Functionality and Performance of an Accessorized Pre-Filled Syringe and an Autoinjector for At-Home Administration of Tezepelumab in Patients with Severe, Uncontrolled Asthma

Figures & data

Figure 1 Study design. *Patient or caregiver to return used APFS or AI and completed questionnaire to the study site.

Abbreviations: AI, autoinjector; APFS, accessorized pre-filled syringe; EOT, end of treatment; IP, investigational product; SC, subcutaneous; V, visit.

Table 1 Baseline Demographics and Clinical Characteristics of Study Participants

Demographic/Characteristic	Tezepelumab 210 mg Q4W via APFS (n=111)	Tezepelumab 210 mg Q4W via AI (n=105)	Total (N=216)
Age, years	48.5 (18.1)	45.8 (18.3)	47.2 (18.2)
Female, n (%)	56 (50.5)	52 (49.5)	108 (50.0)
Weight, kg	85.3 (25.6)	83.4 (21.5)	84.3 (23.6)
BMI, kg/m^2	30.3 (8.4)	28.9 (6.3)	29.6 (7.4)
ICS dose, n (%)
Medium^a	59 (53.2)	57 (54.3)	116 (53.7)
High^b	52 (46.8)	48 (45.7)	100 (46.3)
Receiving OCS, n (%)	5 (4.5)	5 (4.8)	10 (4.6)
Pre-BD FEV1, L,	2.2 (0.7)	2.3 (0.8)	2.3 (0.7)
FEV1 reversibility, %	16.3 (10.7)	20.1 (12.6)	18.1 (11.8)
Duration of asthma, years	19.8 (14.8)	20.5 (16.2)	20.1 (15.5)
Exacerbations in the previous 12 months, n (%)
0	60 (54.1)	53 (50.5)	113 (52.3)
1	33 (29.7)	29 (27.6)	62 (28.7)
2	14 (12.6)	14 (13.3)	28 (13.0)
≥3	4 (3.6)	9 (8.6)	13 (6.0)
ACQ-6 score,^c mean (SD)
Screening	2.29 (0.75)	2.27 (0.73)	NC
Baseline	2.23 (0.73)	2.08 (0.62)	NC

Notes: Data are mean (standard deviation) unless otherwise stated. ^aMedium-dose ICS: >250–500 µg/day fluticasone propionate dry powder formulation or equivalent. ^bHigh-dose ICS: >500 µg/day fluticasone propionate dry powder formulation or equivalent. ^cScores range from 0 (no impairment) to 6 (maximum impairment). Scores ≥1.5 indicate inadequately controlled asthma.

Abbreviations: AI, autoinjector; APFS, accessorized pre-filled syringe; BD, bronchodilator; BMI, body mass index; ACQ, Asthma Control Questionnaire; FEV₁, forced expiratory volume in 1 second; ICS, inhaled corticosteroids; NC, not calculated; OCS, oral corticosteroids; Q4W, every 4 weeks.

Figure 2 Proportion of HCPs, patients and caregivers who successfully administered tezepelumab via APFS or AI in (A) the overall population and (B) adolescents only. Values in the bars represent the number of patients who administered study drug successfully out of the total number of patients who received or attempted to receive study drug.

Abbreviations: AI, autoinjector; APFS, accessorized pre-filled syringe; HCP, healthcare professional.

Table 2 Proportion of HCPs, Patients and Caregivers Who Successfully Administered Tezepelumab via APFS or AI

