Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma

Figures & data

Figure 1 GREGALE study design (A) and accessorized pre-filled syringe (B).

Notes: *Patients returned used APFS to the study site. a=enlarged finger flanges; b=spring-loaded needle guard.
Abbreviations: APFS, accessorized pre-filled syringe; EOT, end of treatment; F/U, follow-up; SC, subcutaneous.

Table 1 Demographics and baseline clinical characteristics

Characteristic	Benralizumab (N=116)
Age (years), median (range)	49 (18–75)
Age group (years), n (%)
≥18 to <50	60 (52)
≥50 to <65	43 (37)
≥65	13 (11)
Sex, n (%)
Male	52 (45)
Female	64 (55)
Race, n (%)
White	94 (81)
Black or African-American	16 (14)
Asian	4 (3)
Other	2 (2)
Ethnic group, n (%)
Hispanic or Latino	9 (8)
Not Hispanic or Latino	107 (92)
BMI (kg/m^2), mean (SD)	32.0 (8.1)
Blood eosinophil count (cells/µL),	250 (175–430)
median (IQR)
FEV1 prebronchodilator(L), mean (SD)	2.311 (0.784)
FEV1 prebronchodilator (% predicted normal), mean (SD)	70.8 (15.4)
FEV1/FVC prebronchodilator (%),mean (SD)	73 (11)
FEV1 reversibility (%), mean (SD)	15.9 (14.2)
Time since asthma diagnosis (years), median (range)	24.4 (0.9–65.6)
Exacerbations in the previous 12 months, mean (SD), n (%)	0.6 (0.8)
0	71 (61)
1	29 (25)
2	13 (11)
3	3 (3)
ACQ-6 score, mean (SD)	2.14 (0.81)
Diagnosis of allergic rhinitis, n (%)	96 (83)
Nasal polyps, n (%)	18 (16)
OCS use, n (%)	2 (2)

Abbreviations: ACQ-6, Asthma Control Questionnaire 6; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; IQR, interquartile range; OCS, oral corticosteroid.

Figure 2 Percentage of dispensed APFS that were successfully used at the clinical site (A) and at home (B).

Notes: Successful administration was defined as a completed injection, an answer of “Yes” to all the 5 questions in the questionnaire, and passing results in visual inspection and function tests of the APFS after use.
Abbreviation: APFS, accessorized pre-filled syringe.

Figure 3 Median eosinophil counts over time.

Notes: Error bars represent the first and third quartiles.
Abbreviation: ADA, antidrug antibody.

Figure 4 Mean (SD) change in ACQ-6 score from baseline.

Abbreviations: ACQ-6, Asthma Control Questionnaire 6; APFS, accessorized pre-filled syringe; EOT, end of treatment.

Table 2 Serum concentrations of benralizumab

Pharmacokinetic parameter	Visits
	Baseline (n=115)	Week 8 (n=113)	Week 20 (n=111)	Week 28 (n=111)
n<LLOQ	114	0	4a	19
Geometric mean, ng/mL (CV [%])	BLQ	1032 (54)	802 (267)	56 (500)
Arithmetic mean, ng/mL (SD)	BLQ	1147 (478)	1205 (658)	140 (134)
Median, ng/mL (range)	BLQ (<LLOQ–13)	1160 (154–2740)	1140 (<LLOQ–2820)	104 (<LLOQ–579)

Notes:

a Antidrug antibodies were persistently elevated in all 4 patients, which may have contributed to the lower than expected serum concentrations of benralizumab.

Abbreviations: BLQ, below limit of quantification; CV, coefficient of variation; LLOQ, lower limit of quantification (3.86 ng/mL).

Table 3 Asthma control status based on ACQ-6 scores at baseline and end of treatment

Asthma control status	Benralizumab (N=116)
Baseline, n (%)
≤0.75 (well-controlled)	5 (4)
>0.75 to <1.5 (partly controlled)	18 (16)
≥1.5 (not well-controlled)	93 (80)
Missing	0 (0)
End of treatment (week 20), n (%)
≤0.75 (well-controlled)	30 (26)
>0.75 to <1.5 (partly controlled)	27 (23)
≥1.5 (not well-controlled)	54 (47)
Missing	5 (4)

Abbreviation: ACQ-6, Asthma Control Questionnaire 6.

Table 4 Most common AEs reported (>5% of patients) during the study period

Adverse event	Benralizumab 30 mg (N=116)
Patients with ≥1 AEa	77 (66)
Nasopharyngitis	16 (14)
Upper respiratory tract infection	13 (11)
Headache	6 (5)
Sinusitis	6 (5)

Notes:

a Patients with >1 event in the same category were counted only once in that category, and patients with events in >1 category were counted once in each of those categories.

Abbreviation: AE, adverse event.