Table 1.
Baseline Characteristics in the Modified Intent-to-Treat Population
| Natalizumab once every 6-wk group (n = 247) | Natalizumab once every 4-wk group (n = 242) | |
| Age, y | 40.9 (9.66) | 40.3 (9.94) |
| Sex | ||
| Female | 174 (70%) | 176 (73%) |
| Male | 73 (30%) | 66 (27%) |
| Ethnicity | ||
| Hispanic or Latino | 9 (4%) | 10 (4%) |
| Not Hispanic or Latino | 220 (89%) | 219 (90%) |
| Not reporteda | 18 (7%) | 13 (5%) |
| Race | ||
| White | 208 (84%) | 205 (85%) |
| Black or African American | 14 (6%) | 23 (10%) |
| Asian | 4 (2%) | 1 (<1%) |
| American Indian or Alaska Native | 1 (<1%) | 1 (<1%) |
| Other | 5 (2%) | 1 (<1%) |
| Not reporteda | 15 (6%) | 11 (5%) |
| Region | ||
| North Americab | 129 (52%) | 130 (54%) |
| Europec and Israel | 101 (41%) | 98 (40%) |
| Australia | 12 (5%) | 9 (4%) |
| United Kingdom | 5 (2%) | 5 (2%) |
| Baseline body weight, kg | ||
| Mean (SD) | 79.70 (19.59) | 78.62 (20.28) |
| ≤80 | 146 (59%) | 138 (57%) |
| Time since multiple sclerosis symptoms onset, yd | 10.0 (6.0–15.0)e | 9.0 (5.0–15.0) |
| Time since RRMS diagnosis, yf | 8.0 (4.0–13.0)g | 8.0 (4.0–12.0)h |
| No. of relapses in the 12 mo before initiation of natalizumab | 1.0 (0.0–2.0)h | 1.0 (0.0–1.0)i |
| Duration of natalizumab exposure at baseline, y | 4.0 (2.1–6.6) | 4.0 (2.2–6.1) |
| Participants with no missed natalizumab doses in the 3 mo before screening | 247 (100%) | 241 (>99%) |
| Participants without dosing gap >3 mo | 227 (92%) | 229 (95%) |
| EDSS score at baseline, mean (SD) | 2.32 (1.3) | 2.31 (1.3) |
| Previous disease-modifying therapy usej | 184 (74%) | 175 (72%) |
| JC virus serostatus at baseline | ||
| Positive | 52 (21%) | 46 (19%) |
| Negative | 194 (79%) | 195 (81%) |
| Missing | 1 (<1%) | 1 (<1%) |
| T2 hyperintense lesion volume, mL | 10.0 (4.8–18.5) | 9.6 (4.3–18.2) |
| T1 hypointense lesion volume, mL | 0.6 (0.2–1.7) | 0.6 (0.1–1.7) |
| Normalized brain volume, mL | 1,516.4 (1,453.4–1,572.7) | 1,532.5 (1,459.1–1,579.0) |
Abbreviations: EDSS = Expanded Disability Status Scale; IQR = interquartile range; Q4W = every 4 wk; Q6W = every 6 wk; RRMS = relapsing-remitting multiple sclerosis.
Data are n (%), mean (SD), or median (IQR) unless otherwise stated.
Not reported because of confidentiality regulations.
Includes the United States and Canada.
Includes Belgium, France, Germany, Israel, Italy, Netherlands, and Spain.
Calculated as year of randomization minus year of multiple sclerosis symptom onset.
n = 246.
Calculated as year of randomization minus year of RRMS diagnosis.
n = 245.
n = 241.
n = 236.
Previous treatment with daclizumab, dimethyl fumarate, fampridine, fingolimod, glatiramer acetate, human immunoglobulin, interferon β (including pegylated interferon β), rituximab, or teriflunomide.
Reprinted from Lancet Neurology, 21(7), Foley JF, et al., Comparison of switching to 6-wk dosing of natalizumab vs continuing with 4-wk dosing in patients with relapsing-remitting multiple sclerosis (NOVA): a randomised, controlled, open-label, phase 3b trial, Pages 608–619, Copyright 2022, with permission from Elsevier.28