Wednesday, June 11, 2014

Ahead of tomorrow's oral presentation at EULAR, BMS has announced data from AVERT, its Phase 3b study of Orencia (abatacept)/MTX in early RA

Ahead of tomorrow's oral presentation at EULAR, BMS has announced data from AVERT, its Phase 3b study of Orencia (abatacept)/MTX in early RA [link]
  • 351 patients with RA for 2yrs, anti-ccp positive and DAS28 CRP>3.2 were randomized to receive MTX, Orencia (abatacept; 125mg qw) or a combination of the two treatments
  • Patients were naive to biologics and MTX
  • DAS28 CRP remission at 12mo was improved from 45% with MTX alone to 61% with an MTX/Orencia combo
  • MRI reported progression (synovitis, osteitis and joint erosion) was also improved with the combination therapy
  • Maintenance of remission over 6mo following the withdrawal of all RA drug therapies (co-primary endpoint) was also higher in patients previously receiving Orencia/MTX (15% vs 8% with MTX alone)
Comments:  Further details will be reported on tomorrow however a number of questions spring to mind.  In particular, what is the mean time to loss of response and are there any biomarkers/baseline characteristics that predict loss of response?  In particular if remission is maintained for a period that is considerably longer than 1wk, maintenance with less frequent Orencia (including the possibility of biomarker tailored injection frequency) may offer potential for future study 

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