Table 1.
Demographic, clinical and radiological data for relapsing–remitting MS patients treated with IFN-β in a 3-year follow-up.
| Demographic, clinical and radiological characteristics | MS0 group—the 1st MRI before treatment with IFN-β—true baseline | MS1 group—the 1st MRI after 1 year of treatment with IFN-β—on-treatment MRI as baseline |
|---|---|---|
| The total number of analysed patients | 45 | 42 |
| Female:male (% of female) | 33:12 (73.3%) | 26:16 (61.9%) |
| Ratio | 2.75:1 | 1.63:1 |
| Patients treated with [n of patients (%)] | ||
| Avonex | 9 (20%) | 8 (19%) |
| Betaferon | 25 (55.6%) | 27 (64.3%) |
| Rebif | 11 (24.4%) | 7 (16.7%) |
| Mean age at the onset of the disease in years ± SD (range) | 32.5 ± 11.3 (18–58) | 28.0 ± 7.9 (13–52) |
| Mean age at the 1st MRI in years ± SD (range) | 35.0 ± 11.7 (19–61) | 32.7 ± 7.8 (19–56) |
| Mean age at the beginning of treatment in years ± SD (range) | 35.2 ± 11.6 (19–61) | 31.7 ± 7.8 (18–55) |
| Mean time of the disease duration from the onset to treatment beginning in months ± SD (range) | 35.7 ± 38.9 (2–156) | 48.9 ± 42.5 (2–192) |
| Mean time of the disease duration from the onset to the 1st MRI in months ± SD (range) | 32.1 ± 38.4 (1–144) | 60.9 ± 42.5 (14–204) |
| Mean baseline EDSS ± SD | 2.3 ± 1.3 | 2.0 ± 0.8 |
| Median baseline EDSS (range) | 2.0 (1–7) | 2.0 (1–5) |
| Mean T2/FLAIR lesion number at the 1st MRI ± SD (range) | 20.5 ± 12.9 (1–45) | 19.3 ± 10.4 (3–45) |
| Patients with the 1st MRI after Gd-contrast administration [n, (%)] | 43 (95.6%) | 36 (85.7%) |
| Presence of Gd-enhancing lesions at the 1st MRI—[n of patients (% of patients with contrast administration)] | 9 (20.9%) | 3 (8.3%) |
| Mean number of Gd-enhancing lesions at the 1st MRI ± SD (range) | 0.7 ± 2.0 (1–11) | 0.1 ± 0.3 (1–1) |
| Presence of cervical spinal cord lesion at the 1st MRI—[n of patients (%)] | 12 (26.7%) | 5 (11.9%) |
| Mean time to loss of NEDA form the treatment beginning in the 3-years FU in month ± SD (range) | 16.2 ± 8.4 (3–35) | NA |
| Mean time to loss of NEDA from the 1st MR in the 2-years FU in months ± SD (range) | NA | 13.7 ± 4.4 (8–24) |
| Mean time to new lesion(s) formation from the treatment beginning in the 3-year FU (loss of “MRI” NEDA) in months ± SD (range) | 18.5 ± 7.8 (8–36) | NA |
| Mean time to new lesion(s) formation from the 1st MRI in the 2-years FU (loss of “MRI” NEDA) in months ± SD (range) | NA | 13.7 ± 3.8 (11–23) |
| Mean time to relapse from the treatment beginning in the 3-years FU (loss of “clinical” NEDA) in months ± SD (range) | 13.7 ± 7.8 (3–25) | NA |
| Mean time to relapse from the 1st MRI in the 2-years FU (loss of “clinical” NEDA) in months ± SD (range) | NA | 14.7 ± 6.2 (8–24) |
| Patients, who discontinued IFN-β treatment in the 3-year FU [n (%)] | 9 (20%) | 1 (2.4%) |
| Mean time of IFN-β treatment in the 3-years FU ± SD (range) | 33.6 ± 5.4 (12–36) | 35.8 ± 1.4 (27–36) |
| Patients, who switched treatment option in the 3-year FU [n (%)] | 8 (17.8%) | 0 (0%) |
| Mean time to alternative therapy in months ± SD (range) | 23.5 ± 6.2 (12–30) | NA |
| Reasons for loss of NEDA during treatment with IFN-β in the 3-year FU with [n of patients] | ||
| MRI activity | 13 | 10 |
| Clinical activity | 10 | 8 |
| Clinical and MRI activity | 9 | 2 |
MS multiple sclerosis, MRI magnetic resonance imaging, IFN-β interferon-β, SD standard deviation, EDSS expanded disability status scale, T2 T2-weigted images, MRI sequence, FLAIR fluid attenuation inversion recovery, MRI sequence, NEDA no evidence of disease activity, Gd gadolinium, FU follow-up, N/A not applicable.