Table 2.

Mean change in PROs from baseline to 12 months.

Measure	Description	Component	Mean (SD) change from baseline to Month 12
			Improved	Stable	Worsened	p-value
MSIS-29a	20 items assess physical impact of MS in terms of mobility and self-care	Physical impactn = 868	+–3.0 (14.1)			<0.0001
	9 items assess psychological impact of MS	Psychological impactn = 860	+–8.0 (18.6)			<0.0001
MFIS-5b	5 items assess how fatigue impacts patients’ lives	n = 867	+–1.7 (3.8)			<0.0001
TSQM-14c	14 items assess patient treatment satisfaction	Effectivenessn = 492	+14.4 (29.5)			<0.0001
		Side effectsn = 500	+25.4 (31.4)			<0.0001
		Conveniencen = 505	+33.4 (25.7)			<0.0001
		Global scoren = 511	+21.8 (26.9)			<0.0001
EQ-5D-5Ld	5 items assess mobility, self-care, usual activities, pain and discomfort, anxiety and depression	EQ-5Dn = 792	+0.02 (0.1)			<0.0001
		EQ-5D VASn = 803	+3.7 (15.9)			<0.0001
PRIMUS activity limitationse	15 items assess activities of daily living	n = 545		±–0.14 (3.2)		0.2134
WPAI-MSf	6 items assess the number of work hours missed, impact on productivity, and daily activities during past 7 days	Work impairmentfn = 327	+–2.2 (19.5)			0.008
		Activity impairmentn = 851	+–4.2 (22.3)			<0.0001
BDI-Fast Screeng	7 items assess depression during the past 2 weeks	n = 854	+–0.8 (2.5)			<0.0001
EDSSh	Assesses disease progression	n = 940		±–0.05 (0.65)		0.0136

BDI-Fast Screen: Beck Depression Inventory-Fast Screen; EDSS: Expanded Disability Status Scale; EQ-5D-5L: EuroQol-5D 5-level version; MFIS-5: Modified Fatigue Impact Scale 5-item version; MSIS-29, Multiple Sclerosis Impact Scale; PRIMUS: Patient-Reported Indices for Multiple Sclerosis; PRO: patient-reported outcome; TSQM-14: Treatment Satisfaction Questionnaire for Medication; WPAI-MS: Work Productivity and Activity Impairment for Multiple Sclerosis.

Mean change in PROs from baseline to 12 months was assessed using a Wilcoxon signed-rank test.

^aLower score indicates better outcome; range, 0–100 (scores were transformed).

^bLower score indicates improved functioning; range, 0–20.

^cHigher score indicates greater satisfaction; range, 0–100; only patients with previous treatment were assessed.

^dHigher score indicates better health; range, 0–100.

^eHigher score indicates better outcome; range, 0–30.

^fHigher score indicates higher impairment and lower productivity; scores are only reported for patients who were employed at the time of PRO administration.

^gLower score indicates less severe depressive symptoms; range, 0–21.

^hLower score indicates less severe disability symptoms; range, 0–10.