Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing

@inproceedings{Schoergenhofer2017SingleVL,
  title={Single, very low rituximab doses in healthy volunteers - a pilot and a randomized trial: implications for dosing and biosimilarity testing},
  author={Christian Schoergenhofer and Michael Schwameis and Christa Firbas and Johann Bartko and Ulla Derhaschnig and Robert M Mader and Raute Sunder Pla\ssmann and Petra Jilma-Stohlawetz and Kalpna Desai and Priya Misra and Ulrich Jaeger and Bernd Jilma},
  booktitle={Scientific Reports},
  year={2017}
}
There are no  dose-finding trials available for rituximab that could guide dosing in non-malignant diseases. We hypothesized that currently used doses (≥375 mg/m2) exceed several hundred-fold the half-maximal effective dose, which is most sensitive for detecting putative differences between biosimilars and important for dose finding. In an open label, exploratory trial healthy volunteers received single infusions of rituximab at doses of 0.1, 0.3 or 1.0 mg/m2. Subsequently, in a double-blind… CONTINUE READING
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A phase I pharmacokinetics trial comparing PF - 05280586 ( a potential biosimilar ) and rituximab in patients with active rheumatoid arthritis

  • S. Cohen
  • Br J Clin Pharmacol
  • 2016

Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial

  • D Porter
  • Lancet
  • 2016

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