Efficacy, tolerability, and safety of infliximab biosimilar in comparison to originator biologic and adalimumab in patients with Crohn disease

INTRODUCTION An infliximab biosimilar has been shown to be equivalent to originator infliximab. However, data concerning the drug's efficacy and safety in patients with Crohn disease (CD) are still limited. OBJECTIVES The aim of the study was to assess the efficacy, tolerability, and safety of an infliximab biosimilar in the Polish population with CD in comparison to its originator biologic and adalimumab. PATIENTS AND METHODS This was a retrospective, single-center study of 286 consecutive patients with CD. They received originator infliximab, an infliximab biosimilar, or adalimumab on the basis of the same inclusion criteria. Disease activity was estimated at baseline, after induction therapy, after 1 year of treatment, and during 12 months of follow-up. RESULTS There were no differences in the Crohn's Disease Activity Index in patients treated with infliximab, infliximab biosimilar, or adalimumab. Clinical response, clinical remission, and glucocorticoid-free remission rates were also comparable between groups. The relapse rate was similar in groups receiving infliximab biosimilar and adalimumab (54% and 61%, respectively), with relapses occurring more often in patients receiving infliximab (83% of patients during 12-month follow-up; P <0.001). CONCLUSIONS We showed the same efficacy and safety of the infliximab biosimilar in comparison to the originator drug and adalimumab in the Polish population, not only during induction and 1-year therapy, but also during 12-month follow-up.