Table 1.

Clinical and magnetic resonance imaging (MRI) outcomes for the four pivotal relapse-remitting multiple sclerosis trials

Clinical and MRI outcomes	Subgroups	Study name
		IFN-β study group		MSCRGa	PRISMS		ADVANCEb
		1.6 MIU	8 MIU	30 µg	22 µg	44 µg	q4 wk	q2 wk
ARR	IFN-β	1.04	0.85	0.61	1.82	1.73	0.288	0.256
	Placebo	1.18		0.90	2.56		0.397
	p-value	0.030c		0.002	<0.005c		0.0007d
Proportion of patients with disease progression	IFN-β	47%	35%	21.20%	18.5/23%e	21.3/31%e	6.05%	6.05%
	Placebo	46%		33.30%	11.9e		10%
	p-value	0.096		0.02	<0.05e		0.038
GdEL+ lesion number	IFN-β	1.8 ± 0.4	2.0 ± 0.7	0.8 ± 0.22	1.4 (0–6.7)	1.3 (0–4)	0.9 ± 0.15	0.2 ± 0.05
	Placebo	4.9 ± 1.3		1.65 ± 0.48	8.0 (2.7–27)		1.4 ± 0.17
	p-value	0.0089		0.05	<0.0001		<0.0001
T2-lesion volume change in %	IFN-β	10.50%	−0.10%	6.50%	−1.20%	−3.80%	7.3 (35%)f	3.7 (67%)f
	Placebo	20.00%		13.20%	10.90%		11.2f
	p-value	<0.001		0.36	<0.0001		<0.0001f
Whole brain volume change	IFN-β	N/A	N/A	−0.233 ± 0.74	N/A	N/A	−0.67 ± 0.83	−0.72 ± 0.75
	Placebo	N/A		−0.521 ± 0.8	N/A		−0.62 ± 0.89
	p-value	N/A		0.03g	N/A		0.084

Interferon β (IFN-β) study group—Betaseron pivotal trial; MSCRG—Multiple Sclerosis Collaborative Research Group pivotal trial for Avonex; PRISMS—Prevention of Relapses and Disability by IFN-β-1a Subcutaneously in Multiple Sclerosis pivotal trial for Rebif; ADVANCE—pegylated interferon (PEG-IFN)-β-1a for relapsing remitting multiple sclerosis pivotal trial for Plegridy. Alpha level of 0.05 was considered as significant and is shown in bold.

MIU, Million international units; q4 wk, every 4 weeks; q2 wk, every 2 weeks; ARR, annualized relapse rate; GdEL, gadolinium-enhancing lesion; N/A, not available.

^a104 weeks study period.

^bResults at 48 weeks follow-up.

^cRelapse rate.

^dBased on negative binomial regression; adjusted for baseline expanded disability status scale (EDSS) (<4 vs. ≥4), baseline relapse rate, and age (<40 vs. ≥40).

^eTime in months for EDSS progression <1/reduction in disease progression.

^fAdjusted mean number of lesions (percentage reduction vs. placebo).

^gMean % brain parenchyma fraction change post hoc analysis of Avonex trial.