Search

Purpose: To analyze treatment persistence and treatment outcomes of vedolizumab as first-line biological treatment in Crohn's disease (CD) and ulcerative colitis (UC) patients in a Finnish real-world setting., Methods: Observational, retrospective, multi-center chart review study that included adult CD and UC patients initiating vedolizumab as first-line biological treatment between 2014 and 2020., Results: The cohort consisted of 54 CD and 69 UC patients. At month 12, treatment persistence was 84.9 % in CD and 64.7 % in UC. Most vedolizumab discontinuations (CD, n = 11; UC, n = 26) were due to inefficacy. Discontinuations due to adverse events were rare (n < 5). Efficacy improvements were observed in treatment persistent patients at 12 months vs. baseline in the Harvey-Bradshaw Index (CD, 1.8 vs. 3.9, p = 0.001), Partial Mayo Score (UC, 1.0 vs. 4.9, p < 0.001), Physician's Global Assessment (CD, 0.9 vs. 1.8, p < 0.001; UC, 0.4 vs. 2.1, p < 0.001), along with positive endoscopic and biochemical outcomes. Clinical remission was 90.9 % vs. 63.0 % for CD, and 81.6 % vs. 12.3 % for UC, while corticosteroid use was 15.9 % vs. 53.7 % for CD, and 14.6 % vs. 92.8 % for UC at 12 months and baseline, respectively., Conclusion: Vedolizumab was associated with improvements in efficacy, endoscopic activity, biochemical parameters, and decreased corticosteroid burden when used as a first-line biological treatment., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Tero Ylisaukko-oja reports financial support was provided by MedEngine Oy. Sarah Smith reports financial support was provided by MedEngine Oy. Jari Jokelainen reports financial support was provided by MedEngine Oy. Paula Haiko reports financial support was provided by Takeda Oy. Anja Eberl reports was provided by Janssen-Cilag SAS. Clas-Göran af Björkesten reports financial support was provided by AbbVie Inc. Clas-Göran af Björkesten reports financial support was provided by Bristol Myers Squibb Co. Clas-Göran af Björkesten reports financial support was provided by Janssen Pharmaceuticals Inc. Clas-Göran af Björkesten reports financial support was provided by Merck Sharp & Dohme Corp. Clas-Göran af Björkesten reports financial support was provided by Pfizer Inc. Clas-Göran af Björkesten reports financial support was provided by Takeda Oy. Clas-Göran af Björkesten reports financial support was provided by Mylan Pharmaceuticals Inc. Clas-Göran af Björkesten reports financial support was provided by Ferring Pharmaceuticals Inc. Clas-Göran af Björkesten reports financial support was provided by Vifor (International) AG. Heikki Nuutinen reports financial support was provided by Takeda Oy. Pauliina Molander reports financial support was provided by AbbVie Oy. Pauliina Molander reports financial support was provided by Bristol Myers Squibb Co. Pauliina Molander reports financial support was provided by Gilead Sciences. Pauliina Molander reports financial support was provided by Janssen-Cilag SAS. Pauliina Molander reports financial support was provided by Orion Corporation. Pauliina Molander reports financial support was provided by Pfizer. Pauliina Molander reports financial support was provided by Sandoz Inc. Pauliina Molander reports financial support was provided by Takeda Oy. Pauliina Molander reports financial support was provided by Tillotts Pharma AG. Pauliina Molander reports financial support was provided by Viatris. Ritva Koskela reports financial support was provided by Pfizer Inc. Ritva Koskela reports financial support was provided by Vifor (International) AG. Ritva Koskela reports financial support was provided by Janssen Pharmaceuticals Inc. Ritva Koskela reports financial support was provided by Takeda Oy. Ritva Koskela reports financial support was provided by Ferring Pharmaceuticals Inc. Taina Sipponen reports financial support was provided by AbbVie Oy. Taina Sipponen reports financial support was provided by Bristol Myers Squibb Co. Taina Sipponen reports financial support was provided by Pfizer. Taina Sipponen reports financial support was provided by Takeda Oy. Taina Sipponen reports financial support was provided by Celltrion, Inc. Taina Sipponen reports financial support was provided by Janssen-Cilag SAS. Tero Ylisaukko-oja reports a relationship with MedEngine Oy that includes: equity or stocks., (© 2024 The Authors.)

