Comparable Ofatumumab Treatment Outcomes in Patients across Racial/Ethnic Groups in the ASCLEPIOS I/II and APOLITOS studies (4139)

Objective: To compare outcomes across different racial/ethnic patient groups with relapsing multiple sclerosis (RMS) following ofatumumab treatment. Background: Ofatumumab is a fully-human anti-CD20 monoclonal antibody approved by the FDA for treatment of adults with RMS. The RMS disease course and treatment response may vary across different racial/ethnic groups. Design/Methods: This post hoc analysis included data from patients treated with ofatumumab 20mg subcutaneous in the Phase 3 ASCLEPIOS I/II studies (n=935; White [n=829], Black/African-American [n=28], Asian [n=36], other [n=42]) and Phase 2 APOLITOS study (n=43; White [n=22], Asian [n=21, Japanese]). We compared efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety outcomes for ofatumumab by these patient groups. Results: In ASCLEPIOS I/II, annualized relapse rates (95%CI) were similar in White (0.13 [0.11; 0.15]), Black/African-American (0.07 [0.02; 0.22], Asian (0.08 [0.03; 0.24]), and other (0.08 [0.03; 0.18]) patients treated with ofatumumab. As per PK analysis, ofatumumab trough concentrations (median [95%CI]) were comparable in White (0.438 [0.05; 2.53] μg/mL), Black/African-American (0.106 [0.05; 1.67] μg/mL), Asian (0.127 [0.05; 1.20] μg/mL) and other (0.453 [0.05; 2.25] μg/mL) patients in ASCLEPIOS I/II, with numerically higher concentrations (0.713 [0.142; 2.00] μg/mL) observed in Asian patients in APOLITOS. A population-PK analysis demonstrated no significant correlations between White, Black/African-American, Asian/others and PK parameters. In APOLITOS, ofatumumab was associated with a consistent depletion of CD19+ B-cells and CD3+CD20+ T-cells in Asian and White patients, indicating similar PD response. No meaningful differences were observed in the incidence of adverse events (AEs) in ASCLEPIOS I/II (White [84.9%], Black/African-American [92.9%], Asian [66.7%], other [69.8%]) nor in APOLITOS. Overall pattern, incidence rate and severity of AEs across the groups was consistent with the overall population with no discernible trends/safety signals. Conclusions: Results revealed no clinically relevant differences in outcomes for RMS patients of different racial/ethnic groups treated with ofatumumab 20mg subcutaneous, suggesting dose adjustment may not be necessary across these groups. Disclosure: Dr. Delgado has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. 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 Abbvie. 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 Celgene/Bristol Myers Squibb. 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 Speakers Bureau for Biogen Idec. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Meyers Squibb. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis Pharmaceuticals. 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 TEVA Neuroscience. 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 a non-compensated relationship as a National Board Member with National MS Society that is relevant to AAN interests or activities. Morten Bagger has received personal compensation for serving as an employee of Novartis. Morten Bagger has received stock or an ownership interest from Novartis. Gordon Graham has nothing to disclose. Etienne Pigeolet has nothing to disclose. Huixin Yu has received personal compensation for serving as an employee of Novartis. Dieter Haering has received personal compensation for serving as an employee of Novartis. Dr. Willi has received personal compensation for serving as an employee of Novartis Pharma. Dr. Willi has received stock or an ownership interest from Novartis. Cecile Kerloeguen has received personal compensation for serving as an employee of Novartis. Cecile Kerloeguen has received personal compensation for serving as an employee of Novartis. Cecile Kerloeguen has received stock or an ownership interest from Novartis. Cecile Kerloeguen has received stock or an ownership interest from novartis. Chao Xu has nothing to disclose. Masaru Hirano has nothing to disclose. Dee Stoneman has nothing to disclose. Wendy Su, PhD has nothing to disclose. Krishnan Ramanathan has received personal compensation for serving as an employee of Novartis. Prof. Nakahara has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mitsubishi-Tanabe. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Prof. Nakahara has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Chugai. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Mitsubishi-Tanabe. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Takeda. Prof. Nakahara has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Abbvie. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Otsuka. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Astellas. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for CSL Behring. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sumitomo-Dainippon. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Behringer-Ingelheim. Prof. Nakahara has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for The Japanese Society for Internal Medicine. Prof. Nakahara has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Kagakuhyoronsha. The institution of Prof. Nakahara has received research support from Biogen. The institution of Prof. Nakahara has received research support from Keio University. The institution of Prof. Nakahara has received research support from Otsuka. The institution of Prof. Nakahara has received research support from Kyowa-Kirin. The institution of Prof. Nakahara has received research support from Chugai. The institution of Prof. Nakahara has received research support from Shionogi. The institution of Prof. Nakahara has received research support from Sumitomo-Dainippon. The institution of Prof. Nakahara has received research support from Eisai. The institution of Prof. Nakahara has received research support from Abbvie. The institution of Prof. Nakahara has received research support from JB. The institution of Prof. Nakahara has received research support from Behringer-Ingelheim. The institution of Prof. Nakahara has received research support from MSD. The institution of Prof. Nakahara has received research support from Tsumura.