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    Health Equity in Multiple Sclerosis (MS)

    Support health equity in MS by understanding issues related to disparities seen in some populations.

    SECTIONS ON THIS PAGE

    Prevalence
    Unmet Need
    Clinical Presentation
    Disease Burden
    Imaging and Biomarkers
    Contributing Factors
    Trial Underrepresentation
    Abbreviations

    Prevalence

    MS in Black and Hispanic Populations

    Historically multiple sclerosis (MS) was thought to primarily affect White persons of Northern European ancestry.1

    Recent studies have shown that in the United States (US), Black and Hispanic persons have MS more than previously recognized.2

    2010 cumulative prevalence of MS per 100,000 US adults3,a

    Retrospective cohort analysis of administrative health claims data including 744,781 adult MS cases (2008-2010).

    1. 95% CIs were 374 to 376 for White, 296 to 301 for Black, and 160 to 163 for Hispanic persons.
    1. Khan O, et al. Neurol Clin Pract. 2015;5(2):132-142.
    2. Amezcua L, McCauley JL. Mult Scler. 2020;26(5):561-567.
    3. Hittle M, et al. JAMA Neurol. 2023;80(7):693-701.

    Unmet Need

    Unmet Need in MS for Minority Populations

    Unity icon

    There are limited data on Black and Hispanic patients from clinical studies.1,2

    These limited data suggest differences in:

    • Clinical presentation1,3
    • Disease activity and disability outcomes4
    • Imaging and other biomarkers

    among MS patients of different racial and ethnic groups5-7

    1. Telesford KM, et al. Front Immunol. 2023;14:1172993.
    2. Williams MJ, et al. Mult Scler Relat Disord. 2023;76:104794.
    3. Amezcua L, et al. Mult Scler J Exp Transl Clin. 2017;3(3):2055217317725103.
    4. Ventura RE, et al. Mult Scler. 2017;23(11):1554-1557.
    5. Rinker JR 2nd, et al. Neurology. 2007;69(1):68-72.
    6. da Gama PD, et al. Biomed Res Int. 2015;2015:217961.
    7. Weinstock-Guttman B, et al. Neurology. 2010;74(7):538-544.

    Clinical Presentation

    • Black and Hispanic Patients can have different clinical presentations of MS compared with White patients1,2
    1. Naismith RT, et al. Mult Scler. 2006;12(6):775-781.
    2. Briggs F, et al. Presented at CMSC; Aurora, CO, USA; May 31-June 3, 2023.

    Disease Burden

    Greater MS Disease Burden in Minorities

    Patient focus target group icon
    • In a US study, Black and Hispanic patients reported greater symptom severity than White patients on all 12 domains of the SymptoMScreen1,a
    Analytics icon
    • In a US study, Black patients (n=419) had a 2.6x higher prevalence of rapidly progressing MS than White patients (n=5819)2,b
    Spine icon

    In a US retrospective cohort study of Black (n=375) and White (n=427) MS patients, Black patients showed:3

    • Faster progression of mobility impairment
    • Use of cane 6 years sooner
    • Dependence on a wheelchair 8 years sooner
    1. Domains of the SymptoMScreen include mobility, dexterity, vision, fatigue, cognition, bladder function, sensory function, spasticity, pain, dizziness, depression, and anxiety.
    2. Based on MSSS scores ≥9.6 (7.3% vs 2.9% in Black and White patients, respectively; p<0.001).
    1. Kister I, et al. Neurol Clin Pract. 2021;11(4):335-341.
    2. Kister I, et al. Neurology. 2010;75(3):217-223.
    3. Cree BAC, et al. Neurology. 2004;63(11):2039-2045.

