Table 2.

Radiological endpoints of fingolimod extension studies

Clinical studies	Mean (95% CI) new or newly enlarging T2 lesions	Mean (95% CI) cumulative GELs	Yearly proportion of patients free from GELs (%)	Yearly proportion of patients without new or enlarging T2 lesions (%)	Mean BVL across study
Phase II long-term extension20			84–96a	68–88a	−2.8%b
Phase 3 FREEDOMS long-term extension21	4.5 (4.27–4.68)c 4.0 (3.8–4.21)d	1.1 (0.98–1.23)c 0.8 (0.7–0.94)d			−1.7 (−1.91 to −1.43)c,e −1.6 (−1.88 to −1.4)d,e
Phase 3 TRANSFORMS long-term extension22			75f	42f	−1.01 (−0.8)g
LONGTERMS31	0.9h		50h		−0.33i
Long-term extension of the TRANSFORMS study25	0.8j		50j	35j

Notes:

^aRegardless of initial randomization group, yearly percentages from year 1 to year 7;

^bcalculated over 84 months;

^cin continuous fingolimod 0.5 mg group over 48 months;

^din continuous fingolimod 1.25 mg group over 48 months;

^e95% CI;

^ffor fingolimod 0.5 mg group between month 13 (beginning of extension phase) and end of study;

^gSD;

^hbetween months 0 and 60 (n=605)31;

ⁱannualized rate of BVL between months 0 and 60 (n=548)31;

^jbetween months 0-60 (n=924).25

Abbreviations: GELs, gadolinium-enhancing lesions; BVL, brain-volume loss.