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Table 3 The summary of treatment emergent adverse events and amyloid-related imaging abnormalities-edema (ARIA-E). Lecanemab was generally well-tolerated with similar incidence rates of AEs and SAEs between placebo and lecanemab, and these events were consistent with the subject population. The most common TEAEs were infusion-related reaction (most were mild to moderate in severity, most responded to prophylactic treatment, and few led to discontinuation) and ARIA-E (most were mild to moderate in severity, and were required to discontinue treatment, but encouraged to continue efficacy assessments). Incidence of treatment-related TEAE were similar for placebo and lecanemab for non-ARIA-E-related events

From: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody

 

Lecanemab

Category

Placebo

(n = 245)

n (%)

2.5 mg/kg

Biweekly

(n = 52)

n (%)

5 mg/kg

Monthly

(n = 51)

n (%)

5 mg/kg

Biweekly

(n = 92)

n (%)

10 mg/kg

Monthly

(n = 253)

n (%)

10 mg/kg

Biweekly

(n = 161)

n (%)

Any TEAE

216 (88.2)

46 (88.5)

48 (94.1)

81 (88.0)

238 (94.1)

39 (86.3)

Treatment-related TEAE

65 (26.5)

23 (44.2)

25 (49.0)

31 (33.7)

135 (53.4)

76 (47.2)

Serious adverse event

43 (17.6)

10 (19.2)

4 (7.8)

16 (17.4)

31 (12.3)

25 (15.5)

Deaths

2 (0.8)

2 (3.8)

0

1 (1.1)

2 (0.8)

0

AE leading to discontinuation

15 (6.1)

7 (13.5)

4 (7.8)

10 (10.9)

47 (18.6)

24 (14.9)

ARIA-E

2 (0.8)

1 (1.9)

1 (2.0)

3 (3.3)

25 (9.9)

16 (9.9)

 ApoE4-positive (n = 436)

2 (1.1)

1 (2.6)

1 (2.5)

3 (3.6)

23 (10.2)

7 (14.3)

 ApoE4-negative(n = 112)

0

0

0

0

2 (7.1)

9 (8.0)

  1. TEAE, treatment emergent adverse event; ARIA-E, amyloid-related imaging abnormalities-edema; ApoE4, apolipoprotein E4