Table 2.
Participant characteristics and follow-up in the dimethyl fumarate, fingolimod and ocrelizumab cohorts for those who experienced disability progression and progression independent of relapsing biology.
| Characteristics | Dimethyl fumarate (n = 160) DP cohort (n = 42, 26.25%) PIRB cohort (n = 6, 3.75%) | Fingolimod (n = 245) DP cohort (n = 74, 30.20%) PIRB cohort (n = 9, 3.67%) | Ocrelizumab cohort (n = 296) DP cohort (n = 44, 14.86%) PIRB cohort (n = 11, 3.82%) | BG p value* | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| No. | DP/PIRB vs. entire cohort | DP vs. PIRB | No. | DP/PIRB vs. entire cohort | DP vs. PIRB | No. | DP/PIRB vs. entire cohort | DP vs. PIRB | ||
| Age at disease onset–mean yr. ± SD | ||||||||||
| Entire cohort | 31.03 ± 8.7130. | 31.40 ± 9.05 | 31.35 ± 8.64 | NS | ||||||
| DP cohort | 30.22 ± 8.91 | NS | NS | 30.86 ± 10.39 | NS | 0.024 | 30.32 ± 9.13 | NS | NS | NS |
| PIRB cohort | 34.26 ± 7.25 | NS | 37.03 ± 5.18 | 0.024 | 29.47 ± 10.49 | NS | NS | |||
| Disease duration at baseline- mean yr. ± SD | ||||||||||
| Entire cohort | 11.57 ± 8.84 | 12.09 ± 7.01 | 10.52 ± 7.88 | 0.0137** | ||||||
| DP cohort | 10.71 ± 6.88 | NS | NS | 13.76 ± 7.49 | NS | NS | 14.82 ± 8.51 | 0.001 | NS | NS |
| PIRB cohort | 11.41 ± 6.66 | NS | 12.91 ± 7.62 | NS | 13.87 ± 11.30 | NS | NS | |||
| Female sex– No. (%) | ||||||||||
| Entire cohort | 120 (75.00) | 188 (76.42) | 220 (74.30) | NA | ||||||
| DP cohort | 31 (73.81) | NA | NA | 50 (65.79) | NA | NA | 32 (72.73) | NA | NA | NA |
| PIRB cohort | 6 (100) | NA | 6 (66.67) | NA | 10 (90.91) | NA | NA | |||
| Baseline EDSS score–median (range) | ||||||||||
| Entire cohort | 2 (0–8) | 2 (0–8.5) | 2 (0–6.5) | NS | ||||||
| DP cohort | 2 (0–6) | NS | NS | 2 (0–7.5) | NS | NS | 3 (0–6.5) | 0.038 | 0.032 | NS |
| PIRB cohort | 2 (0–4) | NS | 1.5 (0–5) | NS | 1.5 (0–4) | NS | NS | |||
| Follow up– mean yr. ± SD | ||||||||||
| Entire cohort | 5.21 ± 0.50 | 5.27 ± 0.59 | 3.36 ± 1.5 | <0.0001** | ||||||
| DP cohort | 5.15 ± 0.55 | NS | NS | 5.20 ± 0.65 | NS | NS | 4.10 ± 1.80 | 0.007 | NS | <0.0001** |
| PIRB cohort | 5.38 ± 0.81 | NS | 5.08 ± 0.44 | NS | 4.03 ± 2.04 | NS | 0.0217** | |||
| Follow-up EDSS–median (range) | ||||||||||
| Entire cohort | 2 (0–8) | 2.5 (0–10)’ | 2 (0–8.5) | 0.0002*** | ||||||
| DP cohort | 4 (1.5–6.5) | <0.0001 | NS | 5 (1.5–10) | <0.0001 | NS | 6 (1.5–8.5) | <0.0001 | 0.01 | <0.0001^ |
| PIRB cohort | 3 (2–6.5) | 0.02 | 3 (1.5–6.5) | NS | 2.5 (1.5–6) | 0.04 | NS | |||
| Progression categorization–No. (% of the entire cohort, % of those with DP) | ||||||||||
| SPMS | 10 (6.25, 23.81) | 28 (11.43, 37.84) | 15 (5.07, 34.09) | NA | ||||||
| Relapse | 5 (3.13, 11.90) | 4 (1.63, 5.45) | 2 (0.68, 4.55) | NA | ||||||
| MRI activity | 10 (6.25, 23.81) | 14 (5.71, 18.92) | 13 (4.39, 29.55) | NA | ||||||
| MRI + relapse activity row | 11 (6.88, 26.19) | 14 (5.71, 18.92) |
0 | NA | ||||||
| Alternative causes | 0 | 5 (2.04, 5.6.76)” | 3 (1.01, 6.82)”’ | NA | ||||||
| PIRB | 6 (3.75, 14.29) | 9 (3.67, 12.16) | 11 (3.72, 25.00) | NA | ||||||
* p value for the between-group (BG) comparisons of dimethyl fumarate vs. fingolimod vs. ocrelizumab. ** Ocrelizumab vs. other cohorts. *** Fingolimod vs. other cohorts. ^ Ocrelizumab vs. fingolimod vs. dimethyl (significant differences across all groups). ‘One death secondary to rapid neurologic decline with marked increase in MRI activity. Categorized as having progressed, with relapse + MRI activity. “One participant with predominantly sensory domain changes was diagnosed with peripheral neuropathy secondary to chemotherapy, two participants with pyramidal/cerebellar changes had strokes that accounted for their symptoms, one participant experienced pyramidal changes following a left knee fracture, and one participant experienced cerebral changes secondary to a psychiatric medication overdose. “‘One participant with predominantly pyramidal/sensory domain changes was diagnosed with compressive myelopathy, one participant with sensory domain changes had severe bilateral median neuropathy, and one highly active participant with pyramidal/cerebellar changes discontinued medication. BG, between groups; DP, disability progression; EDSS, expanded disability status scale, MRI, magnetic resonance imaging; n/No., number; NA, not applicable, NS, not significant; PIRB, progression independent of relapsing biology; SD, standard deviation; SPMS, secondary progressive multiple sclerosis; yr, year.