Population | n | Mean years | Mean | Markov model | Multilevel model | Multilevel model with imputation | ||||
At risk | On treatment | Baseline EDSS | Absolute treatment effect | Relative rate of progression | Absolute treatment effect | Relative rate of progression | Absolute treatment effect | Relative rate of progression | ||
Primary analysis population | 4862 | 8.7 | 7.0 | 3.18 | 0.12 (0.07, 0.17) | 93% (90%, 96%) | 0.61 (0.55, 0.66) | 72% (69%, 74%) | 0.65 (0.59, 0.70) | 73% (70%, 75%) |
Baseline EDSS ≤3.5 | 2940 | 9.0 | 7.4 | 2.02 | 0.35 (0.28, 0.42) | 84% (81%, 87%) | 0.63 (0.56, 0.71) | 74% (71%, 77%) | 0.67 (0.59, 0.74) | 75% (73%, 78%) |
Baseline EDSS 4–5.5 | 1275 | 8.6 | 6.7 | 4.42 | −0.11 (−0.21, −0.02) | 110% (102%, 119%) | 0.59 (0.49, 0.68) | 68% (63%, 73%) | 0.64 (0.54, 0.73) | 69% (65%, 73%) |
Baseline EDSS ≥6 | 647 | 8.0 | 5.5 | 6 | −0.47 (−0.57, −0.36) | 233% (202%, 265%) | 0.52 (0.41, 0.62) | 63% (56%, 70%) | 0.59 (0.48, 0.69) | 65% (59%, 71%) |
RRMS at baseline | 4217 | 8.9 | 7.3 | 2.86 | 0.25 (0.20, 0.31) | 86% (83%, 89%) | 0.68 (0.62, 0.74) | 69% (67%, 72%) | 0.71 (0.66, 0.78) | 71% (69%, 73%) |
SPMS at baseline | 645 | 7.8 | 5.1 | 5.29 | −0.76 (−0.86, −0.66) | 218% (202%, 234%) | 0.10 (0.00, 0.20) | 93% (86%, 101%) | 0.19 (0.09, 0.29) | 90% (85%, 95%) |
RRMS at baseline and: | ||||||||||
Baseline EDSS ≤3.5 | 2882 | 9.0 | 7.5 | 2.00 | 0.39 (0.32, 0.46) | 82% (79%, 86%) | 0.67 (0.59, 0.74) | 73% (69%, 76%) | 0.70 (0.63, 0.77) | 74% (71%, 77%) |
Baseline EDSS 4–5.5 | 1093 | 8.7 | 7.0 | 4.40 | −0.01 (−0.11, 0.10) | 101% (91%, 110%) | 0.68 (0.58, 0.79) | 63% (58%, 68%) | 0.72 (0.62, 0.83) | 65% (60%, 70%) |
Baseline EDSS ≥6 | 242 | 8.4 | 6.2 | 6 | −0.16 (−0.35, 0.04) | 143% (90%, 196%) | 0.84 (0.64, 1.03) | 44% (32%, 56%) | 0.91 (0.72, 1.10) | 47% (37%, 58%) |
SPMS at baseline and: | ||||||||||
Baseline EDSS ≤3.5 | 58 | 8.2 | 5.9 | 2.69 | −1.48 (−1.87, −1.09) | 181% (158%, 203%) | −1.10 (−1.51, −0.70) | 151% (133%, 170%) | −1.05 (−1.46, −0.64) | 142% (125%, 159%) |
Baseline EDSS 4–5.5 | 182 | 7.8 | 5.1 | 4.55 | −0.77 (−0.95, −0.59) | 182% (161%, 202%) | −0.01 (−0.20, 0.19) | 101% (89%, 112%) | 0.13 (−0.06, 0.32) | 94% (85%, 102%) |
Baseline EDSS ≥6 | 405 | 7.8 | 5.1 | 6 | −0.65 (−0.77, −0.53) | 292% (255%, 329%) | 0.32 (0.21, 0.44) | 76% (68%, 84%) | 0.39 (0.28, 0.50) | 76% (69%, 83%) |
Date of baseline assessment | ||||||||||
On or before 28 August 2003 | 2351 | 8.7 | 6.9 | 3.32 | 0.02 (−0.06, 0.10) | 99% (94%, 103%) | 0.53 (0.46, 0.61) | 75% (71%, 78%) | 0.58 (0.51, 0.66) | 75% (72%, 79%) |
After 28 August 2003 | 2511 | 8.8 | 7.0 | 3.05 | 0.21 (0.14, 0.29) | 88% (83%, 92%) | 0.67 (0.60, 0.75) | 69% (66%, 72%) | 0.71 (0.64, 0.78) | 71% (67%, 74%) |
Baseline at or before 31 August 2003 and: | ||||||||||
Baseline EDSS ≤3.5 | 1352 | 8.9 | 7.5 | 2.07 | 0.27 (0.16, 0.38) | 87% (82%, 92%) | 0.57 (0.46, 0.68) | 77% (72%, 81%) | 0.61 (0.50, 0.72) | 77% (73%, 82%) |
Baseline EDSS 4–5.5 | 631 | 8.6 | 6.6 | 4.42 | −0.21 (−0.34, −0.08) | 119% (107%, 131%) | 0.49 (0.36, 0.62) | 73% (66%, 80%) | 0.54 (0.41, 0.66) | 74% (68%, 80%) |
Baseline EDSS ≥6 | 368 | 7.9 | 5.4 | 6 | −0.50 (−0.64, −0.36) | 244% (202%, 287%) | 0.48 (0.34, 0.62) | 65% (56%, 74%) | 0.55 (0.41, 0.69) | 67% (59%, 75%) |
Baseline after 31 August 2003 and | ||||||||||
Baseline EDSS ≤3.5 | 1588 | 9.0 | 7.4 | 1.97 | 0.42 (0.32, 0.52) | 81% (77%, 85%) | 0.69 (0.59, 0.79) | 72% (68%, 76%) | 0.71 (0.61, 0.81) | 73% (69%, 78%) |
Baseline EDSS 4–5.5 | 644 | 8.5 | 6.8 | 4.43 | −0.02 (−0.16, 0.11) | 102% (90%, 114%) | 0.68 (0.54, 0.82) | 62% (55%, 69%) | 0.74 (0.60, 0.87) | 64% (58%, 71%) |
Baseline EDSS ≥6 | 279 | 8.2 | 5.6 | 6 | −0.43 (−0.58, −0.27) | 219% (175%, 264%) | 0.57 (0.41, 0.72) | 61% (50%, 71%) | 0.63 (0.48, 0.78) | 63% (54%, 71%) |
EDSS, Expanded Disability Status Scale; MS, multiple sclerosis; RRMS, relapsing remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis.