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Adalimumab Biosimilar Showed Similar Safety, Efficacy as Reference Product in Patients With RA
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The adalimumab biosimilar ABP 501 showed similar safety, efficacy and immunogenicity as adalimumab in patients with rheumatoid arthritis, according to a recently published analysis.
“Data from this study indicate that the clinical efficacy, safety and immunogenicity of ABP 501 are similar to that of adalimumab in patients with moderate to severe [rheumatoid arthritis] RA,” Stanley Cohen, MD, from the University of Texas Southwestern Medical School, and colleagues wrote. “Additionally, analytical, biofunctional and pharmacokinetic properties of ABP 501 have previously been shown to be highly similar to those of adalimumab. Taken together, these data contribute to the totality-of-evidence-based requirements to demonstrate that ABP 501 is similar to adalimumab.”
Researchers performed a randomized controlled trial of 494 patients with RA who received either ABP 501 or 40 mg of adalimumab every 2 weeks for 26 weeks. Equivalency was defined as a 90% confidence interval risk ratio that fell between 0.738 and 1.355.
Investigators found ACR20 response at week 24 was 74.6% for ABP 501 and 72.4% for adalimumab. The risk ratio was 1.039, with a 90% confidence interval that ranged from 0.954 and 1.133, which investigators noted demonstrated equivalency. In addition, changes in DAS28-CRP and ACR50 showed equivalency; whereas, ACR70 showed similarity, but not a confidence interval that fell within the predetermined range. For the safety profile, serious adverse events occurred in 3.8% of the ABP 501 group and in 5% of the adalimumab group. In total, 38.3% of patients on ABP 501 and 38.2% of patients on adalimumab tested positive for binding antidrug antibodies. – by Will A. Offit
Disclosures: Cohen reports he received grants and personal fees from Amgen during the conduct of the study and he received grants and personal fees from AbbVie, Boehringer Ingelheim, Pfizer and Sandoz outside of the study.
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