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

2018 ◽  
Vol 37 (1) ◽  
pp. 33-44 ◽  
Author(s):  
Peter Hoffmann ◽  
Johannes Krisam ◽  
Wolfgang Stremmel ◽  
Annika Gauss
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Partial Response ◽  
Real World ◽  
University Hospital ◽  
Study Endpoint ◽  
Primary Study ◽  
Inadequate Response ◽  
Inflammatory Bowel

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.

scholarly journals Real-world effectiveness of vedolizumab in inflammatory bowel disease: week 52 results from the Swedish prospective multicentre SVEAH study

2021 ◽  
Vol 14 ◽  
pp. 175628482110233
Author(s):  
Carl Eriksson ◽  
Sara Rundquist ◽  
Vyron Lykiardopoulos ◽  
Ruzan Udumyan ◽  
Per Karlén ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Real World Data ◽  
Inflammatory Bowel

Background: Prospectively and systematically collected real-world data on vedolizumab are scarce. We aimed to assess the long-term clinical effectiveness of vedolizumab in inflammatory bowel disease (IBD). Methods: This study was a prospective, observational, multicentre study. Overall, 286 patients with active IBD were included (Crohn’s disease, n = 169; ulcerative colitis, n = 117). The primary outcomes were clinical response at week 12 and clinical remission at week 52, based on the Harvey Bradshaw Index and the partial Mayo Clinic score. Secondary outcomes included clinical remission at week 12, clinical response at week 52, corticosteroid-free clinical remission at week 52, changes in biochemical measures, and health-related quality of life (HRQoL). Results: At baseline, 88% of the patients were exposed to anti-TNF and 41% of the patients with Crohn’s disease had undergone ⩾1 surgical resection. At week 12, clinical response was 27% and remission 47% in Crohn’s disease; corresponding figures in ulcerative colitis were 52% and 34%. Clinical response, remission and corticosteroid-free remission at week 52 were 22%, 41% and 40% in Crohn’s disease and 49%, 47% and 46% in ulcerative colitis, respectively. A statistically significant decrease in median faecal-calprotectin and C-reactive protein was observed at 12 and 52 weeks in patients with Crohn’s disease and ulcerative colitis. The HRQoL measures Short Health Scale and EuroQol 5-Dimensions improved in both Crohn’s disease and ulcerative colitis patients ( p < 0.001). Clinical disease activity at baseline was inversely associated with clinical remission at week 52. Conclusion: Vedolizumab proved effective for the treatment of refractory IBD in clinical practice.

scholarly journals Early real-world effectiveness of ustekinumab for Crohn’s disease

2019 ◽  
Vol 11 (2) ◽  
pp. 111-116 ◽  
Author(s):  
Richard James Harris ◽  
Martin McDonnell ◽  
David Young ◽  
Marion Bettey ◽  
Louise Downey ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Response ◽  
Real World ◽  
Clinical Remission ◽  
Clinical Care ◽  
University Hospital ◽  
Reactive Protein ◽  
Inflammatory Bowel ◽  
Clinical Records

ObjectiveTo understand the effectiveness of ustekinumab in treating Crohn’s disease (CD) in a UK real-world setting.DesignRetrospective cohort study using prospectively maintained clinical records.SettingSingle UK inflammatory bowel disease centre.PatientsAdult patients with an established diagnosis of CD prescribed ustekinumab outside of clinical trials at University Hospital Southampton (UHS).InterventionsUstekinumab, a monoclonal antibody to the shared p40 subunit of interleukin (IL) 12 and IL-23 as part of routine clinical care.Main outcome measuresEffectiveness as measured by an improvement in physician’s global assessment, drug persistence and improvement in biomarkers (C-reactive protein (CRP), albumin and calprotectin).Results84 patients were included, 72 had a postinduction review and 49 had 1-year data. At postinduction clinical review, clinical response occurred in 53% of patients and clinical remission occurred in 8%. For patients on ustekinumab at 1 year, clinical response occurred in 71% and remission in 14%. Adverse events included four patients with infections requiring admission, one drug-related rash, five CD surgeries and two CD exacerbations.ConclusionsUstekinumab was well tolerated in a complex UK CD population and demonstrated benefit to patients in terms of clinical response and improvement of biomarkers and with some patients attaining clinical remission. No unexpected safety signals were seen.

