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• W3208982854 abstract "Objective: To evaluate the efficacy and safety of ofatumumab in Japanese and Russian relapsing MS (RMS) patients. Background: Ofatumumab, an FDA-approved anti-CD20 monoclonal antibody, is indicated for the treatment of adults with RMS. APOLITOS was designed to support ofatumumab registration for RMS in Japan. In the 24-week (W) core study, ofatumumab demonstrated superior efficacy to placebo. Design/Methods: Patients completing the randomized (2:1), double-blind, 24W core study entered the open-label extension (data cutoff: W48). Patients initially randomized to placebo switched to ofatumumab (placebo-ofatumumab group) in the extension and those on ofatumumab continued treatment for at least 24 weeks. Outcomes included Gd+ T1 lesions and T2 lesions, relapses, and safety parameters. Results: Fifty-nine patients (ofatumumab, N=40; placebo-ofatumumab, N=19) entered the extension part; 57 (97%) completed it. In the ofatumumab group, the mean number of Gd+ T1 lesions was low until W24 (0.106) and further abrogated to 0.027 by W48. Similarly, the annualized rate of new/enlarging T2 lesions was 4.810 by W24 and 0.230 by W48. The annualized relapse rate (ARR) of 0.217 at W24 was reduced to 0.081 by W48. In the placebo-ofatumumab group, the mean number of Gd+ T1 lesions was high until W24 (1.150), with a marked reduction to 0.025 by W48 after switching to ofatumumab. Similarly, the T2 lesion rate dropped from 12.080 to 0.813. ARR was 0.684 until W24 and decreased to 0.083 by W48. Incidence of treatment-emergent AEs by W48 was 74.6%; injection-related reactions were the most common (ofatumumab, 25.0%; placebo-ofatumumab, 21.1%). These were mild to moderate and predominantly reported with the first dose. No deaths or opportunistic infections were reported. Conclusions: Continued treatment with ofatumumab was associated with sustained efficacy through 48 weeks and switching to ofatumumab at W24 led to rapid clinical benefit in Japanese and Russian RMS patients. Safety observations were consistent with the Phase 3 ASCLEPIOS I/II trials. Disclosure: Takahiko Saida has nothing to disclose. 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. Denis Sazonov has nothing to disclose. Takayoshi Kurosawa has received personal compensation for serving as an employee of Novartis. Isao Tsumiyama has received personal compensation for serving as an employee of Novartis Pharmaceutical K.K.. 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. Martin Zalesak has received personal compensation for serving as an employee of Novartis. Ratnakar Pingili has received personal compensation for serving as an employee of Novartis. Dieter Haering has received personal compensation for serving as an employee of Novartis. Krishnan Ramanathan has received personal compensation for serving as an employee of Novartis. Wendy Su, PhD has nothing to disclose. Dr. Kira has nothing to disclose." @default.
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• W3208982854 date "2021-04-13" @default.
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• W3208982854 title "Sustained Efficacy of Ofatumumab in Relapsing Multiple Sclerosis Patients: Results from Extended Treatment in the Phase 2 APOLITOS Study (2032)" @default.
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