Background: Vedolizumab (VDZ) is approved for treatment of moderately-severely Crohn's disease (CD) and ulcerative colitis (UC). Reports on clinical response and remission in registration trials and real world cohorts have shown efficacy, however data on endoscopic response are limited. In this study, we assessed endoscopic response and remission at week 16 and 52.
Methods: Adult patients with CD, UC and IBD unclassified (IBDU) that started VDZ between October '14 and July '16 were prospectively included. Scopic disease activity was assessed at baseline, week 16 and week 52 using the simple endoscopic score (SES) in CD, Rutgeerts score for postoperative CD and MAYO score in UC and IBDU. Endoscopy scoring was randomly performed and blinded for patient characteristics and time points. Endoscopic response was defined as SES-CD reduction ≥50%, Rutgeerts reduction of ≥1 and MAYO score reduction of ≥1. Endoscopic remission was defined as SES-CD <4 or Rutgeerts score ≤1 for CD patients and endoscopic MAYO score ≤1 for IBDU and UC patients. Generalized multivariate analysis were performed to identify predictors of endoscopic response and remission at week 16.
Results: In total, 58 (M24/F34) patients with median age of 39 years (IQR29–47) were started on VDZ after a median disease duration of 11 years (IQR6–16). The study population included 39 CD, 15 UC and 4 IBDU patients. IBDU patients were included in the UC group for analysis. In total 57/58 (98%) patients received previous anti TNF therapy. The start of VDZ was combined with corticosteroid induction therapy in 44/58 (79%) patients. Endoscopic response was achieved in 15/39 (40%) of CD and 10/19 (53%) of UC patients at week 16 (p=0.34). Endoscopic remission at week 16 was achieved in respectively 7/38 (18%) and 8/19 (42%) (p=0.05). At week 16, a significant decrease in mean SES-CD of 5 points was observed (p=0.01), 1 point decrease in Rutgeerts score (p=0.02) and similarly a mean MAYO score decrease of 1 point was observed (p=0.01). After clinical and endoscopic evaluation at 16 weeks, 32/58 (55%) patients continued VDZ. Endoscopic response at week 52 was achieved in 6/16 (38%) CD and 3/6 (50%) UC patients (p=0.59). Endoscopic remission at week 52 was achieved in resp. 1/17 (6%) and 3/6 (50%) (p=0.01). In multivariate analysis, IBD phenotype of CD patients with perianal disease was associated with a decreased likelihood of endoscopic response at week 16 (p=0.03), whereas demographics, disease duration, smoking status, previous surgery and previous medication use did not.
Conclusions: VDZ treatment induces endoscopic response at week 16 in 40% and endoscopic remission in 26% of IBD patients with anti-TNF refractory disease. In UC, endoscopic remission at week 16 is significantly higher as compared to CD.