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An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications

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Abstract

Over the last 1–2 decades, a number of different therapeutic proteins have been developed using pharmaceutical biotechnology. This chapter uses six specific examples to show how using the best available evidence and the principles of shared-decision-making can lead to the appropriate use of these agents.

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References

  • Agache I, Song Y, Rocha C, Beltran J, Posso M, Steiner C et al (2020) Efficacy and safety of treatment with dupilumab for severe asthma: a systematic review of the EAACI guidelines-recommendations on the use of biologicals in severe asthma. Allergy 75:1058–1068. https://doi.org/10.1111/all.14268

    Article  PubMed  Google Scholar 

  • Blauvelt A, Papp KA, Griffiths CEM et al (2017) Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 76:405–417

    Article  CAS  PubMed  Google Scholar 

  • El Dib R, Gomaa H, Carvalho RP, Camargo SE, Bazan R, Barretti P, Barreto FC (2017) Enzyme replacement therapy for Anderson-Fabry disease. Cochrane Database Syst Rev 7:CD006663

    Google Scholar 

  • Eng CM, Guffon N, Wilcox WR, Germain DP, Lee P, Waldek S et al (2001) Safety and efficacy of recombinant human alpha-galactosidase a replacement therapy in Fabry’s disease. N Engl J Med 345:9–16

    Article  CAS  PubMed  Google Scholar 

  • Garegnani L, Styrmisdóttir L, Roson Rodriguez P, Escobar Liquitay CM, Esteban I, Franco JVA (2021) Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children. Cochrane Database Syst Rev 11:CD013757

    PubMed  Google Scholar 

  • Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A (2017) Romosozumab or alendronate for fracture prevention in women with osteoporosis. N Engl J Med 377:1417–1427

    Article  CAS  PubMed  Google Scholar 

  • Sbidian E, Chaimani A, Garcia-Doval I, Doney L, Dressler C, Hua C, Hughes C, Naldi L, Afach S, Le Cleach L (2022) Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis. Cochrane Database Syst Rev 12:CD011535

    Google Scholar 

  • Schmidt AF, Carter JPL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas J (2020) PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev 10:CD011748

    PubMed  Google Scholar 

  • Sindelar RD (2013) Genomics, other “Omic” technologies, personalized medicine. In: Crommelin DJA, Sindelar RD, Meibohm B (eds) Pharmaceutical biotechnology, 4th edn. Springer, New York, pp 190–221

    Google Scholar 

  • Singh S, Dutta S, Khasbage S, Kumar T, Sachin J, Sharma J, Varthya SB (2022) A systematic review and meta-analysis of efficacy and safety of Romosozumab in postmenopausal osteoporosis. Osteoporos Int 33(1):1–12. https://doi.org/10.1007/s00198-021-06095-y

    Article  CAS  PubMed  Google Scholar 

  • Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A (2016) Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting beta2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet 388:31–44

    Article  CAS  PubMed  Google Scholar 

  • Wilcox WR, Banikazemi M, Guffon N, Waldek S, Lee P, Linthorst GE, Desnick RJ, Germain DP, International Fabry Disease Study Group (2004) Long-term safety and efficacy of enzyme replacement therapy for Fabry disease. Am J Hum Genet 75:65–74

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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Correspondence to James P. McCormack .

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McCormack, J.P. (2024). An Evidence-Based Practice Approach to Evaluating Biotechnologically Derived Medications. In: Crommelin, D.J.A., Sindelar, R.D., Meibohm, B. (eds) Pharmaceutical Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-031-30023-3_12

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