Biosimilars in inflammatory bowel disease: A review of post-marketing experience

Table 1 Major real-world studies of CT-P13 in inflammatory bowel disease[32,34,35]

Study	Design	Follow-up	Effect parameters	IBD	Nr	TNF-naive	Efficacy (%, n/n)		Safety (%, n/n)
							Clinical response	Remission rate	Adverse event	IRR
Park et al[27], 2015 South Korea	Open-label, retrospective, multicenter	30 wk	CDAI Mayo score	CD4	95	51	77.83 (35/45)	57.83 (26/45)	17.9 (17/95)	2.1 (2/95)
				UC	78	62	72.25 (39/54)	375 (20/54)	26.9 (21/78)	1.3 (1/78)
Jung et al[28], 2015 South Korea	Open-label, retrospective, multicenter	54 wk	CDAI Mayo score CRP	CD	59	32	87.53 (7/8)	75.03 (6/8)	0 (0/59)	0
				UC	51	42	1003 (12/12)	503 (6/12)	11.8 (6/51)	NR
Kang et al[29], 2015 South Korea	Open-label, case-series, tertiary center	8 wk	CDAI Mayo score	CD	8	3	66.73 (2/3)	66.73 (2/3)	0	NR
				UC	9	5	1003 (5/5)	1003 (5/5)	0	NR
Gecse et al[30], 2015 Hungary	Open-label, prospective, observationalmulticenter	14 wk	CDAI FDA Mayo score CRP PLT count	CD	126	93	81.4 (79/97)	53.6 (52/97)	17.12 (36/210)	6.62 (14/210)
				UC	84	68	77.6 (45/58)	58.6 (34/58)
Farkas et al[31], 2015 Hungary	Open-label, prospective, observational tertiary center	8 wk	CDAI Mayo score	CD	18	16	37.51 (6/16)	50 (8/16)1	NR	NR
				UC	21	19	201 (3/15)	66.71 (10/15)
Jahnsen et al[32], 2015 Norway	Open-label, prospective, observational single-center	14 wk	HBI Mayo score CRP Calprotectin	CD	46	33	NR	79 (34/43)	NR	2.2 (1/46)
				UC	32	27	NR	56 (18/32)	NR	3.1 (1/32)
Sieczkowska et al[35], 2015 Poland	Open-label, prospective, observationalswitching, pediatric	8 mo	PCDAI PUCAI CRP	pCD	325	26	NR	87.5 (28/32)	NR	3.1 (1/32)
		5 mo		pUC	75	6	NR	57.1 (4/7)	NR	28.6 (2/7)

¹The patients who completed induction treatment;

²At week 30;

³In TNF-naïve patients only;

⁴Including fistulizing active CD (n = 12);

⁵Patients had switched from infliximab to CT-P13. NR: Not reported; CDAI: Crohn’s disease activity index; CRP: C-Reactive protein; FDA: Food and drug administration; HBI: Harvey-bradshaw index; PLT count: Platelet count; PCDAI: Pediatric Crohn’s disease activity index; PUCAI: Pediatric ulcerative colitis activity index; CD: Crohn’s disease; UC: Ulcerative colitis.