P352 Ustekinumab is associated with superior treatment persistence compared to vedolizumab in Crohn’s disease patients who failed to anti-TNF therapy: results from a Hungarian cohort study

Abstract

Abstract Background Anti-tumor necrosis factor alpha treatments are effective and safe as first line therapy, however, their long-term efficacy is limited by primary (PNR) and secondary non-response (LOR) resulting in treatment discontinuation in approximately, 40–50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapy could be good alternative in patient with anti-TNF failure, however, no direct comparison has been made. This study aimed to assess treatment persistence and long-term efficacy of VDZ and UST as second- and third line biological therapies in Crohn’s disease (CD) patients refractory to anti-TNF therapy. Methods In this multicentre study, CD patients on VDZ or UST maintenance therapy were enrolled. We analysed data of medical history retrospectively in case of both agents. Demographic and clinical data at baseline and one-year were obtained. Clinical (CDAI<150) and biochemical (CRP<10) activities and steroid-free remission were assessed while concomitant medications, hospitalisations and surgeries were recorded during the follow-up. We performed Kaplan–Meier analyses of persistence on treatment including age, CRP, CDAI at baseline, localisation, disease duration, treatment level as possible predictors. Results 200 UST and, 96 VDZ-treated patients were included in the study. After exclusion of confounders, 162 UST and, 77 VDZ-treated patients were completed the follow-up. Mean age was, 41,1 (±16,5) and, 37,9 (±11,3) years at both agents at baseline. Steroid-free clinical and biochemical remission rates did not differ between VDZ and UST groups at one year (73% vs, 73% and, 67% vs., 51%). Kaplan-Meyer analysis revealed superiority of UST during follow up (86,5% vs., 62,9%, p<0,0001). At both agents, second-line therapy was superior to third line in drug persistence (p=0,019,Exp(B)=, 0,314). None of the further examined parameters predicted treatment outcome. Therapies were terminated due to PNR in, 14 (18%) vs., 8 (5%) cases, while LOR appeared at, 13 (17%) vs., 12 (7,4%) cases at VDZ and UST treatment. One patient discontinued UST therapy due to adverse drug reaction at w20. Other drug-associated adverse reactions didn’t occur during the follow-up. During the follow-up surgery was indicated in, 6 and, 4 cases on VDZ, and, 8 and, 1 cases on UST treatment due to activity and perianal disease (8 and, 5%;, 5 and, 1%, p=0,39, p=0,04). Conclusion We confirmed that VDZ and UST are effective and safe alternatives to CD patients who have failed to anti-TNF therapy. UST has a superiority in drug persistence compared to VDZ. Second compared to third line of sequential therapy results in better outcome in drug persistence in case of both agents, however, head-to-head comparison of both agents are needed to verify our data.