Pharmacokinetic/pharmacodynamic (PK/PD) differentiation of native and PEGylated recombinant human growth hormone (rhGH and PEG-rhGH) in the rat model of osteoarthritis

Xenobiotica. 2010 Aug;40(8):586-92. doi: 10.3109/00498254.2010.488303.

Abstract

Osteoarthritis (OA) is a degenerative joint disease that has no FDA-approved treatment. The current standard of care does not address the regeneration of the damaged cartilage. Human growth hormone (hGH) is part of the insulin-like growth factor (IGF)-1 axis. There has been preclinical data that suggest its potential regenerative property in the joint. However, unformulated recombinant hGH (rhGH) is short-lived in the joint, and does not provide a desirable pharmacokinetic (PK) profile to support a clinical treatment paradigm. Polyethylene glycol (PEG)ylation is a potential method to extend the half-life of rhGH in the joint. The purpose of this study was to delineate the PK/PD profile of PEG-rhGH in the knee joint in a rat preclinical model of OA. After intra-articular (IA) injection of 100 microg into a rat knee joint that underwent medial meniscectomy, PEG-rhGH exhibits 2-fold longer half-lives in joint than native hGH. However, PEG-rhGH has a much longer systemic exposure. IA injections of PEG-rhGH also resulted in higher levels of IGF-1 in the joint and serum when compared with native rhGH. In order to develop PEG-rhGH as an IA therapeutic treatment for OA, careful dose selection is necessary to avoid systemic effects while retaining its anabolic efficacy in the joint.

MeSH terms

  • Animals
  • Disease Models, Animal
  • Half-Life
  • Human Growth Hormone / analogs & derivatives*
  • Human Growth Hormone / pharmacokinetics*
  • Male
  • Osteoarthritis / drug therapy
  • Osteoarthritis / metabolism*
  • Polyethylene Glycols / chemistry
  • Polyethylene Glycols / pharmacokinetics*
  • Rats
  • Rats, Sprague-Dawley
  • Recombinant Proteins / pharmacokinetics*

Substances

  • Recombinant Proteins
  • Human Growth Hormone
  • Polyethylene Glycols