Researchers Report on Infliximab Biosimilars BCD-055 and CT-P13

At the European League Against Rheumatism’s (EULAR) Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers reported on Biocad’s Russian-authorized biosimilar infliximab, BCD-055, and on switches to the widely approved infliximab biosimilar CT-P13 (Inflectra, Remsima).

Biocad’s infliximab biosimilar shows similar safety and efficacy to reference at week 54

Biocad’s BCD-055, an infliximab biosimilar, licensed in Russia in February 2018, is the subject of a presentation on Saturday; researchers will present the 54-week safety and efficacy results of a phase 3 clinical study, ASART-2.¹

The authors of the study, conducted in 199 patients with active ankylosing spondylitis, previously reported noninferiority of the biosimilar after 30 weeks of treatment. The 54-week data showed that the proportions of patients who achieved a 20% or 40% improvement according to the Assessment of Ankylosing Spondylitis was similar at week 54 in patients receiving the biosimilar and those receiving the reference (67.42% versus 52.24%, respectively).

Additionally, rates of adverse events (AEs) were similar: 62.12% of patients who received the biosimilar and 64.18% of those who received the reference had an AE, and 5.3% and 7.46% of patients, respectively, had a serious AE.

In Germany, patients receiving reference infliximab are more likely to continue treatment

Also being presented on Saturday is a retrospective prescription claims analysis that compared utilization patterns of reference infliximab and CT-P13 in treatment-naïve patients.²

Researchers used the QuintilesIMS database to identify 6491 patients who had a claim for either reference or biosimilar infliximab, 101 of whom switched from the reference to the biosimilar. The investigators conducted 12-month post-drug initiation and 6-month post—innovator-to-biosimilar switch retention analyses.

The investigators found that the risk-adjusted probability of treatment retention after 12 months was 23% greater in the group receiving the reference product than in the biosimilar group. The probability of continuing treatment was also greater in men, those who had not been previously exposed to other biologics, and those whose therapy had been prescribed by a rheumatologist.

In a matched, 6-month post-switch analysis that matched each patient who switched to the biosimilar with 5 patients who remained on the reference product, the risk-adjusted probability of continuing treatment was 26% greater in the reference group than the switch group, and those prescribed their therapy by a rheumatologist also had a higher probability of continuing treatment.

A study in patients with Behçet disease suggests that switching to biosimilar infliximab is safe

A recent case report, published in the European Journal of Rheumatology, suggested that switching to biosimilar infliximab in patients with Behçet disease (BD), a chronic, relapsing, systemic vasculitis, was associated with rapid loss of efficacy.

An Italian study published in conjunction with the EULAR congress sought to describe clinical experience with switching patients to CT-P13. The available data, say the study’s authors, suggest that switching to biosimilar infliximab is safe.³

The researchers retrieved data from their 3 centers on all patients with BD (n = 13). All patients were switched to the biosimilar after a median treatment period with reference infliximab of 106.92 months (±46.37 months).

At 3 months post-switch, no patients had discontinued the biosimilar, and no significant difference was noted in disease activity.

At 6 months, 2 patients had discontinued treatment, both for recurrence of mucocutaneous involvement. One of the patients who discontinued had also experienced recurrence while taking reference infliximab.

At 9 months, 2 patients were lost to follow-up, and no difference was observed in disease activity in the remaining patients. No adverse events were observed during the study period.

Though the follow-up period was short, write the authors of the Italian study, the data suggest that switching patients to the biosimilar is safe and does not compromise efficacy. These results will need to be confirmed in a larger cohort and over a longer follow-up period, they add.

Reference

1. Denisov L, Shesternya P, Plaksina T, et al. Efficacy and safety of BCD-055, proposed infliximab biosimilar, compared to infliximab: 54-week results from ASART-2 phase 3 clinical study. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract SAT0267. doi: 0.1136/annrheumdis-2018-eular.2390

2. Ewara EM, Ellis L, Goyal K, Jairath V, Marrache AM, Baraliakos X. A comparative real-world utilization patterns of innovator and biosimilar infliximab in a treatment naïve and switch population from Germany: a prescription claims analysis. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract SAT0209. doi: 10.1136/annrheumdis-2018-eular.1327.

3. Venerito V, Lopalco G, Cantarini L, et al. Switching from originator infliximab to biosimilar infliximab: efficacy and safety in a cohort of patients with established Behçet’s disease. Presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology, June 13-16, 2018; Amsterdam, Netherlands. Abstract AB0709. doi: 10.1136/annrheumdis-2018-eular.3093.