Non-Hispanic Black and Hispanic or Latino individuals on ocrelizumab did not demonstrate significantly greater risk on 24-week confirmed disability progression relative to non-Hispanic Whites.
Post-hoc findings from the phase 3 OPERA I and II studies (NCT01247324; NCT01412333) showed that despite a more severe disease course for non-Hispanic Black (NHB) and Hispanic or Latino (HL) patients with relapsing multiple sclerosis (MS), the risk for disability progression was reduced in these populations while on ocrelizumab (Ocrevus; Genentech).
These data were presented by Mitzi Joi Williams, MD, founder and chief executive officer of Joi Wellness Group Multiple Sclerosis Center, at the 2023 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held February 23-25, in San Diego. In the analysis, 65 NHB, 213 HL, and 1350 non-Hispanic White (NHW) patients with relapsing MS were included, with a goal to understand differences in baseline disease burden, B-cell and B-cell subset levels, and risk for disability progression differs between groups.
Investigators examined several different measures, such as baseline demographics and clinical outcomes like Expanded Disability Status Scale (EDSS), 25-foot walk test (25FW), and 9-hole peg test (9HPT). Additionally, brain MRI outcomes including T2 lesion volume (T2LV) gadolinium and lesion count, and brain volume, as well as blood outcomes such as B-cells and subsets, T-, B-, and NK-cell counts, and immunoglobulin D panels, were assessed. In OPERA I and II, patients with relapsing MS received intravenous ocrelizumab at a dose of 600 mg every 24 weeks or subcutaneous interferon beta-1a at a dose of 44 μg three times weekly for 96 weeks.
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Baseline differences in NHB or HL vs NHW participants were assessed using X2 or Mann-Whitney U tests. At the conclusion of the analysis, compared with NHW, NHB patients showed greater T2LB (median, 8.5; NHW: median, 5.4 cm3), higher 9HPT (NHB, 24.1; NHW, 22.0 sec), greater body mass index (NHB, 28.7; NHW, 24.8 kg/m2), less time since symptom onset (NHB, 2.8; NHW, 5.0 y), less time from symptom onset to diagnosis (NHB, 0.7; NHW, 1.0 y), and younger age (NHB, 36; NHW, 38 y), with all data comparisons showing P values less than 0.05.
Compared with NHW, HL patients with relapsing MS had higher 9HPT (HL, 23.8; NHW, 22.0 sec), higher 25FW (HL, 6.8; NHW, 5.4 sec) and greater BMI (HL, 25.9, NHW, 24.8 kg/m2); all P<0.05. NHB and HL groups had greater baseline CD19+ B cell counts (NHB, 273; HL, 272; NHW, 222 cells/µL), including mature naive (NHB, 177; HL, 170; NHW, 140 cells/µL), plasmablast-plasma (NHB, 5; HL, 5; NHW, 3 cells/µL) and double-negative memory B cells (NHB, 12; HL, 10; NHW, 7 cells/µL); all P<0.005. Risk of 24-week confirmed disability progression, a composite of EDSS, 9HPT, and 25FW, was significantly higher in the NHB (HR, 3.0; 95% CI, 1.4-6.5) and HL (HR, 2.3; 95% CI, 1.6-3.4; P <.0001) groups relative to NHW in the interferon beta-1a arm, but not the ocrelizumab arm.
In the original OPERA I and II trials, the primary end point was annualized relapse rate (ARR). Published in the New England Journal of Medicine in 2017, ocrelizumab showed lower ARRs than interferon beta-1a in trial 1 (0.16 vs 0.29; 46% lowered rate; P <.001) and in trial 2 (0.16 vs 0.29; 47% lowered rate; P <.001). In prespecified pooled analyses, the percentage of patients with disability progression confirmed at 12 weeks was significantly lower with ocrelizumab than with interferon beta-1a (9.1% vs. 13.6%; HR, 0.60; 95% CI, 0.45 to 0.81; P<0.001), as was the percentage of patients with disability progression confirmed at 24 weeks (6.9% vs. 10.5%; HR, 0.60; 95% CI, 0.43 to 0.84; P = 0.003).
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