Anti-drug Antibodies Against a Novel Humanized Anti-CD20 Antibody Impair Its Therapeutic Effect on Primary Biliary Cholangitis in Human CD20- and FcγR-Expressing Mice.

TKM-011-treated mice also showed a trend toward decreased CD5 + CD19 + B cells in the liver and spleen (0.8471 ± 0.5212 vs. 1.853 ± 0.8007 × 10 4 /g liver, p = 0.0074; 1.204 ± 0.6144 vs. 2.102 ± 0.8967 × 10 7 /g spleen, p = 0.0431), although this did not achieve statistical significance for CD5 − CD19 + B cells (1.509 ± 0.9114 vs. 3.286 ± 2.396 × 10 5 /g liver, p = 0.0553: 1.354 ± 1.001 vs. 2.057 ± 1.188 × 10 8 /g spleen, p = 0.0878).

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The magnitude of peripheral B-cell depletion was highly significant during the middle of the treatment period but dwindled toward its end.

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