Colon to Rectum
Inflamm Bowel Dis. 2022;28(4):495–501
Multiple switches from the originator infliximab to biosimilars is effective and safe in inflammatory bowel disease: A prospective multicenter cohort study
Background: Though a single non-medical switch from the originator infliximab (IFX) to a biosimilar is considered effective and safe for most patients with inflammatory bowel disease (IBD), very limited data are available on multiple successive switches.
Methods: The authors performed a prospective multicenter cohort study of adult IBD patients who underwent 2 switches from the originator IFX to CT-P13 to SB2 (group 1), 1 switch from CT-P13 to SB2 (group 2), and 1 switch from the originator IFX to CT-P13 (group 3). Patients were assessed at 4 and 12 months since the most recent switch for remission using clinical (physician’s assessment) and biochemical (C-reactive protein [CRP], and fecal calprotectin [FC]) measures. Patients discontinuing treatment for ineffectiveness or adverse events before month 12 were imputed as non-remitters.
Results: 176 patients (Crohn’s disease 71%, ulcerative colitis 27.8%, IBD unclassified 1.2%; group 1, 69; group 2, 80; group 3, 27) were included. At 12 months after the most recent switch 76.9% (40/52, group 1), 65.7% (46/70, group 2) and 76.9% (20/26, group 3) of patients were in clinical remission. Treatment persistence at 12 months was 85.0%, 87.0%, and 70.1%, respectively. There were no significant differences in the rate of clinical, CRP, FC remission, or treatment persistence at 12 months between the 3 groups. Infusion reactions occurred in 1.7% of patients (3/176), all in patients with anti-drug antibodies from group 2.
Conclusions: Multiple successive switching and switching between biosimilars of infliximab seemed to be effective and safe.