Table 1.
Baseline characteristics in the NfL study population and ITT population.
| Baseline characteristics | OPERA I and II (NfL study population)a |
OPERA I and II (ITT population) |
ORATORIO (NfL study population)a |
ORATORIO (ITT population) |
||||
|---|---|---|---|---|---|---|---|---|
| IFNβ-1a (n = 701) | OCR (n = 720) | IFNβ-1a (n = 829) | OCR (n = 827) | PBO (n = 205) | OCR (n = 391) | PBO (n = 244) | OCR (n = 488) | |
| Age, median (range), years | 38 (18–55) | 38 (18–56) | 37 (18–55) | 38 (18–56) | 46 (19–56) | 47 (20–56) | 46 (18–56) | 45 (20–56) |
| Female, n (%) | 447 (63.8) | 476 (66.1) | 552 (66.6) | 541 (65.4) | 100 (48.8) | 196 (50.1) | 124 (50.8) | 237 (48.6) |
| Male, n (%) | 254 (36.2) | 244 (33.9) | 277 (33.4) | 286 (34.5) | 105 (51.2) | 194 (49.7) | 120 (49.2) | 251 (51.4) |
| Region USA, n (%) | 175 (25.0) | 181 (25.1) | 219 (26.4) | 217 (26.2) | 31 (15.1) | 59 (15.1) | 34 (13.9) | 67 (13.7) |
| Weight, median (range), kg | 75 (42.1–163.6) | 75 (38–170) | 75 (42.1–163.6) | 75 (38–170) | 74 (45–136) | 72 (40.2–135) | 72 (45.0–136.0) | 72 (40.2–135.9) |
| Years since MS diagnosis, median (range) | 1.6 (0.1–28.5) | 1.8 (0–28.9) | 1.7 (0.1–28.5) | 1.8 (0–28.9) | 1.2 (0.1–13.8) | 1.5 (0.1–16.8) | 1.3 (0.1–23.8) | 1.6 (0.1–16.8) |
| Years since last relapse, median (range) | 0.4 (0.1–1.9) | 0.4 (0.1–2) | 0.4 (0.1–2) | 0.4 (0.1–2) | – | – | – | – |
| Patients with T1 Gd+ lesions, n (%) | 273 (39.3) | 289 (40.6) | 327 (39.8) | 333 (40.7) | 50 (24.4) | 93 (24) | 60 (24.7) | 133 (27.5) |
| No. of T1 Gd+ lesions, median (range) | 0 (0–54) | 0 (0–56) | 0 (0–54) | 0 (0–56) | 0 (0–10) | 0 (0–18) | 0 (0–50) | 0 (0–77) |
| No. of T2 lesions, median (range) | 42 (0–226) | 39 (1–209) | 42 (0–226) | 40 (1–233) | 42 (0–208) | 41 (0–226) | 43 (0–208) | 42 (0–249) |
| T2 lesion volume, median (range), mL | 6.2 (0–76.1) | 5.2 (0–96) | 6.2 (0–76.1) | 5.4 (0–96) | 6.2 (0–59.2) | 6.9 (0–89.4) | 6.2 (0–81.1) | 7.3 (0–90.3) |
| EDSS score, median (range) | 2.5 (0–6) | 2.5 (0–6) | 2.5 (0–6) | 2.5 (0–6) | 4.5 (2.5–6.5) | 4.5 (2.5–6.5) | 4.5 (2.5–6.5) | 4.5 (2.5–6.8) |
| 9HPT score, median (range) | 22.4 (11.5–149.1) | 22.4 (10–300) | 22.2 (11.3–149.1) | 22.2 (10–300) | 26.4 (13.2–120.7) | 26.6 (13.3–300) | 26.9 (11.1–120.7) | 26.8 (12.3–300) |
| T25FW score, median (range) | 5.5 (2.7–116.3) | 5.6 (2.6–149.8) | 5.5 (2.7–180) | 5.6 (2.6–149.8) | 7.3 (2.6–145) | 7.8 (3.3–180) | 7.4 (2.6–145.0) | 7.8 (3.3–180) |
| Serum NfL, median (range), pg/mL | 10.4 (2.7–339) | 10.7 (2.7–230.7) | 10.4 (2.7–339) | 10.7 (2.7–230.7) | 10.3 (3.3–102) | 10.3 (2.7–198.9) | 10.3 (2.7–198.9) | 10.3 (2.7–198.9) |
There were no appreciable differences in baseline demographics, clinical measures, and MRI characteristics between the NfL study population and ITT populations of OPERA I and II and ORATORIO. Compared with OPERA I and II, persons in ORATORIO were on average older, had greater disease burden (greater T2 lesion volume and higher EDSS), and had less disease activity (fewer patients had T1 Gd+ lesions) at baseline.
9HPT = Nine-Hole Peg Test; EDSS = Expanded Disability Status Scale; Gd = gadolinium; IFN = interferon; ITT = intention to treat; MS = multiple sclerosis; NfL = neurofilament light; OCR = ocrelizumab; PBO = placebo; T25FW = timed 25-foot walk.
Safety assessment population patients who completed baseline serum collection in OPERA and ORATORIO.