Table 2. Kaplan-Meier Estimates of 12-Week Composite Confirmed Disability Accumulation, Composite Relapse-Associated Worsening, and Composite Progression Independent of Relapse Activity Events, by Treatment Group and Component.
| 12-wk Confirmed value | Kaplan-Meier estimates at week 96, No. of events (%)a | Hazard ratio (95% CI)b | P value | |
|---|---|---|---|---|
| Interferon β-1a (n = 829) | Ocrelizumab (n = 827) | |||
| Composite confirmed disability accumulation | 223 (29.6) | 167 (21.1) | 0.67 (0.55-0.82) | <.001 |
| Expanded Disability Status Scale | 113 (15.2) | 75 (9.8) | 0.60 (0.45-0.81) | <.001 |
| Timed 25-ft walk | 127 (18.5)c | 103 (14.4)d | 0.74 (0.57-0.96) | .02 |
| 9-Hole peg test | 31 (4.6)d | 26 (3.6)e | 0.80 (0.47-1.34) | .39 |
| Relapse-associated worsening | ||||
| Composite | 45 (6.2) | 24 (2.9) | 0.47 (0.29-0.78) | .003 |
| Expanded Disability Status Scale | 34 (4.7) | 16 (1.9) | 0.41 (0.22-0.76) | .003 |
| Timed 25-ft walk | 13 (1.9)c | 10 (1.4)d | 0.71 (0.31-1.62) | .41 |
| 9-Hole peg test | 3 (0.5)d | 3 (0.4)e | 0.96 (0.19-4.75) | .96 |
| Progression independent of relapse activity | ||||
| Composite | 174 (23.3) | 147 (18.5) | 0.78 (0.63-0.98) | .03 |
| Expanded Disability Status Scale | 72 (9.5) | 58 (7.0) | 0.75 (0.53-1.07) | .11 |
| Timed 25-ft walk | 107 (15.5)c | 90 (12.6)d | 0.77 (0.58-1.03) | .07 |
| 9-Hole peg test | 27 (4.0)d | 22 (3.1)e | 0.78 (0.44-1.37) | .38 |
a
Kaplan-Meier proportion of patients with confirmed accumulation at week 96.
b
Based on Cox proportional hazards model adjusted by baseline Expanded Disability Status Scale score (<4.0 vs ≥4.0), region (US vs rest of world), and study (OPERA I vs OPERA II).
c
770 Patients included in analysis.
d
775 Patients included in analysis.
e
773 Patients included in analysis.