P600 Vedolizumab dose optimisation: Findings from a Belgian registry
E. Louis1, V. Muls2, P. Bossuyt3, A. Colard4, A. Nakad5, D. Baert6, F. Mana7, P. Caenepeel8, S. Vanden Branden9, S. Vermeire10, F. D’Heygere11, B. Strubbe12, A. Cremer13, J.C. Coche14, V. Setakhr15, F. Baert16, A. Vijverman17, J.L. Coenegrachts18, F. Flamme19, A. Hantson20, K. Wijnen20, E. Piters20, G. Hantsbarger21, P. Dolin22
1University Hospital CHU of Liège, Gastroenterology, Liege, Belgium, 2Saint Pierre University Hospital, Gastroenterology, Brussels, Belgium, 3Imelda ziekenhuis-, Gastroenterology, Bonheiden, Belgium, 4Hospital CHC, Gastroenterology, Liège, Belgium, 5CHwapi Notre Dame, Gastroenterology, Tournai, Belgium, 6Maria Middelares Medical Centre, Gastroenterology, Ghent, Belgium, 7UZ Brussel- Vrije Universiteit Brussel, Gastroenterology, Brussels, Belgium, 8Ziekenhuis Oost Limburg, Gastroenterology, Genk, Belgium, 9Onze Lieve Vrouwziekenhuis, Gastroenterology, Aalst, Belgium, 10University Hospitals Leuven, Gastroenterology, Leuven, Belgium, 11AZ Groeninge Hospital, Gastroenterology, Kortrijk, Belgium, 12AZ St Lucas, Gastroenterology, Gent, Belgium, 13Hopital Universitaire Erasme, Gastroenterology, Brussels, Belgium, 14Clinique St Pierre, Gastroenterology, Ottignies, Belgium, 15CHU UCL Namur site Sainte Elisabeth, Gastroenterology, Brussels, Belgium, 16AZ Delta, Gastroenterology, Roeselare, Belgium, 17Hospital CHR de la Citadelle, Gastroenterology, Liège, Belgium, 18Jessa Ziekenhuis, Gastroenterology, Hasselt, Belgium, 19CHU Ambroise Paré, Gastroenterology, Mons, Belgium, 20Takeda Pharmaceuticals, Medical Affairs, Brussels, Belgium, 21Takeda Pharmaceuticals, Observational Research Analytics, Boston, USA, 22Takeda Pharmaceuticals, Epidemiology, London, UK
Background
Vedolizumab (VDZ) dose optimisation (DO), by interval shortening from 8-weekly (Q8W) to 4-weekly (Q4W) dosing, is used for patients with secondary loss of response. This report presents outcome data on patients receiving DO in real-world clinical practice in Belgium.
Methods
The Belgian VDZ Registry (ENcePP EUPAS6469) enrolled 202 VDZ-treated ulcerative colitis (UC) or Crohn’s disease (CD) adult patients (26% with no prior use of anti-TNF therapy) from 19 centres. The median length of VDZ therapy prior to enrolment was 11 months. Patients were followed-up every 6 months with the assessment of IBD features, use of biologics, and disease activity. Clinical remission was defined as Harvey–Bradshaw Index (HBI) <5 or partial Mayo Score (pMS) <2, and clinical response as a 2+ point improvement in pMS or a 3+ improvement in HBI.
Results
During a median follow-up of 19 months from enrolment, 57 (28%) patients (41 CD and 16 UC) received VDZ Q4W due to secondary loss of response. Q4W was mostly used in patients with CD or with prior anti-TNF therapy failure. The median starting point for Q4W dosing was 16 months after the start of VDZ (interquartile range (IQR) 8–27 months) and median duration of Q4W dosing was 4 months (IQR 2–8 months). After changing to Q4W dosing 44% achieved clinical remission, 3% clinical response, and 53% showed no improvement (Table 1).
| CD N=41 | UC N=16 | Total N=57 | ||||
| Clinical Remission | 12/27 | 44.4.% | 4/9 | 44.4% | 16/36 | 44.4% |
| Clinical Response | 0 | 0% | 1/9 | 11.2% | 1/36 | 2.8% |
| No Improvement | 15/27 | 55.6% | 4/9 | 44.4% | 19/36 | 52.8% |
| Missing disease activity scores | 14 | - | 7 | - | 21 | - |
Among the 17 patients with clinical remission/response on Q4W dosing, 53% de-escalated back to Q8W, and continued with Q8W for a median duration of 12 months, 23.5% remained on Q4W with clinical remission, and 23.5% eventually stopped VDZ due to loss of response. A limitation of this study is that it did not systematically collect data on DO prior to recruitment, hence the proportion of patients receiving DO may be higher than reported here.
Conclusion
These real-world data show DO plays an important role in management of UC and CD. In this study, 28% of patients received DO following the secondary loss of response to Q8W therapy. Forty-seven per cent of patients receiving Q4W subsequently returned to clinical remission or had a clinical response, and half of these patients successfully returned to Q8W VDZ therapy. Controlled studies are warranted, ideally blinded, using more objective endpoint to reveal the true success rate of dose-optimisation.