Table 3.

Safety

	ADA	ETA	TOC	ETA vs ADA	ADA vs TOC	ETA vs TOC
Patients, n	236; 236.4	419	74
Patient years, n	236.4	524,096	72,47364819
Exposure, years mean ± SD	1.00 ± 0.86	1.25 ± 1.05	0.98 ± 0.60
Adverse events, n; n/patient	386; 1.63	996; 2.37	102: 1.38	p = 0.011		p = 0.004
Rate/100 PY (95% CI)	163.3 (148.8; 180.4)	190.0 (178.6; 202.2)	140,7 (113.5; 167.4)	RR 1.16 (1.03–1.31)	ns	RR 1.35 (1.1–1.66)
Serious adverse events, n; n/patient	26; 0.11	119; 0.28	3; 0.04	p = 0.0008		p = 0.004
Rate/100 PY (95% CI)	11.0 (7.5; 16.2)	22.07 (19.0; 27.2)	4.1 (1.3; 12.8)	RR 2.06 (1.35–3.16)	ns	RR 5.48 (1.74–17.25)
Autoimmunopathy, n; n/patient	3; 0.012	2; 0.004	1; 0.014
Rate/100 PY (95% CI)	1.27 (0.41; 3.39)	0.38 (0.09; 1.53)	1.38 (0.19; 9.59)	ns	ns	ns
Bleeding disorder, n; n/patient	2; 0.008	3; 0.007	0
Rate/100 PY (95% CI)	0.85 (0.21; 3.38)	0.57 (0.18; 1.17)		ns	ns	ns
CED, n; n/patient	1; 0.004	13; 0.031	0	p = 0.09
Rate/100 PY (95% CI)	0.42 (0.06; 3.0)	2.48 (1.44; 4.27)		RR 5.86 (0.77–44.83)	ns	ns
Demyelinisation	0	1; 0.002	0
Rate/100 PY (95% CI)		0.19 (0.03-1.35)		ns	ns	ns
Hepatitis	6; 0.025	10; 0.024	3; 0.041
Rate/100 PY (95% CI)	2.54 (1.14; 5.65)	1.91 (1.03; 3.55)	4.14 (1.31; 12.57)	ns	ns	ns
Hyperlipidemia	0	3; 0.007	1; 0.014
Rate/100 PY (95% CI)		0.57 (0.18; 1.17)	1.38 (0.19; 9.59)	ns	ns	ns
Infection. serious or medically important; n; n/patient	13; 0.055	50; 0.119	3; 0.041	p = 0.076
Rate/100 PY (95% CI)	5.5 (3.19; 9.47)	9.54 (7.23; 12.59)	4.14 (1.31; 12.57)	RR 1.73 (0.94–3.19)	ns	ns
Intolerance, n; n/patient	2; 0.008	3; 0.007	2; 0.027
Rate/100 PY (95% CI)	0.85 (0.21; 3.38)	0.57 (0.18; 1.17)	2.76 (0.68; 10.81)	ns	ns	ns
Malignancy, n; n/patient	0	1; 0.002	0
Rate/100 PY (95% CI)		0.19 (0.03; 1.35)		ns	ns	ns

ADA adalimumab, ETA etanercept, TOC tocilimuzab, PY person years, ns not significant, RR relative risk