Etanercept biosimilar shows potential for the treatment of RA
medwireNews: Phase III trial results suggest that the etanercept biosimilar LBEC0101 has comparable efficacy and safety profiles to its reference product in patients with active rheumatoid arthritis (RA) despite methotrexate treatment.
Yeong Wook Song (Seoul National University Hospital, South Korea) and study authors found that the 187 Japanese and Korean patients who were randomly assigned to receive LBEC0101 and the 187 who were given etanercept experienced similar improvements in their Disease Activity Score at 28 joints based on erythrocyte sedimentation rate (DAS28-ESR) scores from baseline to week 24, with least squared mean decreases of 3.01 and 2.86 points, respectively.
The estimated between-group difference in DAS28-ESR scores was 0.15 points, and the 95% confidence intervals were within the prespecified equivalence margin, report the researchers in the Annals of the Rheumatic Diseases.
The team also found that a comparable proportion of patients in the LBEC0101 and etanercept groups achieved at least a 20% improvement in ACR criteria (ACR20) from baseline to week 24 (93.3 vs 86.7%), and more than 90% of patients in both groups had a moderate or good EULAR response at weeks 12, 24, and 52.
These findings suggest that “[t]he clinical efficacy of LBEC0101 was equivalent to that of [etanercept],” say Song and colleagues.
In all, 92.0% of patients given the biosimilar and 92.5% of their counterparts in the etanercept group experienced adverse events (AEs) from baseline to week 54, and serious AEs were reported in a corresponding 16.6% and 10.7% of participants. Song et al hypothesize that the higher incidence of serious AEs in the biosimilar group was due to “more events unrelated to the study drugs,” such as traffic accidents and falls, and note that the incidence of treatment-related serious AEs was the same in both groups, at 7.0%.
Three patients in the LBEC0101 group died, due to circulatory failure, acute heart failure, and acute respiratory distress syndrome, and one patient given etanercept died due to suicide. The researchers say that this suicide “was not considered related to the study drug,” but that a causal relationship between treatment and the three deaths in the LBEC0101 group “could not be ruled out.”
Overall, “LBEC0101 was well tolerated with a comparable safety profile to [etanercept],” they remark.
Discussing the limitations of their study, the team cautions that “the generalisability of the findings may be limited to the Asian population and a longer term study is warranted.”
However, they believe that given the high degree of similarity between the two drugs, the effects of LBEC0101 treatment are “likely to be insensitive to both intrinsic and extrinsic ethnic factors.”
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