Background: Recently we have shown, that biosimilar infliximab (I) in the treatment of Crohn's disease (CD) patients, is equivalent to biologic originator (R) in terms of efficacy and safety. However data comparing response in anti-TNF naïve and non-naive patients with CD are still limited and controversial.
The aim of the study was to assess the efficacy, tolerability, and safety of biosimilar infliximab in comparison to biologics originator in anti-TNF-alpha naïve and switch CD patients.
Methods: This was a retrospective, one center study enrolled a cohort of 168 consecutive adult CD patients. The patients received either R (73) or I (95) on the basis of the same inclusion criteria (CDAI >300 or active perianal fistula). According to local national regulations, treatment was stopped after one year. Assessments included treatment-emergent adverse events (TEAEs) and disease-specific clinical response and remission after induction therapy, one year of treatment and during 12 months of follow-up.
Results: Both group were comparable according to age, sex, duration and type of disease, concomitant medications and smoking. 47 patients from R group and 68 from I were anti-TNF-alpha naïve. We did not observe differences between anti-TNF-alpha naïve and non-naïve patients in respect to clinical response and remission rate after induction and 1 year of treatment (R – 80.9% vs. 73.1% respectively; I – 79.4% vs. 74.1%). The relapse rate during 1 year follow-up was significantly higher in anti-TNF non-naïve patients (p<0.001) in comparison to naïve, however with no significant differences between R and I groups. TEAEs were mostly mild-moderate in severity and occurred more often in anti-TNF non-naïve patients, with no difference between R and I group (13.33% vs 17.65%). Surprisingly in anti-TNF naïve patients we observed higher rate of TEAEs in I group in comparison to R (8.11% vs 1.92%), however this difference did not reached statistical significance.
Conclusions: Positive outcomes for response/remission in both groups were reported regardless of whether patients had received prior infliximab or not. Biosimilar infliximab was well tolerated and efficacious in both groups. Further study for immunogenicity and interchangeability with long-term follow-up periods are needed to confidently integrate biosimilars into IBD treatment.