Etanercept biosimilar LBEC0101 had a similar clinical efficacy and tolerability profile to etanercept reference product (ETN-RP) in patients with rheumatoid arthritis (RA) who did not benefit from methotrexate, according to a study published in the Annals of the Rheumatic Diseases.
In this phase 3, double-blind study conducted in Japan and Korea, investigators evaluated a total of 374 patients who were randomly assigned to receive either LBEC0101 (n=187) or ETN-RP (n=187). Researchers sought to determine the difference between the 2 therapies with regard to participants’ change in disease activity score in 28 joints (DAS28) from baseline to 24 weeks, as determined by the erythrocyte sedimentation rate (ESR). Final follow-up was at 54 weeks.
The average least squares change in DAS28-ESR from baseline to 24 weeks was -3.01 (95% CI, -3.198 to -2.820) and -2.86 (95% CI, -3.051 to -2.667) in the LBEC0101 and ETN-RP group, respectively. The between-group difference was -0.15 (95% CI, -0.377 to 0.078), falling within the study’s pre-specified equivalence margin of -0.6 to 0.6, thereby demonstrating similar clinical efficacy in the 2 groups.
A 20% improvement in arthritis as assessed by the American College of Rheumatology 20% (ACR20) at 24 weeks was found to be slightly higher in the LBEC0101 vs the ETN-RP arm (93.3% vs 86.7%, respectively). The investigators also found that only 1.6% of patients receiving LBEC0101 developed antidrug antibodies vs 9.6% of patients receiving ETN-RP. Overall, adverse events were similar in both the LBEC0101 and ETN-RP groups (92.0% and 92.5%, respectively).
Participants in this trial were predominantly of Asian descent, and findings generated from the research may not be applicable to other demographic groups. In addition, a longer-term follow-up period than that presented in this study is warranted to provide greater efficacy and safety conclusions associated with these 2 therapeutic options.
The investigators note that the ACR20 response rates seen in this study were higher than those observed in previous ETN-RP trials, possibly due to previous investigators’ and participants’ knowledge “that the active drug was used in both groups, and therefore expected the study drugs to be effective.”
Matsuno H, Tomomitsu M, Hagino A, Shin S, Lee J, Song YW. Phase III, multicentre, double-blind, randomised, parallel-group study to evaluate the similarities between LBEC0101 and etanercept reference product in terms of efficacy and safety in patients with active rheumatoid arthritis inadequately responding to methotrexate [published online December 19, 2017]. Ann Rheum Dis. doi:10.1136/annrheumdis-2017-212172