

et al. 2021

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Background Optimization of treatment with biologics is currently an unmet need for patients with ulcerative colitis (UC). Real-world studies provide neutral estimates of drug efficacy and safety within unselected patient populations and allow for the recognition of specific characteristics that affect response to therapy. Aims We aimed to depict the efficacy of vedolizumab in patients with UC in a real-world setting and identify prognosticators of improved outcomes. Methods Patients with active UC who commenced treatment with vedolizumab were prospectively followed up. Patient-reported outcomes (PROs) and clinical/endoscopic-reported outcomes were recorded at baseline and at weeks 14 and 54. Predefined endpoints of early and persistent efficacy were analyzed against clinical characteristics to identify prognostic factors for response. Results We included 96 patients (anti-TNF-exposed = 38.5%). At week 14, 73 patients (76%) had clinical response and 54 (56.3%) clinical remission. At week 54, the primary endpoint of vedolizumab persistence was met by 72 patients (75%), whereas steroid-free clinical remission by 59.4%. Among patients who had endoscopy, rates for mucosal healing (Mayo endoscopic score of 0) were 29.8% at week 14 and 44.6% at week 54, respectively. Vedolizumab treatment led to significant improvements in quality of life. Corticosteroid-refractory or anti-TNF-refractory disease, articular manifestations, and high baseline UC-PRO2 were associated with decreased efficacy of vedolizumab in the primary and secondary outcomes. Conclusions Vedolizumab is characterized by high efficacy and long-term treatment persistence in UC. More aggressive disease, as indicated by refractoriness to steroids or anti-TNFs and elevated baseline PROs, may predict suboptimal response and help pre-treatment prognostic stratification of patients. Supplementary Information The online version contains supplementary material available at 10.1007/s10620-021-06907-5.

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“…38 Although a cardiac death has been reported in a 66-year-old male 14 days after the first induction dose of vedolizumab (an integrin receptor antagonist currently used to treat UC), it should be emphasised that this patient had a 2-year history of chronic ischaemic heart disease, 39 making unlikely that this drug exerted a toxic effect. In this line, the safety of vedolizumab has been well documented both in naive or in patients previously treated with anti-TNF-α agent, [40][41][42][43] and in studies with a long-term follow-up (up to 5 years). 40 44-47 Based on the data emerged by our case report, the first episode of myocarditis could be attributable to MSZ therapy even though it is not possible to rule out a previously misdiagnosed extra-intestinal manifestation of UC perhaps triggered by MSZ.…”

Section: Discussionmentioning

confidence: 99%

Recurrent myocarditis in a patient with active ulcerative colitis: a case report and review of the literature

Caio

Lungaro

Caputo

et al. 2021

BMJ Open Gastroenterol

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Inflammatory bowel diseases such as ulcerative colitis (UC) may be complicated by several extraintestinal manifestations. These involve joints, skin, eyes and less commonly lungs and heart. Myocarditis may result from the toxic effect of drugs (ie, mesalazine) commonly used for the treatment of UC or due to infections (eg, Coxsackieviruses, enteroviruses, adenovirus). Here, we report a case of a 26-year old man affected by UC and complicated by two episodes of myocarditis. Both episodes occurred during two severe exacerbations of UC. However, in both cases the aetiology of myocarditis remains uncertain being ascribable to extraintestinal manifestation, drug toxicity or both.

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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

Cited by 14 publications

References 46 publications

Efficacy and Safety of Vedolizumab for Pediatrics With Inflammatory Bowel Disease: a Systematic Review

Efficacy and Safety of Vedolizumab for Pediatrics With Inflammatory Bowel Disease: a Systematic Review

Predictors of Response to Vedolizumab in Patients with Ulcerative Colitis: Results from the Greek VEDO-IBD Cohort

Recurrent myocarditis in a patient with active ulcerative colitis: a case report and review of the literature

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