June 27, 2009 A clinical trial of masitinib, a drug in development for the treatment of rheumatoid arthritis, has shown it to be well tolerated and effective. Researchers writing in BioMed Central's open access journal Arthritis Research and Therapy have shown that treatment with masitinib significantly reduced the severity of active arthritis.
Olivier Hermine worked with researchers from several French hospitals to carry out this trial in 43 patients with arthritis resistant to current treatments. He said, "In choosing which interventions to use for the management of rheumatoid arthritis, it is important to recognise that treatment should aim to keep the disease in remission and not be used intermittently to manage exacerbations. We are encouraged from this study that masitinib not only appears to be effective, but that within the first 3 months of treatment the worst of its side-effects were over, possibly making it suitable for long-term treatment regimens". He adds, "The results of this study also help establish the critical role of mast cells in the pathogenesis of rheumatoid arthritis and demonstrate their viability as a therapeutic target. There is sufficient compelling evidence to warrant further placebo-controlled investigation".
Masitinib inhibits the activity of mast cells, a component of the immune system thought to be involved in the pathogenesis of rheumatoid arthritis. The clinical improvement described in the study was supported by laboratory evidence of reduced inflammation. The authors found that adverse effects of the treatment were mainly mild to moderate.
Alain Moussy from AB Science, a pharmaceutical company who are developing masitinib for multiple indications in human and animal medicine said, "This is a milestone article for us, being the first publication of masitinib in a human study". Speaking about the drug, Alain Moussy said, "Our preclinical studies have shown that masitinib selectively targets cell receptors known to be involved in various disease processes but does not affect those associated with toxicity, particularly cardiotoxicity".
Rheumatoid arthritis is a chronic autoimmune condition which causes systemic inflammation, particularly affecting the joints. The ultimate cause remains unknown. The disease affects women more often than men and the prevalence rated is estimated to be 1%.
Masitinib is already approved by EMEA and under registration review with FDA for canine mast cell tumours (trade name Masivet®). The drug is also in numerous phase II/III clinical trials, including further arthritis related studies, which are intended to fully exploit its potential therapeutic benefits over a wide range of cancers, inflammatory diseases, and neurological indications.
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- Jacques Tebib, Xavier Mariette, Pierre Bourgeois, René-Marc Flipo, Philippe Gaudin, Xavier Le Loët, Paul Gineste, Laurent Guy, Colin D Mansfield, Alain Moussy, Patrice Dubreuil, Olivier Hermine and Jean Sibilia. Masitinib in the treatment of active rheumatoid arthritis: results of a multicentre, open-label, dose-ranging, phase 2a study. Arthritis Research & Therapy, (in press) [link]
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