Remsima extension study demonstrate long term efficacy and safety over 2 years

June 12, 2014 9:10 AM

Results presented yesterday at the Celltrion Healthcare satellite symposium during EULAR 2014 confirm that patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) benefit from taking the newly licensed infliximab Remsima for up to two years.

In addition, the open-label studies reported by Professor Dae Hyun Yoo (Hanyang University Hospital for Rheumatic Diseases, Republic of Korea) demonstrate that those patients who switched from the originator therapy after 12 months, experienced comparable treatment benefits for a further year.

The studies were designed to evaluate efficacy and safety over 12 months following on from PLANETRA2 and PLANETAS3 (Remsima marketing approval studies), for a total of 24 months. This enabled investigators to compare the benefits for RA and AS patients maintained on Remsima and those switched from the originator drug. The study in RA, led by Professor Yoo, carried on from PLANETRA. It included a total of 302 patients in the maintenance arm and 144 who switched to Remsima . All patients gave informed consent and were treated every eight weeks. They also received methotrexate and folic acid.

For people with AS included in the study following on from PLANETAS, 88 patients continued with Remsima  and 86 switched from the originator drug. This study was directed by Professor Won Park (Inha University Hospital, Republic of Korea).

Mr. Seung Heon Nam, President, Celltrion Healthcare, commented: “Infliximab is a cornerstone in the treatment of severe RA and AS, and the results of the new extension studies demonstrate that Remsima is equally beneficial in disease control with no increase in adverse events. It also has the potential to increase the cost effectiveness of biologic treatments in arthritis and other serious autoimmune diseases where infliximab is indicated.”

Professor Tore Kvien (Diakonhjemmet Hospital, Norway) discussed how economic circumstances in different areas of Europe are related to access to effective biologic agents and that lower cost can be expected to benefit more people in Europe. He further highlighted that a key question is whether patients on stable treatment on Remicade can switch to a lower cost biosimilar such as Remsima. Further data to address this issue will be provided through the NOR-SWITCH study, a government-financed study. The first patient recruited will probably be early October 2014, and results after one-year follow up can be expected in 2016. The study includes patients with all relevant indications and has a generic primary endpoint (disease worsening according to disease-specific criteria).

The secondary end points are to compare the safety and patient outcomes. The study may also provide data on the cost effectiveness of the two treatments.

Professor Maurizio Cutolo, University of Genova, Chairman of the Symposium highlighted the European Medicine Agency’s role in ensuring the highest standards of quality and safety when approving a newly licensed infliximab compared with the originator product.

“The approval process for a newly licensed infliximab is critical and stringent, and no step in this process is automatic nor without scientific assessment by experts from regulatory authorities.

“In 2013, EULAR updated the RA guidelines to include biosimilar products as treatment options for patients requiring biologic treatment.”

Summing up President Nam said: “We are entering an exciting era for patients with RA, AS and other autoimmune conditions. The availability of the newly licensed infliximab, Remsima, has the potential to increase the availability of cost-effective medicines of quality such as biologics, which can improve accessibility and result in more treatment options and better outcomes for patients.”


Source: Celltrion press release

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