Treatment of rheumatoid arthritis with PEGylated recombinant human soluble tumour necrosis factor receptor type I: a clinical update
Mark W Davisa, Ulrich Feigeb, Alison M Bendelec, Steven W Martinb, Carl K Edwards IIIda Clinical
Development, Amgen Inc, Thousand Oaks, One Amgen Center Drive, Mail
Stop 24-1-B, Thousand Oaks, California, 91320-1789, USA, b Department of Pharmacology, Amgen Inc, c Bolder Path
Inc, University of Colorado, d Research
and Development, Amgen Inc
Correspondence to: Mark W Davis (markd@amgen.com)
| The first 150 words of the full text of this article appear below. |
 |
Introduction |
|---|
A recombinant form of the high affinity, natural
inhibitor of tumour necrosis factor 
(TNF) is currently under
development for the treatment of rheumatoid arthritis
(RA).1 This molecule is referred to as
recombinant-methionyl soluble TNF-type I receptor (r-metHu-sTNF-RI or
sTNF-RI). Recombinant sTNF-RI is an Eschericia coli derived recombinant, truncated, monomeric form of the
4-domain soluble TNF-type I receptor. For optimal delivery, a high
molecular weight (30 kDa) PEG molecule is attached at the N-terminus
(met 1) position to form the molecule intended for clinical
investigations (PEG r-metHu-sTNF-RI or PEG sTNF-RI). PEG sTNF-RI, with
an approximate molecular weight of 42 kDa, has been designed for long
term chronic subcutaneous (SC) administration for the treatment of RA.
Preclinical studies to date demonstrate that PEG sTNF-RI is
efficacious in rodent2-4 and primate5 models
of acute and chronic inflammatory diseases, including
E coli induced septic shock.6
PEG sTNF-RI has demonstrated efficacy in predictive animal models of
RA at doses
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