Study Evaluated Efficacy and Safety of ABP 710 Compared With Infliximab in Patients With Moderate-to-Severe Rheumatoid Arthritis
Amgen to Seek Regulatory Approvals
THOUSAND OAKS, Calif. /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE® (infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary efficacy endpoint, which compared the response difference measured by 20 percent or greater improvement defined by the American College of Rheumatology (ACR) Criteria, ACR20, at week 22. Key secondary endpoints included ACR50, ACR70 and Disease Activity Score 28-joint count C reactive protein (DAS28-CRP).
The primary endpoint of ACR20 had a prespecified equivalence margin of +/- 15 percent, and the observed upper end of the confidence interval was 15.96 percent. ACR50 and ACR70 trended in the same direction as ACR20. Notably, the DAS28-CRP difference in mean change from baseline was close to zero (-0.01 [-0.20, 0.17]). Overall, the safety profile and immunogenicity were comparable between ABP 710 and infliximab.
"We believe this study confirms no clinically meaningful differences between ABP 710 and infliximab," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we've generated supports ABP 710 as highly similar to the reference product."
ABP 710 is being developed as a biosimilar to infliximab, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, which is approved in many regions for the treatment of moderate-to-severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate-to-severe Crohn's disease, moderate-to-severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.
Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the United States (U.S.) and three that are approved in the European Union (EU).
About the Study Design
The above referenced Phase 3 study was a randomized, double-blind trial (study number NCT02937701) that evaluated the efficacy and safety of ABP 710 compared to infliximab in patients with moderate-to-severe rheumatoid arthritis. There were 558 patients enrolled and randomized (1:1) to receive either ABP 710 or infliximab at a dose of 3 mg/kg administered as an infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter. Among them, 279 patients were randomized to the ABP 710 group and 279 patients were randomized to the infliximab group. The primary endpoint was assessment of ACR20 at week 22. Key secondary endpoints included ACR50, ACR70 and the DAS28-CRP.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease of unknown etiology that affects approximately one percent of the adult population worldwide.1 RA can cause pain, stiffness, swelling and limitations in the motion and function of multiple joints.2 In RA, joint damage can significantly worsen over time, especially if left untreated and may impair function.3
About ABP 710
ABP 710 is being developed as a biosimilar candidate for infliximab, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, which is approved in U.S., EU and other regions for the treatment of conditions including moderate-to-severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate-to-severe Crohn's disease, moderate-to-severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis. The active ingredient of ABP 710 is an anti-TNF monoclonal antibody that has the same amino acid sequence as infliximab. ABP 710 has the same pharmaceutical dosage form and strength as infliximab.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen's experience in the development and manufacturing of innovative human therapeutics to expand Amgen's reach to patients with serious illnesses. Biosimilars will help to maintain Amgen's commitment to connect patients with vital medicines, and Amgen is well positioned to leverage its four decades of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.
Forward Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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CONTACT: Amgen, Thousand Oaks
Kelley Davenport, 202-585-9637 (media)
Kristen Davis, 805-447-3008 (media)
Arvind Sood, 805-447-1060 (investors)
References:
- Gibofsky A. Overview of Epidemiology, Pathophysiology, and Diagnosis of Rheumatoid Arthritis. Am J Manag Care. 2012;18:S295-S302.
- Arthritis Foundation. Rheumatoid arthritis symptoms. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/symptoms.php. Accessed June 6, 2018.
- Arthritis Foundation. Joint deformities in rheumatoid arthritis. http://www.arthritis.org/about-arthritis/types/rheumatoid-arthritis/articles/ra-deformities.php. Accessed June 6, 2018.
