Table 3. Summary of infections and serious infections through week 54 of the pivotal phase 3 infliximab IBD studies by treatment and immunomodulator use.

	Crohn's diseasea		Ulcerative colitisa		All inflammatory bowel diseasea
	Placebob	Infliximab	Placebob	Infliximab	Placebob	Infliximab
Pts. treated	161	1,228	245	485	406	1,713
Total/median pt-yrs of follow-up	108/0.7	1,127/1.0	209/0.6	831/1.0	318/0.6	1,958/1.0
No. (%) of pts. with infection	73 (45.3%)	603 (49.1%)	89 (36.3%)	243 (50.1%)	162 (39.9%)	846 (49.4%)
P-valuec	0.402		<0.001		<0.001
Total incidence	144	1,352	224	876	368	2,228
Incidence per 100 pt-yrs	132.81	119.98	106.98	105.41	115.79	113.8
95% CId	(112.00, 156.36)	(113.67, 126.56)	(93.43, 121.94)	(98.54, 112.63)	(104.26, 128.25)	(109.12, 118.62)
No. (%) of pts. with serious infection	9 (5.6%)	55 (4.5%)	6 (2.4%)	26 (5.4%)	15 (3.7%)	81 (4.7%)
P-value	0.547		0.085		0.427
Total incidence	9	86	6	42	15	128
Incidence per 100 pt-yrs	8.3	7.63	2.87	5.05	4.72	6.54
95% CI	(3.80, 15.76)	(6.10, 9.43)	(1.05, 6.24)	(3.64, 6.83)	(2.64, 7.78)	(5.45, 7.77)
System–organ class/common preferred terms (>0.20/per 100 pt-yrs per group)
Resistance mechanism disorder	5.53	4.44	1.91	1.8	3.15	3.32
Abscess	2.77	3.02	0.96	0.36	1.57	1.89
Fever	0	0.27	0	0.24	0	0.26
Infection	0	0.18	0.48	0.84	0.31	0.46
Sepsis	0.92	0.27	0	0.12	0.31	0.2
Cellulitis	0	0.27	0	0	0	0.15
Herpes zoster	0	0.27	0	0	0	0.15
Bacterial infection	1.84	0.09	0.48	0	0.94	0.05
Gastrointestinal system disorder	1.84	1.24	0	0.84	0.63	1.07
Gastroenteritis	1.84	0.18	0	0.36	0.63	0.26
Abdominal pain	0	0.27	0	0	0	0.15
Respiratory system disorder	0.92	0.44	0.96	1.68	0.94	0.97
Pneumonia	0.92	0.44	0	0.96	0.31	0.66
Sinusitis	0	0	0.48	0.12	0.31	0.05
Upper respiratory infection	0	0	0.48	0	0.31	0
Skin and appendages disorder	0	0.53	0	0	0	0.31
Urinary system disorder	0	0.18	0	0.24	0	0.2
Body as a whole–general disorder	0	0.18	0	0	0	0.1
Cardiovascular disorder	0	0.18	0	0	0	0.1
Liver and biliary system disorder	0	0.09	0	0.12	0	0.1
Musculoskeletal system disorder	0	0.18	0	0	0	0.1
Reproductive disorder	0	0.09	0	0.12	0	0.1
Nervous system disorder	0	0.09	0	0	0	0.05
Ear and hearing disorder	0	0	0	0.12	0	0.05
Myo-, endo-, pericardial, coronary and valve disorder	0	0	0	0.12	0	0.05
	No immunomodulatore	Immuno modulatorf	No immunomodulatore	Immunomodulatorf	No immunomodulatore	Immunomodulatorf
Pts. treated	776	613	394	334	1,170	947
Total/median pt-yrs of follow-up	715/1.0	520/1.0	541/0.8	500/1.0	1,256/1.0	1,020/1.0
Number (%) of pts. with infection	397 (51.2%)	279 (45.5%)	169 (42.9%)	163 (48.8%)	566 (48.4%)	442 (46.7%)
P-value	0.04		0.117		0.457
Total incidence	918	578	500	600	1,418	1,178
Incidence per 100 pt-yrs	128.42	111.07	92.47	120.07	112.93	115.48
95% CI	(120.24, 137.00)	(102.20, 120.51)	(84.54, 100.94)	(110.66, 130.08)	(107.13, 118.97)	(108.98, 122.27)
Number (%) of pts. with serious infections	36 (4.6%)	28 (4.6%)	14 (3.6%)	18 (5.4%)	50 (4.3%)	46 (4.9%)
P-value	1		0.277		0.53
Total incidence	63	32	18	30	81	62
Incidence per 100 pt-yrs	8.81	6.15	3.33	6	6.45	6.08
95% CI	(6.77, 11.28)	(4.21, 8.68)	(1.97, 5.26)	(4.05, 8.57)	(5.12, 8.02)	(4.66, 7.79)

AZA, azathioprine; CI, confidence interval; IBD, inflammatory bowel disease; 6-MP, 6-mercaptopurine; MTX, methotrexate; pts., patients; pt-yrs, patient-years.

^aIncludes 3 Crohn's disease and 2 ulcerative colitis, and thus a total of 5, pivotal phase 3 IBD studies.

^bWith or without concomitant conventional therapy.

^cP-values comparing treatment or immunomodulator use subgroups were calculated with the use of Fisher's exact test.

^d95% CIs based on an exact method.

^eNo receipt of AZA, 6-MP, or MTX at baseline.

^fReceipt of AZA, 6-MP, or MTX at baseline.