P612 Immunosuppressive co-treatment with infliximab and adalimumab is not superior to anti-TNF monotherapy to prevent treatment failure and treatment discontinuation in ulcerative colitis

Abstract

Introduction: In Crohn's disease there is clear benefit from combination therapy with infliximab (IFX) and immunosuppressive drugs (IS), while the benefit seems more limited for adalimumab (ADA). Although some studies suggest a benefit of combination therapy with IFX in ulcerative colitis (UC) few data are available [1]. Aims & Methods: Our aim was to compare real life efficacy of anti-TNF monotherapy (IFX and ADA) and anti-TNF+IS for UC maintenance. This was a retrospective study of patients with UC treated with IFX or ADA in 2 Belgian academic and regional Hospitals. Treatment periods were divided into 6-month semesters. A combination therapy semester was defined as anti-TNF+IS for at least 3 months, a failure semester as anti-TNF withdrawal for secondary loss of response, intolerance or surgery, a treatment optimisation semester as anti-TNF dose escalation or steroids start. Semesters with and without failure and with or without optimisation were compared through univariate and multivariate analysis. Patients receiving 6 months anti-TNF+IS during the first semesters were separately analysed. Result(s): 478 semesters in 60 patients with IFX and 175 semesters in 33 patients with ADA were included. The mean IFX and ADA treatment duration were respectively 49 (+/-33) months and 38 (+/-19) months. Within patients treated with IFX, 32/60 patients received IFX+IS during the first semester. IFX was administrated as monotherapy in 361/478 semesters (76%). Respectively 218/478 (46%) and 78/478 semesters (16%) with IFX required dose escalation and corticosteroids course. IFX+IS was associated with more semesters with failure (5% vs 3%, p=0.02) and numerically more semesters with dose escalation (64% vs 28%, p=0.06). There was no difference in corticosteroids use (p=0.63). IS during the first semester was not associated with lower risk of IFX failure (p=0.41) nor with a longer survival without IFX withdrawal (p=0.20). Continuing the IS treatment beyond the first semester was not associated with fewer semesters with failure (p=0.18). Within patients treated with ADA, 19/33 patients received IFX+IS during the first semester. ADA was administrated as monotherapy in 93/175 semesters (53%). Respectively 84/175 (48%) and 42/175 (24%) semesters with ADA required dose escalation and corticosteroids course. ADA+IS was not associated with less semesters with failure (7% vs 5%, p=0.58), less semesters with corticosteroids use (p=0.63). More semesters with ADA+IS required ADA dose escalation (61% vs 30%, p=0.01). IS during the first semester was not associated with lower risk of ADA failure (p=0.84) nor with a longer survival without ADA withdrawal (p=0.78). Continuing the IS treatment beyond the first semester was not associated with fewer semesters with failure (p=0.20). Conclusion(s): In this real-life experience, combination therapy of IFX or ADA with IS during the first semester or prolonged after the first semester was not associated with less dose escalations, steroid courses or treatment failures.