Effectiveness and Response Predictors of Omalizumab in Treating Patients with Seasonal Allergic Rhinitis: A Real-World Study

Figures & data

Table 1 Basic Characteristic of SAR Patients

Variables	N=60
Age, years	35.47 (±17.02)
Sex (male/female), n	25/35
BMI, kg/m^2	23.16 (±4.20)
Body weight, kg	62.3 (±16.1)
Comorbidity, n (%)
Asthma	21 (35%)
Food allergy	3 (5%)
Eczema	2 (3.3%)
Family history, n (%)	36 (60%)
Pollen season, n (%)	34 (56.7%)
Smoking, n (%)	4 (6.7%)
Intermittent/Persistent rhinitis, n	31/29
Disease duration, years	10 (1, 40)
Serum IgE, IU/mL	213 (16.8, 2141)
Total dosage of omalizumab, mg	450 (150, 1800)
Duration of treatment, months	2.9 (±1.2)
Baseline RQLQ overall score	2.55 (±1.04)
Activities	3.42 (±1.55)
Sleep	2.72 (±1.62)
Non-nose/eye symptoms	2.30 (±1.46)
Practical problems	3.62 (±1.37)
Nasal problems	3.84 (±1.36)
Eye problems	1.42 (±1.09)
Emotional function	1.25 (±1.24)
Baseline TNSS	9.97 (±2.29)
Number of respiratory medications	1.4 (±1.2)
AIT	20 (32.8%)
Antihistamines (i.n.)	1 (1.7%)
Antihistamines (p.o.)	33 (55.0%)
Antileukotrienes (p.o.)	17 (28.3%)
Glucocorticoids (i.n.)	12 (20.0%)
Asthma patients (N=21)
Baseline ACT score	16.10 (±4.12)
ICS/LABA	13 (61.9%)

Note: Continuous variables are presented as mean (±standard deviation) or median (range).

Abbreviations: SAR, seasonal allergic rhinitis; BMI, body mass index; RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; TNSS, Total Nasal Symptoms Score; ACT, Asthma Control Test; AIT, allergen immunotherapy; i.n., intranasal drugs; p.o., oral drugs; ICS/LABA, inhaled corticosteroid/long-acting beta-agonist.

Figure 1 Flow-chart of study design.

Abbreviations: RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; TNSS, Total Nasal Symptoms Score.

Table 2 Changes in RQLQ, TNSS, and ACT Scores from Pre- to Post-Treatment of Omalizumab

Scores	Pre-Treatment	Post-Treatment	Change	p^#
RQLQ overall score	2.55 (±1.04)	0.47 (±0.47)	−2.08 (±1.01)	<0.001
Activities	3.42 (±1.55)	0.76 (±0.73)	−2.66 (±1.54)	<0.001
Sleep	2.72 (±1.62)	0.28 (±0.56)	−2.44 (1.64)	<0.001
Non-nose/eye symptoms	2.30 (±1.46)	0.40 (±0.53)	−1.89 (±1.45)	<0.001
Practical problems	3.62 (±1.37)	0.69 (±0.77)	−2.92 (±1.41)	<0.001
Nasal problems	3.84 (±1.36)	0.87 (±0.98)	−2.97 (±1.27)	<0.001
Eye problems	1.42 (±1.09)	0.28 (±0.46)	−1.13 (±1.08)	<0.001
Emotional function	1.25 (±1.24)	0.15 (±0.39)	−1.10 (±1.20)	<0.001
TNSS	9.97 (±2.29)	2.63 (±2.13)	−7.33 (±2.50)	<0.001
ACT score^&	16.10 (±4.12)	22.57 (±2.29)	6.48 (±4.17)	<0.001

Notes: ^#paired t-test; ^&only for 21 patients with asthma.

Abbreviations: RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; TNSS, Total Nasal Symptoms Score; ACT, Asthma Control Test.

Table 3 Comparison of Baseline Characteristics and Treatment Efficacy Between Responders and Non-Responders to Omalizumab

Variables	Responders (N=50)	Non-Responders (N=10)	p
Age, years	35.54 (±17.21)	35.10 (±16.91)	0.941
Sex (male/female), n	19/31	6/4	0.198
BMI, kg/m^2	23.29 (±4.42)	22.46 (±2.88)	0.573
Body weight, kg	62.66 (±16.59)	60.30 (±13.84)	0.676
Asthma (Y/N)	18/32	3/7	0.717
Family history (Y/N)	31/19	5/5	0.480
Pollen season (Y/N)	27/23	7/3	0.351
Intermittent/Persistent rhinitis	27/23	4/6	0.419
Disease duration, years	10 (5, 10)	8 (5, 13.8)	0.902
Serum IgE, IU/mL	220 (138, 454)	132 (103, 226)	0.154
Total dosage of omalizumab, mg	450 (300, 600)	450 (338, 450)	0.783
Number of medications	1.4 (±1.2)	1.4 (±1.3)	0.962
AIT (Y/N)	16/34	4/6	0.624
RQLQ overall scores
Baseline	2.83 (±0.90)	1.15 (±0.37)	<0.001
Post-treatment	0.47 (±0.48)	0.48 (±0.40)	0.951
TNSS
Baseline	10.28 (±2.11)	8.40 (±2.63)	0.017
Post-treatment	2.56 (±2.03)	3.00 (±2.67)	0.556

Note: Chi-square test, t-test, or Mann–Whitney U-test were used as appropriate.

Abbreviations: BMI, body mass index; RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; TNSS, Total Nasal Symptoms Score; AIT, allergen immunotherapy.

Table 4 Multiple Linear Regression Analysis of Baseline Characteristics to Predict RQLQ Response to Omalizumab

Variables	Coefficient	S.E.	t	p
Age, years	0.007	0.005	1.514	0.137
Sex (male)	0.182	0.156	1.165	0.250
Comorbid asthma	−0.043	0.144	−0.299	0.766
Body weight, kg	−0.010	0.006	−1.667	0.102
Family history	−0.133	0.140	−0.954	0.345
Total dosage of omalizumab (≥600mg)	−0.162	0.162	−1.001	0.322
Total serum IgE (IU/mL)	0.000	0.000	0.317	0.753
AIT	0.200	0.139	1.442	0.156
Baseline RQLQ overall score	−0.807	0.069	−11.631	<0.001

Abbreviations: RQLQ, Rhinoconjunctivitis Quality of Life Questionnaire; AIT, allergen immunotherapy.