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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., Competing Interests: Conflict of interest statement: CE has served as a speaker, a consultant and an advisory board member for Takeda, Janssen Cilag, Pfizer, Abbvie, and has received research funding from the Regional Agreement on Medical Training and Clinical Research between Region Örebro County and Örebro University: ALF. SR has served as a speaker for Takeda and has received research funding from the research committee in Region Örebro County and the Regional Agreement on Medical Training and Clinical Research between Region Örebro County and Örebro University: ALF. OG has served as a speaker, a consultant and an advisory board member for Ferring, Janssen, Pfizer and Takeda. SA has served as a speaker, consultant or advisory board member: AbbVie, Janssen, Takeda, Tillotts Pharma, Vifor Pharma. EH has served as a speaker, consultant or advisory board member: Abbvie, Gilead, Janssen, Pfizer and Takeda. JM has served as a speaker, consultant or advisory board member: AbbVie, Bristol-Myers Squibb, Ferring, Hospira, Janssen, MSD, Otsuka, Pfizer, Sandoz, Svar, Takeda, Tillotts and UCB Pharma, and has received grant support from AbbVie, Ferring, Pfizer and Takeda. JG has served as a speaker and consultant: Abbvie, Ferring, Tillotts Pharma, Takeda. CM is an employee of Takeda. HS has served as a speaker, consultant or advisory board member: Abbvie, Ferring, Gilead, Janssen, Pfizer, Takeda and Tillotts Pharma. DB has served as a speaker, consultant or advisory board member: Ferring, Janssen, Pfizer and Takeda. HH has served as a speaker, consultant or advisory board member: AbbVie, Janssen, Pfizer, Takeda, Tillotts Pharma, Vifor Pharma, and received grant support from Ferring and Tillotts Pharma. JH has served as a speaker, consultant or advisory board member: AbbVie, Aqilion, Celgene, Celltrion, Dr Falk Pharma and the Falk Foundation, Ferring, Gilead, Index Pharma, Janssen, Lincs, MSD, Novartis, Olink Proteomics, Pfizer, Prometheus Laboratories Inc., Sandoz, Shire, Takeda, Thermo Fisher Scientific, Tillotts Pharma, Vifor Pharma, and received grant support from Janssen, MSD and Takeda. VL, RU, PK, CS, JD, MS and DÖ have no conflicts of interest., (© The Author(s), 2021.)

Background: Comparisons of second-line anti-tumour necrosis factor (TNF) agents and vedolizumab are sparse., Aim: To evaluate the effectiveness of anti-TNF agents compared to vedolizumab as second-line biologics in inflammatory bowel disease (IBD)., Methods: A propensity score-matched cohort was created using Swedish nationwide registers. Patients with Crohn's disease or ulcerative colitis, exposed to first-line anti-TNF treatment, who initiated a second anti-TNF agent or vedolizumab in 2014-2016 (N = 1363) were included. The primary outcome was drug survival at 12 months. Secondarily, we assessed survival without IBD-related hospitalisation, IBD-related surgery, antibiotics, or hospitalisation because of infection, and also corticosteroid exposure., Results: After 1:1 propensity score matching, 400 patients (Crohn's disease, N = 198; ulcerative colitis, N = 202) remained. For Crohn's disease, drug survival was 73% in the vedolizumab group vs 74% in the anti-TNF group (difference: 1 percentage point; 95% confidence interval [CI]:-11-13; P = 0.87). Survival without IBD-related hospitalisation (82% vs 88%), surgery (82% vs 89%), antibiotics (65% vs 71%), hospitalisation due to infection (95% vs 88%) and corticosteroids (58% vs 48%) were not statistically significantly different between groups. For ulcerative colitis, drug survival was 69% in the vedolizumab group vs 62% in the anti-TNF group (difference: -7 percentage points; 95% CI: -20 to 6; P = 0.30). Vedolizumab-treated patients had lower survival without IBD-related hospitalisation (82% vs 93%, P = 0.02). Survival without colectomy (93% vs 97%), antibiotics (81% vs 70%), hospitalisation due to infection (92% vs 92%) and corticosteroids (58% vs 48%) were not statistically significantly different., Conclusions: Based on Swedish clinical practice, the effectiveness and safety of second-line anti-TNF and vedolizumab at 12 months appeared largely similar., (© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd.)

Objective: Thiopurines are used as maintenance therapy in ulcerative colitis (UC), but whether these drugs influence the natural history of the disease is unknown. We aimed to assess the effect of thiopurines in terms of colectomy, hospital admission, progression in disease extent and anti-tumour necrosis factor (TNF) therapy within 10 years from initiation., Design: Patients diagnosed with UC within the Örebro University Hospital catchment area, during 1963-2010, who initiated thiopurines (n=253) were included. To overcome the risk of confounding by indication, we compared patients who stopped treatment within 12 months because of an adverse reaction (n=76) with patients who continued therapy or discontinued due to other reasons (n=177) and assessed long-term outcomes using Cox regression with adjustment for potential confounding factors., Results: The cumulative probability of colectomy within 10 years was 19.5% in tolerant patients compared with 29.0% in intolerant (adjusted HR 0.49; 95% CI 0.21 to 0.73). The probability of hospital admission was 34.0% in tolerant versus 56.2% in intolerant patients (adjusted HR 0.36; 95% CI 0.23 to 0.56). The risk for progression in disease extent was 20.4% in tolerant patients compared with 48.8% in intolerant (adjusted HR 0.47; 95% CI 0.21 to 1.06). Within 10 years, 16.1% of tolerant and 27.5% of intolerant patients received anti-TNF therapy (adjusted HR 0.49; 95% CI 0.26 to 0.92)., Conclusion: Based on the novel approach of comparing patients tolerant and intolerant to thiopurines, we reveal that thiopurines have a profound beneficial impact of the natural history and long-term colectomy rates of UC., Competing Interests: Competing interests: CE: research grant from the Swedish government’s agreement on medical training and research and speaker’s fee from Takeda. JH: research grants from the Swedish Research Council, the Örebro University Hospital Research Foundation, the Swedish Foundation for Strategic Research and speaker’s and/or consultancy fees from Abbvie, Hospira, Janssen, Medivir, MSD, Pfizer, RenapharmaVifor and Takeda., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)