    Markers and Imaging

    Imaging and Other Biomarkers Vary Among Different Populations

    People icon
    • Compared with White patients with MS, Black patients exhibited:
    Monoclonal antibody icon
    • A greater likelihood of CSF oligoclonal bands and higher CSF IgG index1,2
    Brain icon
    • Greater T1 and T2 lesion volumes on MRI3,4
    Side eye view icon
    • More rapid loss of brain and retinal tissue5,6
    1. Rinker JR 2nd, et al. Neurology. 2007;69(1):68-72.
    2. da Gama PD, et al. Biomed Res Int. 2015;2015:217961.
    3. Howard J, et al. PLoS One. 2012;7(8):e43061.
    4. Weinstock-Guttman B, et al. Neurology. 2010;74(7):538-544.
    5. Gray-Roncal K, et al. Neurology. 2021;97(9):e881-e889.
    6. Caldito NG, et al. Brain. 2018;141(11):3115-3129.

    Contributing Factors

    Greater Severity and Faster Disease Progression for Black and Hispanic Patients

    Unity icon
    • Greater disease severity and faster disease progression in these populations are likely driven by a combination of factors:
    Double stranded DNA icon
    • Genetic factors
    Location icon
    • Environmental factors
    Water drink icon
    • Behaviors
    Connection icon
    • Other social determinants of health
    1. Telesford KM, et al. Front Immunol. 2023;14:1172993.

    Trial Underrepresentation

    Black and Hispanic Patients are Underrepresented in Clinical Trials1-3

    • Modest increases over time in the representation of racial and ethnic minorities in clinical trials have been reported5
    • Out of 52,000 published articles on MS, only 113 focused on Black patients and 23 focused on Hispanic patients6,b
    • A review of phase 3 trials of MS DMTs from 1995-2020 demonstrated that the median percentage of White participants was 93.8%7

    Barriers affecting participation:8-11

    • This lack of diversity limits our understanding of MS and the collection of accurate efficacy and safety data across all patient populations12,13
    1. 2011 report from the Dialogues on Diversifying Clinical Trials conference sponsored by the FDA.
    2. PubMed review conducted in 2014.
    1. Okai AF, et al. Neurology. 2022;98(24):1015-1020.
    2. Robers MV, et al. Practical Neurology. 2020:49-54.
    3. Avasarala J. JAMA Neurol. 2014;71(8):943-944.
    4. FDA. Clinical Trials Shed Light on Minority Health. Available at: https://wayback.archive-it.org/​7993/​20180908114418/​https:/www.fda.gov/​ForConsumers/​ConsumerUpdates/​ucm349063.htm. Accessed July 31, 2023.
    5. Turner BE, et al. Lancet Reg Health Am. 2022;11:100252.
    6. Khan O, et al. Neurol Clin Pract. 2015;5(2):132-142.
    7. Onuorah HM, et al. Neurology. 2022;98(9):e880-e892.
    8. Rivas-Rodríguez E, Amezcua L. Neurol Clin. 2018;36(1):151-162.
    9. Amezcua L, et al. Paper presented at CMSC Annual Meeting; National Harbor, MD, USA; June 1-4, 2022.
    10. Khan O, et al. Neurol Clin Pract. 2015;5(2):132-142.
    11. Garrick O, et al. Ethn Dis. 2022;32(1):61-68.
    12. Telesford KM, et al. Front Immunol. 2023;14:1172993.
    13. Williams MJ, et al. Mult Scler Relat Disord. 2023;76:104794.

