Table 5.
Univariate statistical analysis comparing patients with nonsevere and severe recurring disease activity.
| Nonsevere | Severe | p | |
|---|---|---|---|
| n | 24 | 13 | |
| Sex = female (%) | 20 (83.3) | 10 (76.9) | 0.972 |
| Age at diagnosis [mean (SD)] | 26.83 (6.91) | 26.23 (8.81) | 0.820 |
| Age at discontinuation [mean (SD)] | 32.92 (8.54) | 34.08 (10.27) | 0.715 |
| Disease durationa (years) (median [IQR]) | 4.00 [2.75–9.25] | 6 [4.00–10.00] | 0.406 |
| ARR under FGL [mean (SD)] | 0.47 (0.69) | 0.78 (1.29) | 0.354 |
| EDSS progression under FGLb [mean (SD)] | 0.54 (1.30) | 0.00 (0.88) | 0.205 |
| MRI activity under FGL = yes (%) | 14 (70.0) | 9 (75.0) | 1.000 |
| Duration on FGL (months) [mean (SD)] | 20.67 (16.58) | 30.46 (15.44) | 0.088 |
| Previous DMT (%) | |||
| Platform | −13 (54.2) | −8 (61.5) | |
| NTZ | −6 (25.0) | −3 (23.1) | |
| Treatment naïve | −5 (20.8) | −2 (15.4) | |
| Lymphopenia on FGL = yes (%)c | 22 (91.7) | 13 (100.0) | 0.758 |
| Lymphocyte count 1 month (×109/l) (median [IQR]) | 1.19 [0.95–1.34] | 1.16 [1.02–1.21] | 0.721 |
| Lymphocyte count 3 months (×109/l) (median [IQR]) | 1.05 [0.86–1.41] | 1.05 [0.88–1.44] | 1.000 |
| Lymphocyte count 6 months (×109/l) (median [IQR]) | 1.31 [0.98–1.60] | 1.29 [0.90–1.66] | 0.887 |
| Time to next DMT more than 8 weeks (%) | 15 (62.5) | 3 (23.1) | |
| New DMT within 8 weeksd (%) | |||
| heDMT | −4 (16.7) | −5 (38.5) | |
| Orals | −0 (0.0) | −1 (7.7) | |
| Platform | −2 (8.3) | −3 (23.1) | |
| Reactive treatment (%) | 3 (12.5) | 1 (7.7) | |
| Time until relapse categorized (%) | |||
| No relapse | −4 (16.7) | −1 (7.7) | |
| 0–8 weeks | −8 (33.3) | −10 (76.9) | |
| 8–24 weeks | −12 (50.0) | −2 (15.4) | |
| Time until relapse (weeks)e (median [IQR]) | 12 [4.00–16.00] | 8.00 [4.00–8.00] | 0.114 |
| Any baseline T1 CE lesion = yes (%) | 3 (13.0) | 3 (23.1) | 0.756 |
| Mean volume per T1 CE lesion at baseline (mm3) [mean (SD)] | 3.42 (9.75) | 32.58 (68.39) | 0.050 |
| T2 lesion count at baseline (median [IQR]) | 23.00 [13.00–42.00] | 67.00 [38.00–95.50] | 0.006 |
| T2 lesion count norm at baselinef (median [IQR]) | 5.75 [1.98–11.92] | 8.00 [4.59–16.66] | 0.094 |
| T2 lesion volume at baseline (mm3) (median [IQR]) | 2511.00 [837.70–5412.95] | 6454.80 [3796.70–9610.95] | 0.034 |
| T2 lesion volume norm at baselinef (mm3) (median [IQR]) | 425.47 [191.15–1242.51] | 891.85 [506.32–1654.52] | 0.094 |
| Mean volume per T2 lesion at baseline (mm3) [mean (SD)] | 103.19 (59.73) | 126.20 (79.06) | 0.351 |
ARR, annualized relapse rate; CE, contrast enhancing; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; FGL, fingolimod; NTZ, natalizumab; norm, normalized.
Summary and group comparison of quantitative MRI data at baseline are shown. Baseline scan is last cerebral MRI available before FGL cessation [median (IQR) time to FGL stop 71 days (22.5–183)].
Note that disease duration was calculated at fingolimod discontinuation.
EDSS progression under FGL: an increase in the EDSS of at least 0.5 points for EDSS at fingolimod start ⩾5.5, and of at least 1 point if EDSS at fingolimod start <5.5.
Lymphopenia was defined as ⩽0.9 × 109/l.
New treatments started within 8 weeks after fingolimod discontinuation are summarized in the table and divided in highly effective disease-modifying therapies (natalizumab, ocrelizumab, rituximab), orals (teriflunomide, azathioprine, dimethyl fumarate) and platform (interferon beta, glatiramer acetate). Highly effective disease-modifying therapies in each group: nonsevere group (3 rituximab, 1 natalizumab) and nonsevere (3 rituximab, 2 natalizumab).
Note that in the variable ‘time until relapse’, only the patients who had a relapse are included.
T2 lesion count and volume have been normalized for disease duration.