Researchers Present Real-World Data on Biosimilar Infliximab Agents at APLAR-ARA

This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.

First, a team of researchers will present data on long-term drug survival and safety of CT-P13 (Celltrion’s Inflectra, Remsima) in Korean patients with rheumatoid arthritis (RA).¹

The researchers derived data from the Korean College of Rheumatology’s biologics registry (KOBIO). Patients who received reference infliximab or CT-P13 between 2012 and 2018 were included. In total, 199 patients (147 of whom took the biosimilar and 52 of whom took the reference product) were included.

The drug retention rates of the biosimilar and reference were comparable (P = .8382), as were the retention rates of patients using infliximab in the first line or second line or greater.

The reasons given for discontinuation of either product were inefficacy (31.8% for CT-P13 versus 34.8% for the reference), adverse events (AEs) (20.0% for CT-P13 versus 23.9% for the reference), clinical improvement (3.0% for CT-P13 versus 4.3% for the reference), and others (10.4% for CT-P13 versus 4.3% for the reference).

The incidence of AEs that led to discontinuation in the reference group was comparable to that seen in the reference group; the most common AEs that led to discontinuation were infusion-related reactions (10.2%).

The authors concluded that the study showed that the drug retention rate between the biosimilar and the reference was similar, and that the biosimilar showed a “reasonable long-term safety profile” that was comparable to the reference.

A second research team will discuss experience with BOW015, a product that was developed by the now-defunct drug maker Epirus; the product was launched as a biosimilar in India by Ranbaxy Laboratories under the trade name Infimab.

Given a lack of data on BOW015, a pan-India registry was instituted to assess real-world safety and efficacy of the biosimilar. The researchers analyzed subgroup data for patients with ankylosing spondylitis (AS) who derived from the east India cohort.²

Patients with AS who had 4 to 6 months of follow-up data over the past 1 year (n = 149) were included in the study. Clinical improvement was measured by a change in AS disease activity score, with a change greater than 2 points from baseline during follow up being defined as major clinical improvement.

In total, 61.1% of patients had 4 doses of the drug, 6.7% had 3 doses, 24.8% had 2 doses, and 7.4% had 1 dose. Among the 81 patients with evaluable data, 91% had “major improvement,” 6% had “clinically important improvement,” and 3% did not respond adequately.

The researchers concluded that the biosimilar resulted in significant improvement in patients with AS.

References

1. Shin K, Kim HA, Lee E, et al. Retention and safety of biosimilar CT-P13 in patients with rheumatoid arthritis: data from the Korean College of Rheumatology Biologics Registry. Presented at the 21st Asia Pacific League of Associations for Rheumatology Congress; April 8-11, 2019; Brisbane, Australia. Abstract 3-073.

2. Mohammed S, Parida JR. Real world experience with infliximab biosimilar (BOW015) in ankylosing spondylitis—a sub-group analysis of the East India cohort. Presented at the 21st Asia Pacific League of Associations for Rheumatology Congress; April 8-11, 2019; Brisbane, Australia. Abstract 1-120.