scholarly journals Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

2019 ◽  
Vol 13 (9) ◽  
pp. 1111-1120 ◽  
Author(s):  
N Plevris ◽  
C S Chuah ◽  
R M Allen ◽  
I D Arnott ◽  
P N Brennan ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Inflammatory Bowel

Abstract Background & Aims Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. Methods This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (Harvey–Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. Results Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26–52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. Conclusions Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.

scholarly journals P30 Prescribing vedolizumab in paediatric patients with crohn’s disease (CD) and Ulcerative colitis (UC) in accordance with the clinical guideline in an NHS trust

2020 ◽  
Vol 105 (9) ◽  
pp. e22.1-e22
Author(s):  
Eimear Mc Geehan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Clinical Guideline ◽  
Response To Treatment ◽  
Inadequate Response ◽  
List Type ◽  
Inflammatory Bowel

IntroductionVedolizumab is a gut-selective immunosuppressive biologic used to treat moderate to severe Crohn’s disease and ulcerative colitis. Vedolizumab is not licensed for use in children under 18 years of age. However, there is experience of using Vedolizumab in paediatric1 patients in practice. Vedolizumab incurs a significant cost to the NHS, as a result identification of patient response to treatment is fundamental.AimTo ensure Vedolizumab is prescribed in adherence to guidance documented in the clinical guideline ‘Vedolizumab treatment for inflammatory bowel disease patients’ at an NHS trust.Standards100% of patients on Vedolizumab have been diagnosed with moderate to severe ulcerative colitis or Crohn’s disease100% of patients on Vedolizumab have had and inadequate response with, lost response to, or are intolerant to either conventional therapy or anti-TNF treatment100% of patients were assessed for risk of TB prior to starting treatment100% of patient’s immunisation status was reviewed prior to starting therapy100% of patients were prescribed doses recommended in the guideline100% of patients had Vedolizumab checklist completed:Prior to infusionDuring infusionPost infusion100% of patients had outcome of disease reviewed at 3 monthsMethodA retrospective study was undertaken to investigate the prescribing of Vedolizumab in CD and UC patients since the implementation of the clinical guideline in June 2018. Ethics approval was not required. List of patients prescribed Vedolizumab was obtained from pharmacy dispensing system. Infusion details were obtained from patient notes. Qualitative data was obtained and analysed.ResultsFour patients were prescribed Vedolizumab at the NHS trust between June 2018 and June 2019. One patient had to be excluded from the audit as they had already commenced Vedolizumab prior to the implementation of the clinical guideline. 6 out of the 7 standards were met with a result of 100% except standard 6 which was met with a result of 33% (1 out of the 3 patients).Discussion and Conclusion6 out of the 7 standards were completely met; highlighting a robust system in place. The publication of the guideline has ensured that vedolizumab prescribing is appropriate, as inefficient prescribing could result in treatment failure, drug wastage and safety concerns. The only standard not completely met was standard 6, due to the use of surgical booklets on the outpatient wards, the standardised Vedolizumab checklists were not complete.RecommendationsEnsure Vedolizumab checklist is printed out from the clinical guideline and attached in the patient notes. Medical pharmacist to re-audit data yearly to ensure the clinical guideline is being adhered to.ReferencesEntyvio, Vedolizumab. Summary of Product Characteristics, Accessed via http://emc.medicines.org.uk Last updated 20.08.2015 [accessed 07/06/19]Vedolizumab (review) for the treating moderately to severely active ulcerative colitis. June 2015, NICE Technology Appraisal Guidance 342.O Ledder, A Assa, A Levine, et al. Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN. Journal of Crohn’s and Colitis. 2017:11;1230–1237.

scholarly journals Good efficacy and safety of vedolizumab in Crohn’s disease and ulcerative colitis in a real-world scenario

2020 ◽  
Vol 13 ◽  
pp. 175628482093653
Author(s):  
Fabiana Zingone ◽  
Brigida Barberio ◽  
Federico Compostella ◽  
Giulia Girardin ◽  
Renata D’Incà ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Clinical Benefit ◽  
Real Life ◽  
University Hospital ◽  
Treatment Optimization ◽  
Serious Adverse Events ◽  
Inflammatory Bowel ◽  
The University

