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Masitinib in the treatment of active rheumatoid arthritis: Results of a multicentre, open-label, dose-ranging, phase 2a study
Arthritis Research & Therapy, 06/25/09

Tebib J et al. – Study reports that treatment with masitinib (AB1010; a potent and selective protein tyrosine kinase inhibitor of c-KIT) improved DMARD-refractory active rheumatoid arthritis (RA). Following an initial high incidence of mostly mild to moderate side effects during the first 12 weeks of treatment, masitinib appears to be generally well tolerated. This, together with a sustainable efficacy response, suggests that masitinib is suitable for long-term treatment regimens.

• An evaluation of safety and efficacy of masitinib in the monotherapy treatment of DMARD-refractory RA
• In a dose-ranging, phase 2a trial masitinib was administered orally to 43 pts at initial randomised dosing levels of 3 and 6 mg/kg/d over a 12-wk period
• Dose adjustment was permitted based upon tolerability and response criteria
• Efficacy was assessed via:
  • ACR 20%/50%/70% improvement criteria (ACR20/50/70) responses
  • Disease activity score using 28 joint counts (DAS28)
  • Index of improvement in RA (ACRn), and
  • C-reactive protein (CRP) improvement
    
    relative to baseline at week 12

• Improvement was observed in all efficacy endpoints, including ACR20/50/70 scores of 54%, 26% and 8%, respectively
• Reduction in CRP level by >50% for half the population
• This improvement was sustainable throughout an extension phase (>84 wks) and was also independent of initial DMARD resistance
• Incidence of AEs was high (95%), although the majority were of mild or moderate severity
• AEs declined in frequency observed after 12 wks of treatment
• 2 nonfatal serious AEs were reported
• An initial dosing level of 6.0 mg/kg/d administered orally in 2 daily intakes was the most appropriate, based upon potency and tolerability trends

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