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Επιστροφή στη λίστα
Mediterr J Rheumatol 2019;30(Supp 1):69-75
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Switching patients with inflammatory arthritis from Etanercept (Enbrel) to the biosimilar drug, SB4 (Benepali): A single-centre retrospective observational study in the UK and a review of the literature
Anastasia-Vasiliki Madenidou1,2, Andrew Jeffries1, Sneha Varughese1, Stephen Jones1, Hanadi Sari-Kouzel1, Helen Veevers1, Chandini Rao1
Πληροφορίες Συγγραφέων

1Rheumatology Department, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom

2Centre for Rheumatology, University College London, London, United Kingdom

Λέξεις Κλειδιά: arthritis, biologics, biosimilars, etanercept, SB4
Παραπομπές
  1. Erhorn S. Etanercept Biosimilar (Benepali®). NHS Northern Treatment Advisory Group; 2016.
  2. Cho IH, Lee N, Song D, Jung SY, Bou-Assaf G, Sosic Z, et al. Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. MAbs 2016;8(6):1136-55. [https://doi.org/10.1080/19420862.2016.1193659] [PMID: 27246928] [PMCID: PMC4968139]
  3. Emery P, Vencovsky J, Sylwestrzak A, Leszczynski P, Porawska W, Baranauskaite A, et al. 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis. Rheumatology (Oxford) 2017;56(12):2093-101.  [https://doi.org/10.1093/rheumatology/kex269] [PMID: 28968793] [PMCID: PMC5850652]
  4. Benepali: European Medicines Agency (EMA); 2017 [January 2017]. Available from: [https://www.ema.europa.eu/documents/overview/benepali-epar-summary-public_en.pdf]
  5. von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med 2007;4(10):e296. [https://doi.org/10.1371/journal.pmed.0040296]
  6. Glintborg B, Loft AG, Omerovic E, Hendricks O, Linauskas A, Espesen J, et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann Rheum Dis 2019;78:192-200. Epub 2018 Nov 5. [https://doi.org/10.1136/annrheumdis-2018-213474] [PMID: 30396903]
  7. Tweehuysen L, Huiskes VJB, van den Bemt BJF, Vriezekolk JE, Teerenstra S, van den Hoogen FHJ, et al. Open-Label, Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: Six-Month Results From a Controlled Cohort Study. Arthritis Rheumatol 2018;70(9):1408-18. Epub 2018 Aug 6. [https://doi.org/10.1002/art.40516] [PMID: 29609207]
  8. Krueger K, Selmi C, Cantagrel A, Abad AM, Freudensprung U, Rezk MF, et al. Benefit Study: Results of Interim Analysis of a Pan-European Observational Study to Evaluate Real-World Effectiveness of SB4 Following Transition from Originator Etanercept (ETN) in Patients with Rheumatoid Arthritis (RA) or Axial Spondyloarthritis (AxSpA). ACR/ ARHP Annual Meeting 2018; Chicago, USA [Abstract no 2537]. Arthritis Rheumatol 2018;70(suppl 10). [https://acrabstracts.org/abstract/benefit-study-results-of-interim-analysis-of-a-pan-european-observational-study-to-evaluate-real-world-effectiveness-of-sb4-following-transition-from-originator-etanercept-etn-in-patients-with-rheu/]
  9. Lee SY, Szeto MCH, Galloway JB. Bio-similar to bio-originator switchback: not a reliable quality indicator.  EULAR, Annual European Congress of Rheumatology 2018; Amsterdam, Holland. [Abstract no 1267] Ann Rheum Dis 2018;77:1727-8. [https://doi.org/10.1136/annrheumdis-2018-eular.5750]
  10. Ma J, Petford S, Jones L, Douglas K, John H. Audit of the clinical efficacy and safety of etanercept biosimilar to its reference product in patients with inflammatory arthritis: experience from a district general hospital in the United Kingdom. BSR Annual Conference 2018; Liverpool, UK. [Abstract no 0447] Ann Rheum Dis 2018;77:1386. [https://doi.org/10.1136/annrheumdis-2018-eular.2498]
  11. Rabbitts R, Jewell T, Marrow K, Herbison C, Laversuch C. Switching to biosimilars: An early clinical review. BSR Annual Conference 2017; Birmingham, UK. [abstract] [https://doi.org/10.1093/rheumatology/kex062.211]
  12. Rajamani K, Choy E. Change in Disease Activity after Switching Etanercept (originator) to Biosimilar (Benepali) Is Associated with Active Disease at Baseline.  ACR/ ARHP Annual Meeting 2018; Chicago, USA. [abstract]
  13. Smith R, Fawthrop F. Similar experience of biosimilars: a review of Rotherham Hospital's experience of switching from enbrel to benepali.  BSR Annual Conference 2018; Liverpool, UK. [abstract]
  14. Alkoky H, Pakozdi A, Tahir H. Benepali Switches in Clinical Practice – a Positive Single Centre Experience.  ACR/ARHP Annual Meeting 2018; Chicago, USA. [abstract]
  15. Dyball S, Hoskins V, Christy-Kilner S, Haque S. Effectiveness and tolerability of Benepali in Rheumatoid Arthritis Patients switched from Enbrel.  ACR/ARHP Annual Meeting 2017; San Diego, USA. [abstract]
  16. Kristensen LE, Alten R, Puig L, Philipp S, Kvien TK, Mangues MA, et al. Non-pharmacological Effects in Switching Medication: The Nocebo Effect in Switching from Originator to Biosimilar Agent. BioDrugs. 2018;32(5):397-404.