Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study

Tomomi Tsuru, Yoshiya Tanaka, Mitsumasa Kishimoto, Kazuyoshi Saito, Seiji Yoshizawa, Yoshinari Takasaki, Tomoya Miyamura, Hiroaki Niiro, Shinji Morimoto, Junichi Yamamoto, Rocio Lledo-Garcia, Jing Shao, Shuichiro Tatematsu, Osamu Togo, Takao Koike

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Objectives: This 12-week, randomized, double-blind, placebo-controlled, multicenter phase 1/2 study (NCT01449071) assessed the safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus despite standard of care.Methods: Twenty patients were randomized 1:1:1:1:1 to placebo or one of four epratuzumab dose regimens (100 mg every other week [Q2W], 400 mg Q2W, 600 mg every week [QW], or 1200 mg Q2W) administered during an initial 4-week dosing period. Adverse events (AEs), pharmacokinetics and pharmacodynamics were assessed.Results: Nineteen of 20 patients completed the study. All placebo patients and 13 of 16 epratuzumab patients reported ≥1 AE, 2 of 16 epratuzumab patients reported a serious AE. Cmax and AUCτ increased proportionally with dose after first and last infusion, t1/2 was similar across groups (∼13 days). Epratuzumab treatment was associated with decreased CD22 mean fluorescence intensity in total B cells (CD19 + CD22 + ) and unswitched memory B cells (CD19 + IgD + CD27 + ). Small-to-moderate decreases were observed in total B cell (CD20 + ) count.Conclusions: Epratuzumab was well-tolerated, with no new safety signals identified. The pharmacokinetics appeared linear after first and last infusions. Treatment with epratuzumab was associated with CD22 downregulation and with small-to-moderate decreases in total B cell count.

元の言語英語
ページ(範囲)87-93
ページ数7
ジャーナルModern Rheumatology
26
発行部数1
DOI
出版物ステータス出版済み - 1 2 2016

All Science Journal Classification (ASJC) codes

  • Rheumatology

フィンガープリント Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study' の研究トピックを掘り下げます。これらはともに一意のフィンガープリントを構成します。

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    Tsuru, T., Tanaka, Y., Kishimoto, M., Saito, K., Yoshizawa, S., Takasaki, Y., Miyamura, T., Niiro, H., Morimoto, S., Yamamoto, J., Lledo-Garcia, R., Shao, J., Tatematsu, S., Togo, O., & Koike, T. (2016). Safety, pharmacokinetics, and pharmacodynamics of epratuzumab in Japanese patients with moderate-to-severe systemic lupus erythematosus: Results from a phase 1/2 randomized study. Modern Rheumatology, 26(1), 87-93. https://doi.org/10.3109/14397595.2015.1079292