P801 Maintenance phase effectiveness and persistence after two years in biologic-naïve ulcerative colitis patients treated with vedolizumab or anti-TNF (VEDO-IBD-study)
Plachta-Danielzik, S.(1);Bokemeyer, B.(1,2,3)*;Efken, P.(4);Mohl, W.(5);Krause, T.(6);Hoffstadt, M.(7);Ehehalt, R.(8);Trentmann, L.(9);Schweitzer, A.(10);Jessen, P.(11);Franzenburg, S.(1);Hartmann, P.(4);di Giuseppe, R.(1);Schreiber, S.(1,3);
(1)Competence network IBD, Study department, Kiel, Germany;(2)Interdisciplinary Crohn Colitis Centre Minden, Crohn Colitis Centre, Minden, Germany;(3)University Hospital Schleswig-Holstein- Campus Kiel, Clinic of General Internal Medicine I, Kiel, Germany;(4)Gastroenterology Practice Minden, Practice, Minden, Germany;(5)Center for Gastroenterology Saar MVZ, Practice, Saarbruecken, Germany;(6)Gastroenterology Practice Kassel, Practice, Kassel, Germany;(7)Gastroenterology Practice Iserlohn, Practice, Iserlohn, Germany;(8)Gastroenterology Practice Heidelberg, Practice, Heidelberg, Germany;(9)Gastroenterology Practice Bremen, Practice, Bremen, Germany;(10)Gastroenterology Practice Muenster, Practice, Muenster, Germany;(11)Gastroenterology Practice Altenholz, Practice, Altenholz, Germany;
In this two-arm prospective real-world-evidence (RWE) study with propensity score adjustment, we aimed to analyse the persistence of biologic therapy in biologic-naïve ulcerative colitis (UC) patients and to compare the 2-year effectiveness of vedolizumab (VEDO) and anti-TNF.
Between 2017 and 2020, 1200 consecutively enrolled biologic-naïve and biologic-experienced patients with UC and CD (Crohn’s disease) were prospectively included in the VEDOIBD study from 45 IBD-experienced centres across Germany. After the exclusion of biologic-experienced patients, CD, and missing outcomes, the final sample consisted of 314 biologic-naïve UC patients with 2-year follow-up data. In this mITT analysis switching was considered as outcome failure, and clinical remission and (steroid-free) remission rates (pMayo ≤1 plus a bleeding subscore=0 - and no systemic use of steroids or oral budesonide at two years) at two years were predefined as outcomes. To reduce the effect of confounders, propensity score (PS) adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI).
The two-year maintenance phase effectiveness of 182 VEDO and 132 anti-TNF (ADA: 25.8%; IFX: 58.3%; GOL 15.9%) biologic-naïve UC patients were analysed in this prospective RWE-comparison of VEDO vs anti-TNF. Significantly more patients switched to another biologic in the anti-TNF group when compared to the VEDO group up to 2 years (54% vs 29%; p<0.0001) (Fig. 1). In the mITT analysis after 2 years a statistically significant higher clinical remission rate of 43.2% was found for VEDO vs 25.8% for anti-TNF (OR 95% 2.18 (1.19-3.99), p=0.011) (Fig. 2). Considering the two-year effectiveness of ADA and IFX the response rates of VEDO were numerically higher than those of ADA (45.2% vs 37.9%) but not statistically significant. In contrast, for VEDO versus IFX, there was a clear difference in favour of VEDO that resulted in a clinical remission rate of 43.1% versus 16.5% for IFX (p=0.0003).
As shown previously, in the induction phase, there is comparable effectiveness for VEDO and anti-TNF, although the remission rates are relatively low and similar to the range reported in RCTs. Over one year, the effectiveness tends to improve in favour of VEDO, potentially due to better treatment persistence. After two years, the clinical remission rate in the VEDO group is statistically significantly higher than in the anti-TNF group. The higher treatment persistence of VEDO vs anti-TNF and the higher effectiveness may suggest VEDO as a first-line biologics therapy option in UC patients.