Appropriate selection for omalizumab treatment in patients with severe asthma?

Figures & data

Figure 1. Flowchart for enrolment of patients in the study. The numbers of patients completing 2 and 3 years of therapy were considered too small for analysis. *Patients used for objective 1; **patients used for objective 2. ¹Cause of missing contact: death (1), missing contact information (2); ²side effects registered: general physical discomfort (1), arthralgia (1), headache, fatigue and dyspnoea (1)

Table 1. Baseline characteristics

Characteristics	Study population (N = 24)
Age (years)	43 ± 12
Women	13 (54)
IgE level (IU/mL)	235 ± 190
Body mass index (kg/m^2)	30.8 ± 6.4
Omalizumab dose (mg/4 weeks)	422 ± 225
Correct omalizumab dose	18 (75)
ACT score ^a	12.4 ± 4.5
FEV1% predicted (L)	2.30 (69) ± 0.83 (21)
FVC% predicted (L)	3.22 (82) ± 0.90 (17)
FEV1/FVC	71.0 ± 15.1
PEF (L/min)	365 ± 113
Admissions (in year preceding index date), mean	0.71
Exacerbations (in year preceding index date), mean^b	2.64
Perennial aeroallergen	23 (96)
GINA step
4	19 (79)
5	5 (21)
Tobacco
Never-smoker	12 (50)
Ex-smoker	12 (50)
Comorbidities^b
Coronary and peripheral vascular diseases (antiplatelets and anticoagulants)	2 (9)
Hypertension	4 (17)
Hyperlipidaemia	1 (4)
Ischaemic heart disease	1 (4)
Congestive heart disease (/hypertension)	3 (13)
Diabetes	1 (4)
Acid peptic disease	11 (48)
Thyroid disorders	1 (4)
Chronic IBD	1 (4)
Pain (inflammation)	16 (70)
Pain	8 (35)
Depression	5 (22)
Psychotic illness	1 (4)
Ischaemic heart disease (/hypertension)	3 (13)
Comorbidity, frequency^b
0–2	12 (52)
3–4	7 (30)
5–6	2 (9)
≥7	2 (9)

Continuous data are shown as mean ± SD and categorical data as number (%).

^a Two patients had no registered Asthma Control Test (ACT) score at the index date.

^b One patient lacked information about redeemed prescriptions, as the Odense Pharmaco-Epidemiological Database (OPED) the Region of Southern Denmark outside Funen until 2007.

IgE, immunoglobulin E; FEV₁, forced expiratory volume in 1 sec; FVC, forced vital capacity; PEF, peak expiratory flow; GINA, Global Initiative for Asthma; IBD, inflammatory bowel disease.

Table 2. Fulfilled omalizumab selection criteria

Criteria	Fulfilled, N (%)
Age ≥ 6 years	24 (100)
Severe asthma	24 (100)
Achieved compliance with asthma control medication	19 (79)^a
ACT < 20	20 (83)^b
FEV1 < 80% (if ≥ 12 years)	17 (71)
Perennial aeroallergen	23 (96)
≥ 1 exacerbation	19 (79)^c
Weight [20;150] kg	24 (100)
Total IgE [30;1500] IU/ml	24 (100)
All criteria fulfilled	10 (42)

^a Two patients lacked information about redeemed prescriptions as the Odense Pharmaco-Epidemiological Database (OPED) did not cover the Region of Southern Denmark outside Funen before 2007.

^b Two patients had no Asthma Control Test (ACT) score registered at the index date. The missing values were registered as ACT > 20.

^c One patient lacked information about redeemed prescriptions as OPED did not cover the Region of Southern Denmark outside Funen before 2007.

FEV₁, forced expiratory volume in 1 sec; IgE, immunoglobulin E.

Figure 2. Changes in Asthma Control Test (ACT) score after 16 and 52 weeks of treatment for 17 and 11 patients, respectively. Each line represents a patient and the dotted line represents the mean ACT score. At the 16 and 52 week follow-up the mean ACT score was 17.5 and 19.3, respectively

Table 3. Development in mean pulmonary function test (PFT) measurements and mean exacerbation rates for patients completing 52 weeks of treatment

Characteristics	Baseline	16 weeks	52 weeks
FEV1% predicted (L)
(n = 12)	2.16 (69) ± 0.67	2.47 (81) ± 0.55	2.45 (81) ± 0.62
FVC% predicted (L)
(n = 12)	3.06 (84) ± 0.75	3.34 (89) ± 0.62	3.27 (89) ± 0.69
PEF (L/min)
(n = 9)^b	352 ± 56	403 ± 77	402 ± 70
Exacerbations^a
(n = 11)^b	1.27 ± 0.9	1 ± 2.1	0.64 ± 1.2

Data are shown as mean (%) ± SD; n indicates the number of patients included.

^a The exacerbation rates are biannual and account for the mean number of exacerbations (1) during the 180 days preceding the index date, (2) from the index date to 180 days afterwards, and (3) from 180 to 360 days of treatment, respectively.

^b Because of no registered peak expiratory flow (PEF) measurements and missing information about redeemed prescriptions from the Odense Pharmaco-Epidemiological Database (OPED), only nine and 11 patients were included in calculations of PEF and exacerbation rate, respectively.

FEV₁, forced expiratory volume in 1 sec; FVC, forced vital capacity.