S0809 Is There a Benefit of Immunomodulator and Anti-TNF Combination Therapy Over Monotherapy in the Real World, Long-Term Management of IBD? Assessing Multiyear Treatment Persistence and Mucosal Healing

Abstract

INTRODUCTION: The combination of an anti-TNF biologic with an immunomodulator increases effectiveness in the treatment of patients with severe Inflammatory Bowel Disease (IBD) compared with anti-TNF monotherapy. However, there are safety concerns regarding longterm use of combination therapy (CT). We sought to characterize the impact of CT on persistence of anti TNF treatment (PT) and mucosal healing (MH) in a large IBD cohort over a multiyear time period. METHODS: We utilized a longitudinal natural history registry of consented IBD patients prospectively followed at a tertiary center. Biologic-naïve patients that received anti-TNF treatment (infliximab or adalimumab), either as monotherapy or combined with immunomodulator (thiopurine or methotrexate) during 2012-2018, formed the two groups. Demographic, clinical, biochemistry and endoscopic data were analyzed. The main study outcomes were PT and the presence of MH in 1 and 3 years after the initiation of the treatment. A multivariate logistic regression model was utilized to control for potential confounders. RESULTS: Among 1021 biologic-naive IBD patients (median age 22, females 53%, Crohn’s disease [CD] 73% ulcerative colitis [UC] 27%), 478 (47%) received CT and 543 (53%) received anti-TNF monotherapy. The majority of CT regimens utilized a thiopurine (80%). At baseline, patients in CT group were younger (P = 0.005), had shorter disease duration (P = 0.002) with higher rates of endoscopic active disease (P = 0.001), anemia (P = 0.011), hypoalbuminemia (P = 0.003), elevated CRP (P < 0.001) and ESR (P = 0.001) and higher HBI score (P = 0.010). In the follow-up years, CT was associated with higher rates of PT at 1 (P = 0.001) and 3 years (P < 0.001), MH at 1 (P = 0.018) and 3 years (P = 0.006), lower rates of hospital admissions at 3-years (P = 0.025) and hypoalbuminemia at 1 (P = 0.031) and 3 years (P = 0.014). In multivariate analysis, CT remained significantly associated with PT at 1 (P = 0.032) and 3 years (P = 0.002), MH at 1 (P = 0.019) and 3 years (P = 0.033) and lower rates of hospitalizations at 3 year (P = 0.002) and hypoalbuminemia at 1 (P = 0.002) and 3 years (P = 0.032) in CD patients as well with PT at 3 years (P = 0.011) in UC patients. CONCLUSION: CT is independently associated with long-term PT in both CD and UC patients and MH in CD patients. More studies are required to fully understand the subgroups of patients who will most benefit from anti-TNF + immunomodulator combination therapy in IBD.Table 1Table 2Table 3