Table 1.
Demographic and clinical characteristics at baseline and/or last known follow-up. a
| Characteristic, n (%) except where specified | All trials (N = 6155) | Phase III trials (N = 2092) | ||
|---|---|---|---|---|
| RMS (n = 4558) | PMS (n = 1597) b | OPERA (N = 1448) | ORATORIO (N = 644) | |
| Patient years | 21,079.9 | 7189.5 | 10,808.6 | 4713.1 |
| Median time on treatment, years (range) c | 3.7 (0.0–13.9) | 3.7 (0.0–11.6) | 8.3 (0.0–11.2) | 7.1 (0.1–11.8) |
| ⩽5 years | 3207 (70.4) | 1119 (70.1) | 306 (21.1) | 168 (26.1) |
| 5–10 years | 1019 (22.4) | 278 (17.4) | 894 (61.7) | 276 (42.9) |
| >10 years | 332 (7.3) | 200 (12.5) | 248 (17.1) | 200 (31.1) |
| Mean age at baseline, years (SD) | 35.9 (9.4) | 47.9 (9.0) | 38.1 (9.3) | 45.8 (8.1) |
| Mean age at last known follow-up, years (SD) | 40.5 (10.1) | 52.5 (8.9) | 47.6 (9.2) | 55.6 (7.8) |
| <40 years | 2213 (48.6) | 144 (9.0) | 326 (22.5) | 26 (4.0) |
| 40–59 years | 2189 (48.0) | 1065 (66.7) | 945 (65.3) | 366 (56.8) |
| ⩾60 years | 156 (3.4) | 388 (24.3) | 177 (12.2) | 252 (39.1) |
| Sex | ||||
| Female | 3018 (66.2) | 839 (52.5) | 949 (65.5) | 320 (49.7) |
| Male | 1540 (33.8) | 758 (47.5) | 499 (34.5) | 324 (50.3) |
| Mean BMI at baseline, kg/m2 (SD) | 26.5 (6.3) | 25.3 (5.2) | 26.2 (6.1) | 25.0 (4.9) |
| Underweight <18.5 | 169 (3.7) | 65 (4.1) | 56 (3.9) | 27 (4.2) |
| Normal weight 18.5–25.0 | 2068 (45.4) | 818 (51.2) | 677 (46.8) | 345 (53.6) |
| Overweight 25.0–30.0 | 1202 (26.4) | 443 (27.7) | 389 (26.9) | 174 (27.0) |
| Obese ⩾30.0 | 1078 (23.7) | 254 (15.9) | 312 (21.5) | 97 (15.1) |
| Unknown | 41 (0.9) | 17 (1.1) | 14 (1.0) | 1 (0.2) |
| Subregion | ||||
| ROW d | 3120 (68.5) | 1398 (87.5) | 1089 (75.2) | 558 (86.6) |
| USA | 1438 (31.5) | 199 (12.5) | 359 (24.8) | 86 (13.4) |
| Ethnicity | ||||
| White | 3891 (85.4) | 1305 (81.7) | 1316 (90.9) | 606 (94.1) |
| Others | 485 (10.6) | 113 (7.1) | 132 (9.1) | 37 (5.7) |
| Unknown | 182 (4.0) | 179 (11.2) | 0 (0.0) | 1 (0.2) |
| Comorbidities at last known follow-up | ||||
| Depression | 773 (17.0) | 336 (21.0) | 432 (29.8) | 191 (29.7) |
| Previous infections e | 686 (15.1) | 256 (16.0) | 482 (33.3) | 223 (34.6) |
| Cardiovascular disorders | 448 (9.8) | 349 (21.9) | 270 (18.6) | 181 (28.1) |
| Renal and urinary tract disorders | 476 (10.4) | 293 (18.3) | 253 (17.5) | 172 (26.7) |
| Chronic pulmonary disorders | 226 (5.0) | 75 (4.7) | 125 (8.6) | 45 (7.0) |
| Diabetes | 96 (2.1) | 78 (4.9) | 49 (3.4) | 39 (6.1) |
| Rheumatologic and autoimmune disorders | 114 (2.5) | 57 (3.6) | 50 (3.5) | 34 (5.3) |
| Gastrointestinal disorders | 83 (1.8) | 46 (2.9) | 51 (3.5) | 28 (4.3) |
| Cerebrovascular disorders | 6 (0.1) | 7 (0.4) | 4 (0.3) | 4 (0.6) |
| Malignancies | 5 (0.1) | 3 (0.2) | 4 (0.3) | 3 (0.5) |
| Number of Comorbidities at last known follow-up | ||||
| 0 | 2588 (56.8) | 702 (44.0) | 491 (33.9) | 258 (40.1) |
| 1 | 1305 (28.6) | 489 (30.6) | 458 (31.6) | 198 (30.7) |
| ⩾2 | 665 (14.6) | 406 (25.4) | 499 (34.5) | 188 (29.2) |
