| Autor: |
Bar-Or, Amit, Wiendl, Heinz, Montalban, Xavier, Alvarez, Enrique, Davydovskaya, Maria, Delgado, Silvia R, Evdoshenko, Evgeniy P, Giedraitiene, Natasa, Gross-Paju, Katrin, Haldre, Sulev, Herrman, Craig E, Izquierdo, Guillermo, Karelis, Guntis, Leutmezer, Fritz, Mares, Miroslav, Meca-Lallana, Jose E, Mickeviciene, Dalia, Nicholas, Jacqueline, Robertson, Derrick S, Sazonov, Denis V |
| Předmět: |
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| Zdroj: |
Multiple Sclerosis Journal; May2022, Vol. 28 Issue 6, p910-924, 15p |
| Abstrakt: |
Background: Ofatumumab, the first fully human anti-CD20 monoclonal antibody, is approved in several countries for relapsing multiple sclerosis (RMS). Objective: 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. Methods: 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 (C max) for Weeks 8–12. B-cell depletion and safety/tolerability were assessed. Results: 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); C max, 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. Conclusion: Ofatumumab 20 mg q4w self-administered subcutaneously via autoinjector is bioequivalent to PFS administration and provides rapid B-cell depletion. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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