P406 A retrospective analysis of the efficacy of vedolizumab on extra-intestinal manifestations in patients with inflammatory bowel disease across five European countries
Kopylov, U.(1);Burisch , J.(2); Ben-Horin , S.(1);Braegger, F.(3);Fernández-Nistal , A.(4);Lara, N.(5);Vavricka , S.(6,7);
(1)Gastroenterology Institute- Sheba Medical Center Tel Hashomer, Sackler School of Medicine, Tel Aviv, Israel;(2)Hvidvore University Hospital, Gastrounit- medical division, Hvidvore, Denmark;(3)Takeda Pharmaceuticals International AG, Takeda Pharmaceuticals International AG, Zürich, Switzerland;(4)Takeda Farmacéutica España S.A., Medical Department, Madrid, Spain;(5)IQVIA, Real World Evidence Solutions, Barcelona, Spain;(6)University Hospital Zürich, Department of Gastroenterology and Hepatology, Zürich, Switzerland;(7)Center for Gastroenterology und Hepatology AG, Center for Gastroenterology und Hepatology AG, Zürich, Switzerland
Background
Vedolizumab is an α4β7 integrin monoclonal antibody indicated for moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). There are limited data on how vedolizumab impacts extraintestinal manifestations (EIM) in inflammatory bowel disease (IBD).
The aim of the study was to analyse the effect of vedolizumab on EIM in a real-world cohort of IBD patients.Methods
A multicentre retrospective study was conducted in Belgium, Denmark, Israel, the Netherlands and Switzerland. Adult patients with moderately to severely active IBD and concurrent active EIM with at least 6 months follow-up after vedolizumab initiation (index date) were enrolled. Improvement of EIM was defined as absence of symptoms (resolution) or partial response (reduction of symptoms).
Results
99 patients were included (UC: 44, CD: 55); the majority of active EIM at index were musculoskeletal (Table 1). Median disease duration at index was 9 (IQR: 3-19) years and 77% of patients had been exposed to 1+ biologic.
Overall, after 6 and 12 months of vedolizumab, 37% and 50% of EIM respectively were reported as improved, 22%, 25% as stable (no change) and 1% and 3% as worsened (Table 2), missing values were 5% and 4%, respectively. Median time since first EIM improvement was 0.5 months (Figure 1).
At 6 and 12 months, 48% (10/21) and 33% (6/18) of patients experienced clinical response/remission of their IBD, respectively.
Vedolizumab treatment persistence at 12 months was 83% overall (Figure 2).
Adverse Events were reported for 18% patients; 96% of them non-serious.
Table 1. Demographics and EIM characteristics at index
| Characteristics | Value |
| Median age, years (range) | 44 (19-80) |
| Female, n (%) | 64 (65%) |
| Tabaco use, n (%) | 39 (44%) |
| Active EIM, n (%) | |
| Articular manifestations | |
| Arthralgia | 69 (70%) |
| Peripheral spondylarthritis | 21 (21%) |
| Axial spondylarthritis | 10 (10%) |
| Cutaneous manifestations | |
| Erythema nodosum | 7 (7%) |
| Other manifestations | |
| Uveitis | 1 (1%) |
| Primary sclerosing cholangitis | 6 (6%) |
| Oral aphthous ulcers | 3 (3%) |
Table 2. Evolution of most frequent EIM at 6 and 12 months
| EIM (n 6M/12M)* | Improvement | No change | Worsening | |||
| 6M | 12M | 6M | 12M | 6M | 12M | |
| Arthralgia (58/54) | 18 (31%) | 23 (43%) | 19 (33%) | 17 (32%) | 0 | 1 (2%) |
| Peripheral spondylarthritis (20/20) | 12 (60%) | 14 (70%) | 2 (10%) | 3 (15%) | 1 (5.0%) | 1 (5.0%) |
| Axial spondylarthritis (9/9) | 2 (22%) | 3 (33%) | 2 (22%) | 4 (44%) | 0 | 0 |
| Erythema nodosum (7/7) | 4 (57%) | 5 (71%) | 0 | 0 | 0 | 0 |
| Uveitis (1/1) | 1 (100%) | 1 (100%) | 0 | 0 | 0 | 0 |
| Primary sclerosing cholangitis (6/5) | 1 (17%) | 2 (40%) | 0 | 1 (20.0%) | 0 | 1 (20.0%) |
| Oral aphthous ulcers (3/1) | 0 | 1 (33%) | 0 | 0 | 0 | 0 |
| All EIM | 38 (37%) | 49 (50%) | 23 (22%) | 25 (25%) | 1 (1%) | 3 (3%) |
*34 and 19 patients had no data at 6M and 12M, respectively.
Conclusion
Vedolizumab treatment was associated with an improvement in 37% and 50% of EIM at 6 and 12 months, respectively, in a real-world IBD cohort.