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Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts

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@article{e52a15438ff844b6b74a242723d610e6,
title = "Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes: analysis of two nationwide population-based cohorts",
abstract = "OBJECTIVE: The benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.DESIGN: Our primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA.RESULTS: A total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.CONCLUSION: In two national databases, stopping 5-ASA in patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.",
keywords = "Adult, Anti-Inflammatory Agents, Non-Steroidal/adverse effects, Biological Therapy/adverse effects, Cohort Studies, Colitis, Ulcerative/drug therapy, Databases, Factual, Denmark, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Kaplan-Meier Estimate, Male, Mesalamine/adverse effects, Proportional Hazards Models, Retrospective Studies, Risk Assessment, Severity of Illness Index, Statistics, Nonparametric, Treatment Outcome, United States, Withholding Treatment",
author = "Ungaro, {Ryan C} and Limketkai, {Berkeley N} and Jensen, {Camilla Bj{\o}rn} and Allin, {Kristine H{\o}jgaard} and Manasi Agrawal and Thomas Ullman and Jean-Frederic Colombel and Tine Jess",
note = "{\textcopyright} Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2019",
month = jun,
doi = "10.1136/gutjnl-2018-317021",
language = "English",
volume = "68",
pages = "977--984",
journal = "Gut",
issn = "0017-5749",
publisher = "B M J Group",
number = "6",

}

RIS

TY - JOUR

T1 - Stopping 5-aminosalicylates in patients with ulcerative colitis starting biologic therapy does not increase the risk of adverse clinical outcomes

T2 - analysis of two nationwide population-based cohorts

AU - Ungaro, Ryan C

AU - Limketkai, Berkeley N

AU - Jensen, Camilla Bjørn

AU - Allin, Kristine Højgaard

AU - Agrawal, Manasi

AU - Ullman, Thomas

AU - Colombel, Jean-Frederic

AU - Jess, Tine

N1 - © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2019/6

Y1 - 2019/6

N2 - OBJECTIVE: The benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.DESIGN: Our primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA.RESULTS: A total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.CONCLUSION: In two national databases, stopping 5-ASA in patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.

AB - OBJECTIVE: The benefit of continuing 5-aminosalicylate (5-ASA) in patients with ulcerative colitis (UC) who initiate anti-tumour necrosis factor-alpha (anti-TNF) biologics is unknown. We aimed to compare clinical outcomes in patients with UC already on 5-ASA who started anti-TNF and then either stopped or continued 5-ASA.DESIGN: Our primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, UC-related hospitalisation or surgery. We used two national databases: the United States (US) Truven MarketScan health claims database and the Danish health registers. Patients with UC who started anti-TNF after having been on oral 5-ASA for at least 90 days were included. Patients were classified as stopping 5-ASA if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors and healthcare utilisation. Adjusted HRs (aHR) with 95% CI are reported comparing stopping 5-ASA with continuing 5-ASA.RESULTS: A total of 3589 patients with UC were included (2890 US and 699 Denmark). Stopping 5-ASA after initiating anti-TNF was not associated with an increased risk of adverse clinical events in the U.S. cohort (aHR 1.04; 95% CI 0.90 to 1.21, p=0.57) nor in the Danish cohort (aHR 1.09; 95% CI 0.80 to 1.49, p=0.60). Results were similar in sensitivity analyses investigating concomitant immunomodulator use and duration of 5-ASA treatment before initiating anti-TNF.CONCLUSION: In two national databases, stopping 5-ASA in patients with UC starting anti-TNF therapy did not increase the risk of adverse clinical events. These results should be validated in a prospective clinical trial.

KW - Adult

KW - Anti-Inflammatory Agents, Non-Steroidal/adverse effects

KW - Biological Therapy/adverse effects

KW - Cohort Studies

KW - Colitis, Ulcerative/drug therapy

KW - Databases, Factual

KW - Denmark

KW - Dose-Response Relationship, Drug

KW - Drug Administration Schedule

KW - Female

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Mesalamine/adverse effects

KW - Proportional Hazards Models

KW - Retrospective Studies

KW - Risk Assessment

KW - Severity of Illness Index

KW - Statistics, Nonparametric

KW - Treatment Outcome

KW - United States

KW - Withholding Treatment

UR - http://www.scopus.com/inward/record.url?scp=85056848656&partnerID=8YFLogxK

U2 - 10.1136/gutjnl-2018-317021

DO - 10.1136/gutjnl-2018-317021

M3 - Journal article

C2 - 30420398

VL - 68

SP - 977

EP - 984

JO - Gut

JF - Gut

SN - 0017-5749

IS - 6

ER -

ID: 55650101