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P309 Are results from VARSITY applicable to real world? Adalimumab versus vedolizumab as first line biological in moderate-to-severe IBD.

Moens, A.(1,2);Verstockt, B.(1,2);Alsoud, D.(2);Sabino, J.(1,2);Ferrante, M.(1,2);Vermeire, S.(1,2);

(1)University Hospitals Leuven, Department of Gastroenterology and Hepatology, Leuven, Belgium;(2)Catholic University Leuven, Department of Chronic diseases- Metabolism and Ageing, Leuven, Belgium

Background

Therapeutic options in IBD are rapidly growing, causing new challenges including choice of first line therapy. Both adalimumab (ADM) and vedolizumab (VDZ) are effective at inducing and maintaining endoscopic remission in moderate-to-severe IBD.  The VARSITY trial (Sands et al NEJM 2019) showed superiority of VDZ over ADM in achieving clinical remission and endoscopic improvement at W52 in UC patients. Our aim was to explore if these results withstand in a real world setting of UC patients, and if they are also valid in CD.

Methods

This retrospective cohort study included adult, biological-naive IBD patients starting ADM or VDZ between 2015-2019 in our referral IBD centre. Patients had moderate-to-severe disease (endoscopic Mayo sub score ≥ 2 for UC, presence of ulcerations for CD) prior to start of therapy. For UC, we assessed endoscopic remission (endoscopic Mayo sub score 0) and improvement (endoscopic Mayo sub score ≤ 1) at W52. For CD, we assessed endoscopic remission (absence of ulcerations) and improvement (markedly better endoscopy despite still presence of ulcerations) at weeks 26-52. Missing values were imputed as nonresponses for binary outcomes, and last-observation carried-forward was used for continuous outcomes.

Results

A total of 109 UC and 86 CD patients were included (Table 1). Endoscopic remission at W52 was significantly better for VDZ than ADM in UC (35% vs 15%, p=0.03), and also endoscopic improvement was numerically, yet not significantly, better for VDZ than ADM (56% vs 37%, p=0.08). At baseline, 23 UC patients (50%) in the ADM group and 40 (63%) in the VDZ group were on steroids. By W52, 83% and 78% (p=0.75) of UC patients respectively could discontinue steroids and steroid-free endoscopic remission was not different between groups (ADM: 22% vs VDZ: 23%, p=1.00). For CD patients, similar endoscopic remission (60% vs 48%, p=0.37) and improvement (77% vs 79%, p=1.00) rates at weeks 26-52 were seen between ADM and VDZ. Twenty-five (47%) CD patients in the ADM and 16 (48%) in the VDZ group were on steroids at baseline, and 88% of them in both groups could successfully stop steroids by W52. Again, no difference in steroid-free endoscopic remission was seen between ADM (56%) and VDZ (31%) treated CD patients (p=0.20). At the end of follow-up [81 (27-157) weeks], the rates of treatment persistence were significantly different between ADM and VDZ treatment groups in UC patients, though not in CD patients (Figure 1).



Conclusion

In a real-world cohort of bio-naive UC patients, VDZ was superior to ADM in achieving endoscopic remission at W52, while in bio-naive CD patients VDZ and ADM resulted in similar endoscopic outcomes.

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