. 2021 May 19;11(5):e042374. doi: 10.1136/bmjopen-2020-042374

Table 1.

Characteristics of the studies included

Clinical remission induction
Study name and setting	Cycles (n)	Randomisation*	Patients analysed (n)	Patients achieving response		Patients achieving remission		Time of assessment	Outcome criteria		Concomitant medication
Study name and setting	Cycles (n)	Randomisation*	Patients analysed (n)	%	n	%	n	Time of assessment	Remission	Response	Concomitant medication
Bresci et al 2008¹⁸ single centre study	5	GMA	40	92.5	37	72.5	29	5 weeks	CAI<6; EI <4	CAI<6; EI>4	Oral 5-ASA
Bresci et al 2008¹⁸ single centre study	5	Steroid	40	65.0	26	50.0	20	5 weeks	CAI<6; EI <4	CAI<6; EI>4	Oral 5-ASA
Doménechet al 2018¹⁹ multi-centre study	7	GMA+steroid	62 ¹	58.1	36	19.4	12	12 weeks	Mayo≤2 and no steroid use	Mayo score decrease ≥3 or at least 30% from baseline	Stable dose AZA and steroid were allowed if started before randomisation
Doménechet al 2018¹⁹ multi-centre study	7	Steroid	61 ²	49.2	30	18.0	11	12 weeks	Mayo≤2 and no steroid use	Mayo score decrease ≥3 or at least 30% from baseline
Eberhardson et al 2017²⁰ single centre study	5	GMA	14	57.1	8	35.7	5	12 days	Mayo score ≤3	Mayo score decrease ≥3 or at least 30% from baseline	Stable dose of steroid; 5-ASA and/or thiopurines were allowed
Eberhardson et al 2017²⁰ single centre study	5	Sham	8 ³	37.5	3	12.5	1	12 days	Mayo score ≤3	Mayo score decrease ≥3 or at least 30% from baseline
Hanai et al 2004²² single centre study	7	GMA	46	93.5	43	82.6	38	12 weeks	CAI≤4	CAI had fallen, but still 4<	Steroids and/or 5-ASA
Hanai et al 2004²² single centre study	7	Steroid	23	78.3	18	65.2	15	12 weeks	CAI≤4	CAI had fallen, but still 4<	Steroids and/or 5-ASA
Hanai et al 2008²¹ multi-centre study	11	GMA	35	80.0	28	74.3	26	12 weeks	CAI≤4	CAI decreased by ≥5 points, but remained ≥5	All patients were on salicylates and the majority were on low dose steroid as well
Hanai et al 2008²¹ multi-centre study	11	Steroid	35	62.9	22	48.6	17	12 weeks	CAI≤4	CAI decreased by ≥5 points, but remained ≥5
Nakamura et al 2004²³ single centre study	5	GMA	10	N/A	N/A	80.0	8	6 weeks	Based on CAI, but not specified		All patients received steroid; 5-ASA was unchanged
Nakamura et al 2004²³ single centre study	5	No GMA	10	N/A	N/A	20.0	2	6 weeks	Based on CAI, but not specified		All patients received steroid; 5-ASA was unchanged
Sands et al 2008⁷ A study multi-centre study	10	GMA	31	67.7	21	16.1	5	12 weeks	Mayo score ≤2; 0–1 endoscopic score	Mayo score decrease ≥3	One or more of the following: 5-ASA agents, steroid, 6-MP or AZA
Sands et al 2008⁷ A study multi-centre study	10	Sham	16	62.5	10	18.8	3	12 weeks	Mayo score ≤2; 0–1 endoscopic score	Mayo score decrease ≥3
Sands et al 2008⁷ B study multi-centre study	10	GMA	112	60.7	68	17.0	19	12 weeks	Mayo score ≤2; 0–1 endoscopic score	Mayo score decrease ≥3	One or more of the following: 5-ASA, steroid, 6-MP or AZA
Sands et al 2008⁷ B study multi-centre study	10	Sham	56	50.0	28	10.7	6	12 weeks	Mayo score ≤2; 0–1 endoscopic score	Mayo score decrease ≥3	One or more of the following: 5-ASA, steroid, 6-MP or AZA
Sawada 2005¹⁷ multi-centre study	7	GMA	10	80.0	8	20.0	2	10 weeks	CAI=0	CAI improved >3	Except for steroid, other medications remained unchanged
Sawada 2005¹⁷ multi-centre study	7	Sham	9	33.3	3	11.1	1	10 weeks	CAI=0	CAI improved >3	Except for steroid, other medications remained unchanged
Clinical remission maintenance
Study name	Cycles (n)	Randomisation	Patients analysed (n)	Patients in clinical remission at the end of the study				Close-out examination	Outcome criteria for remission		Concomitant medication
Study name	Cycles (n)	Randomisation	Patients analysed (n)	%		n		Close-out examination	Outcome criteria for remission		Concomitant medication
Emmrich et al 2006²⁴ single centre study	5	GMA	8	62.5		5		6 months	CAI≤4		All patients were on steroid; 5-ASA was allowed; AZA given at baseline remained unchanged
Emmrich et al 2006²⁴ single centre study	5	No GMA	5	20.0		1		6 months	CAI≤4
Fukunaga et al 2012⁹ single centre study	12	GMA	10	40.0		4		12 months	CAI≤4		Stable dose of AZA and steroids were allowed if started before randomisation
Fukunaga et al 2012⁹ single centre study	12	Sham	11	9.1		1		12 months	CAI≤4
Maiden et al 2008²⁵ single centre study	5	GMA	18	77.8		14		6 months	CAI≤6		Only 5-ASA or oral steroid
Maiden et al 2008²⁵ single centre study	5	No GMA	19	26.3		5		6 months	CAI≤6		Only 5-ASA or oral steroid

*All patients received standard of care added to investigator/comparator. 1: one patient was excluded from analysis because of protocol deviations; 2: one patient was excluded from analysis because of protocol deviations; 3: one patient was excluded due to failure to return blood from the column; 4: minimisation may be implemented without a random element, and this is considered to be equivalent to being random.

5-ASA, 5-aminosalicylic acid; AZA, azathioprine; CAI, Clinical Activity Index; EI, Endoscopic Index; GMA, granulocyte and monocyte apheresis; 6-MP, 6-mercaptopurine; n, number.