Table 2.

Serious cases associated with anaphylactic reactions caused by asthma biologics.

N (%)	Omalizumab	Mepolizumab	Benralizumab	Reslizumab	Dupilumab
Seriousnessa
Caused/prolonged hospitalization	433 (21.9%)	28 (19.9%)	20 (23.8%)	2 (28.6%)	17 (27.0%)
Life-threatening	252 (12.8%)	19 (13.5%)	7 (8.3%)	1 (14.3%)	3 (4.8%)
Death	12 (0.6%)	3 (2.1%)	1 (1.2%)	0 (0%)	0 (0%)
Disabling/Incapacitating	10 (0.5%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Congenital anomaly/Birth defect	1 (0.1%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Other	1,255 (63.6%)	91 (64.5%)	56 (66.7%)	4 (57.1%)	43 (68.3%)
Unknown	10 (0.5%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Outcome of serious AEs associated with anaphylactic reactions
Recovered	599 (35.4%)	43 (43.4%)	27 (40.3%)	3 (75.0%)	13 (26.0%)
Recovering	78 (4.6%)	3 (3.0%)	1 (1.5%)	0 (0%)	5 (10.0%)
Recovered with sequelae	17 (1.0%)	0 (0%)	0 (0%)	0 (0%)	1 (2.0%)
Not recovered	29 (1.7%)	4 (4.0%)	1 (1.5%)	0 (0%)	0 (0%)
Fetal	6 (0.4%)	0 (0%)	1 (1.5%)	0 (0%)	0 (0%)
Unknown	962 (56.9%)	49 (49.5%)	37 (55.2%)	1 (25.0%)	31 (62.0%)
Actions taken to address AEs
Drug withdrawn	646 (38.2%)	40 (40.4%)	23 (34.3%)	3 (75.0%)	14 (28.0%)
Dose not changed	90 (5.3%)	5 (5.1%)	8 (11.9%)	1 (25.0%)	9 (18.0%)
Dose reduced	14 (0.8%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Dose increased	11 (0.7%)	0 (0%)	0 (0%)	0 (0%)	0 (0%)
Not applicable	20 (1.2%)	4 (4.0%)	2 (3.0%)	0 (0%)	0 (0%)
Unknown	910 (53.8%)	50 (50.5%)	34 (50.8%)	0 (0%)	27 (54.0%)
Outcomes after actions
Reaction abated	692 (40.9%)	43 (43.4%)	25 (37.3%)	3 (75.0%)	19 (38.0%)
No effect observed	28 (1.7%)	4 (4.0%)	1 (1.5%)	0 (0%)	0 (0%)
Effect unknown	966 (57.1%)	52 (52.5%)	40 (59.7%)	1 (25.0%)	31 (62.0%)
Fetal	5 (0.3%)	0 (0%)	1 (1.5%)	0 (0%)	0 (0%)

Serious cases included reports related to anaphylactic reactions regardless of positive signals.

^aCases reported with one or more than two kinds of seriousness.