Single-use autoinjector for peginterferon-β_1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study

Figures & data

Table 1. Summary of questions used and patient response options to investigate secondary objectives.

Evaluation	Questions	Patient response options
Ease-of-use profile of the single-use autoinjector	How easy or difficult was it to set up the injector? How easy or difficult was it to hold and grip the injector? How easy or difficult was it to perform the injection? How easy or difficult was it to dispose of the injector?	Extremely easy Easy Somewhat easy Difficult Extremely difficult
Patient satisfaction with the single-use autoinjector	How convenient or inconvenient was it to administer your medication with this injector? How convenient or inconvenient would it be to use this injector in your home on a regular basis, that is, once or twice a month? How convenient or inconvenient would it be to use this injector when you are travelling or away from home?	Extremely convenient Convenient Somewhat convenient Inconvenient Extremely inconvenient
	Overall, how satisfied or dissatisfied are you with the injector used to administer your medication?	Extremely satisfied Satisfied Somewhat satisfied Dissatisfied Extremely dissatisfied
	How likely would you be to continue to use this injector to administer your medication?	Extremely likely to continue using Likely to continue using Somewhat likely to continue using Unlikely to continue using Extremely unlikely to continue using
Patient assessment of the autoinjector training materials	Did you review the Autoinjector Information for Patients, written instruction, before or during your self-administration with the single-use autoinjector?	Yes No
	How easy was it to understand the Autoinjector Information for Patients?	Very difficult Somewhat difficult Neutral Somewhat easy Very easy
	How satisfied are you with the level of detail in the Autoinjector Information for Patients? How satisfied are you with the organization and presentation of the Autoinjector Information for Patients?	Extremely dissatisfied Somewhat dissatisfied Neutral Somewhat satisfied Extremely satisfied
	Overall, how effective were the printed instructions in educating you on how to use the Autoinjector Information for Patients?	Not effective at all Somewhat ineffective Neutral Somewhat effective Very effective

Table 2. Patient demographics and baseline clinical characteristics.

Characteristic	Total (N = 39)
Age, years, mean (SD)	40.92 (9.77)
Gender, female, n (%)	26 (67)
BMI, kg/m^2, mean (SD)	24.73 (4.66)
Geographical location, n (%)
Poland	24 (62)
Bulgaria	11 (28)
USA	4 (10)
Race, Caucasian, n (%)	39 (100)
ATTAIN baseline EDSS score, mean (SD)	2.68 (1.40)

BMI: Body mass index; EDSS: Expanded disability status scale; SD: Standard deviation.

Table 3. Summary of AEs.

AE incidence, n (%)	PFS N = 39	Autoinjector N = 39
Any AE(s)	27 (69)	23 (59)
AE severity
Mild	10 (26)	8 (21)
Moderate	15 (38)	14 (36)
Severe	2 (5)	1 (3)
Any treatment-related event	24 (62)	22 (56)
Any AE leading to withdrawal	0 (0)	0 (0)
Any SAEs	2 (5)*	1 (3)^‡
Most common AEs^§
Pyrexia	13 (33)	13 (33)
Injection site erythema	11 (28)	9 (23)
Headache	5 (13)	7 (18)
Influenza-like illness	7 (18)	6 (15)
Injection site pain	9 (23)	6 (15)
Myalgia	7 (18)	6 (15)
Arthralgia	4 (10)	5 (13)
Chills	6 (15)	5 (13)

*MS relapses and ureterolithiasis.

^‡MS relapse.

^§AEs occurring in ≥ 10% of subjects (by preferred term).

AE: Adverse event; MS: Multiple sclerosis PFS: Pre-filled syringe; SAE: Serious adverse event.

Figure 1. Mean pain scores following injection with the PFS and single-use autoinjector.

Figure 2. Patient responses to ease-of-use questions for the single-use autoinjector.

Figure 3. Patient responses to convenience questions for the single-use autoinjector.