TY - JOUR
T1 - Stopping Mesalamine Therapy in Patients With Crohn's Disease Starting Biologic Therapy Does Not Increase Risk of Adverse Outcomes
AU - Ungaro, Ryan C.
AU - Limketkai, Berkeley N.
AU - Jensen, Camilla Bjørn
AU - Yzet, Clara
AU - Allin, Kristine H.
AU - Agrawal, Manasi
AU - Ullman, Thomas
AU - Burisch, Johan
AU - Jess, Tine
AU - Colombel, Jean Frederic
N1 - Funding Information:
Funding Access to the Truven Health MarketScan Commercial Database was provided by the Stanford Center for Population Health Sciences Data Core. The Population Health Sciences Data Core is supported by a National Institutes of Health National Center for Advancing Translational Science Clinical and Translational Science Award (UL1 TR001085) and by internal Stanford funding. Also supported by a Career Development Award from the Crohn's and Colitis Foundation and a National Institutes of Health K23 Career Development Award (K23KD111995-01A1) (R.C.U.). This work was supported in part by the Sinai Ulcerative Colitis Clinical, Experimental and System Studies grant. Conflicts of interest These authors disclose the following: Ryan C. Ungaro has served as an advisory board member or consultant for Janssen, Pfizer, and Takeda, and has received research grants from AbbVie, Boehringer Ingelheim, and Pfizer; Jean-Frederic Colombel has served as an advisory board member or consultant for AbbVie, Amgen, Boehringer-Ingelheim, Arena Pharmaceuticals, Celgene Corporation, Celltrion, Enterome, Eli Lilly, Ferring Pharmaceuticals, Genentech, Janssen and Janssen, Medimmune, Merck & Co, Nextbiotix, Novartis Pharmaceuticals Corporation, Otsuka Pharmaceutical Development and Commercialization, Inc, Pfizer, Protagonist, Second Genome, Gilead, Seres Therapeutics, Shire, Takeda, and Theradiag, has served as a speaker for AbbVie, Ferring, Takeda, and Celgene Corporation, has stock options in Intestinal Biotech Development and Genefit, and has received research grants from AbbVie, Takeda, and Janssen and Janssen; and Johan Burisch has served as an advisory board member or consultant for AbbVie, Janssen-Cilag, Celgene, MSD, Pfizer, Samsung Bioepis, and Takeda, and has received research grants from AbbVie, Takeda, and Tillots Pharma. The remaining authors disclose no conflicts.
Funding Information:
Funding Access to the Truven Health MarketScan Commercial Database was provided by the Stanford Center for Population Health Sciences Data Core. The Population Health Sciences Data Core is supported by a National Institutes of Health National Center for Advancing Translational Science Clinical and Translational Science Award ( UL1 TR001085 ) and by internal Stanford funding. Also supported by a Career Development Award from the Crohn's and Colitis Foundation and a National Institutes of Health K23 Career Development Award ( K23KD111995-01A1 ) (R.C.U.). This work was supported in part by the Sinai Ulcerative Colitis Clinical, Experimental and System Studies grant.
Publisher Copyright:
© 2020 AGA Institute
PY - 2020/5
Y1 - 2020/5
N2 - Background & Aims: Little is known about the effects of discontinuing mesalamine therapy for patients with Crohn's disease (CD) who initiate therapy with an anti–tumor necrosis factor (anti-TNF) agent. We analyzed data from 2 national population cohorts to compare outcomes of patients with CD already on mesalamine therapy who started treatment with an anti-TNF agent and then either stopped or continued mesalamine. Methods: The primary outcome was any adverse clinical event, defined as a composite of new corticosteroid use or CD-related hospitalization or surgery. We collected data from the Truven MarketScan (IBM, Armonk, NY) health claims database in the United States and the Danish health registers. Our analysis included patients with CD who started anti-TNF therapy after at least 90 days of oral mesalamine therapy. Patients were classified as stopping mesalamine if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors, and health care utilization. Adjusted hazard ratios with 95% CIs were calculated, comparing stopping mesalamine with continuing mesalamine. Results: A total of 3178 patients with CD were included in our final analysis (2960 in the United States and 218 in Denmark). Stopping mesalamine after initiating anti-TNF therapy was not associated with an increased risk of adverse clinical events in the US cohort (adjusted hazard ratio, 0.89; 95% CI, 0.77–1.03; P = .13) or in the Danish cohort (adjusted hazard ratio, 1.13; 95% CI, 0.68–1.87; P = .63). Similar results were obtained from sensitivity analyses of concomitant immunomodulator use and duration of mesalamine treatment before initiation of anti-TNF therapy. Conclusions: In a retrospective analysis of 2 national databases, we found that stopping mesalamine therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events. These results should be validated in a prospective study.
AB - Background & Aims: Little is known about the effects of discontinuing mesalamine therapy for patients with Crohn's disease (CD) who initiate therapy with an anti–tumor necrosis factor (anti-TNF) agent. We analyzed data from 2 national population cohorts to compare outcomes of patients with CD already on mesalamine therapy who started treatment with an anti-TNF agent and then either stopped or continued mesalamine. Methods: The primary outcome was any adverse clinical event, defined as a composite of new corticosteroid use or CD-related hospitalization or surgery. We collected data from the Truven MarketScan (IBM, Armonk, NY) health claims database in the United States and the Danish health registers. Our analysis included patients with CD who started anti-TNF therapy after at least 90 days of oral mesalamine therapy. Patients were classified as stopping mesalamine if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors, and health care utilization. Adjusted hazard ratios with 95% CIs were calculated, comparing stopping mesalamine with continuing mesalamine. Results: A total of 3178 patients with CD were included in our final analysis (2960 in the United States and 218 in Denmark). Stopping mesalamine after initiating anti-TNF therapy was not associated with an increased risk of adverse clinical events in the US cohort (adjusted hazard ratio, 0.89; 95% CI, 0.77–1.03; P = .13) or in the Danish cohort (adjusted hazard ratio, 1.13; 95% CI, 0.68–1.87; P = .63). Similar results were obtained from sensitivity analyses of concomitant immunomodulator use and duration of mesalamine treatment before initiation of anti-TNF therapy. Conclusions: In a retrospective analysis of 2 national databases, we found that stopping mesalamine therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events. These results should be validated in a prospective study.
KW - IBD Treatment
KW - Inflammatory Bowel Disease
KW - Mesalamine
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U2 - 10.1016/j.cgh.2019.08.012
DO - 10.1016/j.cgh.2019.08.012
M3 - Article
C2 - 31419574
AN - SCOPUS:85083018003
SN - 1542-3565
VL - 18
SP - 1152-1160.e1
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 5
ER -