Date: 2015-06-10
Type of
information: Presentation of results at a congress
phase: post-marketing
Announcement: presentation of results at the European League Against Rheumatism Annual Congress (EULAR 2015)
Company: Hospira (USA - IL)
Product: Inflectra™/Remsima™ (infliximab)
Action
mechanism:
- biosimilar product. Inflectra® (infliximab) is a biosimilar medicine to the reference medicinal product, Remicade® (infliximab), and is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway. Inflectra® specifically targets tumour necrosis factor (TNF) alpha.
Disease: inflammatory conditions including rheumatoid arthritis, ankylosing spondylitis, Crohn\'s disease, ulcerative colitis, psoriatic arthritis, psoriasis, rheumatoid arthritis
Therapeutic
area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details:
Latest
news:
- • On June 10, 2015, Hospira, a global leader in biosimilars, announced the results of an independent clinical study, showing patients with rheumatic diseases experienced comparable clinical effectiveness and safety after switching from Remicade™ to Inflectra. The study entitled, "Clinical experience with infliximab biosimilar – switch from Remicade™. Abstract SAT0174," supports the use of Inflectra™, the first biosimilar monoclonal antibody approved in the EU, as a treatment option for people suffering from inflammatory conditions such as rheumatoid arthritis, who are currently receiving stable treatment with reference infliximab. The data, presented at the European League Against Rheumatism Annual Congress (EULAR 2015), compared outcomes in 39 patients after a mean of four years of treatment with Remicade®, with the outcomes of those same patients after a median of 11 months following a switch to Inflectra™. Patient symptoms and disease activity were similar before and after the switch between the two treatments, and no immediate safety signals were observed.
- In addition, the results of a meta-analysis of 14 randomised controlled trials assessing safety incidences in 1,454 patients were announced at EULAR. The abstract is titled, \"Meta-analysis of the safety data between infliximab biosimilar (CT-P13) and innovator infliximab in rheumatoid arthritis and ankylosing spondylitis. Abstract AB0433.\" This analysis compared the safety profile of Inflectra from clinical trials in RA and AS, with historical safety data from Remicade clinical trials. The results revealed no meaningful differences in safety (infections, serious infections, malignancies/lymphoma, infusion-related reactions) between patients treated with Inflectra and Remicade.
Is
general: Yes
