Real-World Safety and Effectiveness of Omalizumab in Moderate to Severe Allergic Asthma Patients in China: A Post-Authorization Study

Figures & data

Figure 1 Patient disposition.

Table 1 Patient Demographics and Clinical Characteristics at Baseline

		Overall Population, ≥6 Years, N=1528	Pediatric Patients, 6 to <12 Years, N=191
Gender, n (%)	Male	754 (49.3)	142 (74.3)
	Female	773 (50.6)	49 (25.7)
	Unknown	1 (0.1)	0
Age (years)	Mean (SD)	n=1527	n=191
		40.0 (20.04)	8.5 (1.72)
Age group, n (%)	6 to <12 years	191 (12.5)	191 (100)
	≥12 years	1336 (87.4)	0
	Unknown	1 (0.1)	0
Weight (kg)	Mean (SD)	n=1528	n=191
		61.38 (15.88)	35.67 (11.24)
Historical allergic asthma, n (%)	n (%)	1528 (100)	191 (100)
	Moderate	1145 (74.9)	176 (92.1)
	Severe	383 (25.1)	15 (7.9)
Time since first diagnosis (years)	Mean (SD)	n=1525	n=190
		7.64 (9.96)	3.22 (2.16)
Total Serum IgE (IU/mL)	Mean (SD)	n=1514	n=189
		457.01 (703.17)	617.79 (949.40)
Smoking, n (%)	Current smokers	85 (5.6)	0
	Former smokers	170 (11.1)	0
	Non-smokers	1273 (83.3)	191 (100)
Seasonal aeroallergen, n (%)	n (%)	382 (25.0)	59 (30.9)
	Autumn allergen	321 (21.0)	57 (29.8)
	Spring allergen	161 (10.5)	23 (12.0)
	Other	53 (3.5)	4 (2.1)
Perennial aeroallergen, n (%)	n (%)	700 (45.8)	134 (70.2)
	Dermatophagoides pteronyssinus	495 (32.4)	100 (52.4)
	Dermatophagoides farina	467 (30.6)	100 (52.4)
	Cat hair	153 (10.0)	19 (9.9)
	Dog hair	121 (7.9)	17 (8.9)
	Cockroach	86 (5.6)	7 (3.7)
	Fungi	164 (10.7)	51 (26.7)
	Other	213 (13.9)	43 (22.5)

Abbreviations: IgE, immunoglobulin E; SD, standard deviation.

Table 2 Overview of Adverse Events (Safety Analysis Set)

	Overall Population, n (%), N=1528	Pediatric Patients 6 to <12 Years, n (%), N=191
AEs	361 (23.6)	27 (14.1)
Mild	206 (13.5)	15 (7.9)
Moderate	121 (7.9)	12 (6.3)
Severe	34 (2.2)	0 (0.0)
Study drug related	58 (3.8)	5 (2.6)
AE/SAE leading to study discontinuation	2 (0.1)	0 (0.0)
AE leading to treatment discontinuation	29 (1.9)	3 (1.6)
Death*	3 (0.2)	0 (0.0)
Treatment-emergent AEs	339 (22.2)	24 (12.6)
SAEs	68 (4.5)	3 (1.6)
Study drug related	1 (0.1)	0 (0.0)
SAE leading to treatment discontinuation	9 (0.6)	1 (0.5)
AESI	2 (0.1)	0 (0.0)
Lung adenocarcinoma	1 (0.1)	0 (0.0)
Lung neoplasm malignant	1 (0.1)	0 (0.0)
Study drug–related AESI	0 (0.0)	0 (0.0)
AEs occurred in at least 2% of patients in overall population by SOC and PT
Infections and infestations	139 (9.1)	15 (7.9)
Upper respiratory tract infection	53 (3.5)	9 (4.7)
Nasopharyngitis	38 (2.5)	3 (1.6)
Respiratory, thoracic, and mediastinal disorders	96 (6.3)	3 (1.6)
Asthma	46 (3.0)	1 (0.5)
Gastrointestinal disorders	45 (2.9)	2 (1.0)
General disorders and administration-site conditions	42 (2.7)	2 (1.0)
Skin and subcutaneous tissue disorders	38 (2.5)	3 (1.6)
Nervous system disorders	32 (2.1)	–

Notes: Results presented in the number of events, number of patients (percentage) order. AEs excluded special scenarios, for instance, drug-drug or drug-food interaction, drug use during lactation, lack of efficacy, overdose, intentional drug abuse and misuse, medication errors including drug maladministration, dispensing or prescribing errors, drug dependence or addiction, withdrawal reaction/syndrome or rebound symptoms, unexpected beneficial effect, and treatment non-compliance (with clinical symptoms), etc. *Among the 3 cases of AEs with the outcome of death in the overall population, 2 cases were reported as discontinued from the study.

Abbreviations: AE, adverse event; AESI, adverse event special interest; N, number of patients; SAE, serious adverse event; SOC, system organ class; PT, preferred term.

Figure 2 Effectiveness endpoints in the overall population. (A) GETE responder. GETE of excellent or good was defined as the responder; GETE of moderate, poor, or worsening was defined as the non-responder. The percentages are calculated based on the number of patients who had been evaluated by the investigator and patient in each visit. (B) Mini AQLQ mean change from baseline. (C) PAQLQ change from baseline (patient <18 years). (D) Asthma exacerbation events. The summary of the annualized number of asthma exacerbation events that occurred at 0–16 weeks and 0–24 weeks.

Table 3 Summary of Pulmonary Function Test

							Change From Baseline
	n	Mean	SD	Med	Min	Max	n	Mean	SD	Med	Min	Max
Pulmonary function test*
FEV1 (L)
Baseline	947	2.97	7.20	2.27	0.33	100.90
Week 16	244	2.71	5.50	2.29	0.42	87.30	191	0.16	0.48	0.09	−2.39	1.97
Week 24	179	2.41	0.89	2.31	0.48	4.94	136	0.18	0.42	0.13	−0.87	1.49
FEV1% predicted (%)
Baseline	936	80.47	25.13	84.70	12.60	168.00
Week 16	243	85.89	20.29	87.41	16.30	131.00	189	5.39	16.53	3.00	−45.38	78.10
Week 24	179	86.49	22.05	88.00	20.00	143.20	135	6.40	16.27	4.00	−27.30	57.00
FVC (L)
Baseline	945	4.17	9.65	3.07	0.62	129.50
Week 16	244	3.18	1.01	3.12	0.62	7.00	189	−0.38	7.27	0.05	−99.56	2.98
Week 24	179	3.45	3.32	3.10	0.79	45.61	135	−0.26	9.31	0.07	−99.69	40.56
FEV1/FVC (%)
Baseline	942	71.91	14.10	74.60	16.94	99.63
Week 16	244	74.61	12.52	76.29	35.74	99.00	189	2.70	9.83	2.15	−40.19	57.64
Week 24	178	74.35	12.22	75.63	30.10	100.00	134	2.22	7.63	1.68	−23.71	25.19
PEF (L/s)
Baseline	937	6.55	8.63	5.63	0.84	105.30
Week 16	243	5.97	2.29	5.70	0.56	17.80	188	0.42	1.39	0.34	−6.11	6.03
Week 24	179	5.89	2.10	5.51	0.90	12.73	136	0.51	1.15	0.49	−1.95	4.19

Notes: *If both results of previous and after using a bronchodilator of pulmonary function test existed, the result of “previous” use of a bronchodilator is preferable.

Abbreviations: FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; PEF, peak expiratory flow; Med, Median; SD, standard deviation.