Biologics in the management of pediatric inflammatory bowel disease: When and what to choose

Table 4 Summary of the studies on the efficacy of biosimilars in pediatric inflammatory bowel disease

Ref.	Biosimilar	Patient population	Control group	Main outcomes
		Age (years), mean ± SD/median age (years); IQR	Age (years), mean ± SD/median age (years); IQR
Infliximab biosimilar
Sieczkowska-Golub et al[38], prospective	CT-P13	36 CD; 27 anti-TNF naive	No	86% CRes; 67% clinical remission at week 14
		11.8 ± 4
Chanchlani et al[39], prospective	Inflectra and remsima	82 (63 CD, 14 UC, 5 IBD-U)	175 (148 CD, 33 UC, 15 IBD-U) children on originator infliximab	Clinical remission 79% for biosimilar and 68% for the originator at week 12
		12; 10-14	12; range 10-14
Nikkonen et al[40], retrospective	CT-P13	28 (16 CD, 3 UC, 9 IBD-U)	23 (17 CD, 2 UC, 4 IBD-U) on originator infliximab	90% CRes; no difference between the two groups at week 12
		12; 4-16	12.0; 5.4-16	65% vs 61% patients on maintenance treatment at 1 year
Sieczkowska et al[41], prospective	CT-P13	39 (32 CD, 7 UC) elected to switch	No	80% and 100% clinical remission at the last follow-up assessment (median 8 months) for CD and UC patients, respectively
		CD: 11.1 ± 3.3; UC: 12.3 ± 2.3
Kang et al[42], prospective	CT-P13	38 (32 CD, 6 UC) elected to switch	36 (28 CD, 8 UC) on originator infliximab	Clinical remission rate 77.8% and 78.9% for biosimilar and originator IFX at 1 year
		17.5 ± 4.0	17.3 ± 3.4
Gianolio et al[45], retrospective	IFX-SC	7 CD	No	All (100%) remained in clinical remission at week 40
		16.5 ± 0.8
Adalimumab biosimilar
Dipasquale et al[43], retrospective	ABP501	41 (39 CD, 2 UC)	No	Clinical remission rate 70.7% at week 14 and 72% at week 52
		13.6; 11.3-15.8

IQR: Interquartile range; CD: Crohn’s disease; TNF: Tumor necrosis factor; CRes: Clinical response; UC: Ulcerative colitis; IBD-U: Inflammatory bowel disease unclassified; IFX: Infliximab; SC: Subcutaneous.