Benralizumab in Severe Eosinophilic Asthma and Chronic Rhinosinusitis with Nasal Polyps: The Real-World, Multi-Country RANS Observational Study

Figures & data

Table 1 Baseline (12-Month Pre-Index Period) Demographics and Characteristics

Characteristic		N=233
Age, years	Mean (SD)	56.0 (12.6)
Sex, n (%)	Female	125 (53.6)
Race, n (%)	White	175 (75.1)
	Asian	19 (8.2)
	Black or African American	4 (1.7)
	Other^a	2 (0.9)
	Not reported	33 (14.2)
Smoking status, n (%) [n=229]	Never	148 (64.6)
	Former	79 (34.5)
	Current	2 (0.9)
BMI category, n (%) [n=207]	Underweight (<18.5 kg/m^2)	3 (1.4)
	Normal (18.5 to <25.0 kg/m^2)	94 (45.4)
	Overweight (25.0 to <30.0 kg/m^2)	68 (32.9)
	Obese (≥30 kg/m^2)	42 (20.3)
	Moderately obese (30.00–34.99 kg/m^2)	28 (66.7)
	Severely obese (≥35.00 kg/m^2)	14 (33.3)
Type of hospital^b, n (%)	University hospital	196 (84.1)
	Private clinic or hospital	21 (9.0)
	Non-university specialty hospital	14 (6.0)
	Other public hospital	2 (0.9)
Pre-bronchodilator forced expiratory volume in 1 second, L [n=189]	Mean (SD)	2.2 (0.8)
	Median (range)	2.1 (0.6, 4.5)
Blood eosinophil count [n=176]	Mean (SD), cells/µL^c	726.5 (465.8)
	Median (range), cells/μL^c	621.5 (0, 2000)
	≥300 cells/μL, n (%)	152 (86.4)
FeNO^d [n=87]	Mean (SD), ppb	64.1 (51.1)
	Median (range), ppb	54.0 (5.0, 274.0)
	≥25 ppb, n (%)	67 (77.0)
Total immunoglobulin E in peripheral blood [n=129]	Mean (SD), IU/mL	420.4 (566.5)
	Median (range), IU/mL	219.0 (11.0, 3368.0)
	≥100 IU/mL, n (%)	98 (76.0)
Age at asthma diagnosis, years [n=208]	Mean (SD)	40.2 (15.3)
	Median (range), years	40.0 (4.0, 77.0)
Age at rhinitis diagnosis, years [n=127]	Mean (SD)	43.3 (14.5)
	Median (range), years	44.0 (4.0, 77.0)
Time since first appearance of nasal polyps symptoms, years^e [n=199]	Mean (SD)	10.3 (10.4)
	Median (range), years	7.0 (0, 50.0)
Nasal polyp surgery prior to index, n (%)	In the 12 months pre-index	24 (10.3)
	At any time pre-index	129 (55.4)

Notes: ^aIncluded patients with multiple races. ^bRelevant physician specialties across countries included allergy/immunology, otolaryngology, and pulmonology; the actual specialties were: France – pulmonology, Spain – allergy/immunology, pulmonology, Italy, Japan, and USA – allergy/immunology, otolaryngology, and pulmonology. ^cBlood eosinophil count capped at 2000 cells/μL. ^dExcluded FeNO average results (n=12) reported in case report form based on average of multiple successful FeNO measurements. ^eIndex date minus date of first appearance of symptoms.

Abbreviations: BMI, body mass index; FeNO, fractional exhaled nitric oxide; SD, standard deviation.

Table 2 Baseline (12-Month Pre-Index Period) Disease-Related Comorbidities Reported in ≥1% of Patients

Characteristic, n (%)	N=233
Asthma-, nasal polyp- and eosinophil-related comorbidities^a	207 (88.8)
Asthma^b	195 (83.7)
Nasal polyps^b	154 (66.1)
Chronic sinusitis	38 (16.3)
Allergic rhinitis	31 (13.3)
Rhinitis	18 (7.7)
Allergy	10 (4.3)
Aspirin-exacerbated respiratory disease	7 (3.0)
NSAID-exacerbated respiratory disease	7 (3.0)
Bronchiectasis	6 (2.6)
Chronic obstructive pulmonary disease	4 (1.7)
Gastroesophageal reflux	4 (1.7)
Eosinophilic esophagitis	3 (1.3)
Oral corticosteroid-related comorbidities^a	52 (22.3)
Osteoporosis	17 (7.3)
Obstructive sleep apnea syndrome	9 (3.9)
Sleep apnea syndrome	9 (3.9)
Osteopenia	6 (2.6)
Depression	5 (2.1)
Anxiety	5 (2.1)
Pneumonia	4 (1.7)
Cataract	3 (1.3)

Notes: Percentages add to >100% as more than one comorbidity may be reported per person. ^aOnly conditions with prevalence ≥1% are reported. ^bAsthma and nasal polyp diagnosis in the 12 months pre-index.

Abbreviation: NSAID, non-steroidal anti-inflammatory drug.

Figure 1 Mean change in total NPS from baseline following benralizumab initiation. Changes from baseline were evaluated in the subset of patients who had both baseline and follow-up available data. *All data. Baseline (n=91) 3.8 (2.4); >0–<3 months, n=20; ≥3–<6 months, n=22; ≥6–<9 months, n=21; ≥9–≤12 months, n=35; up to 12 months, n=63.

Abbreviations: CI, confidence interval; NPS, Nasal Polyp Score; SD, standard deviation.

Figure 2 Percentage of patients with clinically meaningful improvement in (A) NPS, and (B) SNOT-22 total score, following benralizumab initiation. Improvement was defined as total NPS reduction ≥1 point; SNOT-22 total score reduction ≥8.9 points. Within the first 6 months, 54.8% (17/31) of patients achieved clinically meaningful reduction in NPS and 48.8% (21/43) in SNOT-22 score.

Abbreviations: NPS, Nasal Polyp Score; SNOT-22, SinoNasal Outcome Test-22.

Figure 3 Mean change in SNOT-22 total score from baseline following benralizumab initiation. *All data. Baseline (n=161) 47.5 (22.6); >0–<3 months, n=18; ≥3–<6 months, n=34; ≥6–<9 months, n=22; ≥9–≤12 months, n=54; up to 12 months, n=114.

Abbreviations: CI, confidence interval; SNOT-22, SinoNasal Outcome Test-22; SD, standard deviation.

Figure 4 Asthma outcomes at baseline (12-month pre-index period) and following benralizumab initiation: (A) AER, (B) patients with exacerbations, (C) mean ACQ-6 score, and (D) mean ACT score. Changes from baseline were evaluated in the subset of patients who had both baseline and follow-up available data.

Abbreviations: AER, annualized exacerbation rate; ACQ-6, 6-item Asthma Control Questionnaire; ACT, Asthma Control Test; CI, confidence interval; SD, standard deviation.

Figure 5 Percentage of patients with controlled asthma at baseline (12-month pre-index period) and during follow-up. Controlled asthma defined as ACQ-6 score <1.5 (well-controlled/partly controlled) or ACT score ≥20 (well-controlled).

Abbreviations: ACQ-6, 6-item Asthma Control Questionnaire; ACT, Asthma Control Test.