Table 1.
Baseline characteristics of the study population.
| Overall | |
|---|---|
| n | 110 |
| Sex = female (%) | 79 (71.8) |
| Disease course at discontinuation RRMS (%) | 91 (82.7) |
| Age at diagnosis [mean (SD)] | 30.65 (9.87) |
| Age at discontinuation [mean (SD)] | 40.22 (11.18) |
| Disease duration at discontinuation (years) (median [IQR]) | 9.50 [3.00–13.75] |
| EDSS at FGL start (median [IQR]) | 3.0 [2.0–4.0] |
| Duration on FGL (months) [mean (SD)] | 26.98 (19.12) |
| ARR under FGL (median [IQR]) | 0.00 [0.00–0.77] |
| Previous DMT (%) | |
| Platform | −58 (52.7) |
| NTZ | −25 (22.7) |
| Others | −6 (5.5) |
| Treatment naïve | −21 (19.1) |
| Time to next DMT more than 8 weeks (%) | 49 (44.5) |
| New DMT within 8 weeksa (%) | |
| heDMT | −39 (35.5) |
| Orals | −12 (10.9) |
| Platform | −6 (5.5) |
| Reactive treatmentb (%) | 4 (3.6) |
| Reason for discontinuation (%) | |
| Pregnancy/childbearing preferences | −16 (14.5) |
| Disease activity | −48 (43.6) |
| Side effects | −24 (21.8) |
| Noncompliance | −2 (1.8) |
| Others | −20 (18.2) |
ARR, annualized relapse rate; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; FGL, fingolimod; heDMT, highly effective disease-modifying therapy; IQR, interquartile range; NTZ, natalizumab; RRMS, relapsing-remitting multiple sclerosis.
New DMT started within 8 weeks after FGL 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). In the group of patients who did not start a new DMT within 8 weeks, we have not summarized the next treatment.
Finally, four pwMS had a relapse during the treatment-free period and started another DMT as a consequence of this new disease activity, this group is presented separately as reactive treatment.