Nishan Lamichhane [1]*, Nikolaos Melas [1,2]*, Viktoria Bergqvist [3,4], The SWIBREG study group, Nils-Peter Ekholm[5], Ola Olén [6-8], Jonas F Ludvigsson [9-11], Henrik Hjortswang [12], Jan Marsal [3,4], Carl Eriksson [6, 13]** and Jonas Halfvarson [13]** *Equally contributed **Equally contributed

Affiliates

[1] School of Medical Sciences, Örebro University, Örebro, Sweden [2] Karlstad Central Hospital, Karlstad, Sweden [3] Department of Gastroenterology, Skåne University Hospital, Lund/Malmö, Sweden [4] Section of Medicine, Department of Clinical Sciences, Lund University, Lund, Sweden [5] Takeda Pharma, Stockholm, Sweden [6] Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden [7] Sachs' Children and Youth Hospital, Stockholm South General Hospital, Stockholm, Sweden [8] Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden [9] Department of Paediatrics, Örebro University Hospital, Örebro, Sweden [10] Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA [11] Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden [12] Department of Gastroenterology and Hepatology in Linköping, and Department of Health, Medicine, and Caring Sciences, Linköping University, Linköping, Sweden [13] Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. *This study is funded by Takeda Pharma, Sweden.

Abstract

Background: Real-world data on patients with inflammatory bowel disease (IBD), transitioning from intravenous (IV) to subcutaneous (SC) vedolizumab (VDZ) are scarce.
Aim: To assess clinical outcomes in patients with IBD, i.e. ulcerative colitis (UC), Crohn’s disease (CD) and IBD-unclassified, who transition from IV to SC VDZ treatment in real-world setting.
Methods: Adult IBD patients transitioning from IV to SC VDZ up until 31 December 2021 were identified through the Swedish Inflammatory Bowel Disease Quality Register (SWIBREG). Patients were followed from first IV dose until termination of SC VDZ, death or end of the study period, i.e. 25 February 2022. The primary outcome was the persistence rate of SC VDZ at the end of the study period. Secondary outcomes included corticosteroid-free clinical remission (defined as a patient-reported Mayo rectal bleeding score=0 and stool frequency score≤1 in UC, and a stool frequency≤ 3 and abdominal pain score≤ 1 in CD) rates at last follow-up and changes from baseline, i.e. start of IV VDZ, in C-reactive protein (CRP), fecal (f)-Calprotectin and health-related quality of life (HRQoL) measures. Comparisons between baseline and last follow-up were performed using the Wilcoxon matched-pairs signed-rank test.
Results: 421 IBD patients (CD, n=193, UC, n=217 and IBD-U, n=11) transitioning from IV to SC VDZ treatment were identified. After a median follow-up of 30 (interquartile range (IQR), 15-50) months from initiation of IV VDZ, the SC VDZ persistence rates were 98% (190/193) in CD, 93% (180/193) in UC and 100% (11/11) in IBD-U. 84% transitioned to SC VDZ during maintenance therapy, and the median follow up from transition was 10 (IQR, 5-13) months. The median f-calprotectin concentrations decreased from 445 (IQR,114-1189) µg/g to 59 (IQR, 25-227)µg/g in CD (n=43, p<0.001) and from 663 QR, 258-1662) µg/g to 43 (IQR, 20-278) µg/g in UC (n=52, p<0.001). No statistically significant changes in median P-CRP concentrations were observed. Improvements in HRQoL measures (p<0.01) were identified in patients with CD and UC.
Conclusion: Transitioning from IV to SC VDZ was associated with high drug persistence and we observed improvements in biochemical and HRQoL measures in this nationwide real-world cohort of VDZ-treated patients with IBD.