Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.
Rapid and sustained B-cell depletion with subcutaneous ofatumumab in relapsing multiple sclerosis: APLIOS, a randomized phase-2 study.
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DOI：
10.1177/13524585211044479
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发表时间：
2022-05
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影响因子：
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中科院分区：
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Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS). To demonstrate the bioequivalence of ofatumumab administered by an autoinjector versus a pre-filled syringe (PFS) and to explore the effect of ofatumumab on B-cell depletion. APLIOS (NCT03560739) is a 12-week, open-label, parallel-group, phase-2 study in patients with RMS receiving subcutaneous ofatumumab 20 mg every 4 weeks (q4w) (from Week 4, after initial doses on Days 1, 7, and 14). Patients were randomized 10:10:1:1 to autoinjector or PFS in the abdomen, or autoinjector or PFS in the thigh, respectively. Bioequivalence was determined by area under the curve (AUC τ ) and maximum plasma concentration (Cmax) for Weeks 8–12. B-cell depletion and safety/tolerability were assessed. A total of 256 patients contributed to the bioequivalence analyses (autoinjector-abdomen, n = 128; PFS-abdomen, n = 128). Abdominal ofatumumab pharmacokinetic exposure was bioequivalent for autoinjector and PFS (geometric mean AUC τ , 487.7 vs 474.1 h × µg/mL (ratio 1.03); Cmax, 1.409 vs 1.409 µg/mL (ratio 1.00)). B-cell counts (median cells/µL) depleted rapidly in all groups from 214.0 (baseline) to 2.0 (Day 14). Ofatumumab was well tolerated. Ofatumumab 20 mg q4w self-administered subcutaneously via autoinjector is bioequivalent to PFS administration and provides rapid B-cell depletion.
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影响因子：
9.9
作者：
Lublin FD;Reingold SC;Cohen JA;Cutter GR;Sørensen PS;Thompson AJ;Wolinsky JS;Balcer LJ;Banwell B;Barkhof F;Bebo B Jr;Calabresi PA;Clanet M;Comi G;Fox RJ;Freedman MS;Goodman AD;Inglese M;Kappos L;Kieseier BC;Lincoln JA;Lubetzki C;Miller AE;Montalban X;O'Connor PW;Petkau J;Pozzilli C;Rudick RA;Sormani MP;Stüve O;Waubant E;Polman CH
通讯作者：
Polman CH
影响因子：
4
作者：
Mayer, Lori;Kappos, Ludwig;Wolinsky, Jerry S.
通讯作者：
Wolinsky, Jerry S.
影响因子：
158.5
作者：
Hauser, Stephen L.;Bar-Or, Amit;Kappos, Ludwig
通讯作者：
Kappos, Ludwig
影响因子：
158.5
作者：
Hauser, S. L.;Bar-Or, A.;Kappos, L.
通讯作者：
Kappos, L.
影响因子：
11.2
作者：
Polman CH;Reingold SC;Banwell B;Clanet M;Cohen JA;Filippi M;Fujihara K;Havrdova E;Hutchinson M;Kappos L;Lublin FD;Montalban X;O'Connor P;Sandberg-Wollheim M;Thompson AJ;Waubant E;Weinshenker B;Wolinsky JS
通讯作者：
Wolinsky JS