Wednesday, June 18, 2014

UpdatesPlus- EULAR 2014 - Achieving new PsA "minimal disease activity"target with Simponi is associated with considerable improvement in disability and joint progression

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

  • Simponi approval for SpA was supported by GO-REVEAL.  This study compared 50mg or 100mg to placebo
  • The co-primary endpoints were ACR20 at 14wks and radiographic progression at 24wks.  Thereafter, patients in the placebo arm were allowed to cross over Simponi (50mg)
  • 5yr data were published May 2014 reporting good patient retention (66%) and durable efficacy ACR20 (primary endpoint measure was 63-70% at 5yrs (data are imputed)
  • PASI 75 rates were 60-70%
  • Further data reported this morning described the impact of persistent minimal disease activity (MDA) on outcomes.  The definition of MDA has recently been reported
  • 50% patients achieved MDA (albeit after approximately 3 years).  Patients achieving MDA displayed much improved disability score (HAQ data - top left panel in the figure below), and improved radiographic progression (top right).  Joint structure improvement was optimized with the inclusion of MTX
  • Achieving MDA confered minimal benefit on PASI score

Comments:  This study not only adds further weight to the potential benefits of Simponi but it also offers a validation of the recently agreed MDA definition.  The benefit in terms of joint improvement achieved with MDA supports the use of this target as a treatment goal


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