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Study of Remsima/Inflectra (Hospira) shows equivalence to Remicade in RA

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Last updated:2nd Nov 2013
Published:2nd Nov 2013
Source: Pharmawand

Results of an open-label extension study of Remsima/Inflectra (infliximab-biosimilar), from Hospira, in patients with Rheumatoid Arthritis, were presented at the 2013 American College of Rheumatology meeting. In the 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.

PLANETRA was a prospective, randomized, double-blind, multicenter, parallel-group, Phase III trial that evaluated Remsima/Inflectra (infliximab-biosimilar) relative to the Remicade (infliximab) reference product in 606 patients with active Rheumatoid Arthritis who were not receiving adequate response to methotrexate alone over at least 3 months.

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