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Efficacy When Using Biosimilar Renflexis (infliximab abda) Compared to Biologic Remicade (infliximab) Indicated for Treatment of Patients Diagnosed with Rheumatoid Arthritis and Spondyloarthritis.

Silversteyn, Laura
http://orcid.org/0000-0001-8547-4341
http://rave.ohiolink.edu/etdc/view?acc_num=kent1648501433633264

Abstract Details

2022, DNP, Kent State University, College of Nursing.
Biosimilars are pharmaceutical agents approved by the Food and Drug Administration (FDA) as an option to treat multiple medical conditions. In rheumatology, they are used as an option to treat inflammatory diseases such as rheumatoid arthritis (RA) and spondyloarthritis (SpA). The term spondyloarthritis is used to describe a group of disorders, including ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-axSpA), forms of arthritis associated with psoriasis (PsO), psoriatic arthritis (PsA), and with inflammatory bowel diseases (IBD), among others. The structure and therapeutic effects of biosimilars are similar to previously developed and approved patented biologic pharmaceutical agents. However, they cannot be considered identical, as they are not a product of controlled chemical synthesis but are produced by living cells. The main reason for possible differences is related to patent expiration dates, which typically occur for an active ingredient several years prior to the expiration of patent protection for a manufacturing process. Consequently, competitors may produce the active ingredient, but utilizing a different process, which can often result in variations in impurities and efficacy. With biologic production further complicated by the use of live organisms as production “reactors”, FDA’s decision to classify off-patent biologic pharmaceutical agents as “biosimilar” rather than “generic”, as is done for small molecule synthetic pharmaceuticals, underscores the similar rather than identical efficacy of a reference biologic vs. its biosimilar. However, as with small molecule generic pharmaceuticals, biosimilars can be made available at a lower cost making them an economically preferred alternative. Available research data suggests that biosimilars and their reference products have comparable pharmacokinetics, safety, and efficacy. In January of 2019 majority of patients diagnosed with rheumatic diseases managed by the department of rheumatology at the Cleveland Veteran Administration (VA) being treated with Remicade (infliximab) were switched to treatment with biosimilar Renflexis (infliximab – abda). The decision was mostly driven by cost considerations as the price for biosimilar Remicade is approximately three times less than that of the reference product. The goal of this proposed project is a retrospective chart review based analysis was to evaluate the results of treatment change from Remicade to Renflexis in patients diagnosed with RA and SpA and determine if the intended cost savings were achieved without adverse impact on patients’ outcomes.
Lynn Gaddis (Committee Chair)
Dana Hensen (Committee Member)
Lisa Onesko (Committee Member)
48 p.
Nursing
Biosimilars; rheumatology; autoimmune; patient acceptance; physician acceptance; rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; chronic inflammatory disease; drug costs; health economics; infliximab; switching treatments; disease activity scores; treatment guidelines.

Recommended Citations

Citations

  • Silversteyn, L. (2022). Efficacy When Using Biosimilar Renflexis (infliximab abda) Compared to Biologic Remicade (infliximab) Indicated for Treatment of Patients Diagnosed with Rheumatoid Arthritis and Spondyloarthritis. [Doctoral dissertation, Kent State University]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=kent1648501433633264

    APA Style (7th edition)

  • Silversteyn, Laura. Efficacy When Using Biosimilar Renflexis (infliximab abda) Compared to Biologic Remicade (infliximab) Indicated for Treatment of Patients Diagnosed with Rheumatoid Arthritis and Spondyloarthritis. 2022. Kent State University, Doctoral dissertation. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=kent1648501433633264.

    MLA Style (8th edition)

  • Silversteyn, Laura. "Efficacy When Using Biosimilar Renflexis (infliximab abda) Compared to Biologic Remicade (infliximab) Indicated for Treatment of Patients Diagnosed with Rheumatoid Arthritis and Spondyloarthritis." Doctoral dissertation, Kent State University, 2022. http://rave.ohiolink.edu/etdc/view?acc_num=kent1648501433633264

    Chicago Manual of Style (17th edition)

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This open access ETD is published by Kent State University and OhioLINK.