Systematic review and meta-analysis on the association of tuberculosis in Crohn’s disease patients treated with tumor necrosis factor-α inhibitors (Anti-TNFα)

Table 1 Summary of randomized, placebo-controlled, double-masked trials included

Study	Follow-up duration (wk)	Anti-TNFα treatment		Placebo
		N1	N2	N1	N2
Adalimumab
Hanauer et al[44], 2006	4	0	225	0	74
Colombel et al[47], 2007	52	2	517	0	261
Sandborn et al[35], 2007a	52	0	37	0	18
Sandborn et al[34], 2007b	4	0	159	0	166
Rutgeerts et al[37], 2012	48	0	64	0	65
Watanabe et al[28], 2012	52	0	25	0	25
Watanabe et al[28], 2012	4	0	67	0	23
		Total	1094		632
Certolizumab pegol
Winter et al[27], 2004	12	0	66	0	24
Schreiber et al[30], 2005	20	0	145	0	73
Sandborn et al[36], 2007c	26	0	331	0	329
Schreiber et al[31], 2007	20	1	216	0	212
Sandborn et al[33], 2011	6	0	223	0	215
UCB Pharma[42], 2014	36	0	87	0	87
		Total	1068		940
Infliximab
Targan et al[29], 1997	12	0	83	0	25
D’Haens et al[46], 1999	4	0	22	0	8
Present et al[41], 1999	18	0	63	0	31
Rutgeerts et al[38], 1999	36	0	37	0	36
Hanauer et al[45], 2002	44	1	385	0	188
Sands et al[32], 2004	40	0	139	0	143
Lémann et al[43], 2006	52	0	57	0	58
Colombel et al[48], 2010	30	1	169	0	170
Regueiro et al[40], 2011	52	0	11	0	13
Regueiro et al[39], 2016	104	1	147	0	150
		Total	1113		822

¹Number of TB cases;

²Number of total subjects.

Table 2 Risk of Mycobacterium tuberculosis infection associated with the use of tumor necrosis factor-alpha inhibitors in patients with Crohn’s disease

	n	Risk estimate	95%CI	P value
Risk difference odds ratio	23	0.028	(0.0011, 0.055)	0.042
Including Double-Zero Studies	23	4.85	(1.02, 22.99)	0.047
Excluding Double-Zero Studies	5	5.85	(1.13, 30.38)	0.036

n: Number of individual clinical studies pooled together.

Table 3 Estimated absolute incidence of Mycobacterium tuberculosis infection in patients with Crohn’s disease treated with tumor necrosis factor-alpha inhibitors and the number of patients with Crohn’s disease who need to be treated with tumor necrosis factor-alpha inhibitors to expect one Mycobacterium tuberculosis case

	Incidence of TB with TNFα treatment (cases/person-years)1	Number of patients treated to see one TB Case in one year
Based on risk difference	177/100000	565
Based on relative odds estimated with background correction	97/100000	1031
Based on relative odds estimated without background correction	117/100000	855

¹The background incidence was assumed to be 20 cases/100000 person-years as reported by Aberra et al[24]. TB: Mycobacterium tuberculosis.