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    TOP

    • 9HPT
      9-hole peg test

    • AAAAI
      American Academy of Allergy Asthma & Immunology

    • AAN
      American Academy of Neurology

    • ABC
      activated B-cell–like subtype

    • AE
      Adverse event

    • Ang2
      Angiopoietin-2

    • ARR
      Annualized Relapse Rate

    • ART
      Assisted Reproductive Technology

    • ASTCT
      American Society for Transplantation and Cellular Therapy

    • ATG
      Anti-thymocyte globulin

    • AUC
      area under the serum concentration–time curve

    • CALs
      chronic active lesions

    • CAR
      Chimeric antigen receptor

    • cCDP
      composite clinical disease progression

    • CCOD
      clinical cut-off date

    • CD3
      Cluster of differentiation 3

    • CD4
      Cluster of differentiation 4

    • CD8
      Cluster of differentiation 8

    • CD19
      Cluster of differentiation 19

    • CD20
      Cluster of differentiation 20

    • CD226
      Cluster of differentiation 226

    • CDA
      confirmed disability accumulation

    • CDC
      Centers for Disease Control and Prevention

    • CDP
      clinical disease progression

    • CI
      Confidence Interval

    • CIS
      clinically isolated syndrome

    • Cmax
      maximum serum concentration

    • COVID-19
      Coronavirus disease of 2019

    • CNS
      central nervous system

    • CPAP
      Continuous positive airway pressure

    • CR
      Complete response

    • CRP
      C-reactive protein

    • CRS
      Cytokine release syndrome

    • CSF
      cerebrospinal fluid

    • CT
      Computed tomography

    • CTCAE
      Common Terminology Criteria for Adverse Events

    • DIC
      Disseminated intravascular coagulation

    • DLBCL
      Diffuse large B-cell lymphoma

    • DMT
      Disease-modifying therapy

    • DMT
      Disease-modifying treatment

    • DoCR
      Duration of complete response

    • DoR
      Duration of response

    • DBPCFC
      Double-blind, placebo-controlled food challenge

    • ECOG PS
      Eastern Cooperative Oncology Group performance status

    • ECTRIMS
      European Committee for Treatment and Research in Multiple Sclerosis

    • EDSS
      Expanded Disability Status Scale

    • EFSefficacy
      event-free survival for efficacy causes (time from randomization to the earliest occurrence of disease progression/relapse, death due to any cause, initiation of any non-protocol specified anti-lymphoma treatment, or biopsy-confirmed residual disease after treatment completion)

    • EMA
      European Medicines Association

    • EOT
      end of treatment

    • EPIC
      expression/genomics, proteomics, imaging, and clinical

    • FAERS
      FDA Adverse Event Reporting System

    • FDA
      Food and Drug Administration

    • FDA
      US Food and Drug Administration

    • FL
      Follicular lymphoma

    • GCB
      germinal-center B-cell–like subtype

    • Gd
      gadolinium-enhanced

    • Gd+
      gadolinium-enhancing

    • GFAP
      glial fibrillary acidic protein

    • GMR
      geometric mean ratio

    • HCP
      Health Care Provider

    • HGBCL
      High-grade B-cell lymphoma

    • HGBL
      high-grade B-cell lymphoma

    • HHV8
      human herpesvirus 8

    • HLA
      human leukocyte antigen

    • HLH
      Hemophagocytic lymphohistiocytosis

    • HR
      hazard ratio

    • ICANS
      Immune effector cell-associated neurotoxicity syndrome

    • ICU
      Intensive care unit

    • Ig
      Immunoglobulin

    • IgE
      Immunoglobulin E

    • IgG
      immunoglobulin G

    • IgG1
      Immunoglobulin G1

    • INR
      International normalized ratio

    • IPI
      International Prognostic Index

    • IR
      injection reaction

    • IRC
      Independent Review Committee

    • IRR
      Infusion-related reaction

    • ITIM
      Immunoreceptor tyrosine-based inhibitory motif

    • ITT
      intention-to-treat

    • IV
      intravenous

    • LLN
      Lower limit of normal

    • LLOQ
      lower limit of quantification

    • LMP
      last menstrual cycle

    • LMP
      Last menstrual period

    • MAS
      Macrophage activation syndrome

    • MBP
      myelin basic protein

    • MCA
      Major congenital anomalies

    • MedDRA
      Medical Dictionary for Regulatory Activities

    • MHC
      Major histocompatibility complex

    • min
      minutes

    • MRI
      magnetic resonance imaging

    • MS
      Multiple sclerosis

    • MSFC
      Multiple Sclerosis Functional Composite

    • MSKCC
      Memorial Sloan Kettering Cancer Center

    • MSSS
      Multiple Sclerosis Severity Scale

    • N/E
      new/enlarging

    • NfH
      neurofilament heavy chain

    • NfL
      neurofilament light chain

    • NK
      Natural killer

    • NO
      Nitric oxide

    • NOS
      Not otherwise specified

    • OB/Gyn
      Obstetrics and Gynecology

    • OCR
      ocrelizumab

    • OCR
      OCREVUS (ocrelizumab)