Background: Data on vedolizumab (VDZ) use in inflammatory bowel disease (IBD) patients are still limited. We aimed to assess the effectiveness and tolerability of VDZ in a real-life clinical scenario. Methods: We retrospectively collected data of all consecutive IBD patients who started VDZ from September 2016 to December 2018 at our IBD Unit of the University Hospital of Padua and strictly followed them for 1 year. Clinical benefit (rate of clinical steroid-free remission plus clinical response), endoscopic and histological responses were evaluated over 1 year. Results: A total of 117 patients who started VDZ for Crohn’s disease (CD) and ulcerative colitis (UC) were included in the main analysis (69 CD patients, 48 UC patients). We obtained a clinical benefit in 68.1%, 68.1% and 59.4% of CD patients and in 68.7%, 54.2% and 54.1% of UC patients after induction, and at 30 weeks and 52 weeks, respectively. After 1 year, endoscopy response was observed in 47% of CD and 38.2% of UC patients, while the histological response was 19.6% and 23.5%, respectively. Finally, we found that 20.5% of patients needed treatment optimization, with 33.3% of them failing to respond despite this action. No deaths or serious adverse events requiring hospitalization were observed. The main cause of VDZ interruption was drug inefficacy. During the study, two patients developed new spondylarthritis, and two had a worsening of pre-existing arthralgia. Conclusion: Vedolizumab resulted in being effective and safe in CD as well as in UC patients.

Prebiotics and Probiotics in Inflammatory Bowel Disease: Where are we now and where are we going?

2020 ◽  
Vol 15 (3) ◽  
pp. 216-233 ◽  
Author(s):  
Maliha Naseer ◽  
Shiva Poola ◽  
Syed Ali ◽  
Sami Samiullah ◽  
Veysel Tahan
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Adverse Effects ◽  
Bowel Disease ◽  
Relapse Prevention ◽  
Remission Induction ◽  
Inflammatory Bowel

The incidence, prevalence, and cost of care associated with diagnosis and management of inflammatory bowel disease are on the rise. The role of gut microbiota in the causation of Crohn's disease and ulcerative colitis has not been established yet. Nevertheless, several animal models and human studies point towards the association. Targeting intestinal dysbiosis for remission induction, maintenance, and relapse prevention is an attractive treatment approach with minimal adverse effects. However, the data is still conflicting. The purpose of this article is to provide the most comprehensive and updated review on the utility of prebiotics and probiotics in the management of active Crohn’s disease and ulcerative colitis/pouchitis and their role in the remission induction, maintenance, and relapse prevention. A thorough literature review was performed on PubMed, Ovid Medline, and EMBASE using the terms “prebiotics AND ulcerative colitis”, “probiotics AND ulcerative colitis”, “prebiotics AND Crohn's disease”, “probiotics AND Crohn's disease”, “probiotics AND acute pouchitis”, “probiotics AND chronic pouchitis” and “prebiotics AND pouchitis”. Observational studies and clinical trials conducted on humans and published in the English language were included. A total of 71 clinical trials evaluating the utility of prebiotics and probiotics in the management of inflammatory bowel disease were reviewed and the findings were summarized. Most of these studies on probiotics evaluated lactobacillus, De Simone Formulation or Escherichia coli Nissle 1917 and there is some evidence supporting these agents for induction and maintenance of remission in ulcerative colitis and prevention of pouchitis relapse with minimal adverse effects. The efficacy of prebiotics such as fructooligosaccharides and Plantago ovata seeds in ulcerative colitis are inconclusive and the data regarding the utility of prebiotics in pouchitis is limited. The results of the clinical trials for remission induction and maintenance in active Crohn's disease or post-operative relapse with probiotics and prebiotics are inadequate and not very convincing. Prebiotics and probiotics are safe, effective and have great therapeutic potential. However, better designed clinical trials in the multicenter setting with a large sample and long duration of intervention are needed to identify the specific strain or combination of probiotics and prebiotics which will be more beneficial and effective in patients with inflammatory bowel disease.

scholarly journals The Changing Prognosis of Ulcerative Colitis and Crohn’s Disease by Decades

2021 ◽  
Author(s):  
Burton I Korelitz ◽  
Judy Schneider
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Medical Therapy ◽  
Bowel Disease ◽  
Surgical Intervention ◽  
Inflammatory Bowel

Abstract We present a bird’s eye view of the prognosis for both ulcerative colitis and Crohn’s disease as contained in the database of an Inflammatory Bowel Disease gastroenterologist covering the period from 1950 until the present utilizing the variables of medical therapy, surgical intervention, complications and deaths by decades.

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