Wednesday, June 18, 2014

UpdatesPlus - EULAR - PRIZE data suggests Enbrel dose reduction may be feasible in patients with early RA who achieve rapid remission with Enbrel/MTX

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

  • In a previous EULAR alert we highlighted data from early RA study, AVERT
  • In this study an MTX/Orencia combo produced DAS28 CRP remission at 12mo in 61% patients.  Remission was subsequently lost over 6 months following withdrawal of all RA drugs in 85% of these patients
  • Data from PRIZE, a second early RA study were also reported last week at EULAR
  • The study was designed to investigate tapered withdrawal of treatment from patients achieving remission with Enbrel/MTX in an initial open label period (study design is shown bleow left)
  • Patients who were DAS28-ESR responders (39wks) and remitters (52wks) were then randomized to reduced dose (25mg qw) Enbrel/MTX, MTX alone or drug withdrawal.  All treatment was withdrawn from patients with continued remission at 91wks
  • Previously reported data include:
    • 65% of patients were in remission after 52wks (ACR 2012)
    • 64% patients in remission at 52wks remained in remission
  • Data were reported on Thursday on predictors of sustained remission.  Of interest there were no baseline predictors however delayed DAS28 remission during the initial period of treatment was a significant predictor of reduced sustained remission.  Indeed 80% patients who achieved remission within 6mo achieved sustained remission after being switched to low dose Enbrel plus MTX

The present data suggests that reducing Enbrel dose may offer a realistic approach  to those patients who enter remission early with full dose Enbrel.  This could introduce a significant cost saving.  Further data from the third phase of PRIZE, during which treatment is withdrawn altogether is awaited.  These data will be interesting given that most patients in AVERT for whom treatment was withdrawn from patients in remission relapsed.  In the Q&A following the AVERT presentation it was suggested that less sudden drug withdrawal may be required to maintain remission.  PRIZE may support this concept should reduced Enbrel dosing as a stepping stone to withdrawal is successful


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