Table 3.

Hazard ratio of the association between baseline pNfL level and prospective outcomes.

	Placebo	Teriflunomide	Overall
First confirmed clinical relapse during DB period
n/N (%)	15/33 (45%)	27/78 (35%)	42/111 (38%)
Hazard ratio (95% CI)	1.00 (0.66, 1.50)	1.22 (0.91, 1.62)	1.10 (0.88, 1.38)
p value	0.98	0.18	0.41
High MRI activity or first confirmed clinical relapse during DB period
n/N (%)	23/33 (70%)	35/78 (45%)	58/111 (52%)
Hazard ratio (95% CI)	1.21 (0.90, 1.64)	1.27 (0.99, 1.63)	1.22 (1.01, 1.48)
p value	0.21	0.06	0.04
24-week sustained disability progression in OLE
n/N (%)	8/32 (25%)	11/74 (15%)	19/106 (18%)
Hazard ratio (95% CI)	1.01 (0.56, 1.80)	1.40 (0.95, 2.06)	1.26 (0.92, 1.73)
p value	0.98	0.09	0.15

Hazard ratios (95% CIs) were estimated using Cox proportional hazards regression with adjustment for age. pNfL was modeled using log base 2 transformation so that the hazard ratio of pNfL would reflect the hazard of each outcome per doubling of baseline pNfL level. Analyses of 24 week sustained disability progression extend to the OLE; the 5 patients who did not enter the OLE were excluded from the disability progression analyses.

CI = confidence interval; DB = double blind; MRI = magnetic resonance imaging; OLE = open-label extension; pNfL = plasma neurofilament light chain.