Introduction Vedolizumab (VDZ) is an α4β7 anti-integrin licensed to treat UC and CD. We aimed to assess clinical outcomes and safety of VDZ in IBD patients treated in several hospitals across northern England.
Method We retrospectively collected data of patients treated with VDZ at 8 UK centres since 2014. We evaluated clinical response at 12 and 52 weeks using the Physician Global Assessment (PGA), Harvey-Bradshaw Index (HBI) or Mayo score. We collected C reactive protein (CRP) and faecal calprotectin (FC) at baseline and follow-up. Fisher exact test and student’s t-test were used to determine statistical significance.
Results Of 183 patients (mean 41 years, F/M ratio 1.4:1) 120 (65.6%) had CD, 61 (33.3%) UC, and 2 (1.1%) IBD-U. 18 patients were active smokers. 57 (31%) received immunomodulators, 68 (37%) steroid bridging therapy and 27 (15%) patients were anti-TNF naïve. PGA remission was observed in 33 (31%) CD, 26 (44.8%) UC and 2 (100%) IBD-U patients at 12 weeks and in 6/48 (12.5%) CD and 16/36 (44.4%) UC patients at 52 weeks. A partial response was observed in 51 (48%) CD and 25 (43.1%) UC patients at 12 weeks and in 8/48 (16.6%) CD and 10/36 (27.7%) UC patients at 52 weeks. At 52 weeks, VDZ was more effective in maintaining remission in UC than CD (p<0.05). In CD patients, mean CRP, FC and HBI significantly improved at 12 weeks, with a further improvement of HBI at 52 weeks. In UC, mean FC and Mayo score significantly decreased at 12 weeks, whereas CRP did not improve. Non-smoking status was associated with better response (p<0.05). 43 patients (23.5%) discontinued VDZ (average exposure 4.5 months). Reported side effects occurred in 21 cases (11%): 3 urticarial rashes, 6 pneumonias, 3 nasopharyngitis, 2 skin infections, 2 sepsis, 1 viral meningitis, 1 EBV infection, 1 urinary tract infection, and 2 abnormal liver function tests. Overall incidence of infection was 12 per 100 person-years of VDZ exposure.
Conclusion VDZ is a safe and effective therapy even in this cohort of predominantly anti-TNF exposed patients. Induction data are similar for CD and UC, but VDZ seems to be more successful in maintaining remission for UC. The incidence of infectious complications was comparable to that seen with anti-TNF therapies (average 14 per 100 person-years).
Disclosure of Interest M. Lenti: None Declared, S. Levison: None Declared, E. Eliadou: None Declared, R. Robert Willert: None Declared, K. Kemp: None Declared, C. Stansfield: None Declared, A. Assadsangabi: None Declared, S. Singh: None Declared, B. Crooks: None Declared, S. Tattersall: None Declared, C. Kenneth: None Declared, S. Subramanian: None Declared, C. Probert: None Declared, D. Storey: None Declared, B. Gregg: None Declared, P. Smith: None Declared, E. Liu: None Declared, J. Limdi: None Declared, A. Johnston: None Declared, PJ Hamlin: None Declared, C. Selinger Conflict with: Warner Chilcott, and Abbvie, Conflict with: Warner Chilcott, Dr Falk, Abbvie, Janssen and Takeda
- Biologic therapy
- Crohn’s disease
- Ulcerative colitis
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