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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

LAKE FOREST, Ill., Oct. 31, 2013 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, this week shared the results of two open-label extension studies of CT-P13 (infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, which were presented at the 2013 American College of Rheumatology (ACR)/Association of Rheumatology Health Professionals (ARHP) Annual Meeting in San Diego. Hospira's CT-P13, branded as Inflectra, was approved by the European Medicines Agency (EMA) in September 2013 as a biosimilar to reference product, Remicade® (infliximab). Inflectra is not currently approved for use in the United States.

The objective of these open-label extension studies was to confirm long-term efficacy and safety of Inflectra in patients who had completed the original 54-week European Union (EU) clinical studies and to investigate switching from the reference Remicade product to Inflectra.

In one study, 302 of 455 patients with rheumatoid arthritis who completed the Phase III PLANETRA study entered into the open-label extension phase. Of these, 158 were continuously treated with Inflectra (maintenance group) and 144 were switched from Remicade to Inflectra (switch group) for one additional year.  The maintenance group and the switch group at weeks 78 and 102 were similar as measured by American College of Rheumatology (ACR) ACR20/50/70, DAS28-CRP, DAS28-ESR, EULAR-CRP, and EULAR-ESR response rates. Overall incidence of treatment-emergent adverse events (TEAE) was similar in both groups.

In the other study, 174 of 210 patients with ankylosing spondylitis who com
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SOURCE Hospira, Inc.
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