Doctor's aptitude for switching from innovator etanercept to biosimilar etanercept in inflammatory rheumatic diseases: experience from a single French rheumatology tertiary care center.
Biosimilar
Etanercept
Rheumatoid arthritis
SB4
Spondyloarthritis
Switch
Journal
European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
10
02
2020
accepted:
09
07
2020
pubmed:
6
9
2020
medline:
23
9
2021
entrez:
5
9
2020
Statut:
ppublish
Résumé
To describe the switch to biosimilar etanercept (bETN), evaluate factors associated with this switch, and evaluate the efficacy of this switch in a real-life setting METHODS: We included patients, from October 2016 to April 2017, with rheumatoid arthritis (RA) and spondyloarthritis (SpA) who received innovator ETN (iETN) for at least 6 months. After receiving information on biosimilars, all physicians were invited to propose a switch from iETN to bETN. Factors associated with bETN discontinuation were explored by univariate and multivariate analyses. We estimated the proportion of patients still on bETN over time by Kaplan-Meier survival analysis. We assessed serum trough concentrations of iETN and bETN and anti-drug antibodies to ETN. Overall, 183 outpatients were eligible for a potential switch; 94 (51.6%) switched from iETN to bETN. The probability of a switch was greater with an older than younger aged physician (mean [SD] age 50.4 [14.3] with a switch vs 44.8 [11.3] with no switch, p = 0.005) and the physician having a full-time academic position than other position (56.4% with a switch vs 13.5% with no switch, p < 0.001). After a 6-month follow-up, bETN retention rate was 83% (95% CI: 0.76-0.92). The first cause of bETN discontinuation was inefficacy (50%). On multivariate analysis, no factor was independently associated with a bETN switch or discontinuation. Drug trough levels did not significantly differ by discontinuation or continuation of bETN. No patient showed anti-drug antibodies. The probability of switching from iETN to bETN was likely related to physician characteristics.
Identifiants
pubmed: 32888052
doi: 10.1007/s00228-020-02957-2
pii: 10.1007/s00228-020-02957-2
doi:
Substances chimiques
Antirheumatic Agents
0
Biosimilar Pharmaceuticals
0
Etanercept
OP401G7OJC
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
25-33Références
Beck A, Wurch T, Bailly C, Corvaia N (2010) Strategies and challenges for the next generation of therapeutic antibodies. Nat Rev Immunol 10(5):345–352
doi: 10.1038/nri2747
Strohmeier R, Draghia-Akli R, Rys A, Silvan PO, Lennon T, Incerti C, Bergström R, Chibout S, Doliveux R, Andersen PH (2011) IMI moves forward. Nat Biotechnol 29(8):689–691
doi: 10.1038/nbt.1944
Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan VM, Stasiuk B, Milasiene R, Barrera Rodriguez AA, Cheong SY, Ghil J (2017) A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 76(1):51–57
doi: 10.1136/annrheumdis-2015-207588
Cho IH, Lee N, Song D, Jung SY, Bou-Assaf G, Sosic Z et al (2016) Evaluation of the structural, physicochemical, and biological characteristics of SB4, a biosimilar of etanercept. mAbs 8(6):1136–1155
doi: 10.1080/19420862.2016.1193659
Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Ureña S, Lim MJ, Lee YA, Lee SJ, Kim HU, Yoo DH, Braun J (2013 Oct) A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study. Ann Rheum Dis 72(10):1605–1612
doi: 10.1136/annrheumdis-2012-203091
Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS (2017) A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 76(1):58–64
doi: 10.1136/annrheumdis-2015-207764
Smolen JS, Choe J-Y, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH (2017) Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology. 56(10):1771–1779
