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Safety profile of Remsima biosimilar appears to be similar to Remicade in patients with RA, AS

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A safety profile consistent with that of the historical safety data of Remicade was observed among patients with rheumatoid arthritis and ankylosing spondylitis treated with the Remicade biosimilar, Remsima, according to analysis results.

Researchers conducted a meta-analysis of clinical trials with 1,454 patients with rheumatoid arthritis (RA) or ankylosing spondylitis (AS) who were treated with Remicade (infliximab, Janssen) or Remsima (CT-P13, Celltrion). Eight of 660 random clinical trials in RA and six of 52 trials in AS were selected for analysis.

In the combined studies, 42.4% of patients treated with CT-P13 developed an infection, and serious infections were observed in 3.6% of patients; these data were in line with historical studies of infliximab, according to the researchers. Incidences of infection occurred 40.2 times during the course of 100 patient-years among patients with RA or AS who received CT-P13 compared with 75.6 incidences per 100 patient-years among patients with RA or AS treated with infliximab, based on historical data.

Serious infections occurred 3.4 times per 100 patient-years with CT-P13 compared with 4.8 times with patients who received infliximab, and malignancies or lymphoma occurred 0.4 times with CT-P13 per 100 patient-years compared with 0.5 occurrences per 100 patient-years with infliximab.

The researchers also found infusion-related reactions occurred 8.7 times per 10 patient-years compared with 23.3 occurrences per 100 patient-years in patients who received infliximab. - by Shirley Pulawski

Reference:

Park W, et al. Paper #AB0433. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosures: Park is a consultant and speaker for Celltrion and has received grants or research support from Celltrion. Please see the full study for a list of all other authors’ relevant financial disclosures.