Table 1.

Summary of methotrexate trials in Crohn’s disease

Study		Dose MTX	Route of admin	n	Study design	Patients	Duration follow up (wk)	MTX response	MTX remission	Placebo or (Comparator) Response	AE MTX	AE Placebo
Kozarek		25 mg/wk	sq	14	Non-Randomized-open Label	CD	12	79%
Feagan		25 mg/wk	im	141	Double-blind Placebo controlled multi center	Steroid dependent CD	16		39.4%1	19.1%	1%	2%
Oren		12.5 mg/wk	po	84	Randomized Double-Blind Placebo Controlled	Active CD	36		38%	46%
Arora		22.5 mg/wk	po	33	Randomized Double Blind Placebo Controlled	Steroid Dependent CD	52	54%		20%	23%	0
Feagan		15 mg/wk	im	76	Double Blind Placebo Controlled Multi-Center	CD Maintenance	40		65%1	39%	1%	2%
Mate- Jimenez		15 mg/wk	po	38	Randomized Single Center	Steroid Dependent CD	76		80%1 Induction 66.6%1 Maintenance	14% Induction 0 Maintenance	11.5%	0
Lemann		25 mg/wk	im	49	Retrospective	Active CD			84%		49%
Fraser		20 mg/wk (10-25)	po/im	48	Retrospective	Active CD-Maintenance			62%		27%
Ardizzone		25 mg/wk	iv	54	Investigator Blind, randomized	Active CD	24		56%	63% AZA	11%
Mahadevan		25 mg/wk	im	16	Retrospective case series	Fistulizing CD		56%			6%
Wahed		25 mg/wk Induction 15 mg/wk Maintenance	im/po-Induction po-Maintenance	99	Retrospective	AZA Intolerance/ AZA non-responders		62%			8.3%
Feagan		Wk0-10 mg/wk Wk3-20 mg/wk Wk5-25 mg/wk	sq	126	Double Blind Placebo Controlled Multi-center	Active CD	50		IFX + MTX 56%	IFX + PCBO 57%

¹P < 0.05 vs MTX response. MTX: Methotrexate; CD: Crohn’s disease; AE: Adverse events; AZA: Azathioprine.