Table 1. Baseline Characteristics (Full Analysis Set).
| Characteristic | No. (%) | |
|---|---|---|
| Biosim-NTZ (n = 131) | Ref-NTZ (n = 133) | |
| Positive JCV status | 51 (38.9) | 55 (41.4) |
| Positive for ADAsa | 9 (7) | 8 (6) |
| Age, mean (SD), y | 36.8 (9.1) | 36.6 (9.7) |
| Male | 47 (35.9) | 55 (41.4) |
| Femaleb | 84 (64.1) | 78 (58.6) |
| Childbearing potential | 73 (86.9) | 70 (89.7) |
| Whitec | 131 (100) | 133 (100) |
| Absence/presence of gadolinium-enhancing lesions | ||
| 0 | 68 (51.9) | 72 (54.1) |
| >0 | 63 (48.1) | 61 (45.9) |
| Presence of T2 lesions | ||
| ≤15 | 4 (3.1) | 5 (3.8) |
| >15 | 127 (96.9) | 128 (96.2) |
| Time since diagnosis, y | ||
| Mean (SD) | 5.3 (4.7) | 5.3 (4.8) |
| Median (range) | 4.2 (0.1-21.8) | 4.4 (0.1-20.5) |
| Time since last relapse, mo | ||
| Mean (SD) | 5.1 (2.9) | 5.9 (3.0) |
| Median (range) | 4.3 (1.7-12.7) | 5.6 (1.7-12.6) |
| No. of relapses in the year prior to screening | ||
| 1 | 86 (65.6) | 91 (68.4) |
| 2 | 37 (28.2) | 38 (28.6) |
| ≥3 | 8 (6.1) | 4 (3.0) |
| Mean (SD) | 1.4 (0.7) | 1.4 (0.6) |
| Baseline EDSS score | ||
| Mean (SD) | 3.4 (1.1) | 3.2 (1.2) |
| Median (range) | 3.5 (2-5) | 3.5 (1-5) |
Abbreviations: ADAs, anti-drug antibodies; biosim-NTZ, biosimilar natalizumab; EDSS, Kurtzke Expanded Disability Status Scale; JCV, John Cunningham virus; ref-NTZ, reference natalizumab.
The reported proportion of patients with positive ADA results is part of the safety analysis performed in the safety population, which was identical to the full analysis set population.
A serum pregnancy test was conducted to confirm nonpregnancy in those of childbearing potential. Female participants of childbearing potential sexually active with a fertile male partner and male participants sexually active with female partners of childbearing potential agreed to use adequate contraception from screening until 90 days after the last dose of the study drug.
Race and ethnicity data were collected per trial protocol. The choices were American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, White, not reported, and other.