P603 Persistence of vedolizumab maintenance therapy: 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, P. Dolin21
1Department of Gastroenterology, University Hospital CHU of Liège, Liege, Belgium, 2Department of Gastroenterology, Saint Pierre University Hospital, Brussels, Belgium, 3Department of Gastroenterology, Imelda ziekenhuis, Bonheiden, Belgium, 4Department of Gastroenterology, Hospital CHC, Liège, Belgium, 5Department of Gastroenterology, CHwapi Notre Dame, Tournai, Belgium, 6Department of Gastroenterology, Maria Middelares Medical Centre, Ghent, Belgium, 7Department of Gastroenterology, UZ Brussel- Vrije Universiteit Brussel, Brussels, Belgium, 8Department of Gastroenterology, Ziekenhuis Oost Limburg, Genk, Belgium, 9Department of Gastroenterology, Onze Lieve Vrouwziekenhuis, Aalst, Belgium, 10Department of Gastroenterology, University Hospitals Leuven, Leuven, Belgium, 11Department of Gastroenterology, AZ Groeninge Hospital, Kortrijk, Belgium, 12Department of Gastroenterology, AZ St Lucas,Gent, Belgium, 13Department of Gastroenterology, Hopital Universitaire Erasme, Brussels, Belgium, 14Department of Gastroenterology, Clinique St Pierre, Ottignies, Belgium, 15Department of Gastroenterology, CHU UCL Namur site Sainte Elisabeth, Brussels, Belgium, 16Department of Gastroenterology, AZ Delta, Roeselare, Belgium, 17Department of Gastroenterology, Hospital CHR de la Citadelle, Liège, Belgium, 18Department of Gastroenterology, Jessa Ziekenhuis- Hasselt, Hasselt, Belgium, 19Department of Gastroenterology, CHU Ambroise Paré, Mons, Belgium, 20Department of Medical Affairs, Takeda Pharmaceuticals, Brussels, Belgium, 21Department of Epidemiology, Takeda Pharmaceuticals, London, UK
Background
Clinical trials and observational studies have demonstrated the clinical efficacy of vedolizumab (VDZ) as maintenance therapy for Crohn’s disease (CD) and ulcerative colitis (UC). This report presents long-term data on persistence of VDZ maintenance therapy 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 across Belgium. The median length of VDZ therapy prior to enrolment was 11 months. Patients were followed-up every 6 months after enrolment with the assessment of IBD features, use of biologics, and disease activity. Clinical remission was defined as the Harvey–Bradshaw Index (HBI) <5 or partial Mayo Score (pMS) <2. Missing value imputation (last observation carried forward) was used to partially account for missing disease activity scores. If a 6-monthly disease activity score was missing, the disease activity score from the previous 6-monthly assessment was used.
Results
The mean duration of VDZ therapy, including use prior to enrolment, was 31 months, with 68% of CD patients and 75% of UC patients using VDZ therapy for 48 months. Clinical remission rate after 42 months of VDZ therapy was higher in UC (84%) than CD (67%), and higher for patients without prior anti-TNF therapy (87%) than those with prior anti-TNF therapy (70%).
| CD | UC | |||
| Duration of VDZ therapy (Months) | Persisting with VDZ, % | Clinical Remission1, % | Persisting with VDZ, % | Clinical Remission1, % |
| 6 | 98% (124/126) | 64% (21/33) | 99% (67/68) | 58% (7/12) |
| 12 | 92% (116/126) | 71% (39/55) | 96% (65/68) | 68% (19/28) |
| 18 | 83% (105/126) | 67% (55/82) | 91% (62/68) | 76% (31/41) |
| 24 | 79% (99/126) | 57% (46/81) | 88% (60/68) | 80% (35/44) |
| 30 | 73% (92/126) | 54% (37/69) | 79% (54/68) | 82% (31/38) |
| 36 | 72% (91/126) | 67% (36/54) | 76% (52/68) | 86% (24/28) |
| 42 | 69% (87/126) | 67% (24/36) | 75% (51/68) | 84% (16/19) |
| 48 | 68% (86/126) | 75% (51/68) | ||
1Clinical remission denominators at each time point do not include patients enrolled after the time point, whose follow-up had yet to reach the time point, or with HBI/pMS score missing.
Fifty-seven (29.4%) patients discontinued VDZ during follow-up, due to loss of response (
Conclusion
These real-world long-term Belgian data demonstrate a high persistence of VDZ maintenance therapy among both CD and UC patients, with highest clinical remission rates seen in patients with UC and those with no prior anti-TNF therapy.