    • OCT
      optical coherence tomography

    • OR
      Odds ratio

    • ORR
      Objective response rate

    • OS
      overall survival

    • PD
      pharmacodynamic

    • PD-1
      Programmed cell death protein 1

    • PD-L1
      Programmed death-ligand 1

    • PET
      Positron emission tomography

    • PDR
      protocol-defined relapse

    • PET-CT
      positron emission tomography and computed tomography

    • PFS
      Progression-free survival

    • PIRA
      progression independent of relapse activity

    • PK
      pharmacokinetics

    • PMBCL
      Primary mediastinal B-cell lymphoma

    • PML
      progressive multifocal leukoencephalopathy

    • Pola-R-CHP
      polatuzumab plus rituximab, cyclophosphamide, doxorubicin, prednisone

    • PPMS
      Primary progressive multiple sclerosis

    • PRLs
      paramagnetic rim lesions

    • PRO
      patient reported outcome

    • PTT
      Partial thromboplastin time

    • PVR
      Poliovirus receptor

    • R-CHOP
      rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone

    • R-CHP
      rituximab plus cyclophosphamide, doxorubicin, prednisone

    • RADIEMS
      Reserve Against Disability in Early MS

    • RAN
      rapid automatized naming

    • RAW
      relapse-associated worsening

    • rHuPH20
      recombinant human hyaluronidase PH20

    • RID
      Relative infant dose

    • RMS
      relapsing forms of multiple sclerosis

    • RMS
      Relapsing multiple sclerosis

    • RRMS
      Relapsing-remitting multiple sclerosis

    • SAE
      Serious adverse event

    • SC
      subcutaneous

    • SELs
      slowly expanding lesions

    • SPMS
      secondary progressive multiple sclerosis

    • T
      Trimester

    • T25FW
      Timed 25-Foot Walk

    • TCR
      T-cell receptor

    • TIGIT
      T cell immunoreceptor with Ig and ITIM domains

    • UCSF
      University of California San Francisco

    • USPI
      United States Prescribing Information

    • URTI
      Upper respiratory tract infection

    • UTI
      Urinary tract infection

    • VWF
      von Wilebrand factor

    • NIH
      National Institutes of Health

    • h
      hour

    • ALT
      Alanine aminotransferase

    • ASCO
      American Society of Clinical Oncology

    • BMI
      Body mass index

    • CAP
      College of American Pathologists

    • CCOD
      Clinical cutoff date

    • CDK4/6
      Cyclin-dependent kinase 4 and 6

    • CDx
      Companion diagnostic test

    • CKD-EPI
      Chronic Kidney Disease Epidemiology Collaboration

    • CTCAE v4.03
      Common Terminology Criteria for Adverse Events version 4.03

    • CTCAE v4
      Common Terminology Criteria for Adverse Events version 4

    • CTCAE v5.0
      Common Terminology Criteria for Adverse Events version 5.0

    • ctDNA
      Circulating tumor DNA

    • DOR
      Duration of response

    • DPP-4
      Dipeptidyl peptidase-4

    • eGFR
      Estimated glomerular filtration rate

    • ER
      Endocrine receptor

    • ESMO
      European Society for Medical Oncology

    • ESO
      European School of Oncology

    • ET
      Endocrine therapy

    • Fulv
      Fulvestrant

    • HbA1c
      Hemoglobin A1c

    • HCP
      Health care provider/professional

    • HER2
      Human epidermal growth factor receptor 2

    • HR
      Hazard ratio or hormone receptor, depending on context

    • Inavo
      Inavolisib

    • NCI
      National Cancer Institute

    • NGS
      Next-generation sequencing

    • ORR
      Overall response rate

    • Palbo
      Palbociclib

    • Pbo
      Placebo

    • PCR
      Polymerase chain reaction

    • PgR
      Progesterone receptor

    • PI3K
      Phosphatidylinositol 3-kinase

    • PIK3CA
      Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

    • RECIST v1.1
      Response Evaluation Criteria In Solid Tumors version 1.1

    • SGLT2
      Sodium-glucose co-transporter 2

    • ULN
      Upper limit of normal