TY - JOUR
T1 - Comparative Effectiveness and Safety of Anti–Tumor Necrosis Factor Agents in Biologic-Naive Patients With Crohn's Disease
AU - Singh, Siddharth
AU - Heien, Herbert C.
AU - Sangaralingham, Lindsey R.
AU - Schilz, Stephanie R.
AU - Kappelman, Michael D.
AU - Shah, Nilay D.
AU - Loftus, Edward V.
N1 - Funding Information:
Funding This study was supported by the American College of Gastroenterology Clinical Research Award 2014 (to SS), the Center for the Science of Health Care Delivery, Mayo Clinic, and a CTSA grant (UL1 TR000135) from the National Center for Advancing Translational Sciences, a component of the National Institutes of Health. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2016 AGA Institute
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Background & Aims Inhibitors of tumor necrosis factor (anti-TNF agents) are the most effective therapy for Crohn's disease (CD). We evaluated the real-world comparative effectiveness and safety of different anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) in biologic-naive patients with CD in a retrospective, propensity-matched cohort study using a national administrative claims database (Optum Labs Data Warehouse). Methods We identified 3205 biologic-naive patients with CD (mean age, 41 ± 15 years; 45% male; median follow-up period after anti-TNF therapy, 19 months; 44.5% on infliximab and 38.9% on adalimumab) who received their first prescription for an anti-TNF agent (infliximab, adalimumab, or certolizumab pegol) after a 12-month period without any anti-TNF treatment (baseline), and with a minimum follow-up period of 6 months after their initial anti-TNF prescription, between 2006 and 2014. The primary outcomes were all-cause and CD-related hospitalization, abdominal surgery, corticosteroid use, and serious infections. We performed a propensity-matched, Cox proportional hazards analysis, accounting for baseline demographics, health care use, comorbidities, and use of CD-related medication. Results Compared with adalimumab-treated patients, infliximab-treated patients had a lower risk of CD-related hospitalization (adjusted hazard ratio [aHR], 0.80; 95% confidence interval [CI], 0.66–0.98), abdominal surgery (aHR, 0.76; 95% CI, 0.58–0.99), and corticosteroid use (aHR, 0.85; 95% CI, 0.75–0.96). Compared with certolizumab pegol–treated patients, infliximab-treated patients had a lower risk of all-cause hospitalization (aHR, 0.70; 95% CI, 0.52–0.95) and CD-related hospitalization (aHR, 0.59; 95% CI, 0.39–0.90). Adalimumab-treated patients had outcomes comparable with those of certolizumab pegol–treated patients. All agents had comparable risk of serious infections. Conclusions In a retrospective analysis of a large cohort of biologic-naive patients with CD, we found infliximab to be superior to adalimumab and certolizumab pegol for patient-relevant outcomes, without increased risk of serious infections.
AB - Background & Aims Inhibitors of tumor necrosis factor (anti-TNF agents) are the most effective therapy for Crohn's disease (CD). We evaluated the real-world comparative effectiveness and safety of different anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) in biologic-naive patients with CD in a retrospective, propensity-matched cohort study using a national administrative claims database (Optum Labs Data Warehouse). Methods We identified 3205 biologic-naive patients with CD (mean age, 41 ± 15 years; 45% male; median follow-up period after anti-TNF therapy, 19 months; 44.5% on infliximab and 38.9% on adalimumab) who received their first prescription for an anti-TNF agent (infliximab, adalimumab, or certolizumab pegol) after a 12-month period without any anti-TNF treatment (baseline), and with a minimum follow-up period of 6 months after their initial anti-TNF prescription, between 2006 and 2014. The primary outcomes were all-cause and CD-related hospitalization, abdominal surgery, corticosteroid use, and serious infections. We performed a propensity-matched, Cox proportional hazards analysis, accounting for baseline demographics, health care use, comorbidities, and use of CD-related medication. Results Compared with adalimumab-treated patients, infliximab-treated patients had a lower risk of CD-related hospitalization (adjusted hazard ratio [aHR], 0.80; 95% confidence interval [CI], 0.66–0.98), abdominal surgery (aHR, 0.76; 95% CI, 0.58–0.99), and corticosteroid use (aHR, 0.85; 95% CI, 0.75–0.96). Compared with certolizumab pegol–treated patients, infliximab-treated patients had a lower risk of all-cause hospitalization (aHR, 0.70; 95% CI, 0.52–0.95) and CD-related hospitalization (aHR, 0.59; 95% CI, 0.39–0.90). Adalimumab-treated patients had outcomes comparable with those of certolizumab pegol–treated patients. All agents had comparable risk of serious infections. Conclusions In a retrospective analysis of a large cohort of biologic-naive patients with CD, we found infliximab to be superior to adalimumab and certolizumab pegol for patient-relevant outcomes, without increased risk of serious infections.
KW - Biologics
KW - Database Analysis
KW - Propensity Matching
KW - Real-World Effectiveness
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U2 - 10.1016/j.cgh.2016.03.038
DO - 10.1016/j.cgh.2016.03.038
M3 - Article
C2 - 27058635
AN - SCOPUS:84977574388
SN - 1542-3565
VL - 14
SP - 1120-1129.e6
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 8
ER -