Abstract Details

Title 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

Topic Multiple Sclerosis

Presentation(s) S3 - Multiple Sclerosis: Clinical Trials (1:36 PM-1:48 PM)

Poster/Presentation
Number 004

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

Objective

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

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.

Authors/Disclosures
Lilyana M. Amezcua, MD, FAAN (USC) PRESENTER	Dr. Amezcua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for serono. Dr. Amezcua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Amezcua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Amezcua has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for genentech. The institution of Dr. Amezcua has received research support from National MS Society. The institution of Dr. Amezcua has received research support from Genentech. The institution of Dr. Amezcua has received research support from Medday. The institution of Dr. Amezcua has received research support from Bristol Myers Squibb Foundation. The institution of Dr. Amezcua has received research support from NIH NINDS.
Nancy Monson (University of Texas Southwestern)	Nancy Monson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech, Inc.. Nancy Monson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for GenrAb, Inc.. Nancy Monson has stock in GenrAb, Inc.. The institution of Nancy Monson has received research support from NIH. Nancy Monson has received intellectual property interests from a discovery or technology relating to health care.
Mitzi J. Williams, MD, FAAN (Joi Life Wellness Group)	Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen Idec. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis Pharmaceuticals. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon Therapeutics. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Williams has received publishing royalties from a publication relating to health care. Dr. Williams has received publishing royalties from a publication relating to health care. Dr. Williams has a non-compensated relationship as a National Board Member with National MS Society that is relevant to AAN interests or activities.
Anthony Reder, MD (University of Chicago)	The institution of Dr. Reder has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for genentech. Dr. Reder has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for serono. Dr. Reder has received personal compensation in the range of $500-$4,999 for serving as a Consultant for sanofi. The institution of Dr. Reder has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for bms. Dr. Reder has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NK max. Dr. Reder has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for genentech. Dr. Reder has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for medlink. The institution of Dr. Reder has received research support from genentech. The institution of Dr. Reder has received research support from biogen. The institution of Dr. Reder has received research support from serono. The institution of Dr. Reder has received research support from novartis.
Gregory F. Wu, MD, FAAN	Dr. Wu has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Progentec. Dr. Wu has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Wu has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Journal of Neuroimmunology. Dr. Wu has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Department of Justice.
Timothy K. Vartanian, MD, PhD (Weill Cornell Medical College)	Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Vartanian has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Vartanian has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Tisch MS Center. Dr. Vartanian has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen.
Jinglan Pei	Jinglan Pei has nothing to disclose.
Christopher Harp	Christopher Harp has received personal compensation for serving as an employee of Genentech. Christopher Harp has received stock or an ownership interest from Genentech, Inc..
David Clayton	David Clayton has received personal compensation for serving as an employee of Genentech/Roche. David Clayton has received stock or an ownership interest from Roche. An immediate family member of David Clayton has received publishing royalties from a publication relating to health care.
Ajibola Abioye (Genentech)	Ajibola Abioye has received personal compensation for serving as an employee of Genentech, Inc.
Evanthia Bernitsas, MD, FAAN (Wayne State School of Medicine)	Dr. Bernitsas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen@Janssen. Dr. Bernitsas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Bernitsas has received research support from Roche/Genentech.

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