Table 2.
Predictor | Level | 3-month confirmed worsening events (n = 391) | 12-month sustained worsening events (n = 307) | ||
---|---|---|---|---|---|
n (% of level) | Adjusted HR (95% CI) P-value1 | n (% of level) | Adjusted HR (95% CI) P-value2 | ||
Demographics | |||||
Sex | Male | 110 (19.3%) | 1.05 (0.84, 1.31) 0.677 | 83 (14.5%) | 0.97 (0.75, 1.25) 0.823 |
Female | 281 (19.8%) | 1.00 | 224 (15.8%) | 1.00 | |
Age at CIS onset | Per 10 years | – | 1.17 (1.06, 1.30) 0.002 | – | 1.17 (1.04, 1.31) 0.007 |
Clinical | |||||
KFS ambulation | 0 | 318 (17.9%) | 1.00 | 254 (14.3%) | 1.00 |
1+ | 73 (35.1%) | 1.60 (1.09, 2.34) 0.015 | 53 (25.5%) | 1.45 (0.94, 2.22) 0.092 | |
KFS pyramidal | 0–1 | 242 (16.5%) | 1.00 | 194 (13.2%) | 1.00 |
2+ | 149 (28.7%) | 1.45 (1.13, 1.89) 0.003 | 113 (21.7%) | 1.38 (1.05, 1.83) 0.023 | |
KFS cerebellar | 0–1 | 306 (18.5%) | 1.00 | 243 (14.7%) | 1.00 |
2+ | 85 (25.6%) | 1.06 (0.78, 1.44) 0.710 | 64 (19.3%) | 1.33 (0.95, 1.86) 0.097 | |
KFS bowel/bladder | 0–1 | 342 (18.5%) | 1.00 | 272 (14.8%) | 1.00 |
2+ | 49 (33.8%) | 0.78 (0.52, 1.18) 0.246 | 35 (24.1%) | 0.75 (0.47, 1.21) 0.241 | |
Relapses | |||||
ARR | – | 1.20 (1.18, 1.22) <0.001 | – | 1.01 (0.98, 1.05) 0.456 | |
MRI | |||||
T2 lesion load | 0 | 27 (35.1%) | 1.00 | 25 (32.5%) | 1.00 |
1–2 | 26 (24.5%) | 1.17 (0.67, 2.04) 0.578 | 22 (20.8%) | 1.06 (0.59, 1.92) 0.834 | |
3–8 | 195 (19.0%) | 0.91 (0.60, 1.38) 0.649 | 148 (14.4%) | 0.83 (0.53, 1.30) 0.424 | |
≥9 | 101 (18.7%) | 1.07 (0.69, 1.68) 0.753 | 78 (14.4%) | 0.98 (0.61, 1.58) 0.939 | |
Not recorded | 42 (17.8%) | 0.88 (0.53, 1.46) 0.634 | 34 (14.2%) | 0.82 (0.48, 1.40) 0.472 | |
Treatment | |||||
Proportion follow-up years treated | 0 (no treatment) | 157 (23.6%) | 1.07 (0.81, 1.39) 0.645 | 142 (21.3%) | 0.75 (0.56, 1.02) 0.066 |
>0–50% treated | 87 (24.9%) | 1.00 | 68 (19.5%) | 1.00 | |
>50–80% treated | 95 (18.3%) | 0.64 (0.47, 0.86) 0.003 | 59 (11.4%) | 0.43 (0.31, 0.59) <0.001 | |
>80–100% treated | 52 (11.4%) | 0.35 (0.25, 0.50) <0.001 | 38 (8.4%) | 0.24 (0.17, 0.35) <0.001 |
Cox Proportional Hazards Regression.
Hazard proportionality test: p = 0.3025;
Hazard proportionality test: p = 0.2772
CIS, Clinically Isolated Syndrome; KFS, Kurtzke Functional System; ARR, annualized relapse Rate; DMT Disease Modifying Therapy; IM Intramuscular; SC Subcutaneous; CI Confidence Interval.