By a News Reporter-Staff News Editor at Biotech Week A new study on Drugs and Therapies - Monoclonal Antibodies is now available. According to news reporting from Chapel Hill, North Carolina, by NewsRx journalists, research stated, "Several authors have hypothesized that adverse drug events (ADEs) upon switching from reference biologics to biosimilar products are related to the nocebo effect. However, a thorough and current review of the existing literature has not been conducted."
The news correspondents obtained a quote from the research from the University of North Carolina, "To evaluate if patient and/or physician knowledge of a switch from a reference biologic product to a biosimilar product was associated with an increase in ADEs likely to be susceptible to the nocebo effect. Studies reporting efficacy and safety outcomes of a switch from a reference product to a biosimilar product were reviewed. Biologics with FDA-approved biosimilars in the United States were considered for review, including adalimumab, bevacizumab, etanercept, and infliximab. Studies were identified by searching controlled vocabulary (e.g., MeSH terms) and keywords within MEDLINE (via PubMed) and Embase. Descriptive statistics were used to quantify subjective and objective complications in double-blinded and single-blinded or open-label studies. Thirty-one trials including 3,271 patients were reviewed in the full analysis. Median discontinuation rates for any reason were 14.3% (range = 0.0-33.3) in open-label studies compared with 6.95% (range = 5.211.0) in double-blinded studies. Discontinuation rates for ADEs were 5.6% (range = 0.0-24.2) in open-label studies versus 3.1% (range = 2.0-5.2) in double-blinded studies, suggesting the nocebo effect does affect biosimilar adoption. Subgroup analyses of antidrug antibody (ADA) development and infusion reactions were similar between infliximab open-label and double-blinded studies. Discontinuation rates for any reason, for ADEs, and for lack of efficacy were generally higher in infliximab open-label trials compared with double-blinded trials. Etanercept biosimilar discontinuation rates for any reason were similar between study designs; however, incidences of injection site reactions and discontinuation rates for ADEs were higher in double-blinded compared with open-label study designs. Current evidence is insufficient to confirm a biosimilar nocebo effect, although higher discontinuation rates in infliximab biosimilar open-label studies support this theory."
According to the news reporters, the research concluded: "Further studies are needed to evaluate the existence of a biosimilar nocebo effect."
For more information on this research see: The Biosimilar Nocebo Effect? A Systematic Review of Double-Blinded Versus Open-Label Studies. Journal of Managed Care & Specialty Pharmacy, 2018;24(10):952-959. Journal of Managed Care & Specialty Pharmacy can be contacted at: Acad Managed Care Pharmacy, 100 N Pitt St, 400, Alexandria, VA 22314-3134, USA (see also Drugs and Therapies - Monoclonal Antibodies).
Our news journalists report that additional information may be obtained by contacting G.A. Heindel, University of North Carolina, Medical Center, Dept. of Pharm, Chapel Hill, NC 27515, United States. Additional authors for this research include C.E. Day, J.L. Cruz and J.S. Odinet.
The direct object identifier (DOI) for that additional information is: https://doi.org/10.18553/jmcp.2018.24.10.952. This DOI is a link to an online electronic document that is either free or for purchase, and can be your direct source for a journal article and its citation.
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