Abstract Details

Title An Interim Analysis of Efficacy and Safety Data in Black and Hispanic Patients With Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial

Topic Multiple Sclerosis

Presentation(s) S31 - MS Clinical Decision Making and Special Populations (4:30 PM-4:42 PM)

Poster/Presentation
Number 006

Background

Black and Hispanic patients are underrepresented in MS trials, and these patients may have higher MS incidence, faster disease progression and/or an increased risk of progression to disability vs White patients. The CHIMES trial (NCT04377555) was designed to evaluate disease activity and OCR response in Black and Hispanic patients.

Objective To analyze the interim efficacy and safety data for ocrelizumab (OCR) treatment in Black and Hispanic patients with relapsing multiple sclerosis (pwRMS).

Design/Methods This prospective, open-label, single-arm, Phase IV study included pwRMS who self-identified as Black or Hispanic, were aged 18-65 years and had Expanded Disability Status Scale (EDSS) scores of 0-5.5 points at screening. Patients received two 300-mg OCR infusions 14 days apart, and 600 mg every 24 weeks for 1 year, with an optional 3-year extension. The interim data cutoff was March 30, 2022, with patients who completed 1-year OCR treatment. The primary outcome was no evidence of disease activity (NEDA), defined as the proportion of patients free from a protocol-defined event at Week 48.

Results This interim analysis included 49/182 patients enrolled, 36 (73.5%) Black and 13 (26.5%) Hispanic. Mean (SD) age was 33.3 (8.1) years, weight was 90.6 (23.9) kg and 85.7% of patients were female. Patients had a mean (SD) time since first MS symptoms of 3.8 (5.1) years and time since RMS diagnosis was 1.6 (3.4) years. Baseline mean (SD) EDSS score was 2.5 (1.5), Gd-enhancing T1 lesions was 2.5 (3.9) and total T2 lesion volume was 21.7 (21.8) cm³. The proportion of patients with NEDA was 40.8% (95% CI 27.0%–55.8%). Overall, 38 patients experienced ≥1 AE, 3 had a serious AE and 22 had a non-serious infusion-related reaction. No deaths occurred.

Conclusions

The CHIMES interim analysis provides essential preliminary data for OCR treatment response among Black and Hispanic patients.

Authors/Disclosures
Evanthia Bernitsas, MD, FAAN (Wayne State School of Medicine) PRESENTER	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.
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 $5,000-$9,999 for serving as a Consultant for biogen . 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 $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for NK max. Dr. Reder has received personal compensation in the range of $10,000-$49,999 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.
Angel R. Chinea, MD	Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for allergan.
Craig E. Herrman, MD	The institution of Dr. Herrman has received research support from Genentech. The institution of Dr. Herrman has received research support from Merck . The institution of Dr. Herrman has received research support from Novartis.
Barbara O'Brien, MD (Neurology Clinic)	Dr. O'Brien has nothing to disclose.
Richard A. Sater, MD, PhD, FAAN (Guilford Neurological Associates)	Dr. Sater has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Hoffman-LaRoche. Dr. Sater has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Sater has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Sater has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Sater has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Sater has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Sater has received research support from Biogen. The institution of Dr. Sater has received research support from Roche. The institution of Dr. Sater has received research support from EMD Serono.
Lilyana M. Amezcua, MD, FAAN (USC)	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.
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.
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	No disclosure on file
Juan A. Acosta, MD (Roche)	Dr. Acosta has received personal compensation for serving as an employee of Genentech.
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.