Skip to main content

Table 3 TEAEs reported in the HELP and HELP OLE studies by race/ethnicity

From: Effectiveness and safety of lanadelumab in ethnic and racial minority subgroups of patients with hereditary angioedema: results from phase 3 studies

Adverse events, n (%)

All lanadelumab groups (total)

Race

Ethnicity

HELP (n = 84)

White (n = 74)

Black/African American (n = 8)

Asian (n = 2)

Other (NA)

Non-Hispanic/non-Latino (n = 77)

Hispanic/Latino (n = 6)

Any TEAE

68 (91.9)

7 (87.5)

1 (50.0)

–

69 (89.6)

6 (100.0)

Most frequently reported TEAEs (in ≥ 5% of White or non-Hispanic/non-Latino groups)

  

 Injection site pain

30 (40.5)

5 (62.5)

1 (50.0)

–

34 (44.2)

2 (33.3)

 Viral upper respiratory tract

19 (25.7)

1 (12.5)

0

–

18 (23.4)

1 (16.7)

 Headache

14 (18.9)

3 (37.5)

0

–

15 (19.5)

2 (33.3)

 Injection site erythema

8 (10.8)

0

0

–

8 (10.4)

0

 Injection site bruising

6 (8.1)

0

0

–

6 (7.8)

0

 Dizziness

5 (6.8)

0

0

–

5 (6.5)

0

 Abdominal pain

4 (5.4)

0

0

–

2 (2.6)

0

 Respiratory tract infection

4 (5.4)

0

1 (50.0)

–

1 (1.3)

1 (16.7)

 Urinary tract infection

4 (5.4)

0

0

–

3 (3.9)

1 (16.7)

 Myalgia

4 (5.4)

0

0

–

3 (3.9)

1 (16.7)

 Rash

3 (4.1)

1 (12.5)

0

–

4 (5.2)

0

 Toothache

0

0

0

–

4 (5.2)

0

Any treatment-related TEAE

42 (56.8)

7 (87.5)

1 (50.0)

–

47 (61.0)

3 (50.0)

Most frequently reported treatment-related AEs (in ≥ 5% of White or non-Hispanic/non-Latino)

  

 Injection site pain

29 (39.2)

5 (62.5)

1 (50.0)

–

33 (42.9)

1 (16.7)

 Injection site erythema

8 (10.8)

0

0

–

8 (10.4)

0

 Injection site bruising

5 (6.8)

0

0

–

5 (6.5)

0

 Headache

4 (5.4)

2 (25.0)

0

–

4 (5.2)

2 (33.3)

Any serious AE

4 (5.4)

0

0

–

4 (5.2)

0

Any treatment-related serious AE

0

0

0

–

0

0

Any AE leading to discontinuation

1 (1.4)

0

0

–

1 (1.3)

0

Adverse events, n (%)

Lanadelumab 300 mg q2w

Race

Ethnicity

HELP OLE (n = 212)

White (n = 198)

Black/African American (n = 10)

Asian (n = 2)

Other (n = 2)

Non-Hispanic/non-Latino (n = 198)

Hispanic/Latino (n = 13)

Any TEAE

194 (98.0)

8 (80)

2 (100)

2 (100)

192 (97.0)

13 (100.0)

Most frequently reported TEAEs (in ≥ 10% of White or non-Hispanic/non-Latino groups)

 Injection site pain

94 (47.5)

4 (40)

1 (50)

1 (50)

97 (49.0)

3 (23.1)

 Viral upper respiratory tract infection

87 (43.9)

1 (10)

1 (50)

0

86 (40.3)

3 (23.1)

 Upper respiratory tract infection

54 (27.3)

1 (10)

0

0

51 (25.8)

3 (23.1)

 Headache

48 (24.2)

1 (10)

1 (50)

2 (100)

52 (26.3)

0

 Injection site erythema

36 (18.2)

0

0

0

36 (18.2)

0

 Injection site bruising

26 (13.1)

0

0

0

25 (12.6)

1 (7.7)

 Arthralgia

25 (12.6)

2 (20)

0

0

26 (13.1)

0

 Back pain

24 (12.1)

0

0

0

26 (13.1)

0

 Diarrhea

23 (11.6)

0

0

0

23 (11.6)

0

 Nausea

22 (11.1)

0

0

0

21 (10.6)

1 (7.7)

 Sinusitis

22 (11.1)

1 (10)

0

0

23 (11.6)

0

 Abdominal pain

21 (10.6)

1 (10)

0

0

22 (11.1)

0

 Influenza

21 (10.6)

1 (10)

0

0

21 (10.6)

0

 Urinary tract infection

21 (10.6)

2 (20)

0

0

20 (10.1)

0

 Pain in extremity

20 (10.1)

0

0

0

20 (10.1)

1 (7.7)

 Fatigue

19 (9.6)

1 (10)

0

0

20 (10.1)

0

Any treatment-related TEAE

109 (55.1)

5 (50)

1 (50)

1 (50.0)

112 (56.6)

3 (23.1)

Most frequently reported treatment-related AEs (in ≥ 5% of White or non-Hispanic/non-Latino)

 Injection site pain

75 (37.9)

4 (40.0)

1 (50.0)

1 (50.0)

80 (40.4)

1 (7.7)

 Injection site erythema

29 (14.6)

0

0

0

29 (14.6)

0

 Injection site bruising

15 (7.6)

0

0

0

14 (7.1)

1 (7.7)

 Injection site swelling

10 (5.1)

0

0

0

10 (5.1)

0

Any serious AE

18 (9.1)

2 (20)

0 (0)

 

19 (9.6)

2 (15.4)

Any treatment-related serious AE

0 (0)

0 (0)

0 (0)

 

0 (0)

0 (0)

Any AE leading to discontinuation

6 (3)

0 (0)

0 (0)

 

4 (2.0)

1 (7.7)

  1. AE adverse event, TEAE treatment-emergent adverse event, NA not applicable, OLE open-label extension; q2w every 2 weeks