| Median EDSS at OCR f start, (IQR) g | 2.0 (1.5–3.0) | 5.0 (4.0–6.0) | 2.5 (1.8–3.5) | 4.5 (3.5–6.0) |
| <3.0 | 2964 (66.5) | 79 (4.9) | 810 (55.9) | 12 (1.9) |
| 3.0–6.0 | 1433 (32.2) | 890 (55.7) | 625 (43.2) | 529 (82.1) |
| ⩾6.0 | 59 (1.3) | 628 (39.3) | 13 (0.9) | 102 (15.8) |
| Unknown | − | – | 0 (0.0) | 1 (0.2) |
| Disease duration since symptom onset, years | ||||
| <5 years | 2946 (64.9) | 450 (28.7) | 658 (45.4) | 190 (29.5) |
| 5–10 years | 1042 (23.0) | 520 (33.1) | 405 (28.0) | 288 (44.7) |
| >10 years | 550 (12.1) | 600 (38.2) | 385 (26.6) | 147 (22.8) |
| Relapses in year before study start h | ||||
| Any relapses | 3807 (83.5) | 85 (5.3) | 1394 (96.3) | – |
| Mean number of relapses, (SD) | 1.18 (0.82) | 0.07 (0.30) | 1.32 (0.69) | – |
| Previous DMTs | ||||
| 0 | 2675 (58.7) | 908 (56.9) | 1065 (73.5) | 571 (88.7) |
| 1 | 1213 (26.6) | 350 (21.9) | 345 (23.8) | 56 (8.7) |
| ⩾2 | 670 (14.7) | 339 (21.2) | 38 (2.6) | 17 (2.6) |
| Last DMT i | ||||
| Interferons | 645 (34.3) | 175 (25.4) | 252 (65.8) | 48 (64.0) |
| Glatiramer acetate | 467 (24.8) | 95 (13.8) | 118 (30.8) | 23 (30.7) |
| Dimethyl fumarate | 357 (19.0) | 82 (11.9) | 1 (0.3) | – |
| Fingolimod | 228 (12.1) | 82 (11.9) | 2 (0.5) | – |
| Natalizumab | 13 (0.7) | 59 (8.6) | 1 (0.3) | 1 (1.3) |
| Biotin | 28 (1.5) | 39 (5.7) | 4 (1.0) | 2 (2.7) |
| Teriflunomide | 125 (6.6) | 60 (8.7) | – | – |
| Azathioprine | 3 (0.2) | 21 (3.0) | 1 (0.3) | 1 (1.3) |
| Cyclophosphamide | 1 (<0.1) | 21 (3.0) | – | – |
| Other j | 16 (0.8) | 55 (8.0) | 4 (1.0) | – |
Patients from phase III trials OPERA and ORATORIO are a subset of the entire RMS and PMS population represented in the first two columns. These are the largest cohorts available with longer exposure to OCR. Not all data on BMI, EDSS at OCR start, and disease duration were available for analysis.
Last known follow-up was at time of study discontinuation/completion or as of November 25, 2022 for patients still ongoing.
Includes patients with primary progressive MS (n = 1076) and secondary progressive MS (n = 521).
Time on OCR of “0” years relates to patients who discontinued after the first infusion.
Europe, Middle East, Africa, Central and South America, Canada, Australia.
Previous infection recorded in the medical history before OCR start.
Last valid assessment before OCR treatment in the CTP and in the open-label extension, for patients originally randomized to OCR and for switchers, respectively.
For the IQR, 25th and 75th quartiles are reported.
Not applicable for patients from ORATORIO as this was an exclusion criterion.
Last DMT refers to that at study start.
Other: Cladribine, diroximel fumarate, mitoxantrone, methotrexate, laquinimod, daclizumab, masitinib, siponimod, minocycline, OCR, and rituximab.
BMI, body mass index; CTP, controlled treatment period; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; IQR, interquartile range; MS, multiple sclerosis; OCR, ocrelizumab; PMS, progressive multiple sclerosis; RMS, relapsing multiple sclerosis; ROW, rest of the world; SD, standard deviation.