Sara Rundquist [1], Carl Eriksson [1], Vyron Lykiardopoulos [2], Per Karlén [3], Olof Grip [4], Charlotte Söderman [5], Sven Almer [6], Erik Hertervig [7], Jenny Gunnarsson [8], Carolina Malmgren [9], Jenny Delin [10], Hans Strid [11], Mats Sjöberg [12], David Öberg [13], Daniel Bergemalm [1], Ruzan Udumyan [14], Henrik Hjortswang [2], The SWIBREG SVEAH Study Group, Jonas Halfvarson [1]

Affiliates

1. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro 2. Department of Gastroenterology, Linköping University, Linköping 3. Department of Internal Medicine, Danderyd Hospital, Stockholm 4. Department of Gastroenterology, Skåne University Hospital, Malmö 5. Department of Internal Medicine, St Göran Hospital, Stockholm 6. Department of Medicine, Karolinska Institute, Stockholm 7. Department of Gastroenterology, Skåne University Hospital Lund, Lund 8. Department of Internal Medicine, Kungsbacka Hospital, Kungsbacka 9. Takeda Pharma AB, Solna 10. Department of Gastroenterology, Ersta hospital, Stockholm 11. Department of Internal Medicine, Södra Älvsborgs Hospital, Borås 12. Department of Internal Medicine, Skaraborgs hospital Lidköping, Lidköping 13. Department of Internal Medicine, Sunderby Hospital, Sunderbyn 14. Clinical Epidemiology and Biostatistics, Örebro University, Örebro, Sweden

Abstract

Background: Clinical trials may not appropriately reflect real world clinical practice. Therefore, we aimed to assess the clinical effectiveness of vedolizumab in a real world Crohn’s disease (CD) cohort.
Methods: This is a prospective, observational, multi-centre cohort study. Eligible patients had active CD confirmed by colonoscopy, contrast enhancement, bowel thickening, or combs sign at magnetic resonance imaging, C-reactive protein (CRP) >upper threshold, Hs-CRP >2.87mg/l or f-Calprotectin >200µg/g at initiation of vedolizumab therapy and had started treatment with vedolizumab from 1/6/2015. Data on clinical characteristics, treatment, disease activity and the short health scale (SHS) were recorded at baseline and prospectively, using an electronic Case Record Form, integrated with the Swedish National Quality Registry for IBD (SWIBREG). Data on the patients who had completed the 52 week follow-up are presented. The primary outcome at week 52 was clinical remission, defined as a Harvey Bradshaw Index (HBI) <5. Continuous data are presented as median (interquartile range). Differences between baseline and week 52 were assessed by the Wilcoxon-signed rank test.
Results: 169 CD patients had been included by 19/09/2017. Clinical characteristics of patients (n=104) who had completed the 52 week study period are shown in Table 1. At week 52, 71/104 (68%) were still on treatment with vedolizumab and 45/104 (43%) had achieved clinical remission. Among the 71 patients who had continued vedolizumab treatment, a decrease in the median HBI [6 (3-10) vs. 3 (2-5.5); n=68; p<0.001], median CRP [4.0 (2.0-10) mg/L vs. 3.0 (1.4-5.0) g/L; n=67; p=0.01] and median f-Calprotectin [561 (139.5-830) vs. 232.5 (77.5-464) µg/g; n=36; p=0.09] was observed from baseline to week 52. Consistently, quality of life improved, defined by a significant reduction of the overall SHS score (n=68; p<0.001).
Conclusions: Vedolizumab treated patients represented a treatment-refractory group. Significant improvements in clinical- and inflammatory activity, as well as in quality of life, were observed in patients who continued treatment through to week 52.

The study was financially supported by Takeda.