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

Table 1 Baseline characteristics and demographics for patients in the lanadelumab groups in HELP and HELP OLE

Characteristic, n (%) unless otherwise stated	All lanadelumab groups (total)
Characteristic, n (%) unless otherwise stated	Race				Ethnicity
HELP (n = 84)^a	White (n = 74)	Black/African American (n = 8)	Asian (n = 2)	Other (NA)	Non-Hispanic/non-Latino (n = 77)	Hispanic/Latino (n = 6)
Geographical region
United States	51 (68.9)	8 (100)	2 (100)	–	54 (70.1)	6 (100)
Canada	4 (5.4)	0	0	–	4 (5.2)	0
Europe	17 (23.0)	0	0	–	17 (22.1)	0
Jordan	2 (2.7)	0	0	–	2 (2.6)	0
Race	–	–	–
White				–	68 (88.3)	5 (83.3)
Black/African American				–	7 (9.1)	1 (16.7)
Asian				–	2 (2.6)	0
Ethnicity					–	–
Non-Hispanic/non-Latino	68 (91.9)	7 (87.5)	2 (100)	–
Hispanic/Latino	5 (6.8)	1 (12.5)	0	–
Unknown	1 (1.4)	0	0	–
BMI, mean (SD)	28.8 (6.3)	28.2 (6.1)	25.8 (1.1)	–	28.7 (6.1)	29.4 (7.8)
Baseline HAE attack rate, mean (SD), attacks per month^b	3.67 (2.25)	2.03 (1.51)	2.41 (1.99)	–	3.50 (2.20)	3.70 (2.69)
Lanadelumab treatment group in HELP
150 mg q4w	25 (33.8)	1 (12.5)	2 (100)	–	27 (35.1)	1 (16.7)
300 mg q4w	23 (31.1)	6 (75.0)	0	–	27 (35.1)	2 (33.3)
300 mg q2w	26 (35.1)	1 (12.5)	0	–	23 (29.9)	3 (50.0)

Characteristic, n (%) unless otherwise stated	Lanadelumab 300 mg q2w
Characteristic, n (%) unless otherwise stated	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)
Geographical region
United States	133 (67.2)	10 (100)	2 (100)	2 (100)	133 (67.2)	13 (100)
Canada	13 (6.6)	0	0	0	13 (6.6)	0
Europe	39 (19.7)	0	0	0	39 (19.7)	0
Jordan	13 (6.6)	0	0	0	13 (6.6)	0
Race	–	–	–	–
White					185 (93.4)	12 (92.3)
Black/African American					9 (4.5)	1 (7.7)
Asian					0	0
Other					2 (1.0)	0
Ethnicity					–	–
Non-Hispanic/non-Latino	185 (93.4)	1 (10)	2 (100)	2 (100)
Hispanic/Latino	12 (6.1)	9 (90)	0	0
Unknown	1 (0.5)	0	0	0
BMI, mean (SD)	28.3 (7.2)	28.4 (7.2)	25.8 (1.1)	31.1 (12.1)	28.3 (7.1)	28.5 (8.7)
Baseline attack rate, mean (SD), attacks per month^b	3.13 (2.70)	1.82 (1.61)	2.41 (1.99)	1.38 (0.65)	3.02 (2.66)	3.37 (2.72)
Patient group in OLE
Rollover	99 (50.0)	8 (80.0)	2 (100)	0	101 (51.0)	8 (61.5)
Non-rollover	99 (50.0)	2 (20.0)	0	2 (100)	97 (49.0)	5 (38.5)

BMI body mass index, HAE hereditary angioedema, NA not applicable, OLE open-label extension
^aOf the 125 patients enrolled in the HELP study, 84 were enrolled to the lanadelumab cohorts and baseline characteristics for only these patients are reported here
^bThe baseline HAE attack rate was calculated for each patient as the number of investigator-confirmed HAE attacks that occurred during the run-in period of the HELP study for rollover patients or during the historical reporting period for non-rollover patients, divided by the number of days the patient contributed to the run-in period for rollover patients or historical reporting period for non-rollover patients, multiplied by 28 days. For non-rollover patients, the historical rate in the last 3 months before screening was used

ISSN: 1710-1492