Clinical efficacy and durability of subcutaneous infliximab in patients with inflammatory bowel disease after switching from intravenous in a Korean multicenter prospective cohort study

초록

Background Subcutaneous infliximab (IFX-SC) has shown comparable efficacy and safety with IV infliximab (IFX-IV) in inflammatory bowel disease (IBD), such as ulcerative colitis (UC) or Crohn's disease (CD), since its launching in 2021. We aimed to investigate the real-life efficacy and durability of IFX-SC after IFX-IV in Korea. Methods This multicenter, prospective cohort study included IBD patients who administered IFX-IV maintenance therapy from September 2021 to November 2023. Patients received IFX-SC 120mg after the last IFX-IV administration (Week [W] 0), and every 2 weeks thereafter. Patients who administered IFX-SC less than W8 were excluded. Clinical relapse (CREL) at W26, W50, and one-year drug survival were assessed. Among IBD patients with W0 clinical remission, CREL was partial Mayo score ≥2 points among UC patients, and Crohn’s disease activity index ≥150 points among CD patients. Drug survival was evaluated based on the time of drug persistence from W0 to the last date of IFX-SC administration among drug-off cases. Rate of drug re-switch (from IFX-SC to IFX-IV) was also investigated. Results A total of 447 patients (UC with 154, and CD with 287) were enrolled. Enrolled patients included young adults with a male predominance (Table 1). At W0, 77 patients with UC and 185 patients with CD showed clinical remission. Patients with UC showed 15.7% (11 out of 70 patients) of W26 CREL, and 12.1% (seven out of 58 patients) of W50 CREL (Figure 1A). Among patients with CD, rates of W26 CREL and W50 CREL were 5.9% (nine out of 153 patients) and 10% (11 out of 110 patients), respectively. On the other hands, one-year drug survival was also investigated (Figure 1B). Among patients with UC, W26 drug survival rate was 89.8% (95% confidence interval [CI], 0.836–0.937), and W50 drug survival rate was 89.0% (95% CI, 0.827–0.931). Among patients with CD, it showed higher drug survival rate, showing W26 drug survival rate of 97.8% (95% CI, 0.951–0.990) and W50 of 94.9% (95% CI, 0.911–0.971). During the study, 3.4% (15 patients) of serious adverse events were reported. Drug re-switch rate was 5.4%, mainly due to injection site discomfort. Conclusion In real-world settings, IFX-SC seems to be a feasible option for the maintenance therapy, following IFX-IV administration. Considering favorable drug survival rate, low relapse rate, and tolerable safety profile, it may facilitate individualized treatment.