Table 2.
Univariate statistical analysis comparing patients with postfingolimod recurring disease activity (active) and patients without postfingolimod recurring disease activity (nonactive).
| Active | Nonactive | p | |
|---|---|---|---|
| n | 37 | 73 | |
| Sex = female (%) | 30 (81.1) | 49 (67.1) | 0.189 |
| Age at diagnosis [mean (SD)] | 26.62 (7.51) | 32.68 (10.34) | 0.002 |
| Age at discontinuation [mean (SD)] | 33.32 (9.06) | 43.71 (10.56) | <0.001 |
| Disease durationa (years) (median [IQR]) | 5 [3.00–10.00] | 11 [5.00–15.00] | 0.003 |
| ARR under FGL [mean (SD)] | 0.58 (0.94) | 0.55 (1.10) | 0.883 |
| EDSS progression under FGLb [mean (SD)] | 0.36 (1.19) | 0.34 (1.01) | 0.939 |
| MRI activity under FGL = yes (%) | 23 (71.9) | 29 (43.9) | 0.017 |
| Duration on FGL months [mean (SD)] | 24.11 (16.66) | 28.44 (20.20) | 0.264 |
| Previous DMT (%) | |||
| Platform | −21 (56.8) | −37 (50.7) | |
| NTZ | −9 (24.3) | −16 (21.9) | |
| Others | −0 (0.0) | −6 (8.2) | |
| Treatment naïve | −7 (18.9) | −14 (19.2) | |
| Lymphopenia on FGL = yes (%)c | 35 (94.6) | 70 (98.6) | 0.560 |
| Lymphocyte count 1 month (×109/l) (median [IQR]) | 1.17 [0.94–1.29] | 1.07 [0.77–1.42] | 0.617 |
| Lymphocyte count 3 months (×109/l) (median [IQR]) | 1.05 [0.87–1.42 ] | 1.15 [0.76–1.47] | 0.985 |
| Lymphocyte count 6 months (×109/l) (median [IQR]) | 1.29 [0.90–1.66 ] | 1.10 [0.89–1.43] | 0.373 |
| Time to next DMT more than 8 weeks (%) | 18 (48.6) | 31 (42.5) | |
| New DMT within 8 weeksd (%) | |||
| heDMT | −9 (24.3) | −30 (41.1) | |
| Orals | −1 (2.7) | −11 (15.1) | |
| Platform | −5 (13.5) | −1 (1.4) | |
| Reactive treatmente (%) | 4 (10.8) | 0 (0.0) |
ARR, annualized relapse rate; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; FGL, fingolimod; heDMT, highly effective disease-modifying therapy; IQR, interquartile range; MRI, magnetic resonance imaging; NTZ: natalizumab.
Note that disease duration was calculated at fingolimod discontinuation.
EDSS progression under FGL: an increase on 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 DMT started within 8 weeks after FGL discontinuation are summarized in the table and divided in highly effective disease-modifying therapy (natalizumab, ocrelizumab, rituximab), orals (teriflunomide, azathioprine, dimethyl fumarate), and platform (interferon beta, glatiramer acetate).
Highly effective disease-modifying therapy in each group: active group (6 rituximab and 3 natalizumab, in addition, 4 patients had a relapse during the treatment-free period and started rituximab as a consequence of this new disease activity, this last group is presented separately, as reactive treatment) and nonactive group (21 rituximab, 7 natalizumab, 2 ocrelizumab).