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Hospira Shares Results From Two Open-label Extension Studies for Biosimilar Infliximab in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis
Date:10/31/2013

on ClinicalTrials.gov and can be accessed at: http://www.clinicaltrials.gov/ct2/show/NCT01220518?term=ct-p13&rank=3

Definitions

  • ASAS: Assessment in Ankylosing Spondylitis
  • ASAS 20: An improvement of > 20% and absolute improvement of > 1 units on a 0–10 scale from baseline in > 3 of the following 4 domains:
    • Patient global assessment (by VAS global assessment)
    • Pain assessment (the average of VAS total and nocturnal pain scores)
    • Function (represented by BASFI)
    • Inflammation (the average of the BASDAI's last two VAS concerning morning stiffness intensity and duration)
  • ASDAS: Ankylosing Spondylitis Disease Activity Score
  • ASDAS-CRP: Ankylosing Spondylitis Disease Activity Score-C-Reactive Protein
  • DAS 28-CRP: Disease Activity Score 28-C-Reactive Protein
  • DAS 28-ESR: Disease Activity Score 28- Erythrocyte Sedimentation Rate
  • EULAR-CRP: The European League Against Rheumatism-C-Reactive Protein
  • EULAR-ESR: The European League Against Rheumatism- Erythrocyte Sedimentation Rate

About Hospira Biosimilars
Hospira has many years of experience in the field of biologics and one of the largest biosimilar pipelines in the industry. It is the only U.S.-based company with biosimilars on the European market, including Retacrit™ (epoetin zeta) which was launched in Europe in early 2008 and Nivestim™ (filgrastim), which entered the European market in 2010 and Australian market in 2011.

About Inflectra
Inflectra (infliximab) is a chimeric human‑murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF alpha but not to lymphotoxin alpha (TNF beta). Inflectra is the
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SOURCE Hospira, Inc.
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