Baseline characteristics of the IIT and the PP patient cohort
| Intention-to-treat cohort (n=38) | Per-protocol cohort (n=28) | |
| Age (years) | 37.2±10.0 | 38.0±10.5 |
| Women | 29 (76%) | 23 (82%) |
| Disease course: CIS, RRMS | 1/37 | 1/27 |
| Time since onset (years) | 7.9±8.5 | 8.6±9.3 |
| Time since diagnosis (years) | 5.8±6.2 | 6.2±6.7 |
| EDSS at baseline | 1.76±1.08 | 1.57±0.98 |
| MSFC at baseline | 0.49±0.54 | 0.00±0.58 |
| Number of relapses in the last 12 months | 1.0±0.7 | 0.9±0.5 |
| Number of relapses in the last 24 months | 1.6±0.9 | 1.5±0.8 |
| Number of patients with previous MS treatments* | 13 (36%) | 10 (36%) |
| Total number of contrast-enhancing lesions during baseline phase | 1.25 (0.75–3.50) | 1.00 (0.75–3.38) |
| Number of new contrast-enhancing lesions during baseline phase | 1.00 (0.75–3.00) | 0.88 (0.63–2.63) |
| Total number of T2 lesions during baseline phase | 33.88 (23.33–62.00) | 30.21 (22.00–49.13) |
| Number of new T2 lesions during baseline phase | 8.50 (4.75–14.50) | 7.50 (4.88–12.88) |
Data are presented as mean (SD) or absolute numbers, MRI parameters are presented as median (IQR).
*Patients may have received more than one previous multiple sclerosis disease-modifying drug. There were no significant differences between the intention-to-treat and the per-protocol patient cohort.
CIS, clinically isolated syndrome; EDSS, Expanded Disability Status Scale; ITT, intention to treat; MS, multiple sclerosis; MSFC, multiple sclerosis functional composite; PP, per protocol; RRMS, relapsing-remitting multiple sclerosis.