A review of the literature analyzing benefits and concerns of infliximab biosimilar CT-P13 for the treatment of rheumatologic diseases: focus on interchangeability

Figures & data

Figure 1 Comparative 30- and 54-week ASAS20 responses between infliximab innovator- and CT-P13-treated patients in the PLANETAS study.^26,32

Abbreviations: ASAS20, Assessment of SpondyloArthritis International Society 20% response; INX, infliximab innovator; PLANETAS, Program evaluating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients.

Figure 2 Comparative 30- and 54-week ACR20 response between infliximab innovator- and CT-P13-treated patients in the PLANETRA study.^27,39

Abbreviations: ACR20, American College of Rheumatology 20% response; INX, infliximab innovator; PLANETRA, Program evaluating the Autoimmune disease iNvEstigational drug cT-p13 in RA patients.

Table 1 PLANETRA and PLANETAS studies: open-label extension up to 102 weeks

PLANETRA			PLANETAS
	Previous CT-P13	Previous INX		Previous CT-P13	Previous INX
No of pts	158	144	No of pts	88	86
Response at week 78 (% pts)			Response at week 78 (% pts)
ACR20	71.7	78.2	ASAS20	70.1	77.1
ACR50	48.7	47.9	ASAS40	57.5	51.8
ACR70	25.0	29.6	ASAS PR	20.7	19.3
Response at week 102 (% pts)			Response at week 102 (% pts)
ACR20	71.7	71.8	ASAS20	80.7	76.9
ACR50	48.0	51.4	ASAS40	63.9	61.5
ACR70	24.3	26.1	ASAS PR	19.3	23.1

Note: Data from Lambert et al²⁹ and Krintel et al.⁴⁹

Abbreviations: pts, patients; ACR20/50/70, American College of Rheumatology 20/50/70; ASAS 20/40, Assessment of SpondyloArthritis International Society Response Criteria 20/40; ASAS PR, ASAS partial remission; INX, infliximab innovator; PLANETAS, Program evaluating the Autoimmune disease iNvEstigational drug cT-p13 in AS patients; PLANETRA, Program evaluating the Autoimmune disease iNvEstigational drug cT-p13 in RA patients.

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	^Citation53
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	^Citation54
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	^Citation55
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	^Citation56
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	^Citation57,Citation58

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.

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