title: Impact of concomitant immunomodulator use on long-term outcomes in patients receiving scheduled maintenance infliximab.
abstract: The long-term benefits of combining scheduled infliximab with concomitant immunomodulators [azathioprine or 6-mercaptopurine (6-MP)] in patients with Crohn's disease are unclear. Historical cohort followed for 5 years after initiation of infliximab for active Crohn's disease. Data were available on 123 patients who received scheduled maintenance infliximab infusions, for up to 5 years after initiation of infliximab. Clinical remission rates in the entire cohort were 73% (82/113) at 1 year, 65% (65/100) at 2 years, and 58% (21/36) at 5 years. Remission rates with maintenance infliximab were significantly improved in those receiving concomitant immunomodulators at 1 year (86% versus 68%, P = 0.03), but not at 2 years (80% versus 72%, P = 0.4). In a multivariate logistic regression model, concomitant immunomodulator use was not associated with a significantly improved odds ratio of remission in patients on maintenance infliximab [odds ratio (OR) 1.1, 95% confidence intervals (CI) 0.9-1.2, P = 0.9]. The risk of surgery was significantly reduced in those receiving immunomodulators at the commencement of maintenance infliximab (OR 0.3, 95% CI 0.1-0.7, P = 0.01), but not in patients who continued maintenance concomitant therapy (OR 0.4, 95% CI 0.1-1.5, P = 0.1). The combination of maintenance infliximab and an immunomodulator produced modest improvements in outcomes beyond maintenance infliximab alone in this cohort.
authors.affiliation: Harvard Medical School, Beth Israel Deaconess Medical Center, Center for Inflammatory Bowel Disease, Rabb 4/East, BIDMC, 330 Brookline Ave, Boston, MA 02215, USA. amoss@bidmc.harvard.edu
authors.forename: Alan C
authors.initials: AC
authors.lastname: Moss
authors.forename: Kyung Jo
authors.initials: KJ
authors.lastname: Kim
authors.forename: Nielsen
authors.initials: N
authors.lastname: Fernandez-Becker
authors.forename: Didia
authors.initials: D
authors.lastname: Cury
authors.forename: Adam S
authors.initials: AS
authors.lastname: Cheifetz
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D001379:Azathioprine / Q000008:administration & dosage / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003424:Crohn Disease / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D000069285:Infliximab; D007262:Infusions, Intravenous; D016015:Logistic Models; D008297:Male; D015122:Mercaptopurine / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D012044:Regression Analysis; D012074:Remission Induction; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007155:Immunologic Factors; D000069285:Infliximab; D015122:Mercaptopurine; D001379:Azathioprine