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DOP75 Effectiveness and Safety of tofacitinib versus vedolizumab in Patients with Ulcerative Colitis; A Nationwide, ICC Registry study

Straatmijer , T.(1);Visschedijk , M.(2);de Vries , A.(3);Hoentjen , F.(21);van Bodegraven , A.A.(5);Bodelier , A.G.L.(6);de Boer , N.K.H.(7);Dijkstra , G.(2);Festen , E.A.M.(2);Horjus , C.(8);Jansen , J.M.(9);Jharap , B.(10);Mares , W.(11);Oldenburg , B.(12);Ponsioen , C.Y.(13);Romkens , T.E.H.(14);Srivastava , N.(15);van der Voorn , M.M.(16);West , R.L.(17);van der Woude , J.C.(3);Wolvers , M.D.J.(18);Pierik , M.(19);van der Meulen , A.E.(20);Duijvestein , M.(4);

(1)Initiative on Crohn and Colitis, Gastroenterology, Amsterdam / Leiden, The Netherlands;(2)University Medical Center Groningen, Gastroenterology, Groningen, The Netherlands;(3)Erasmus Medical Center, Gastroenterology, Rotterdam, The Netherlands;(4)Radboud University Medical Center, Gastroenterology, Nijmegen, The Netherlands;(5)Zuyderland, Gastroenterology, Geleen, The Netherlands;(6)Amphia Hospital, Gastroenterology, Breda, The Netherlands;(7)Amsterdam University Medical Centre- Vrije Universiteit Amsterdam, Gastroenterology, Amsterdam, The Netherlands;(8)Rijnstate Hospital, Gastroenterology, Arnhem, The Netherlands;(9)Onze Lieve Vrouwe Gasthuis, Gastroenterology, Amsterdam, The Netherlands;(10)Meander Medical Center, Gastroenterology, Amersfoort, The Netherlands;(11)Ziekenhuis Gelderse Vallei, Gastroenterology, Ede, The Netherlands;(12)University Medical Center Utrecht, Gastroenterology, Utrecht, The Netherlands;(13)Amsterdam University Medical Center- University of Amsterdam- Gastroenterology Endocrinology Metabolism AGEM Research Institute, Gastroenterology, Amsterdam, The Netherlands;(14)Jeroen Bosch Hospital, Gastroenterology, 's-Hertogenbosch, The Netherlands;(15)Haaglanden Medical Center, Gastroenterology, Den Haag, The Netherlands;(16)Haga Hospital, Gastroenterology, Den Haag, The Netherlands;(17)Franciscus Gasthuis & Vlietland, Gastroenterology, Rotterdam, The Netherlands;(18)Amsterdam University Medical Center, Epidemiology and Data Science, Amsterdam, The Netherlands;(19)Maastricht University Medical Center +, Gastroenterology, Maastricht, The Netherlands;(20)Leiden University Medical Center, Gastroenterology, Leiden, The Netherlands;(21)University of Alberta, Division of Gastroenterology, Edmonton, Canada; Dutch Initiative on Crohn and Colitis

Background

Background

Clinicians face difficulty in positioning biologics and JAK inhibitors in anti-TNF refractory ulcerative colitis (UC) patients. Head-to-head trials comparing the efficacy of vedolizumab and tofacitinib in UC patients are lacking. We aimed to compare the effectiveness and safety of vedolizumab and tofacitinib in anti-TNF experienced UC patients in our prospective, nationwide registry using a propensity score weighted cohort.

Methods

Methods

UC patients who failed anti-TNF treatment (with or without thiopurine) and initiated vedolizumab or tofacitinib treatment subsequently, were identified in the observational prospective Initiative on Crohn and Colitis (ICC) Registry. We selected patients with both clinical (Simple Clinical Colitis Activity Index (SCCAI) >2) and biochemical (C-reactive protein (CRP) >5mg/L or faecal calprotectin (FC) >250 µg/g) or endoscopic disease activity (endoscopic MAYO score ≥ 1) at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (SCCAI<2), biochemical remission (CRP ≤5 mg/L and/or FC ≤250 µg/g) and safety outcomes were compared after 52 weeks of treatment. Inverse propensity scores weighted comparison was used to adjust for confounding and selection bias.

Results

Results

Overall, 83 vedolizumab and 65 tofacitinib treated patients were included (table 1). Propensity score weighted analysis showed that tofacitinib treated patients were more likely to achieve corticosteroid-free clinical remission at week 12, 24 and 52 compared to vedolizumab treated patients (OR: 5.87, 95%CI:3.55-9.70, P<0.01, OR: 2.96, 95%CI: 1.85-4.73, P<0.01 and OR 2.96, 95%CI: 1.85-4.73, P<0.01, respectively) (table 2). In addition, tofacitinib treated patients were more likely to achieve biochemical remission at week 12 and week 24, remaining only statistically borderline at week 52 (OR: 2.96, 95%CI: 1.85-4.73, P<0.01, OR: 2.96, 95%CI: 1.85-4.73, P<0.01 and OR 1.68, 95%CI: 0.99-2.86, P=0.05, respectively) (table 2). There was no difference in infection rate (OR:1.057, 95%CI: 0.60-1.86, p=0.85) or severe adverse events (OR: 0.39, 95%CI: 0.03-4.33, P=0.44). No thromboembolic events were observed. Most common reason for treatment discontinuation was loss of response (table 3).


Conclusion

Conclusion

In tofacitinib treated, anti-TNF experienced, UC patients, we observed that a higher proportion of patients achieved corticosteroid-free remission after 12, 24 and 52 weeks compared to vedolizumab treated patients. In addition, more tofacitinib treated patients achieved biochemical remission at week 12 and 24. There was no statistically significant difference in severe adverse events.