AS Infliximab Biosimilar Performs Well in Study

Researchers writing in the journal Arthritis Research & Therapy report that for patients with ankylosing spondylitis (AS), infliximab (Remicade) and the biosimilar CT-P13 (Remsima, Inflectra), have a highly comparable efficacy and safety.

Infliximab was the first TNF antagonist proven to be efficacious in patients with ankylosing spondylitis. It is widely used for this and other rheumatic diseases with positive outcomes, but it is associated with infections, tuberculosis and other side effects, and can cost as much as $20,000 per year.

Led by Jurgen Braun, M.D., of Rheumazentrum Ruhrgebiet in Herne, Germany, the new study shows that CT-P13 was well-tolerated over one year with a safety profile comparable to infliximab.[[{"type":"media","view_mode":"media_crop","fid":"45364","attributes":{"alt":"@Lightspring/Shutterstock.com","class":"media-image media-image-right","id":"media_crop_7947421183343","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5190","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.008px; line-height: 1.538em; float: right;","title":"@Lightspring/Shutterstock.com","typeof":"foaf:Image"}}]]

This was a randomized, double-blind, parallel-group study of 250 patients with active ankylosing spondylitis. Study participants received either CT-P13 (5 mg/kg) or infliximab (5 mg/kg) at baseline and weeks two, six and every eight weeks up to 54. They found that ASAS 20 response, ASAS 40 response and ASAS partial remission were comparable to treatment groups.

Most adverse events were mild or moderate, but there was no statistically significant difference in adverse events between treatment groups in term of the incidence of adverse events, serious adverse events, infections and infusion-related reactions.

“The main limitation of this analysis is that PLANETAS (study) was primarily designed to compare the pharmacokinetics profiles of CT-P13 and RP at 30 weeks. While prospectively planned, the longer-term efficacy, safety and PK data presented here are from a secondary analysis of the study,” the authors wrote.

CT-P13 is approved in Europe and elsewhere.

Biosimilars:  FDA Review and Approval in Europe

Biosimilars could offer an alternative and a less expensive option for patients, but to date, only one, a cancer drug, has been approved in the U.S. On Monday, Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted for review ABP 501, a biosimilar candidate to adalimumab (Humira, AbbVie), which reportedly shows promise for improving rheumatoid arthritis symptoms.

On Tuesday, Reuters reported that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has recommended biosimilar treatments for rheumatoid arthritis (Inflectra and Remsima), which are copies of Remicade (Merck, Johnson & Johnson). Four other drugs were also endorsed:  AbbVie's Humira, Pfizer's Enbrel, UCB's Cimzia and Bristol-Myers Squibb's Orencia.

References:

Won Park, Dae Hyun Yoo, et al. "Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study,"

Arthritis Research and Therapy.

First online: 20 January 2016 DOI 10.1186/s13075-016-0930-4