. Author manuscript; available in PMC: 2021 May 1.

Published in final edited form as: Aliment Pharmacol Ther. 2020 Mar 23;51(9):831–842. doi: 10.1111/apt.15685

Table 1A.

Study Characteristics (RCT and Post-hoc Analysis of RCTs)

Author Journal/Conference Year	Study type	Patient	Size	Study Duration	Intervention(s)	Disease Duration Definitions for Evaluating Early Biologic Use
Panaccione, J Crohns Colitis 2019²¹	Post hoc analysis	Adult	2207	NR	ADA	< 2 yrs, 2 to 5 yrs, >5 yrs
Dulai, ECCO, 2019³⁹	Post hoc analysis	Adult	1253	7 yrs	VDZ	≤2 vs. >2, ≤3 vs. >3, and ≤5 vs. >5 yrs
Reinisch, ECCO, 2009²⁰	Post hoc analysis	Adult^†	945	20 wks	ADA	<2 yrs, 2 to 5 yrs, >5 yrs
Schreiber, J Crohns Colitis., 2013¹¹	Post hoc analysis (RCT and open label extension)	Adult	777	3 yrs	ADA	<2 yrs, 2 to <5 yrs, ≥5 yrs
Rubin, DDW, 2009³²	Post hoc analysis	Adult	491	48 wks	ADA, PBO	2 yrs, ≥2 yrs
Schreiber, Am J Gastroenterol., 2010¹²	Post hoc analysis	Adult	425	26 wks	CER	<1 year, ≥1 to < 2 yrs, ≥2 to <5 yrs, ≥5 yrs
Colombel, Lancet, 2018²⁹	RCT	Adult	244	48 wks	ADA	≤2 yrs, >2 yrs
Colombel, Aliment Pharmacol Ther., 2015¹⁷	Post hoc analysis	Adult	188	26 wks	AZA, IFX and AZA+IFX	≤18 mon, >18 mon
D’Haens, Lancet, 2008¹⁵	RCT	Adult	129	2 yrs	IFX+AZA vs AZA	Newly diagnosed
Feagan, Gastroenterology, 2014⁴³	RCT	Adult	126	50 wks	IFX+MTX, IFX+PBO	<2 yrs
Yzet, ECCO, 2019²⁴	Post hoc analysis	Adult	122	3.02 yrs	ADA	≤2 yrs, >2 yrs
Sandborn, DDW, 2010²⁷	Post hoc analysis	Adult	123	1 year	ADA, PBO	<2 yrs, 2 to 5 yrs, >5 yrs
Hyams, ECCO, 2009⁵¹	Post hoc analysis	Paediatric	112	54 wks	IFX+IM	<2 yrs, ≥2 yrs
Colombel, Clin Gastroenterol Hepatol., 2014¹⁶	Post hoc analysis	Adult	69	1 year	ADA	<2 yrs, 2 to 5 yrs, >5 yrs
Baert, Gastroenterology., 2010³⁰	Extension study (follow up of an RCT)	Adult	46	2 yrs	IFX+AZA vs AZA	Newly diagnosed

ADA: adalimumab, IFX: infliximab; PBO: placebo; AZA: azathioprine; CER: certolizumab; IM: immunomodulators; IS: immunosuppressants NR: Not reported, VDZ: Vedolizumab; yrs: years.

^†

Assumed to be adult.