Wednesday, June 18, 2014

UpdatesPlus - EULAR - Long term data from ORAL START reports prolonged improvement in patient reported outcomes with Xeljanz

The alert below is from our EULAR 2014 coverage.  We have captured most of the key oral and poster presentations delivered at EULAR and will be analyzing these more comprehensively in upcoming issues of our UpdatesPlus service.UpdatesPlus is a service comprising alerts and monthly reports including pipeline and trial updates plus analysis of key information.  The service is designed for industry and academics across the Immunology & Inflammation spectrum.  To register for UpdatesPlus or to get further information please contact

  • The FDA approved an sNDA in Nov 2013 resulting in the inclusion of patient-reported outcomes on the Xeljanz label
  • This approval was based on improvements in SF-36 domains at 3 months
  • Further data were reported at EULAR on 24month outcomes from ORAL Start, a Phase 3 study comparing Xeljanz to MTX in MTX-naive patients
  • The SF-36 physical component score improved rapidly with tofacitinib at either dose.  Efficacy was significantly greater than with MTX, remained so for 2 years and was considerably greater than the minimal clinically important difference  
  • Patient reported disability, pain and fatigue were also significantly improved, although improvement in the SF-36 Mental component score vs MTX was unclear

The speed and durability of PRO improvement is remarkable.  Explaining the limited improvement in physical component score is difficult but we presume that this reflects variability


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