Limited data is available on vedolizumab combination therapies in real-world clinical practice. Here, we evaluated the concomitant corticosteroid, immunosuppressive, and 5-aminosalicylic acid utilization of inflammatory bowel disease (IBD) patients treated with vedolizumab in a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centres with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) who had at least one vedolizumab infusion since it's availability in Finland were included in the study. Data were collected from medical charts at baseline (vedolizumab treatment initiation), week 14, and month 6. The majority of patients who used corticosteroids at the baseline and persisted on vedolizumab treatment for 6 months were taken off corticosteroid treatment by the 6-month time point (CD, 54.5%; UC, 69.8%). Modest corticosteroid dose reductions were observed among treatment persistent CD patients from the baseline until month 6. Corticosteroid users had less vedolizumab discontinuations due to primary ineffectiveness and more discontinuations due to adverse events than patients not using corticosteroids. Vedolizumab may have a corticosteroid sparing effect in real-world clinical practice. Concomitant corticosteroid use may lead to a lower rate of vedolizumab discontinuation due to primary ineffectiveness, but a higher discontinuation rate due to adverse events., (Copyright © 2019. Published by Elsevier Ltd.)

Objectives: The efficacy and tolerability of vedolizumab in the treatment of inflammatory bowel diseases (IBD) has been demonstrated in an extensive GEMINI clinical trial programme. Clinical trials represent highly selected patient populations and, therefore, it is important to demonstrate effectiveness in real-life clinical practice. We set out to assess real-world treatment outcomes of vedolizumab in a nationwide cohort of treatment refractory Finnish Crohn's disease (CD) and ulcerative colitis (UC) patients., Methods: This was a nationwide, retrospective, non-interventional, multi-centre chart review study. All adult patients from 27 Finnish gastroenterology centers with a diagnosis of UC or CD who had at least one vedolizumab infusion since the availability of the product in Finland, were included in the study. Data were collected retrospectively from medical charts at baseline, week 14, and month 6. The primary outcome measure was treatment persistence 24 weeks post-vedolizumab initiation., Results: A total of 247 patients were included (108 CD, 139 UC). A total of 75.0% (n = 81) of all CD patients and 66.2% (n = 92) of all UC patients, were persistent on vedolizumab therapy for 6 months post treatment initiation. At month 6, 41.8% (28/67) of the treatment persistent CD patients and 73.3% (63/86) of the treatment persistent UC patients achieved clinical remission. Significant improvement in endoscopic scores were observed among treatment persistent patients (CD, n = 17, ΔSES-CD=-5.5, p = .008; UC, n = 26, ΔMayo endoscopic score =-0.5, p = .003) at month 6., Conclusions: Vedolizumab provides an effective and well-tolerated treatment option in real-world clinical practice even among treatment refractory IBD patients.

Objective: The association between psychosocial factors and gastrointestinal symptoms is unclear. It has been proposed that they simply drive health-care seeking of patients. We therefore aimed to study whether mental distress would increase health-care utilization in functional dyspepsia (FD)., Methods: 171 primary care FD patients completed questionnaires screening gastrointestinal symptoms, mental distress, and health-care utilization between 1993 and 2000. These included the Bowel Disease Questionnaire and 12-item General Health Questionnaire. The patients' medical records were reviewed in primary care centers, Kuopio University Hospital, local hospitals, and private clinics., Results: The majority of patients revisited their general practitioner (GP), and most of them were prescribed antisecretory medication. Repeated gastroscopy and lower gastrointestinal endoscopy were performed in 26% of the patients. A radiological reinvestigation, usually upper abdominal ultrasound, was performed in one-third. Nine percent were hospitalized due to gastrointestinal reasons. A single additional bowel symptom increased the probability of repeated endoscopy by 19%, a visit to the GP by 19%, and an inpatient period by 51%. Neither an increase in the dyspepsia score nor the presence of mental distress or suspicion of serious illness increased the probability of health-care utilization., Conclusion: There is no association between mental distress and health-care utilization for gastrointestinal symptoms.