Abstract Details

Title Demographics and Baseline Disease Characteristics of Black and Hispanic Patients With Multiple Sclerosis in the CHIMES Trial

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-005

Objective

To present the baseline demographics and disease characteristics of Black and Hispanic patients with relapsing multiple sclerosis (RMS) enrolled in the CHIMES trial (NCT04377555).

Background

Black and Hispanic patients with MS have greater disease severity, faster disease progression and a greater risk of disability than White patients yet they are underrepresented in clinical research. This lack of representation of Black and Hispanic patients in clinical trials is due to multiple factors including systemic, financial, cultural and logistical barriers. A key objective of the CHIMES trial is to evaluate both disease characteristics and ocrelizumab (OCR) treatment responses in Black and Hispanic patients.

Design/Methods

The CHIMES trial was specifically designed to address barriers to trial inclusion for Black and Hispanic patients by including accessible study sites, tailoring eligibility criteria, translating patient materials and enhancing scheduling flexibility. Baseline demographics and disease characteristics in this study were evaluated against the benchmark of the existing data from other OCR studies.

Results

The demographics and baseline disease characteristics of patients in the CHIMES trial were overall similar to those observed in the broader OCR clinical trial population. Potential distinguishing factors included younger age, higher BMI, greater T2 burden, shorter duration of disease and time to diagnosis despite similar disease activity than patients from other OCR studies.

Conclusions

Underrepresentation of Black and Hispanic patients in clinical trials limits the understanding of MS and hinders the collection of pathophysiology, safety and efficacy data related to therapies in inclusive patient populations. Data from the CHIMES trial, the first MS trial to focus on Black and Hispanic patients, indicate some differences in demographics and baseline disease characteristics between Black and/or Hispanic and White patients; however, these differences alone do not justify nor explain the lack of representation of Black and Hispanic patients in clinical research.

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 EMD serono. 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 $500-$4,999 for serving as a Consultant for TG Therapeutics. 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 Bristol Myers Squibb Foundation. The institution of Dr. Amezcua has received research support from NIH NINDS. The institution of Dr. Amezcua has received research support from Sanofi/Genzyme. The institution of Dr. Amezcua has received research support from Alexion.
Annette Okai, MD, FAAN (North Texas Institute of Neurology and Headache)	Dr. Okai has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genentech. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Okai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme . The institution of Dr. Okai has received research support from Sanofi Genzyme. The institution of Dr. Okai has received research support from Roche Genetech. The institution of Dr. Okai has received research support from Novartis. The institution of Dr. Okai has received research support from EMD Serono. The institution of Dr. Okai has received research support from TG Therapeutics.
Anne H. Cross, MD, FAAN (Washington University School of Medicine)	Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech / F. Hoffman la Roche. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb . Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Octave. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Cross 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. Cross has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Cross has received personal compensation in the range of $5,000-$9,999 for serving as an officer or member of the Board of Directors for Consortium of MS Centers. Dr. Cross has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for AAN. The institution of Dr. Cross has received research support from Genentech. Dr. Cross has received intellectual property interests from a discovery or technology relating to health care.
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.
Ben W. Thrower, MD (Shepherd Center)	Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Thrower has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Horizon. Dr. Thrower has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS.
Anthony Reder, MD (University of Chicago)	Dr. Reder has nothing to disclose.
Jeffrey B. English, MD (Atlanta Neuroscience Institute)	Dr. English has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for biogen idec. Dr. English has received personal compensation in the range of $500-$4,999 for serving as a Consultant for bristol myer squibb. Dr. English has received personal compensation in the range of $500-$4,999 for serving as a Consultant for genentech. Dr. English has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for sanofi genzyme. Dr. English has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for biogen idec. Dr. English has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for genzyme. Dr. English has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for genentech. Dr. English has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for bristol myer squibb. Dr. English has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TG Therpeutics. Dr. English has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. English has received intellectual property interests from a discovery or technology relating to health care.
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. The institution of Dr. Wu has received research support from EMD Serono. The institution of Dr. Wu has received research support from Biogen.
Evanthia Bernitsas, MD, FAAN (Wayne State School of Medicine)	Dr. Bernitsas has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Bernitsas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vanda. The institution of Dr. Bernitsas has received research support from Roche/Genentech.
	No disclosure on file
Jugena Smith	Jugena Ndrio has received personal compensation for serving as an employee of Genentech. Jugena Ndrio has received stock or an ownership interest from Genentech.
Jinglan Pei	Jinglan Pei has nothing to disclose.
Ellen M. Mowry, MD, FAAN (Johns Hopkins University)	Dr. Mowry has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octave. Dr. Mowry has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SetPoint. The institution of Dr. Mowry has received research support from Genentech/Roche. The institution of Dr. Mowry has received research support from Biogen. Dr. Mowry has received publishing royalties from a publication relating to health care.
Fabio Magrini, MD (Genentech Inc. - South San Francisco, CA)	Dr. Magrini has received personal compensation for serving as an employee of Genentech. Dr. Magrini has received stock or an ownership interest from Genentech Inc. - South San Francisco, CA.
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 Sanofi 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 Amgen. 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 Amgen. 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 personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. 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. Dr. Williams has a non-compensated relationship as a Board Trustee with Consortium of MS Centers that is relevant to AAN interests or activities. Dr. Williams has a non-compensated relationship as a Board Chair with Joi Life Foundation that is relevant to AAN interests or activities.

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