doi: 10.1093/rheumatology/kex254
Jørgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, Lundin KEA, Mørk C, Jahnsen J, Kvien TK, Berset IP, Fevang BTS, Florholmen J, Kalstad S, Mørk NJ, Ryggen K, Tveit KS, Sæther SK, Gulbrandsen B, Hagfors J, Waksvik K, Warren D, Henanger KJ, Asak Ø, Baigh S, Blomgren IM, Bruun TJ, Dvergsnes K, Frigstad SO, Gjesdal CG, Grandaunet BHJ, Hansen IM, Hatten ISH, Huppertz-Hauss G, Henriksen M, Hoie SS, Krogh J, Kruse JR, Ljoså MKA, Midtgard IP, Mielnik P, Moum B, Noraberg G, Poyan A, Prestegård U, Rashid HU, Rydning JH, Sagatun L, Seeberg KA, Skjetne K, Strand EK, Stray H, Stray N, Torp R, Vold C, Ystrøm CM, Zettel CC (2017) Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 389(10086):2304–2316
doi: 10.1016/S0140-6736(17)30068-5
Glintborg B, Sørensen IJ, Loft AG, Lindegaard H, Linauskas A, Hendricks O, Hansen IMJ, Jensen DV, Manilo N, Espesen J, Klarlund M, Grydehøj J, Dieperink SS, Kristensen S, Olsen JS, Nordin H, Chrysidis S, Dalsgaard Pedersen D, Sørensen MV, Andersen LS, Grøn KL, Krogh NS, Pedersen L, Hetland ML (2017) A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 76(8):1426–1431
doi: 10.1136/annrheumdis-2016-210742
Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, Sokka T (2015) Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 15(12):1677–1683
doi: 10.1517/14712598.2015.1103733
Tweehuysen L, Huiskes VJ, van den Bemt BJ, Vriezekolk JE, Teerenstra S, van den Hoogen FH, et al. Open-label non-mandatory transitioning from originator etanercept to biosimilar SB4: 6-month results from a controlled cohort study. Arthritis Rheumatol. 2018 Apr 2 [cited 2018 Apr 13]; Available from: http://doi.wiley.com/10.1002/art.40516
Avouac J, Moltó A, Abitbol V, Etcheto A, Salcion A, Gutermann L, Klotz C, Elhai M, Cohen P, Soret PA, Morin F, Conort O, Chast F, Goulvestre C, Jeunne CL, Chaussade S, Kahan A, Roux C, Allanore Y, Dougados M (2018) Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: the experience of Cochin University Hospital, Paris, France. Semin Arthritis Rheum 47(5):741–748
doi: 10.1016/j.semarthrit.2017.10.002
Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, Zhou L, Peloso P (2007) The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol 25(1):40–46
pubmed: 17417989
Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Stasiuk B, Hilt J, Mosterova Z, Cheong SY, Ghil J (2017) Long-term efficacy and safety in patients with rheumatoid arthritis continuing on SB4 or switching from reference etanercept to SB4. Ann Rheum Dis 76(12):1986–1991
doi: 10.1136/annrheumdis-2017-211591
Vincent FB, Morand EF, Murphy K, Mackay F, Mariette X, Marcelli C (2013) Antidrugantibodies (ADAb) to tumour necrosis factor (TNF)-specific neutralising agents inchronic inflammatory diseases: a real issue, a clinical perspective. Ann RheumDis 72(2):165–178
doi: 10.1136/annrheumdis-2012-202545
Kay J, Schoels MM, Dörner T, Emery P, Kvien TK, Smolen JS, Breedveld FC, Task Force on the Use of Biosimilars to Treat Rheumatological Diseases (2018) Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 77(2):165–174
doi: 10.1136/annrheumdis-2017-211937
Skingle D (2015) Biosimilars: what do patients need to consider? RMD Open 1(1):e000141
doi: 10.1136/rmdopen-2015-000141
Scherlinger M, Germain V, Labadie C, Barnetche T, Truchetet M-E, Bannwarth B et al (2017) Switching from originator infliximab to biosimilar CT-P13 in real-life: the weight of patient acceptance. Jt Bone Spine Rev Rhum 14
Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, le Loët X, Combe B (2014) Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Jt Bone Spine Rev Rhum 81(4):352–359
doi: 10.1016/j.jbspin.2014.02.014