Background
Methods
Patients
Measures
Statistical analysis
Results
Variable | Covariate | Untreated | IFN-β treated | p-value |
---|---|---|---|---|
No. of patients | 77 | 41 | ||
Age at disease onset (yrs) | 30.3 ± 9.7 | 28.7 ± 10.5 | 0.42 | |
Age at inclusion (yrs) | 42.1 ± 11.2 | 36.8 ± 11.5 |
0.02
| |
Gender | Male | 28 (36.4) | 8 (19.5) | 0.06 |
Female | 49 (63.6) | 33 (80.5) | ||
Disease duration (yrs) | 12.0 ± 7.8 | 8.9 ± 8.1 |
0.04
| |
Disease course | RR | 58 (75.3) | 34 (82.9) | 0.34 |
SP | 19 (24.7) | 7 (17.1) | ||
School education (degree-yrs) | <5 | 10 (12.9) | 6 (14.6) | 0.97 |
6–8 | 16 (21) | 7 (17.1) | ||
9–13 | 38 (49.2) | 19 (46.3) | ||
>13 | 13 (16.9) | 9 (22) |
Untreated n. 77 | IFN-β treated n.41 | p-value* | ||||
---|---|---|---|---|---|---|
Time-varying covariates
|
Baseline
|
Change
|
Baseline
|
Change
|
Baseline
|
Change
|
Relapse rate** | 0.2 ± 0.3 | 0.0 ± 0.4 | 0.7 ± 0.5 | -0.1 ± 0.6 |
<0.0001
| 0.37 |
EDSS | 3.1 ± 1.7 | 0.4 ± 0.8 | 3.0 ± 1.8 | 0.4 ± 1.1 | 0.84 | 0.93 |
BDI | 9.5 ± 7.7 | 1.3 ± 10.3 | 10.8 ± 9.2 | 2.2 ± 9.8 | 0.57 | 0.88 |
FSS | 2.5 ± 1.8 | 1.1 ± 1.7 | 2.8 ± 1.9 | 1.2 ± 1.8 | 0.53 | 0.75 |
MMSE-c | 28.5 ± 2.0 | -0.6 ± 2.4 | 28.1 ± 3.7 | -0.5 ± 2.5 | 0.78 | 0.70 |
MSQoL-54 Measures
| ||||||
Physical health composite score | 65.5 ± 21.4 | -5.5 ± 17.2 | 65.1 ± 22.3 | -9.1 ± 18.9 | 0.91 | 0.45 |
Mental health composite score | 69.1 ± 19.8 | 1.2 ± 20.2 | 71.6 ± 18.2 | -12.1 ± 19.1 | 0.54 |
0.006
|
Physical function | 67.7 ± 35.8 | -2.3 ± 14.7 | 69.5 ± 35.4 | -8.8 ± 19.1 | 0.80 | 0.13 |
Health perceptions | 47.5 ± 23.4 | -3.0 ± 23.1 | 48.7 ± 22.7 | -6.0 ± 26.9 | 0.76 | 0.64 |
Energy | 47.7 ± 22.6 | 1.1 ± 23.0 | 47.0 ± 23.0 | -1.2 ± 23.0 | 0.91 | 0.57 |
Role limitation-physical | 67.6 ± 43.5 | -4.6 ± 42.9 | 65.2 ± 40.7 | -14.3 ± 41.8 | 0.48 | 0.52 |
Bodily pain | 79.7 ± 25.7 | -8.7 ± 30.9 | 74.0 ± 29.7 | -8.1 ± 28.6 | 0.39 | 0.41 |
Sexual function | 83.1 ± 26.6 | -6.0 ± 35.6 | 81.5 ± 27.0 | -12.0 ± 36.5 | 0.67 | 0.62 |
Social function | 74.2 ± 23.3 | -5.8 ± 23.4 | 74.4 ± 21.3 | -10.0 ± 21.5 | 0.87 | 0.49 |
Health distress | 70.8 ± 23.0 | -2.0 ± 31.6 | 71.9 ± 20.4 | -13.3 ± 24.0 | 0.98 | 0.06 |
Overall quality of life | 67.5 ± 19.0 | -1.0 ± 22.3 | 64.4 ± 18.8 | -8.6 ± 24.3 | 0.46 | 0.17 |
Cognitive function | 78.6 ± 20.6 | -0.4 ± 23.0 | 82.4 ± 20.6 | -12.2 ± 23.9 | 0.31 | 0.06 |
Emotional well-being | 57.1 ± 22.8 | 5.4 ± 43.2 | 59.5 ± 16.7 | -21.6 ± 42.5 | 0.65 |
0.014
|
Role limitation- emotional | 70.6 ± 43.3 | 0.4 ± 27.2 | 78.9 ± 36.3 | -6.4 ± 21.0 | 0.37 | 0.22 |
Satisfation with sexual function | 60.4 ± 26.7 | 2.0 ± 34.9 | 54.3 ± 30.6 | -3.7 ± 37.0 | 0.33 | 0.40 |
