37 research outputs found

    Vedolizumab in paediatric Inflammatory Bowel Disease: A retrospective multi-centre experience From the paediatric IBD Porto Group of ESPGHAN

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    Background Vedolizumab, an anti-integrin antibody, has proven to be effective in adults with Inflammatory Bowel Disease (IBD), but the data in pediatrics are limited. We describe the short-term effectiveness and safety of vedolizumab in a European multi-center pediatric IBD cohort. Method Retrospective review of children (2-18 years) treated with vedolizumab from 19 centers affiliated with the Paediatric IBD Porto group of ESPGHAN. Primary outcome was week 14 corticosteroid-free remission (CFR). Results 64 children were included [32 (50%) male, mean age 14.5±2.8 years, with a median follow-up 24 weeks (IQR 14-38; range 6-116)]; 41 (64%) UC/IBDU and 23 (36%) CD. All were previously treated with anti-TNF (28% primary failure, 53% secondary failure). Week 14 CFR was 37% in UC, and 14% in CD (p=0.06). CFR by last follow-up was 39% in UC and 24% in CD (p=0.24). Ten (17%) children required surgery, 6 of whom had colectomy for UC. Concomitant immunomodulatory drugs did not affect remission rate (42% vs 35%; p=0.35 at week 22). There were 3 minor drug-related adverse events. Overall 5% achieved endoscopic mucosal healing with 9% achieving stool calprotectin &lt;100mcg/gm. Conclusion Vedolizumab was safe and effective in this cohort of pediatric refractory IBD. These data support previous findings of slow induction rate of vedolizumab in CD and a trend to be less effective compared to patients with UC.</p

    Vedolizumab in pediatric inflammatory bowel disease: a retrospective multi-center experience from the Paediatric IBD Porto group of ESPGHAN

    No full text
    Background: Vedolizumab, an anti-integrin antibody, has proven to be effective in adults with inflammatory bowel disease [IBD], but the data in paediatrics are limited. We describe the short-term effectiveness and safety of vedolizumab in a European multi-centre paediatric IBD cohort. Method: Retrospective review of children [aged 2–18 years] treated with vedolizumab from 19 centres affiliated with the Paediatric IBD Porto group of ESPGHAN. Primary outcome was Week 14 corticosteroid-free remission [CFR]. Results: In all, 64 children were included (32 [50%] male, mean age 14.5 ± 2.8 years, with a median follow-up 24 weeks [interquartile range 14–38; range 6–116]); 41 [64%] cases of ulcerative colitis/inflammatory bowel disease unclassified [UC/IBD-U] and 23 [36%] Crohn’s disease [CD]. All were previously treated with anti-tumour necrosis factor [TNF] [28% primary failure, 53% secondary failure]. Week 14 CFR was 37% in UC, and 14% in CD [P = 0.06]. CFR by last follow-up was 39% in UC and 24% in CD [p = 0.24]. Ten [17%] children required surgery, six of whom had colectomy for UC. Concomitant immunomodulatory drugs did not affect remission rate [42% vs 35%; p = 0.35 at Week 22]. There were three minor drug-related adverse events. Only 3 of 16 children who underwent endoscopic evaluation had mucosal healing after treatment (19%). Conclusions: Vedolizumab was safe and effective in this cohort of paediatric refractory IBD. These data support previous findings of slow induction rate of vedolizumab in CD and a trend to be less effective compared with patients with UC

    Vedolizumab in Pediatric inflammatory bowel diseases: a retrospective multi-center experience from the paediatric IBD Porto group of ESPGHAN

    No full text
    Vedolizumab (VDZ) has proven as an effective medication in adult Inflammatory Bowel Disease (IBD). There has been increased off-label use of VDZ also in children but with very limited published experience. Therefore we aimed to describe the short-term effectiveness and safety of VDZ in children with IBD in the largest pediatric cohort to date

    Prevalence and Determinants of Physician Bedside Rationing: Data from Europe

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    BACKGROUND: Bedside rationing by physicians is controversial. The debate, however, is clouded by lack of information regarding the extent and character of bedside rationing. DESIGN, SETTING, AND PARTICIPANTS: We developed a survey instrument to examine the frequency, criteria, and strategies used for bedside rationing. Content validity was assessed through expert assessment and scales were tested for internal consistency. The questionnaire was translated and administered to General Internists in Norway, Switzerland, Italy, and the United Kingdom. Logistic regression was used to identify the variables associated with reported rationing. RESULTS: Survey respondents (N =656, response rate 43%) ranged in age from 28 to 82, and averaged 25 years in practice. Most respondents (82.3%) showed some degree of agreement with rationing, and 56.3% reported that they did ration interventions. The most frequently mentioned criteria for rationing were a small expected benefit (82.3%), low chances of success (79.8%), an intervention intended to prolong life when quality of life is low (70.6%), and a patient over 85 years of age (70%). The frequency of rationing by clinicians was positively correlated with perceived scarcity of resources (odds ratio [OR]=1.11, 95% confidence interval [CI] 1.06 to 1.16), perceived pressure to ration (OR=2.14, 95% CI 1.52 to 3.01), and agreement with rationing (OR=1.13, 95% CI 1.05 to 1.23). CONCLUSION: Bedside rationing is prevalent in all surveyed European countries and varies with physician attitudes and resource availability. The prevalence of physician bedside rationing, which presents physicians with difficult moral dilemmas, highlights the importance of discussions regarding how to ration care in the most ethically justifiable manner
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