. 2013 Sep;4(5):192–205. doi: 10.1177/2040622313492810

Table 2.

Magnetic resonance imaging outcomes from the TEMSO trial.

Magnetic resonance imaging outcomes	Placebo (n = 363)	Teriflunomide 7 mg (n = 365)	Teriflunomide 14 mg (n = 358)
Total lesion volume
Change from baseline (ml)	2.21 ± 7.00	1.31 ± 6.80	0.72 ± 7.59
Relative reduction versus placebo (%)^*		39.4	67.4
p value		0.03	< 0.001
Volume of hypointense lesions on T1-weighted images
Change from baseline (ml)	0.53 ± 1.06	0.50 ± 1.15	0.33 ± 1.01
Relative reduction versus placebo (%)^*		16.7	31.3
p value		0.19	0.02
Volume of hyperintense lesion components on T2-weighted images^$
Change from baseline (ml)	1.67 ± 6.47	0.81 ± 6.18	0.39 ± 6.90
Relative reduction versus placebo (%)^*		44.0	76.7
p value		0.04	< 0.001
Gadolinium-enhanced lesions per T1-weighted scan^‡
Estimated no. (95% CI)	1.33 (1.06–1.67)	0.57 (0.43–0.75)	0.26 (0.17–0.41)
Relative risk (95% CI)		0.43 (0.31–0.59)	0.20 (0.12–0.32)
p value		< 0.001	< 0.001
Absence of gadolinium-enhanced lesions on T1-weighted images
No. of patients (%)^§	135 (39.0)	180 (51.4)	218 (64.1)
p value		< 0.001	< 0.001
Unique active lesions per scan^‡
Estimated no. (95% CI)	2.46 (2.10–2.89)	1.29 (1.07–1.54)	0.75 (0.58–0.99)
Relative risk (95% CI)		0.52 (0.42–0.65)	0.31 (0.23–0.41)
p value		< 0.001	< 0.001
Brain parenchymal fraction^‖
Change from baseline^¶	–0.004 ± 0.001	–0.003 ± 0.001	–0.003 ± 0.001
Difference versus placebo^¶		0.001 ± 0.001	0.001 ± 0.001
Relative reduction versus placebo (%)		25.0	25.0
p value		0.19	0.35

Data are based on a mixed-effects model and repeated-measures analysis, with the use of a cube-root transformation of the volume data.

This measure is the portion of the total lesion volume that appears hyperintense on T2-weighted images (dual echo spin density and fluid-attenuation inversion recovery images), but does not appear hypointense on T1-weighted images obtained after the administration of gadolinium.

^‡

Unique active lesions were defined as the number of gadolinium-enhanced lesions on T1-weighted images, or new or enlarged lesions on T2-weighted images, without double counting. Values were calculated with the use of a Poisson regression model adjusted for treatment, Expanded Disability Status Scale score, and number of lesions at baseline and geographic region, with the log of the number of magnetic resonance imaging scans serving as an offset variable.

^§

Data were missing for 17 patients in the placebo group, 15 patients in the lower dose teriflunomide group, and 18 patients in the higher dose teriflunomide group.

^‖

Brain parenchymal fraction was calculated as the inverse of the normalized cerebrospinal fluid volume and assessed with the use of a mixed-effects model with repeated-measures analysis.

^¶

Plus–minus values are least-square means ± standard error.

CI, confidence interval.