Change in health | 47.1 ± 19.9 | 0.5 ± 21.3 | 50.6 ± 22.7 | 4.6 ± 35.5 | 0.43 | 0.36 |
Physical Health Composite Score | Mental Health Composite Score | |||
---|---|---|---|---|
Effect | β | p | β | p |
Intercept* | 65.08 |
<.0001
| 69.31 |
<.0001
|
Age at inclusion | -0.19 |
0.043
| -0.22 | 0.06 |
Gender (Male vs. Female) | -1.51 | 0.43 | -6.95 |
0.005
|
Disease duration | -0.1 | 0.41 | -0.04 | 0.82 |
Disease course (SP vs. RR) | 3.69 | 0.24 | 8.39 |
0.037
|
Relapse rate 2-yrs before study entry | 0.69 | 0.75 | 0.62 | 0.83 |
EDSS | -3.44 |
0.0003
| -0.85 | 0.47 |
BDI | -0.59 |
<.0001
| -1.44 |
<.0001
|
FSS | -6.69 |
<.0001
| -2.08 |
0.019
|
MMSE-c | -0.28 | 0.44 | 0.45 | 0.34 |
IFN-β treatment (Yes vs No)
| -0.09 | 0.97 | 2.75 | 0.36 |
Relapse rate change after 2-yrs | 2.15 | 0.42 | 0.60 | 0.84 |
EDSS change after 2-yrs | -1.57 | 0.26 | 1.59 | 0.31 |
BDI change after 2-yrs | -0.60 |
<.0001
| -1.08 |
<.0001
|
FSS change after 2-yrs | -5.21 |
<.0001
| -2.48 |
0.01
|
MMSE-c change after 2-yrs | -0.35 | 0.53 | -0.16 | 0.81 |
Time** | 1.32 | 0.54 | 3.33 | 0.19 |
Time × IFN-β treatment (Yes vs No)
| -1.65 | 0.58 | -9.19 |
0.01
|
Energy | Health perceptions | Physical function | Role limitation physical | Bodily pain | Social function | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Effect | β | p | β | p | β | p | β | p | β | p | β | p |
Intercept* | 45.11 |
<.0001
| 44.67 |
<.0001
| 69.40 |
<.0001
| 71.72 |
<.0001
| 74.23 |
<.0001
| 72.54 |
<.0001
|
Age at inclusion | -0.12 | 0.36 | 0.06 | 0.68 | -0.4 |
0.01
| -0.60 |
0.03
| -0.36 |
0.04
| 0.06 | 0.66 |
Gender (Male vs. Female) | -0.51 | 0.84 | 2.00 | 0.52 | 1.07 | 0.75 | -17.3 |
0.003
| 3.74 | 0.31 | -0.32 | 0.90 |
Disease duration | -0.02 | 0.92 | -0.36 | 0.08 | 0.10 | 0.64 | 0.19 | 0.60 | -0.38 | 0.12 | -0.30 | 0.10 |
Disease course (SP vs. RR) | 9.54 |
0.03
| 7.35 | 0.16 | -8.44 | 0.12 | 8.77 | 0.34 | 17.33 |
0.004
| 8.65 | 0.06 |
Relapse rate 2-yrs before study entry | 0.37 | 0.90 | -2.01 | 0.58 | 0.70 | 0.86 | 1.39 | 0.83 | -0.20 | 0.96 | 3.76 | 0.24 |
EDSS | -2.33 | 0.06 | -3.54 |
0.02
| -8.44 |
<.0001
| -4.69 | 0.09 | -2.82 | 0.11 | -2.65 |
0.05
|
BDI | -1.16 |
<.0001
| -0.26 | 0.20 | 0.25 | 0.26 | -0.92 |
0.01
| 0.22 | 0.36 | -0.66 |
0.0004
|
FSS | -4.80 |
<.0001
| -6.8 |
<.0001
| -8.69 |
<.0001
| -10.0 |
<.0001
| -9.74 |
<.0001
| -6.72 |
<.0001
|
MMSE-c | -0.19 | 0.71 | -0.43 | 0.46 | 0.05 | 0.94 | -1.90 | 0.10 | 0.02 | 0.98 | -0.30 | 0.57 |
IFN-β treatment (Yes vs No)
| 1.43 | 0.65 | 3.56 | 0.32 | 1.20 | 0.77 | 5.03 | 0.50 | 4.54 | 0.32 | 0.23 | 0.94 |
Relapse rate change after 2-yrs | 4.96 | 0.17 | 2.40 | 0.61 | 3.76 | 0.20 | -2.71 | 0.69 | 2.96 | 0.54 | 6.77 | 0.08 |
