Table 1.
Clinical end points from the fingolimod extension studies
| Clinical studies | Patients Enrolled (n, % of ITT) | Patients having completed the study (n, % of ITT) | Mean (SD) exposure to fingolimod, years | Relapse in year prior to study enrollment (mean, SD) | ARR (95% CI)a | Patients free from relapse (%, 95% CI) | Patients free of 6-months confirmed CDP (%, 95% CI) |
|---|---|---|---|---|---|---|---|
| Phase II long- term extension20 | 250 (89) | 122 (43) | 5.1b | 0.17c | 60.9d | 82d | |
| Phase III FREEDOMS long-term extension21 | 920 (72) | 773 (61) | 3.8 (0.6)e 3.7 (0.6)f |
1.5 (0.8)e 1.5 (0.9)f |
0.19 (0.16-0.22)e 0.16 (0.14-0.2)f |
59.3 (54.2-64.4)e 59.9 (53.9-65.8)f |
80 (76-84)e 79 (75-84)f |
| Phase III TRANSFORMS long-term extension22 | 1,027 (79) | 772 (60) | 3e 2.8f |
1.5 (1.3)e 1.5 (0.9)f |
0.16 (0.12-0.19)g | NA | NA |
| Long-term extension of the LONGTERMS31 | 3,168 | 2,767 | 3.1 (0.2–10.4) |
1.2 (1) | 0.19 | NA | 79.3h |
Notes:
a
Over entire duration of observation period;
b
median;
c
in patients having received at least 6 months of fingolimod;
d
Kaplan–Meier estimates adjusted for dropouts in patients exposed to fingolimod for 6 months at least;
e
in continuous fingolimod 0.5 mg group;
f
in continuous fingolimod 1.25 mg group;
g
between month 13 (beginning of extension phase) and end of study;
h
at month 60 for 729 patients.
Abbreviations: ITT, intent to treat; ARR, annualized relapse rate; CDP, confirmed disease progression.