Infliximab Biosimilar Performs Well in Phase III Trial

A Phase III study comparing an infliximab biosimilar to Remicade for rheumatoid arthritis patients, found similar outcomes among the two treatments. The findings appear in the Sept. 11 issue of the Annals of Rheumatic Diseases. Not all rheumatoid arthritis patients respond to disease modifying antirheumatic drugs (DMARDs), such as methotrexate, which is usually the first line of defense after a rheumatoid arthritis diagnosis. Biological treatments, including tumor necrosis factor (TNF) inhibitors, are an alternative and for some rheumatoid arthritis patients, have produced positive results. In this study, researchers compared the effects of SB2, an infliximab biosimilar, to the infliximab reference product (INF). The study, which was conducted by Josef S. Smolen of the University of Vienna and funded by Samsung Bioepis Co., enrolled 584 subjects of which 290 were assigned SB2 and 293 were assigned INF in the randomized, double-blind phase III study. Patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomized in a 1:1 ratio to receive either SB2 or INF of 3 mg/kg. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30. At 30 weeks, researchers found equivalent outcomes in 64.1% of SB2 as compared to 66.0% of patients receiving INF.  The adjusted rate difference was −1.88% (95% CI −10.26% to 6.51%), which was within the predefined equivalence margin. Other efficacy outcomes such as ACR50/70, disease activity score measured by 28 joints and European League against Rheumatism response were similar between SB2 and INF.  The incidence of treatment-emergent adverse events was comparable (57.6% in SB2 vs 58.0% in INF) as well as the incidence of antidrug antibodies (ADA) to infliximab up to week 30 (55.1% in SB2 vs 49.7% in INF). The PK profile was similar between SB2 and INF.  In terms of adverse events, 499 treatment emergent AEs (TEAEs) occurred in 167 patients (57.6%) in the SB2 treatment group. In the INF group, 529 TEAEs occurred in 170 patients (58.0%). The most common TEAEs that occurred were latent TB, increased alanine aminotransferase levels and headache. Most of the TEAEs were mild to moderate in severity.

Disclosures:

This study was funded by Samsung Bioepis Co., Ltd.

References:

Choe JY, Prodanovic N, et. al.

A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite 

methotrexate therapy.Annals of Rheumatic Diseases.

Sept. 11, 2015. doi:10.1136/annrheumdis-2015-207764