Imaging and Fluid Biomarkers of Disability Progression During 2 Years of Ocrelizumab Treatment in Black/African American and Hispanic/Latino People with Multiple Sclerosis (MS) in CHIMES
Lilyana Amezcua1, Nancy Monson2, Mitzi Williams3, Anthony Reder4, Gregory Wu5, Timothy Vartanian6, Jinglan Pei7, Christopher Harp7, David Clayton7, Ibraheem Abioye7, Evanthia Bernitsas8
1University of Southern California, 2University of Texas Southwestern, 3Joi Life Wellness Group, 4University of Chicago, 5Washington University, 6Weill Cornell Medical College, 7Genentech, Inc, 8Wayne State School of Medicine
Objective:

To analyze disease activity via MRI and blood biomarkers at Week 96 of the CHIMES ocrelizumab trial (NCT04377555).

Background:
This prospective, single-arm, Phase IV study is evaluating ocrelizumab in Black/African American (BpwRMS) and Hispanic/Latino people with relapsing MS (HpwRMS).
Design/Methods:

PwRMS received ocrelizumab per standard prescribing information. T1 gadolinium-enhancing lesions (Gd+Ls), new/enlarging T2 lesions (NET2Ls), T1 hypointense lesions (T1HLs) and total brain, cortical gray matter and thalamic volumes (TBV, CGMV and TV) were measured via MRI. Lesion rates (total lesion count/all MRIs) were adjusted for baseline T2 lesion count, disability status and prior treatment. Blood neurofilament light chain (NfL) and glial fibrillary acidic protein (GFAP) were measured serially.

Results:

After 96 weeks of ocrelizumab treatment, 97.2% (BpwRMS, 96.3%; HpwRMS, 98.6%) had no new Gd+Ls, 52.5% (46.4%; 62.3%) had no NET2Ls and 58.3% (51.4%; 69.9%) had no new T1HLs. During Weeks 24–96, 99.5% and 92.9% had no Gd+Ls and NET2Ls, respectively. New Gd+L rate was 0.012 (BpwRMS, 0.017; HpwRMS, 0.005); NET2L rate (adjusted) was 0.599 (0.733; 0.336); and new T1HL rate (adjusted) was 0.380 (0.539; 0.167). TBV (−0.69%), normalized CGMV (−0.79%) and normalized TV (−1.7%) declined (P<0.001). T2 lesion volume declined (−5.9%; P<0.001), but T1HL volume remained stable (P=0.1). Blood NfL decreased −48.1% (SD, 32.7), especially in PwRMS with baseline Gd+Ls (−62.7% [26.0]) vs those without (−35.9% [21.9]). GFAP remained stable (−4.4% [27.9]).

Conclusions:

Prevention of new Gd+Ls and NET2Ls and reduced NfL support efficacy of ocrelizumab treatment in CHIMES participants. Disease activity on MRI in CHIMES aligned with results in OPERA I/II (NCT01247324/NCT01412333) participants who received ocrelizumab. We observed decreases in blood NfL similar to those observed in OBOE (NCT02688985), but we did not observe the same increase in blood GFAP. Results from the ongoing CHIMES trial support the efficacy and safety of ocrelizumab in BpwRMS and HpwRMS.

10.1212/WNL.0000000000210703
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