EDSS change after 2-yrs | -0.11 | 0.95 | -1.49 | 0.54 | -4.54 |
0.003
| 0.59 | 0.86 | 0.70 | 0.77 | -2.72 | 0.16 |
BDI change after 2-yrs | -0.67 |
0.0005
| -0.48 |
0.05
| -0.14 | 0.37 | -1.59 |
<.0001
| -0.82 |
0.002
| -0.67 |
0.001
|
FSS change after 2-yrs | -5.20 |
<.0001
| -4.89 |
0.001
| -4.65 |
<.0001
| -4.75 | 0.03 | -5.98 |
0.0001
| -4.39 |
0.0003
|
MMSE-c change after 2-yrs | -1.09 | 0.15 | 0.20 | 0.84 | -0.10 | 0.87 | -3.04 | 0.04 | -0.64 | 0.53 | 0.18 | 0.81 |
Time** | 8.67 |
0.004
| 3.36 | 0.37 | -4.84 |
0.05
| -1.00 | 0.86 | -1.81 | 0.65 | 0.64 | 0.84 |
Time × IFN-β treatment (Yes vs No)
| -0.76 | 0.86 | -1.72 | 0.74 | -6.15 | 0.07 | -2.54 | 0.77 | 3.82 | 0.50 | -1.73 | 0.69 |
Emotional well being | Role limitation emotional | Health distress | Cognitive function | Overall quality of life | ||||||
---|---|---|---|---|---|---|---|---|---|---|
Effect | β | p | β | p | β | p | β | p | β | p |
Intercept* | 73.6 |
<.0001
| 53.68 |
<.0001
| 69.6 |
<.0001
| 78.3 |
<.0001
| 68.6 |
<.0001
|
Age at inclusion | -0.31 | 0.32 | -0.11 | 0.45 | 0.08 | 0.57 | -0.41 |
0.01
| 0.02 | 0.86 |
Gender (Male vs. Female) | -19.83 |
0.003
| 1.68 | 0.57 | -3.69 | 0.19 | -8.55 |
0.01
| -4.05 | 0.14 |
Disease duration | -0.29 | 0.49 | 0.13 | 0.50 | 0.08 | 0.69 | -0.16 | 0.49 | 0.13 | 0.49 |
Disease course (SP vs. RR) | 15.2 | 0.15 | 8.75 | 0.08 | 4.21 | 0.37 | 14.8 |
0.008
| -2.55 | 0.57 |
Relapse rate 2-yrs before study entry | -0.31 | 0.97 | 0.15 | 0.96 | -0.31 | 0.92 | -0.40 | 0.92 | -1.40 | 0.66 |
EDSS | 1.15 | 0.71 | -2.13 | 0.14 | -0.11 | 0.93 | -0.70 | 0.67 | -1.51 | 0.25 |
BDI | -1.50 |
<.0007
| -1.86 |
<.0001
| -1.75 |
<.0001
| -1.01 |
<.0001
| -1.35 |
<.0001
|
FSS | -8.33 |
<.0005
| 1.67 | 0.12 | -2.86 |
0.005
| -1.06 | 0.38 | 0.02 | 0.98 |
MMSE-c | 0.15 | 0.91 | 0.42 | 0.44 | 0.84 | 0.11 | 1.69 |
0.009
| 0.39 | 0.46 |
IFN-β treatment (Yes vs No)
| 7.67 | 0.34 | 5.22 | 0.13 | 4.99 | 0.13 | 3.12 | 0.44 | -1.16 | 0.73 |
Relapse rate change after 2-yrs | -4.36 | 0.57 | 3.64 | 0.39 | -1.90 | 0.72 | 2.90 | 0.51 | -3.34 | 0.35 |
EDSS change after 2-yrs | 2.95 | 0.44 | -1.32 | 0.54 | 1.57 | 0.56 | 3.09 | 0.17 | -0.24 | 0.89 |
BDI change after 2-yrs | -1.65 |
<.0001
| -1.20 |
<.0001
| -0.84 |
0.003
| -0.91 |
.0001
| -1.15 |
<.0001
|
FSS change after 2-yrs | -3.63 | 0.13 | -1.14 | 0.38 | -3.66 |
0.02
| -0.20 | 0.88 | -2.65 | 0.02 |
MMSE-c change after 2-yrs | -1.29 | 0.42 | 0.58 | 0.50 | 1.42 | 0.20 | 0.04 | 0.97 | -1.40 | 0.6 |
Time** | 5.68 | 0.37 | 5.31 | 0.11 | 4.15 | 0.32 | -0.64 | 0.86 | 0.31 | 0.91 |
Time × IFN-β treatment (Yes vs no)
| -19.11 |
0.03
| -4.95 | 0.27 | -12.29 |
0.03
| -9.65 | 0.05 | 2.53 | 0.54 |