Table 2.

Real-life data on switching from infliximab RP to CT-P13

Country (study/registry)	No of patients (diseases)	Study conclusions	References
Finland	39 (RA, AS, PsA, JIA, and chronic reactive arthritis)	The clinical effectiveness and the safety profile of CT-P13 were comparable to the reference product during the first year of switching	53
Italy	23 (PsA, AS, RA, CD associated with axSpA, and Behçet’s disease associated with axSpA)	Seven out of 23 patients experienced a disease relapse after a mean time of 1.71 months from the start of infliximab biosimilar	54
Italy	41 (AS, enteropathic arthritis, PsA, and undifferentiated SpA)	No significant differences in efficacy after 6 months of switching from the reference product to CT-P13. No change in circulating infliximab or anti-infliximab antibody levels was described	55
Norway (NOR-SWITCH NCT02148640)	481 (RA, AS, PsA, psoriasis, CD, and ulcerative colitis)	Similar rate of disease reactivation in switching vs maintenance groups (26.2% vs 29.6%, respectively). An apparently increased incidence of disease flares in switcher patients with CD. No differences in immunogenicity	56
Denmark (DANBIO registry)	768 (RA, PsA, and axSpA)	The fluctuations 3 months before and after the switch were similar, demonstrating that disease activity was largely unaffected in the majority of patients after nonmedical switch to biosimilar	57,58

Note: CT-P13, the first biosimilar of infliximab.

Abbreviations: AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; CD, Crohn’s disease; JIA, juvenile idiopathic arthritis; PsA, psoriatic arthritis; RA, rheumatoid arthritis; RP, reference product; SpA, spondyloarthritis.