Shirley Cohen-Mekelburg1,2,3, Beth I Wallace1,2,3, Tony Van2, Wyndy L Wiitala2, Shail M Govani4,5, Jennifer Burns2, Rachel Lipson2, Huifeng Yun6, Jason Hou7,8, James D Lewis9,10,11, Jason A Dominitz12,13, Akbar K Waljee1,2,3,14. 1. Department of Internal Medicine, University of Michigan, Ann Arbor. 2. Veterans Affairs Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan. 3. Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor. 4. Department of Medicine, Division of Gastroenterology, South Texas Veterans Healthcare System, San Antonio. 5. Department of Medicine, Division of Gastroenterology, UT Health San Antonio, San Antonio, Texas. 6. Department of Epidemiology, School of Public Health, University of Alabama at Birmingham. 7. Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas. 8. Section of Gastroenterology and Hepatology, Department of Medicine, Baylor College of Medicine, Houston, Texas. 9. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia. 10. Division of Gastroenterology, University of Pennsylvania, Philadelphia. 11. Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia. 12. Center for Innovations in Quality, Effectiveness, and Safety, Veterans Affairs Puget Sound Health Care System, Seattle, Washington. 13. Department of Internal Medicine, Division of Gastroenterology, University of Washington School of Medicine, Seattle. 14. Michigan Integrated Center for Health Analytics and Medical Prediction, Ann Arbor.
Abstract
Importance: Inflammatory bowel disease (IBD) is commonly treated with corticosteroids and anti-tumor necrosis factor (TNF) drugs; however, medications have well-described adverse effects. Prior work suggests that anti-TNF therapy may reduce all-cause mortality compared with prolonged corticosteroid use among Medicare and Medicaid beneficiaries with IBD. Objective: To examine the association between use of anti-TNF or corticosteroids and all-cause mortality in a national cohort of veterans with IBD. Design, Setting, and Participants: This cohort study used a well-established Veteran's Health Administration cohort of 2997 patients with IBD treated with prolonged corticosteroids (≥3000-mg prednisone equivalent and/or ≥600 mg of budesonide within a 12-month period) and/or new anti-TNF therapy from January 1, 2006, to October 1, 2015. Data were analyzed between July 1, 2019, and December 31, 2020. Exposures: Use of corticosteroids or anti-TNF. Main Outcomes and Measures: The primary end point was all-cause mortality as defined by the Veterans Health Administration vital status file. Marginal structural modeling was used to compare associations between anti-TNF therapy or corticosteroid use and all-cause mortality. Results: A total of 2997 patients (2725 men [90.9%]; mean [SD] age, 50.0 [17.4] years) were included in the final analysis, 1734 (57.9%) with Crohn disease (CD) and 1263 (42.1%) with ulcerative colitis (UC). All-cause mortality was 8.5% (n = 256) over a mean (SD) of 3.9 (2.3) years' follow-up. At cohort entry, 1836 patients were new anti-TNF therapy users, and 1161 were prolonged corticosteroid users. Anti-TNF therapy use was associated with a lower likelihood of mortality for CD (odds ratio [OR], 0.54; 95% CI, 0.31-0.93) but not for UC (OR, 0.33; 95% CI, 0.10-1.10). In a sensitivity analysis adjusting prolonged corticosteroid users to include patients receiving corticosteroids within 90 to 270 days after initiation of anti-TNF therapy, the OR for UC was statistically significant, at 0.33 (95% CI, 0.13-0.84), and the OR for CD was 0.55 (95% CI, 0.33-0.92). Conclusions and Relevance: This study suggests that anti-TNF therapy may be associated with reduced mortality compared with long-term corticosteroid use among veterans with CD, and potentially among those with UC.
Importance: Inflammatory bowel disease (IBD) is commonly treated with corticosteroids and anti-tumor necrosis factor (TNF) drugs; however, medications have well-described adverse effects. Prior work suggests that anti-TNF therapy may reduce all-cause mortality compared with prolonged corticosteroid use among Medicare and Medicaid beneficiaries with IBD. Objective: To examine the association between use of anti-TNF or corticosteroids and all-cause mortality in a national cohort of veterans with IBD. Design, Setting, and Participants: This cohort study used a well-established Veteran's Health Administration cohort of 2997 patients with IBD treated with prolonged corticosteroids (≥3000-mg prednisone equivalent and/or ≥600 mg of budesonide within a 12-month period) and/or new anti-TNF therapy from January 1, 2006, to October 1, 2015. Data were analyzed between July 1, 2019, and December 31, 2020. Exposures: Use of corticosteroids or anti-TNF. Main Outcomes and Measures: The primary end point was all-cause mortality as defined by the Veterans Health Administration vital status file. Marginal structural modeling was used to compare associations between anti-TNF therapy or corticosteroid use and all-cause mortality. Results: A total of 2997 patients (2725 men [90.9%]; mean [SD] age, 50.0 [17.4] years) were included in the final analysis, 1734 (57.9%) with Crohn disease (CD) and 1263 (42.1%) with ulcerative colitis (UC). All-cause mortality was 8.5% (n = 256) over a mean (SD) of 3.9 (2.3) years' follow-up. At cohort entry, 1836 patients were new anti-TNF therapy users, and 1161 were prolonged corticosteroid users. Anti-TNF therapy use was associated with a lower likelihood of mortality for CD (odds ratio [OR], 0.54; 95% CI, 0.31-0.93) but not for UC (OR, 0.33; 95% CI, 0.10-1.10). In a sensitivity analysis adjusting prolonged corticosteroid users to include patients receiving corticosteroids within 90 to 270 days after initiation of anti-TNF therapy, the OR for UC was statistically significant, at 0.33 (95% CI, 0.13-0.84), and the OR for CD was 0.55 (95% CI, 0.33-0.92). Conclusions and Relevance: This study suggests that anti-TNF therapy may be associated with reduced mortality compared with long-term corticosteroid use among veterans with CD, and potentially among those with UC.
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