Table 2

Disability outcomes at 16 y for patients participating in the long-term follow-up population according to the original pivotal trial treatment groups

Endpoint at 16 yOriginal assignment in pivotal trial
PlaceboIFNB-1b 50 μgIFNB-1b 250 μg
Original number of patients123125124
N (proportion of original N)79 (64%)85 (68%)96 (77%)
Median EDSS5.505.006.00
Median change in EDSS2.002.502.50
Median MSFC–0.203–0.508–0.468
N (%) reaching EDSS 6.036 (45.6)33 (38.8)44 (45.8)
Median time from onset of clinical symptoms to EDSS 6.0 (y)*14.4512.8016.05
N (%) reaching SPMS34 (43.0)28 (32.9)42 (43.8)
Median time from onset of symptoms to SPMS (y)16.6515.8017.35
Patients with EDSS ≥6.0 or SPMS, N (%)44 (55.7)41 (48.2)55 (57.3)
Median time from onset of symptoms to EDSS ≥6.0 or SPMS (y)14.0513.0016.60
Median duration of IFNB-1b 250 μg use (y)5.858.408.90
Median of exposure to any currently approved DMDs (y)9.5013.4013.10
  • Note: Time was only calculated for patients who reached EDSS score of 6.0 and converted to SPMS.

  • * Time is calculated as the first date of EDSS score of 6.0 from the date of diagnosis of multiple sclerosis. The first date that the EDSS score was ≥ 6.0 is confirmed 12 months (±3 months) later to be ≥ 6.0.

  • DMDs, disease-modifying drugs; EDSS, Expanded Disability Status Scale; MSFC, Multiple Sclerosis Functional Composite Measure; SPMS, secondary progressive multiple sclerosis.