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

Table 3 Summary of the pediatric studies on the efficacy and safety of infliximab and adalimumab

Ref.	CD				UC
	Number of cases	Details of cases	Efficacy	Adverse event	Number of cases	Details of cases	Efficacy	Adverse event
	Age (years), mean ± SD/median age (years); IQR				Age (years), mean ± SD/ IQR
Infliximab
Hyams et al[21], REACH trial	112	Moderate to severe	CRes and CR 89% and 59% at week 10; 63% and 56% at week 54th	94.6% (serious 19.6%)	-	-	-	-
	13.3 ± 2.5
Crandall et al[23]	22	Fistulizing perianal disease, all biologic naive	Response in 41% (9/22, partial response-4, complete response-5) at week 2nd; 73% (16/22, partial-1, complete-15) at week 54th	95.7% (serious 4.5%)	-	-	-	-
	13.3 ± 2.5
Hyams et al[26]	-	-	-	-	52	Moderate to severe, all biologic naive	CRes 27%: 6 months; CRes 38%: 12 months; CRes 21%: 24 months	None
					13.3 ± 2.6
deBruyn et al[31]	147	Moderate to severe; all biologic naive	SFCR 59% at 1 year, 59.5% at 2 years	5.4% (serious 4.7%)	-	-	-	-
	14.3; 12.1-15.1
Adalimumab
Hyams et al[30], IMAgINE trial	188	Moderate to severe, 44% infliximab exposed	CR 33.5% at week 26th	89% drug related 41% (serious 22.3%)	-	-	-	-
	13.6 ± 2.5
Croft et al[34], ENVISION I trial, high dose vs standard dose vs placebo	-	-	-	-	93	Moderate to severe, all biologic-naive	Endoscopic remission at week 8th: High dose vs placebo-60% vs 20%, P = 0.0001; standard dose vs placebo-43% vs 20%, P = 0.38	78% (serious 23%)
					4-17		At week 52th: High dose vs placebo: 45% vs 18%, P = 0.0001; standard dose vs placebo-29% vs 18%, P = 0.38)
deBruyn et al[31]	147	Moderate to severe; all biologic naive	SFCR: 63% at 1 year; 59% at 2 years	1.3% (serious-none)	-
	13.4;11.6-14.9
Rinawi et al[114]	65	Moderate to severe, all biologic-naive	CR 60% at week 24th	NA	-	-	-	-
	12.1; 10.5-13.8

Reported adverse events: (1) Infliximab: Infections, severe infections, intestinal stenosis, pneumonia, H zoster, abscess, sepsis, colitis, furunculosis, adenitis, abdominal pain, fever, vomiting, enterocolitis, infusion reaction, injection site reaction, delayed type infusion reaction; and (2) Adalimumab: Injection site reaction, hematologic-, allergic, hepatic, tooth abscess, scarlet fever, Bartholin’s/abdominal abscess, disseminated histoplasmosis, gastroenteritis, anal abscess, Influenza A, headache, anemia, nasopharyngitis.

CD: Crohn’s disease; UC: Ulcerative colitis; CRes: Clinical response; CR: Clinical remission; SFCR: Steroid free clinical remission; NA: Not available.