Severe asthma and eligibility for biologics in a Brazilian cohort

Figures & data

Table 1. Eligibility criteria used to classify patients for each biologic treatment.

Biologicals	Indication Label in Brazil	Number of Exacerbations in the last 12 months	IgE level	EOS counts (cells/µL)
Mepolizumab	Indicated as a complementary maintenance treatment for severe eosinophilic asthma in adult patients.	≥2	–	≥150
Reslizumab	Indicated as a complementary maintenance treatment for severe eosinophilic asthma in adult patients (Approved but not marketed in Brazil)	≥1	–	≥400
Benralizumab	Indicated as a complementary maintenance treatment for severe eosinophilic asthma in adult patients.	≥2	–	≥300
Omalizumab	Persistent, moderate to severe allergic asthma whose symptoms are inadequately controlled with inhaled corticosteroids (IC).	≥1	According to weight	–

Notes. EOS, Eosinophils; IGE, Immunoglobulin.

Table 2. Demographic and clinical characteristics of patients with severe asthma (SA) from the Brazilian ProAR Cohort according to the ERS/ATS 2014 definition modified.

	Severe asthma (n = 172)
Age in years, mean (SD)	54 (12)
Age in years at onset of asthma symptoms, mean (SD)*	15 (15)
Sex, female (%)	84.3
Ethnicity (%)
Afro-Caribbean	36.0
Caucasian	8.1
Mixed	53.5
Indigenous	1.2
Asian	1.2
Education* (%)
<Elementary school	7.6
Elementary School	52.0
High School	34.5
College	5.8
Nutritional status (%)
Underweight	0.6
Eutrophic	18.0
Overweight	34.3
Obesity I and II	43.0
Obesity III	4.1
Number of self-reported comorbidities (%)
1	6.4
2	20.3
≥3	73.3
Comorbid condition (n, %)
Rhinitis	166 (96.5)
Gastroesophageal reflux disease (GERD)	136 (79.1)
Hypertension	98 (57.0)
Dyslipidemia	62 (36.0)
Psychiatric disorders	25 (14.5)
Diabetes mellitus	24 (14.0)
Osteoporosis	18 (10.5)
Hypothyroidism	10 (5.8)
Autoimmune disease	4 (2.3)
Hyperthyroidism	1 (0.6)
Other	72 (42.1)

* Notes. 1 patient missing data; SD, Standard deviation.

Table 3. Description of inflammatory markers in severe asthma from the Brazilian ProAR Cohort patients according to ERS/ATS 2014 definition modified.

	Severe asthma
Eosinophils (cells/µL)
N	170
Mean (SD)	310 (317)
<150, n (%)	61 (35.9)
150 – 199, n (%)	15 (8.8)
200 – 299, n (%)	39 (22.9)
300 – 399, n (%)	18 (10.6)
≥ 400, n (%)	37 (21.8)
IgE, (IU/ml)
N	168
Mean (SD)	537 (730)
≥ 160, %	66.1
< 160 , %	33.9
Atopy
N	153
Yes, %	63.4
No, %	36.6
C-reactive protein (mg/L)
N	84
Mean (SD)	6.47 (6.66)

* Notes. Defined by a positive skin prick test to any aeroallergen; IGE, Immunoglobulin E; SD, Standard deviation.

Table 4. Assessment of asthma control and number of self-reported exacerbations in severe asthma (SA) from the Brazilian ProAR Cohort patients according to ERS/ATS 2014 definition modified.

	SA (ERS/ATS 2014)		Patients eligible for mepolizumab	Patients eligible for omalizumab	Patients eligible for reslizumab	Patients eligible for benralizumab
N	172		61	60	29	32
ACQ-6 score
Missing data	0
Controlled/partially controlled (<1.5), n (%)	76 (44.2)
Uncontrolled (≥1.5), n (%)	96 (55.8)
Mean (SD)	1.70 (1.04)		1.96 (1.18)	1.59 (0.89)	2.08 (1.07)	2.21 (1.08)
GINA symptom control
Missing data	0
Controlled, n (%)	47 (27.3)
Partially controlled, n (%)	63 (36.6)
Uncontrolled, n(%)	62 (36.0)
Distribution by number of self-reported exacerbations* (%)
0	21.5%		0.0%	0.0%	0.0%	0.0%
1	21.5%		0.0%	28.3%	24.1%	0.0%
2	11.6%		24.6%	15.0%	17.2%	25.0%
3	15.1%		21.3%	25.0%	27.6%	25.0%
4	8.1%		13.1%	11.7%	10.3%	15.6%
≥5	22.1%		41.0%	20.0%	20.7%	34.4%

* Notes. Considered as emergency room visits, hospitalization or oral corticosteroid cycles.

ACQ-6, asthma control questionnaire – 6-item; GINA, Global Initiative for Asthma; SD, Standard deviation.

Table 5. Patient reported use of inhaler combinations from the Brazilian ProAR Cohort severe asthma patients according to ERS/ATS 2014 definition modified.

	Severe asthma (n = 172)
High doses of ICS*
ICS, %	0.6
ICS + ICS/LABA, %	84.3
ICS/LABA, %	0.6
Non-high doses of ICS
ICS/LABA, %	14.5

* Notes. Considered as ≥1000 mcg of fluticasone or equivalent; SD, Standard deviation; ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist.

Figure 1. Frequency of eligible patients for biological therapy for patients with severe asthma from the Brazilian ProAR Cohort according to ATS/ERS 2014 criteria modified.

Data availability

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