Slide 1: One-Year Analysis of Efficacy and Safety Data From Black/African American and Hispanic/Latino People With RMS
Clinical Trials Plenary Session https://ter.li/n7lvea One-Year Analysis of Efficacy and Safety Data From Black/African American and Hispanic/Latino People With Relapsing Multiple Sclerosis Receiving Ocrelizumab Treatment in the CHIMES Trial Lilyana Amezcua,1 Nancy L. Monson,2 Mitzi J. Williams,3 Tim
Slide 2: Disclosures
Disclosures • Lilyana Amezcua reports personal compensation for consulting or • Krupa Pandey has served as a consultant for Biogen, Bristol Myers serving on steering committees or advisory boards for Biogen, Squibb, Genentech/Roche and Sanofi and has served as a speaker Novartis, Genentech, Inc. and
Slide 3: Clinical trials in MS historically lack diversity among participants
Clinical trials in MS historically lack diversity among participants • Black/African American and Hispanic/Latino pwMS typically Participation in four published, multinational, have greater disease severity, faster disease progression randomized controlled trials of MS DMTs5 and greater eventual dis
Slide 4: CHIMES investigated the efficacy and safety of ocrelizumab in Black/African American and Hispanic/Latino pwRMS
CHIMES investigated the efficacy and safety of ocrelizumab in Black/African American and Hispanic/Latino pwRMS Objective To evaluate the efficacy and safety of ocrelizumab during 48 weeks of treatment in Black/African American and Hispanic/Latino pwRMS BpwRMS and HpwRMS may have greater Ocrelizumab
Slide 5: Collaborative development guided the design of the phase IV CHIMES trial
Collaborative development guided the design of the phase IV CHIMES trial CHIMES was developed in collaboration with patients, national advocacy groups and clinical researchers Inclusion of the Kenya site Nairobi, Kenya • African regions have a much MS Minority lower reported incidence of MS Research
Slide 6: The CHIMES trial design mitigated common barriers to clinical trial participation for understudied groups
The CHIMES trial design mitigated common barriers to clinical trial participation for understudied groups1 Barriers Facilitators • Lack of trial access due to location • Recruitment at community-based study sites • Unconscious bias in trial design and execution • Study materials available in Spanish
Slide 7: The currently presented data are related to the CHIMES Week 48 analysis
The currently presented data are related to the CHIMES Week 48 analysis Inclusion criteria for BpwRMS and HpwRMS Tailored eligibility requirements additionally facilitated • EDSS score of ≤5.5 at enrollment inclusive enrollment such as: • Age 18–65 years • Baseline laboratory values (e.g., neutrophi
Slide 8: Baseline demographic characteristics of CHIMES participants were broadly representative of typical neurology patients
Baseline demographic characteristics of CHIMES participants were broadly representative of typical neurology patients BpwRMS HpwRMS All CHIMES Characteristic n=113 n=69 N=182 Age, mean (SD), years 36.3 (10.4) 34.2 (10.5) 35.5 (10.5) Female, n (%) 88 (77.9) 44 (63.8) 132 (72.5) Ethnicity, n (%) Hispa
Slide 9: Most CHIMES participants were DMT naive at baseline and had higher lesion burdens
Most CHIMES participants were DMT naive at baseline and had higher lesion burdens BpwRMS HpwRMS All CHIMES Characteristic n=113 n=69 N=182 Time since symptom onset, mean (SD), years 5.1 (5.7) 4.6 (5.5) 4.9 (5.7) Time since RMS diagnosis, mean (SD), years 2.9 (4.6) 2.9 (4.4) 2.9 (4.5) Baseline EDSS s
Slide 10: Half of CHIMES participants achieved NEDA-3 at 48 weeks of ocrelizumab treatment
Half of CHIMES participants achieved NEDA-3 at 48 weeks of ocrelizumab treatment Characteristic BpwRMS HpwRMS All CHIMES n (%) n=113 n=69 N=182 95% CI 52 (46.0) 40 (58.0) 92 (50.5) NEDA-3 36.6–55.6 45.5–69.8 43.1–58.0 107 (94.7) 66 (95.7) 173 (95.1) Free from protocol-defined relapse 88.8–98.0 87.8–
Slide 11: No new safety signals were reported in ocrelizumab-treated participants at CHIMES Week 48
No new safety signals were reported in ocrelizumab-treated participants at CHIMES Week 48 BpwRMS HpwRMS All CHIMES Characteristic n=113 n=69 N=182 Any AE in ≥5% of participants in any group, n (%) 91 (80.5) 55 (79.7) 146 (80.2) Infection 49 (43.4) 23 (33.3) 72 (39.6) COVID-19 23 (20.4) 17 (24.6) 40
Slide 12: Secondary clinical endpoints supported the efficacy of ocrelizumab treatment in BpwRMS and HpwRMS in CHIMES
Secondary clinical endpoints supported the efficacy of ocrelizumab treatment in BpwRMS and HpwRMS in CHIMES Unadjusted relapse rate EDSS score 0.2 1.5 48-Week unadjusted relapse rate (95% CI) 0.047 (0.010–0.139) Mean change (SD) 0.059 1 0.15 (0.022–0.128) from baseline 0.055 (0.025–0.104) 0.5 0.1 0
Slide 13: Ocrelizumab treatment resulted in consistent reductions in serum B-cell counts in CHIMES participants
Ocrelizumab treatment resulted in consistent reductions in serum B-cell counts in CHIMES participants Serum CD19+ B-cell count 100% Mean change (SD) from baseline 75% 50% 25% 0% -25% The trajectory of serum CD19+ B-cell -50% counts in CHIMES was consistent with -75% that observed in the OPERA trials
Slide 14: Conclusions and lessons learned from CHIMES
Conclusions and lessons learned from CHIMES • CHIMES is the first and only prospective study addressing the paucity of data on the efficacy of DMTs in pwMS in underrepresented populations • By considering and addressing common barriers to trial inclusion, CHIMES met its recruitment goal early and re
Slide 15: Further results from and analyses of CHIMES will help fill important knowledge gaps
Further results from and analyses of CHIMES will help fill important knowledge gaps Additional biomarkers: Patient-reported outcomes: Genomics: peripheral blood T- and B- Work Productivity and Activity HLA class II haplotypes, cell populations, cytokines, Impairment Questionnaire ancestral markers i
Slide 16: Acknowledgements
Acknowledgements • We thank all the participants who volunteered for this trial and their families and site staff who provided support to the participants • We are grateful to the study site investigators and staff who facilitated the trial’s recruitment, enrollment and data collection • We thank th