European Public Assessment Report för ORENCIA® (abatacept)

När ett läkemedel blivit godkänt för försäljning så publicerar den europeiska läkemedelsmyndigheten, European Medicines Agency (EMA), ett utredningsprotokoll kallat European Public Assessment Report (EPAR).

Det finns tre centrala slutsatser i utredningsprotokollet för ORENCIA® (abatacept):

  • Abatacept short-term efficacy seems to be similar to other biologics
  • Abatacept demonstrated favourable maintenance of long-term efficacy due to higher retention rates
  • Abatacept has a lower occurrence of serious or other infections than anti-TNF agents and rituximab

Vill du läsa utredningsprotokollet i sin helhet så kan du ladda ner det i PDF-format från European Medicines Agency.


Key Facts on ORENCIA®(abatacept) - Extracts from the Scientific Discussion for ORENCIA®, Variation Assessment
Report as adopted by the CHMP London, 21 May 2010 - EMA/361627/2010

Efficacy data from the AMPLE study

The AMPLE study is the first head-to-head phase III study powered to compare ORENCIA®(abatacept) with adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis. The primary endpoint was at 1 year but the blinded study continued for 2 years to provide controlled, comparative assessment of long term safety, efficacy and radiographic outcomes. (1)

Results from the first year of the study revealed comparable onset of action, magnitude of efficacy and similar inhibition of radiographic damage progression between ORENCIA®and adalimumab. At year 2, the efficacy outcomes, including radiographic, remained comparable between the groups and with year 1 results. (1)

Read more about the efficacy data from the AMPLE study.


  1. Schiff M et al. Ann Rehum Dis. 2014;73:86-94.