Study Examines Effectiveness of New RA Biosimilar

The biosimilar ABP 501 is just as safe and effective as adalimumab for treating moderate to severe rheumatoid arthritis (RA), according to a recent treatment trial.

For 26 weeks, the researchers conducted a randomized, double-blind, phase III equivalence study, which included 100 medical centers in 12 countries throughout Europe, North America, and Latin America. The trial assessed 526 patients with moderate to severe RA who were refractory to methotrexate. Each patient received either 40 mg of ABP 501 or adalimumab subcutaneously on day 1 and every 2 weeks until week 22.
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A total of 494 patients completed the study and were included in analysis. About 81% of participants were female, 95% were white, and the mean age was 55.9 years.

Data from the study were analyzed through primary endpoint assessments conducted at week 24 and final safety and immunogenicity assessments conducted at week 26.

The results showed that American College of Rheumatology 20% improvement criteria (ACR20) response was 74.6% for ABP 501 and 72.4% for adalimumab at week 24. The researchers observed similar changes between the 2 groups from baseline to week 24 in Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP), American College of Rheumatology 50% improvement criteria (ACR50), and American College of Rheumatology 70% improvement criteria (ACR70).

Key safety endpoint assessments indicated that there were no significant differences in adverse events or laboratory abnormalities. Tests found binding drug antibodies in 38.3% of ABP 501 patients and 38.2% of adalimumab patients.

“Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA,” the researchers concluded.

—Christina Vogt

Reference:

Cohen S, Genovese MC, Choy E, et al. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. Published online June 5, 2017. doi:10.1136/annrheumdis-2016-210459.