Update on the management of inflammatory bowel disease: specific role of adalimumab

Figures & data

Table 1 Randomized controlled trials on adalimumab in Crohn’s disease

	No. of patients	Treatment	Primary outcomes
Hanauer et al^Citation7	299		Week 4% (P vs placebo)
		Induction:	Remission rate
		40 mg/20 mg week 0–2	18 (0.36)
		80 mg/40 mg week 0–2	24 (0.06)
		160 mg/80 mg week 0–2	36 (0.001)
		Placebo week 0–2	12
Sandborn et al^Citation8	276		Week 56% (P vs placebo)
		55^a maintenance:	Remission rate
		40 mg eow for 56 weeks	79 (0.05)
		40 mg weekly for 56 weeks	83 (0.05)
		Placebo	44
Colombel et al^Citation9	854	778^b maintenance:	Week 26% (P vs placebo)	Week 56% (P vs placebo)
		40 mg eow for 56 weeks	40 (0.001)	36 (0.001)
		40 mg weekly for 56 weeks	47 (0.001)	41 (0.001)
		Placebo	17	12
Colombel et al^Citation16	117	117^c maintenance:	Week 56 mean number of draining fistula
		40 mg eow for 56 weeks	0.85
		40 mg weekly for 56 weeks	0.91
		Both adalimumab group for 56 weeks	0.88 (P < 0.002 vs placebo)
		Placebo	1.34
Sandborn et al^Citation18	325		Week 4% (P vs placebo)
		Induction:	Remission rate
		160 mg/80 mg week 0–2	21 (P < 0.001)
		Placebo	7
Colombel et al^Citation21	135		Week 12	Week 52
		129^d maintenance:	Remission rate %	(P vs placebo)
		40 mg eow	16 (0.34)	19
		Placebo	10	0
Hyams et al^Citation25	192	188^e maintenance for 48 weeks:	Clinical remission week 26
		High dose (40 mg eow BW > 40 kg, 20 mg eow BW < 40 kg)	High dose 39% vs low dose 28% (P = 0.075)
		Low dose (20 mg eow BW > 40 kg, 10 mg eow BW < 40 kg)

Notes:

a In remission at week 0 and 2 after 2 open-label 40 mg adalimumab doses;

b after an open-label induction 80/40 mg at week 0 and 2;

c patients with draining fistula at baseline in the cohort of the CHARM trial;

d after an open-label induction 160/80 mg at week 0–2;

e after an open-label adalimumab induction per body-weight (160 mg/80 mg week 0–2 if body weight > 40 kg, 80 mg/40 mg week 0–2 if body weight < 40 kg).

Abbreviation: eow, every other week.

Table 2 Randomized controlled trials on adalimumab in ulcerative colitis

	No. of patients	Treatment	Outcomes
Reinisch et al^Citation33	576	Induction:	Clinical remission
		160 mg/80 mg week 0–2	18.5 (0.031)
		Placebo week 0–2	9.2 (0.833)
		80 mg/40 mg^a week 0–2	10
Sandborn et al^Citation36	494	Induction:	Clinical remission
		160 mg/80 mg week 0–2	% (P vs placebo) week 8
		Placebo week 0–2	16.5 (0.02) 9.3
		Maintenance:	% (P vs placebo) week 52
		40 mg eow starting at week 4	17.3 (<0.01)
		Placebo week 0–2	8.5

Note:

a This arm was included after amendment 3, adding a third arm of adalimumab at induction, with a dose of 80/40 mg.

Abbreviation: eow, every other week.

HanauerSBSandbornWJRutgeertsPHuman anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn’s disease: the CLASSIC-I trialGastroenterology200613032333316472588

 PubMed Web of Science ®Google Scholar

SandbornWJHanauerSBRutgeertsPAdalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trialGut2007561232123917299059

 PubMed Web of Science ®Google Scholar

ColombelJ-FSandbornWJRutgeertsPAdalimumab for maintenance of clinical response and remission in patients with Crohn’s disease: the CHARM trialGastroenterology2007132526517241859

 PubMed Web of Science ®Google Scholar

ColombelJFSchwartsDASandbornWJAdalimumab for the treatment of fistulas in patients with Crohn’s diseaseGut20095894094819201775

 PubMed Web of Science ®Google Scholar

SandbornWJRutgeertsPEnnsRAdalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trialAnn Intern Med200714682983817470824

 PubMed Web of Science ®Google Scholar

ColombelJFRutgeertsPSandbornWJDeep remission for adalimumab-treated patients with moderate to severe ileocolonic Crohn’s disease: results from EXTEND [abstract]J Crohns Colitis20104S10

 Google Scholar

HyamsJSGriffithsAMMarkowitzJInduction and maintenance adalimumab therapy for the treatment of moderate to severe Crohn’s disease in children [abstract]Gastroenterology2011140Suppl 1S90

 Google Scholar

ReinischWSandbornWJHommesDWAdalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trialGut20116078078721209123

 PubMed Web of Science ®Google Scholar

SandbornWJVan AsscheGAReinischWInduction and maintenance of clinical remission by adalimumab in patients with moderate-to-severe ulcerative colitis [abstract]Gastroenterology20111405 Suppl 1S123S124

 Web of Science ®Google Scholar