User Trial Questionnaire and Quality of Life Responses in Patients with Multiple Sclerosis By Neurological and Cognitive Status: MOSAIC Study

Background: The 12-wk, Phase IIIb, open-label, single-arm, MOSAIC study (NCT00958009) evaluated the Rebidose^® single-use autoinjector (SA) for self-injection of 44 mcg subcutaneous interferon beta-1a (IFN β-1a SC) three times weekly in 109 relapsing multiple sclerosis (RMS) patients (pts). 

Objectives: Evaluate pt-reported acceptability, satisfaction, and quality of life (QoL) perception following 12 wks of SA use between pts enrolled in MOSAIC with non-normal and normal status, as determined by neurological and cognitive assessments at baseline (BL).

Methods: Pre-specified analyses compared pt perception of the SA using a 25-item User Trial Questionnaire (UTQ; range –50 to 50) administered after initial dose and at 6 and 12 wks. Comparisons were made between pts with non-normal and normal status for 15 neuro-cognitive subtypes (eg, visual, mental, physical, memory). QoL change was analyzed using paired t-tests in intent-to-treat (ITT) pts and in subgroups with non-normal status using the Short Form-36 (SF-36) assessment at BL and Wk 12.

Results: Mean age of the ITT population was 6.0±9.3 yrs; 86.2% white, 69.7% female. Wk 12 UTQ score was significantly different between normal and non-normal status pts for 3 neuro-cognitive subtypes: pts with ‘impaired extraocular movement’ (n=10) and ‘dominant hand abnormality’ (n=38) were less positive (scores decreased from 46.7 to 25.5 and 44.4 to 27.8, respectively), and pts with non-normal ‘sensory status’ (n=15) were more positive with use of the SA than pts with normal status (score increased from 23.0 to 49.2). There were no significant differences between pts with non-normal and normal dominant hand status for the individual UTQ items. Pts indicated that they would continue to use the SA after the study (100% and 98.6% for non-normal and normal status, respectively). QoL, as measured by SF-36 in ITT pts, increased significantly (p=0.04) from screening to Wk 12 for the domain assessing physical health (role-physical). Significant improvements from BL to Wk 12 were observed for SF-36 domains in subgroups with non-normal memory (n=83, role-physical, p=0.02; role-emotional, p=0.04) and with non-normal executive function (n= 82, role-physical, p=0.03; physical health component, p=0.04).

Conclusions: After 12 wks of SA use for IFN β-1a SC self-injection, RMS pts were satisfied overall, would continue using the SA, and reported improvement in QoL despite some degree of neurological or cognitive impairment.