Time Point (Location)	Tezepelumab 210 mg Q4W via APFS (N=111)			Tezepelumab 210 mg Q4W via AI (N=105)
	N	n (%)	95% CI	N	n (%)	95% CI
HCPs
Week 0 (in clinic)	111	109 (98.2)	93.7–99.5	105	105 (100)	96.5–100
Week 4 (in clinic)	50	50 (100)	92.9–100	46	46 (100)	92.3–100
Patients
Week 4 (in clinic)	54	54 (100)	93.4–100	56	53 (94.6)	85.4–98.2
Week 8 (in clinic)	96	96 (100)	96.2–100	94	92 (97.9)	92.6–99.4
Week 12 (at home)	96	96 (100)	96.2–100	94	93 (98.9)	94.2–99.8
Week 16 (at home)	95	91 (95.8)	89.7–98.4	94	91 (96.8)	91.0–98.9
Week 20 (in clinic)	95	91 (95.8)	89.7–98.4	94	91 (96.8)	91.0–98.9
Weeks 8–20 combined	95^a	89 (93.7)	86.9–97.1	94^a	89 (94.7)	88.2–97.7
Caregivers
Week 4 (in clinic)	7	7 (100)	64.6–100	3	3 (100)	43.9–100
Week 8 (in clinic)	14	14 (100)	78.5–100	11	11 (100)	74.1–100
Week 12 (at home)	14	14 (100)	78.5–100	11	11 (100)	74.1–100
Week 16 (at home)	14	13 (92.9)	68.5–98.7	11	11 (100)	74.1–100
Week 20 (in clinic)	14	14 (100)	78.5–100	10	10 (100)	72.3–100
Weeks 8–20 combined	14^a	13 (92.9)	68.5–98.7	10^a	10 (100)	72.3–100

Note: ^aThe number of patients who received or attempted to receive study drug at all specified visits.

Abbreviations: AI, autoinjector; APFS, accessorized pre-filled syringe; CI, confidence interval; HCP, healthcare professional; Q4W, every 4 weeks.

Table 3 Proportion of Devices Reported as Malfunctioning

	APFS (N=655)	AI (N=624)
Reported as malfunctioning, n/N (%)^a,b	6/655 (0.9)	5/624 (0.8)
Administered in the clinic, n/N (%)
All	3/438 (0.7)	5/418 (1.2)
By HCP	2/161 (1.2)	0/152 (0)
By patient	1/242 (0.4)	5/242 (2.1)
By caregiver	0/35 (0)	0/24 (0)
Administered at home, n/N (%)
All	3/217 (1.4)	0/206 (0)
By patient	2/189 (1.1)	0/184 (0)
By caregiver	1/28 (3.6)	0/22 (0)

Notes: ^aTwelve kits were lost and were not evaluated after administration of study drug. These kits are not included in this analysis. ^bN refers to the cumulative number of used and returned devices over relevant visits.

Abbreviations: AI, autoinjector; APFS, accessorized pre-filled syringe; HCP, healthcare professional.

Figure 3 Proportion of patients with well-controlled, partially controlled and not well-controlled asthma at baseline and at week 24, by device group. ^aData were missing for two patients in the APFS group and the mean ACQ-6 score was not calculated for these patients.

Abbreviations: ACQ-6, Asthma Control Questionnaire; AI, autoinjector; APFS, accessorized pre-filled syringe.

Table 4 Proportions of Patients Who Reported AEs During the Treatment Period

AE Category	APFS (n=111)	AI (n=105)	Total (N=216)
All AEs	52 (46.8)	55 (52.4)	107 (49.5)
AEs related to device malfunction	0 (0)	0 (0)	0 (0)
AEs related to study drug^a	0 (0)	6 (5.7)	6 (2.8)
Injection-site reactions	0 (0)	6 (5.7)	6 (2.8)
AEs by severity
Mild	32 (28.8)	27 (25.7)	59 (27.3)
Moderate	18 (16.2)	26 (24.8)	44 (20.4)
Severe	2 (1.8)	2 (1.9)	4 (1.9)
Serious AEs	3 (2.7)	3 (2.9)	6 (2.8)
AE leading to death	0 (0)	0 (0)	0 (0)
AEs leading to treatment discontinuation	2 (1.8)	0 (0)	2 (0.9)
AEs by preferred term^b
Nasopharyngitis	8 (7.2)	12 (11.4)	20 (9.3)
Upper respiratory tract infection	7 (6.3)	5 (4.8)	12 (5.6)
Asthma	5 (4.5)	5 (4.8)	10 (4.6)

Notes: Data are number of patients (%). ^aAs judged by the investigator. ^bAEs by Medical Dictionary for Regulatory Activities (MedDRA) preferred term experienced by >3% of the patients overall. Patients with multiple AEs categorized under the same preferred term were only counted once for that preferred term.

Abbreviations: AE, adverse event; AI, autoinjector; APFS, accessorized pre-filled syringe.