No Evidence That Azathioprine Increases Risk of Cholangiocarcinoma in Patients With Primary Sclerosing Cholangitis
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No Evidence That Azathioprine Increases Risk of Cholangiocarcinoma in Patients With Primary Sclerosing Cholangitis. / Zenouzi, Roman; Weismüller, Tobias J; Jørgensen, Kristin K; Bubenheim, Michael; Lenzen, Henrike; Hübener, Peter; Schulze, Kornelius; Weiler-Normann, Christina; Sebode, Marcial; Ehlken, Hanno; Pannicke, Nadine; Hartl, Johannes; Peiseler, Moritz; Hübener, Sina; Karlsen, Tom H; Boberg, Kirsten M; Manns, Michael P; Lohse, Ansgar W; Schramm, Christoph.
In: CLIN GASTROENTEROL H, Vol. 14, No. 12, 12.2016, p. 1806-1812.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - No Evidence That Azathioprine Increases Risk of Cholangiocarcinoma in Patients With Primary Sclerosing Cholangitis
AU - Zenouzi, Roman
AU - Weismüller, Tobias J
AU - Jørgensen, Kristin K
AU - Bubenheim, Michael
AU - Lenzen, Henrike
AU - Hübener, Peter
AU - Schulze, Kornelius
AU - Weiler-Normann, Christina
AU - Sebode, Marcial
AU - Ehlken, Hanno
AU - Pannicke, Nadine
AU - Hartl, Johannes
AU - Peiseler, Moritz
AU - Hübener, Sina
AU - Karlsen, Tom H
AU - Boberg, Kirsten M
AU - Manns, Michael P
AU - Lohse, Ansgar W
AU - Schramm, Christoph
N1 - Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.
PY - 2016/12
Y1 - 2016/12
N2 - BACKGROUND & AIMS: Patients with primary sclerosing cholangitis (PSC) are at increased risk for developing cholangiocarcinoma (CCA). Patients with PSC also can have inflammatory bowel diseases (IBDs) or features of autoimmune hepatitis (AIH), and therefore are treated with azathioprine. Azathioprine has been associated with an increased risk for malignancy, therefore we investigated whether azathioprine use affects the risk of CCA in persons with PSC.METHODS: We performed a retrospective study of well-defined patients with PSC using data collected from 3 large-volume, tertiary care centers in Germany and Norway. We analyzed data from 638 patients (70% men; 5900 patient-years of follow-up evaluation); 91 patients had received azathioprine therapy (considered to be effective at 90 days after first intake). Risk analysis was performed using the Cox proportional hazard model when risks competing with study end points were present.RESULTS: Of patients who received azathioprine treatment, 3.3% developed CCA, compared with 6.8% of patients without azathioprine treatment. However, azathioprine did not significantly affect the risk for CCA (hazard ratio, 0.96; 95% confidence interval, 0.29-3.13; P = .94). The only factor associated with an increased risk of CCA was age 35 years or older at PSC diagnosis (hazard ratio, 3.87; 95% confidence interval, 1.96-7.67; P < .01). Patient sex, concomitant IBD, or AIH did not affect the risk of CCA. Overall, the cumulative 10-year incidence of CCA was 4.6% and the cumulative 15-year incidence was 7.7%.CONCLUSIONS: A retrospective analysis of patients with PSC treated at tertiary centers in Europe found no evidence that azathioprine significantly affects the risk of CCA. Azathioprine therefore should not be withheld from patients with PSC and concomitant IBD and/or AIH.
AB - BACKGROUND & AIMS: Patients with primary sclerosing cholangitis (PSC) are at increased risk for developing cholangiocarcinoma (CCA). Patients with PSC also can have inflammatory bowel diseases (IBDs) or features of autoimmune hepatitis (AIH), and therefore are treated with azathioprine. Azathioprine has been associated with an increased risk for malignancy, therefore we investigated whether azathioprine use affects the risk of CCA in persons with PSC.METHODS: We performed a retrospective study of well-defined patients with PSC using data collected from 3 large-volume, tertiary care centers in Germany and Norway. We analyzed data from 638 patients (70% men; 5900 patient-years of follow-up evaluation); 91 patients had received azathioprine therapy (considered to be effective at 90 days after first intake). Risk analysis was performed using the Cox proportional hazard model when risks competing with study end points were present.RESULTS: Of patients who received azathioprine treatment, 3.3% developed CCA, compared with 6.8% of patients without azathioprine treatment. However, azathioprine did not significantly affect the risk for CCA (hazard ratio, 0.96; 95% confidence interval, 0.29-3.13; P = .94). The only factor associated with an increased risk of CCA was age 35 years or older at PSC diagnosis (hazard ratio, 3.87; 95% confidence interval, 1.96-7.67; P < .01). Patient sex, concomitant IBD, or AIH did not affect the risk of CCA. Overall, the cumulative 10-year incidence of CCA was 4.6% and the cumulative 15-year incidence was 7.7%.CONCLUSIONS: A retrospective analysis of patients with PSC treated at tertiary centers in Europe found no evidence that azathioprine significantly affects the risk of CCA. Azathioprine therefore should not be withheld from patients with PSC and concomitant IBD and/or AIH.
U2 - 10.1016/j.cgh.2016.07.032
DO - 10.1016/j.cgh.2016.07.032
M3 - SCORING: Journal article
C2 - 27521513
VL - 14
SP - 1806
EP - 1812
JO - CLIN GASTROENTEROL H
JF - CLIN GASTROENTEROL H
SN - 1542-3565
IS - 12
ER -
