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Background The comparative efficacy and safety of infliximab (IFX) and adalimumab (ADA) have shown variable results in biologic-naïve patients with Crohn’s disease (CD). Thus, long-term comparisons between IFX and ADA with or without immunomodulator therapies are still needed. The purpose of this study was to evaluate the long-term clinical effectiveness and safety profile of IFX compared to ADA in biologic-naïve patients with CD. Methods Data of all adult CD patients treated with IFX or ADA as their first biologic agent was collected retrospectively between December 2007 and February 2021. We compared CD-related hospitalization, CD-related major abdominal surgery, steroid use and serious infections leading to treatment cessation. Results Out of 224 biologic-naïve patients with CD, 101 started IFX first (median age at onset: 38.12 years, 61.4% male) and 123 started ADA first (median age at onset: 30.2 years, 64.2% male). Median disease duration was 6.94 years (IQR: 3.82–12.17) and 6.91 years (IQR: 3.94–10.95) for IFX and ADA, respectively, of whom 33% and 37.4% had active smokers, 10.9% and 13.4% had family history of inflammatory bowel disease (IBD) 22.8% and 19.5% had perianal disease, 43.6% and 43.9 had prior major abdominal surgery and 52.6% and 49.6% had extraintestinal manifestations. There were no significant differences between the two groups with respect to the age at onset of tumor necrosis factor antagonist, gender, smoking status, family history of IBD, perianal disease, prior major abdominal surgery, extraintestinal manifestations, prior immunomodulator (Thiopurine or Methotrexate) or steroid usage, all laboratory test results and Crohn’s Disease Activity Index (CDAI) score at baseline (p&amp;gt;0.05). Overall, the median follow-up time was 2.81 and 3.55 years after starting the first IFX and ADA group, respectively. There were no significant differences in the rate of steroid use (4% IFX vs. 10.6% ADA p=0.109), CD-related hospitalization (13.9% IFX vs. 22.8% ADA p=0.127), CD-related major abdominal surgery (9.9% IFX vs. 13% ADA p=0.608) and serious infections leading to treatment cessation (1% IFX vs 0.8% ADA p&amp;gt;0.999) between IFX and ADA. These outcomes were similar in patients treated with IFX or ADA monotherapy or in combination with an immunomodulator. Conclusion In this retrospective observational tertiary referral center study, we observed that there was no significant difference in long-term effectiveness and safety of infliximab and adalimumab in biologic-naïve patients with CD.

journal of crohn's and colitis

P563 Comparison of long-term outcomes of infliximab with adalimumab in biologic naïve patients with Crohn’s disease: a tertiary referral center 13-year experience