Abstract

Introduction: Hepatobiliary and pancreatic disorders are common extra-intestinal manifestations in inflammatory bowel diseases (IBD), both in Crohn’s Disease & Ulcerative Colitis (UC). Anti-TNF agents have been widely used in the management of IBD and are considered relatively safe. We sought to investigate the impact of anti-TNF on the prevalence of hepatobiliary and pancreatic disorders in IBD patients. Methods: We used a commercial database (Explorys Inc, Cleveland, OH) which includes electronic health record data from 26 major integrated US healthcare systems. We identified adults who were diagnosed with either CD or UC between 1999 and 2022 who were treated with any type of anti-TNF agents. We investigated the prevalence of known hepatobiliary and pancreatic disorders in IBD including Autoimmune Hepatitis (AIH), Cholelithiasis, Primary Sclerosing Cholangitis (PSC), portal vein thrombosis (PVT), Cholangiocarcinoma (CCA), and idiopathic pancreatitis (IP) in patients with & without anti-TNF therapy. We also identified patients with CD & UC on anti-TNF who developed lupus (excluding Sulfasalazine). Results: Out of the 69,260,780 adult patients in the database, we identified 249,480 patients with CD (0.36%) of whom 39280 received anti-TNF (15.7%). In addition, 209,020 with UC (0.30%) of whom 19860 received anti-TNF (9.50%). Figure illustrates demographic characteristics of IBD patients on anti-TNF. CD patients who received anti-TNF were less likely to develop cholelithiasis (OR 0.88 [0.84-0.93]), PVT (OR 0.61 [0.50-0.74]), PSC (OR 0.59 [0.37-0.94)] or CCA (OR 0.50 [0.34-0.73]). Similarly, UC patients who received anti-TNF were less likely to develop cholelithiasis (OR 0.88 [0.79-0.97]), PVT (OR 0.65 [0.52-0.81]), PSC (OR 0.64 [0.44-0.93]), or CCA (OR 0.52 [0.36-0.75]). Both CD & UC groups on anti-TNF have a higher risk of AIH (OR 1.38 [1.13-1.69]) vs (OR 1.27 [1.02-1.58]). Likewise, both groups are at higher risk of IP (OR 1.95 [1.59-2.38] vs (OR 1.79 [1.38-2.31]). Furthermore, patients on CD & UC groups who received anti-TNF are more likely to develop lupus (OR 2.14 [1.59-2.90]) vs (OR 1.92 (1.29-2.84]. Conclusion: In this large retrospective study, we found that IBD patients who were treated with anti-TNF were significantly less likely to develop cholelithiasis, PVT, PSC or CCA. However, a higher risk of AIH and IP is observed in the anti-TNF group. This relationship may reflect an autoimmune side effect of anti-TNF, e.g. lupus-like reactions. Further study is needed to explore potential causality.Figure 1.: Demographic characteristics of IBD patients on anti-TNF Table 1. - Hepatobiliary and pancreatic disorders in CD and UC with anti-TNF therapy Crohn's Disease Ulcerative Colitis Total (Percentage) On Anti-TNF (percentage) OR (95% CI) Total (Percentage) On Anti-TNF (percentage) OR (95% CI) 249,480 39280 209,020 19,860 AIH 590 (0.23%) 120 (0.030%) 1.38 (1.13-1.69) 790 (0.37%) 90 (0.45%) 1.27 (1.02-1.58) CCA 350 (0.14%) 30 (0.07%) 0.50 (0.34-0.73) 590 (0.28%) 30 (0.15%) 0.52 (0.36-0.75) Cholelithiasis 16420 (6.58%) 1560 (3.97%) 0.88 (0.84-0.93) 13030 (6.23%) 430 (2.16%) 0.88 (0.79-0.97) IP 490 (0.19%) 130 (0.33%) 1.95 (1.59-2.38) 450 (0.21%) 70 (0.35%) 1.79 (1.38-2.31) PVT 1090 (0.43%) 110 (0.28%) 0.61 (0.50-0.74) 1320 (0.63%) 80 (0.40%) 0.65 (0.52-0.81) PSC 200 (0.08%) 20 (0.05%) 0.59 (0.37-0.94) 480 (0.22%) 30 (0.15%) 0.64 (0.44-0.93) Lupus* 210 (0.084%) 60 (0.15%) 2.14 (1.59-2.90) 180 (0.086%) 30 (0.15%) 1.92 (1.29-2.84) Footnote: OR: Odds Ratio; CI; Confidence Interval; AIH: Auto-immune hepatitis; CCA: Cholangiocarcinoma; IP: Idiopathic Pancreatitis; PVT: Portal vein thrombosis; PSC: Primary Sclerosing Cholangitis.*Lupus is investigated for correlation with anti-TNF.

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