Table 1.
Demographic and clinical characteristics of the cohort.
| Whole cohort (n = 171) | N-PIRA (n = 130) | PIRA (n = 41) | p-Value (N-PIRA vs. PIRA) | |
|---|---|---|---|---|
| Femalea | 125 (73.1) | 97 (74.6) | 28 (68.2) | 0.426d |
| Ageb (years) | 35.2 (9.6) | 34.7 (9.4) | 36.7 (10.1) | 0.242e |
| MS disease durationb (years) | 6.1 (6.5) | 5.8 (6.2) | 6.9 (7.3) | 0.326e |
| DMT at baselinec | ||||
| N-DMT | 55 (32.2) | 40 (30.8) | 15 (36.6) | 0.178d |
| M-DMT | 77 (45.0) | 56 (43.1) | 21 (51.2) | |
| H-DMT | 39 (22.8) | 34 (26.2) | 5 (12.2) | |
| DMT during observation periodc | ||||
| N-DMT | 27 (15.8) | 21 (16.2) | 6 (14.6) | 0.226d |
| M-DMT | 44 (25.7) | 36 (27.7) | 8 (19.5) | |
| H-DMT | 47 (27.5) | 38 (29.2) | 9 (22.0) | |
| ESC-DMT | 53 (31.0) | 35 (26.9) | 18 (43.9) | |
| EDSS at baselinec | 1.5 (0–6.5) | 1.5 (0–6.5) | 2.0 (0–6.5) | 0.174f |
| EDSS worseninga | 60 (34.9) | 20 (15.4) | 40 (97.6) | <0.001d |
| SDMTb | 54.0 (10.3) | 54.5 (10.3) | 52.2 (10.1) | 0.193e |
| SDMT worseninga | 53 (29.0) | 12 (9.2) | 41 (100) | <0.001d |
| Relapse during observation perioda | 69 (40.4) | 54 (41.5) | 15 (36.6) | 0.715d |
| Relapse without subsequent EDSS worseninga | 41 (24.0) | 29 (22.3) | 12 (29.3) | 0.225d |
| Previous optic neuritisa | 36 (21.1) | 27 (20.8) | 9 (22.0) | 0.871d |
| pRNFL thickness (µm)b | 92.0 (14.2) | 94.8 (13.6) | 83.1 (12.3) | <0.001e |
| GCIPL thickness (µm)b | 81.9 (12.3) | 84.6 (12.5) | 73.2 (12.4) | <0.001e |
aNumber (percentage).
bMean and standard deviation.
cMedian and range. p-values calculated for comparison of stable and clinically progressing patients using.
dChi-square-test.
eIndependent t-test.
fMann-Whitney-U-test as appropriate.
DMT: disease modifying therapy. EDSS: Expanded Disability Status Scale. GCIPL: macular ganglion cell and inner plexiform layer. MS: multiple sclerosis. N-PIRA: no PIRA. PIRA: progression independent of relapse. pRNFL: peripapillary retinal nerve fibre layer. SDMT: Symbol Digit Modalities Test. N-DMT: patients receiving no DMT at least 6 months prior to baseline visit and during the whole observation period. M-DMT: defined as patients receiving one or more DMT of either interferon beta preparations, glatiramer acetate, dimethylfumarate, or teriflunomide during the whole observation period. H-DMT: defined as patients receiving one or more DMT of either natalizumab, fingolimod, alemtuzumab, ocrelizumab and cladribine during the whole observation period. ESC-DMT: defined as patients in whom DMT was escalated either from N-DMT to M-DMT or from M-DMT to H-DMT during the observation period. NA: not applicable.