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|Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab|
The study met the primary endpoint, which was achievement of ACR20 (20 percent or greater improvement in ACR assessment) at week 24. At week 24, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria. The risk ratio of ACR20 was 1.039 with the two-sided 90 percent CI of 0.954–1.133, which fell within the predefined equivalence margin.
"Demonstrating biosimilarity is scientifically complex, but
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe plaque psoriasis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.
Secondary endpoints included the achievement of ACR50 and ACR70 (a 50 or 70 percent improvement in ACR assessment) within the predefined equivalence margin. At week 24, patients treated with ABP 501 compared with those treated with adalimumab achieved ACR50 (49.2 percent vs. 52.0 percent) and ACR70 (26.0 percent vs. 22.9 percent), respectively. Additionally, the secondary endpoint of a difference in change from baseline of DAS28-CRP (Disease Activity Score examines 28 joints in the body as measured by C reactive protein in the blood) over the entire study was also achieved. The difference in mean change from baseline in DAS28-CRP between ABP 501 and adalimumab was –0.01 (90 percent CI, –0.18 to 0.17) at week 24.
The incidence of treatment-emergent adverse events (TEAEs) was 50 percent for ABP 501 and 55 percent for adalimumab. The most frequently reported TEAEs (for ABP 501 and adalimumab, respectively) were nasopharyngitis (6.4 percent vs. 7.3 percent), headache (4.5 percent vs. 4.2 percent), arthralgia (3.0 percent vs. 3.4 percent), cough (2.7 percent vs. 3.1 percent) and upper respiratory tract infection (1.5 percent vs. 3.8 percent). Serious adverse events (3.8 percent vs. 5.0 percent) and serious infections (0.8 percent vs. 1.1 percent) were reported in patients treated with ABP 501 and adalimumab, respectively. By the end of week 24, binding antibodies (38.3 percent vs. 38.2 percent) and neutralizing antibodies were identified (9.1 percent vs. 11.1 percent) in patients treated with ABP 501 and adalimumab, respectively.
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