Long-term safety and tolerability of bapineuzumab in patients with Alzheimer’s disease in two phase 3 extension studies

Table 1 Patient disposition and exposure

	ApoE ε4 carriers		ApoE ε4 noncarriers
	PBO + BAP 0.5	BAP 0.5 + BAP 0.5	PBO + BAP 0.5	BAP 0.5 + BAP 0.5	PBO + BAP 1.0	BAP 1.0 + BAP 1.0
Patients, n (%)
Randomized	216 (100)	276 (100)	39 (100)	66 (100)	37 (100)	56 (100)
Treated	215 (99.5)	275 (99.6)	39 (100)	66 (100)	37 (100)	56 (100)
Completed^a	1 (0.5)	2 (0.7)	0	0	0	0
Withdrawn from treatment and/or study^a	214 (99.5)	273 (99.3)	39 (100)	66 (100)	37 (100)	56 (100)
Primary reason for withdrawal from treatment (safety analysis population), n (%)
Unsatisfactory response-efficacy	3 (1.4)	6 (2.2)	1 (2.6)	1 (1.5)	2 (5.4)	2 (3.6)
Adverse event	16 (7.4)	11 (4.0)	2 (5.1)	5 (7.6)	2 (5.4)	6 (10.7)
Study termination	163 (75.8)	217 (78.9)	31 (79.5)	54 (81.8)	30 (81.1)	45 (80.4)
Subject request	19 (8.8)	25 (9.1)	1 (2.6)	4 (6.1)	3 (8.1)	3 (5.4)
Death	3 (1.4)	1 (0.4)	0	0	0	0
Recurrent episode of ARIA-E	1 (0.5)	0	0	0	0	0
All other reasons^b	9 (4.2)	13 (4.7)	4 (10.2)	2 (3.0)	0	0
Person-years of study drug exposure^c
N	215	275	39	66	37	56
Mean (SD)	0.9 (0.58)	1.0 (0.58)	1.0 (0.53)	1.0 (0.61)	1.0 (5.4)	1.0 (5.4)
Median (range)	1 (0–3)	1 (0–3)	1 (0–2)	1 (0–3)	1 (0–2)	1 (0–2)

ApoE apolipoprotein E, ARIA-E amyloid-related imaging abnormalities with edema or effusions, BAP bapineuzumab, PBO placebo
^aPercentage of treated patients
^bIncludes investigator request, protocol violation, failed to return, lost to follow-up, loss of caregiver, other
^cCalculated as the number of days for each individual patient from the day of the first infusion of the extension study through either the day of the last infusion plus 137 days or the day of last study visit plus 1 day, whichever is shorter, divided by 365.25

ISSN: 1758-9193