Study of Remsima/Inflectra (Hospira) shows equivalence to Remicade in RA
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.
Related news and insights
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced that Health Canada has approved Ferriprox (deferiprone) for the treatment of iron overload in patients with sickle cell disease (SCD) or other anemias.
The Menarini Group and Radius Health announced positive topline results from the phase III EMERALD study evaluating RAD 1901 (elacestrant) as a monotherapy versus the standard of care (SoC) for the treatment of ER+/HER2- advanced or metastatic breast cancer (mBC).
Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.