title: Comparative effectiveness and safety of infliximab and adalimumab in patients with ulcerative colitis.
abstract: BACKGROUND
  Real-world comparative benefits and risks of infliximab (IFX) and adalimumab (ADA) in patients with ulcerative colitis (UC) are unclear.
  
  
  OBJECTIVE
  To evaluate the comparative effectiveness and safety of IFX and ADA in patients with UC who were new users of anti-TNF agents.
  
  
  METHODS
  Using an administrative claims database (Optum Labs Data Warehouse), we identified patients who received first anti-TNF (IFX, ADA) prescription after a 12-month period without any anti-TNF treatment (baseline), and with a minimum 6-month follow-up after anti-TNF initiation. Primary outcome measures were: all-cause and UC-related hospitalisation, abdominal surgery, corticosteroid use >60 days after starting anti-TNF, and serious infections. We performed 2:1 propensity-score matched Cox proportional hazard analysis, and inverse probability-of-treatment weight (IPTW) analysis, accounting for healthcare utilisation, comorbidities and use of UC-related medication.
  
  
  RESULTS
  We included 1400 new users of anti-TNF agents (age, 43 ± 15 years; 52% males), from 2006 to 2014. On propensity-score matched analysis, there was no significant difference in the risk of UC-related hospitalisation [IFX vs. ADA; adjusted hazard ratio (aHR), 1.04; 95% confidence interval (CI) 0.71-1.51], corticosteroid use (aHR, 0.85; 95% CI, 0.68-1.06) and serious infections (aHR, 0.62; 95% CI, 0.29-1.34) between IFX- and ADA-treated patients; the number of surgical events was very small. On IPTW analysis, risk of corticosteroid use was significantly lower in IFX - as compared to ADA - treated patients (aHR, 0.82; 95% CI, 0.68-0.99). Results were stable on multiple sensitivity analyses.
  
  
  CONCLUSIONS
  In a large retrospective cohort of patients with UC who were new users of anti-TNF agents, IFX-treated patients may have lower corticosteroid use than ADA-treated patients, but risk of hospitalisation and serious infections were comparable.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.|Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.|Division of Biomedical Informatics, University of California San Diego, La Jolla, CA, USA.
authors.forename: S
authors.initials: S
authors.lastname: Singh
authors.affiliation: Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
authors.forename: H C
authors.initials: HC
authors.lastname: Heien
authors.affiliation: Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
authors.forename: L R
authors.initials: LR
authors.lastname: Sangaralingham
authors.affiliation: Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
authors.forename: S R
authors.initials: SR
authors.lastname: Schilz
authors.affiliation: Division of Pediatric Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: M D
authors.initials: MD
authors.lastname: Kappelman
authors.affiliation: Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.|Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA.|Optum Labs, Cambridge, MA, USA.
authors.forename: N D
authors.initials: ND
authors.lastname: Shah
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.
authors.forename: E V
authors.initials: EV
authors.lastname: Loftus
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005938:Glucocorticoids / Q000008:administration & dosage; D006760:Hospitalization; D006801:Humans; D000069285:Infliximab / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007345:Insurance Claim Review; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies
chemical_list: D005765:Gastrointestinal Agents; D005938:Glucocorticoids; D000069285:Infliximab; D000068879:Adalimumab