메뉴 건너뛰기




Volumn 36, Issue 9, 2017, Pages 2129-2134

Therapeutic drug monitoring (TDM) as a tool in the switch from infliximab innovator to biosimilar in rheumatic patients: results of a 12-month observational prospective cohort study

Author keywords

Biosimilars; Infliximab; Rheumatology; Switch study; Therapeutic drug monitoring

Indexed keywords

AZATHIOPRINE; C REACTIVE PROTEIN; DRUG ANTIBODY; INFLIXIMAB; INFLIXIMAB DYYB; METHOTREXATE; ANTIRHEUMATIC AGENT; BIOSIMILAR AGENT;

EID: 85020284797     PISSN: 07703198     EISSN: 14349949     Source Type: Journal    
DOI: 10.1007/s10067-017-3686-6     Document Type: Article
Times cited : (18)

References (23)
  • 1
    • 84879343393 scopus 로고    scopus 로고
    • The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure
    • COI: 1:CAS:528:DC%2BC3sXhtVeiu7fN
    • Krintel SB, Grunert VP, Hetland ML, Johansen JS, Rothfuss M, Palermo G et al (2013) The frequency of anti-infliximab antibodies in patients with rheumatoid arthritis treated in routine care and the associations with adverse drug reactions and treatment failure. Rheumatol Oxf Engl 52(7):1245–1253
    • (2013) Rheumatol Oxf Engl , vol.52 , Issue.7 , pp. 1245-1253
    • Krintel, S.B.1    Grunert, V.P.2    Hetland, M.L.3    Johansen, J.S.4    Rothfuss, M.5    Palermo, G.6
  • 2
    • 84883746909 scopus 로고    scopus 로고
    • 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
    • COI: 1:CAS:528:DC%2BC3sXhs1eis7nM, PID: 23687259
    • Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P et al (2013) 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
    • (2013) Ann Rheum Dis , vol.72 , Issue.10 , pp. 1605-1612
    • Park, W.1    Hrycaj, P.2    Jeka, S.3    Kovalenko, V.4    Lysenko, G.5    Miranda, P.6
  • 3
    • 84883752718 scopus 로고    scopus 로고
    • A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study
    • COI: 1:CAS:528:DC%2BC3sXhs1eis7nN, PID: 23687260
    • Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S et al (2013) A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis 72(10):1613–1620
    • (2013) Ann Rheum Dis , vol.72 , Issue.10 , pp. 1613-1620
    • Yoo, D.H.1    Hrycaj, P.2    Miranda, P.3    Ramiterre, E.4    Piotrowski, M.5    Shevchuk, S.6
  • 4
    • 84942237438 scopus 로고    scopus 로고
    • Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study
    • PID: 26395834
    • Park W, Lee SJ, Yun J, Yoo DH (2015) Comparison of the pharmacokinetics and safety of three formulations of infliximab (CT-P13, EU-approved reference infliximab and the US-licensed reference infliximab) in healthy subjects: a randomized, double-blind, three-arm, parallel-group, single-dose, Phase I study. Expert Rev Clin Immunol 11(Suppl 1):S25–S31
    • (2015) Expert Rev Clin Immunol , vol.11 , pp. S25-S31
    • Park, W.1    Lee, S.J.2    Yun, J.3    Yoo, D.H.4
  • 5
    • 84962037330 scopus 로고    scopus 로고
    • A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study
    • Yoo DH, Racewicz A, Brzezicki J, Yatsyshyn R, Arteaga ET, Baranauskaite A et al (2015) A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 18:82
    • (2015) Arthritis Res Ther , vol.18 , pp. 82
    • Yoo, D.H.1    Racewicz, A.2    Brzezicki, J.3    Yatsyshyn, R.4    Arteaga, E.T.5    Baranauskaite, A.6
  • 6
    • 85011547070 scopus 로고    scopus 로고
    • Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study
    • Park W, Yoo DH, Miranda P, Brzosko M, Wiland P, Gutierrez-Ureña S, et al. (2016) Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 26
    • (2016) Ann Rheum Dis , vol.26
    • Park, W.1    Yoo, D.H.2    Miranda, P.3    Brzosko, M.4    Wiland, P.5    Gutierrez-Ureña, S.6
  • 7
    • 85011374077 scopus 로고    scopus 로고
    • Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study
    • Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre E, Lanzon A, et al. (2016) Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 29
    • (2016) Ann Rheum Dis , vol.29
    • Yoo, D.H.1    Prodanovic, N.2    Jaworski, J.3    Miranda, P.4    Ramiterre, E.5    Lanzon, A.6
  • 8
    • 85011685257 scopus 로고    scopus 로고
    • Combining therapeutic drug monitoring with biosimilars, a strategy to improve the efficacy of biologicals for treating inflammatory bowel diseases at an affordable cost
    • Gils A (2017) Combining therapeutic drug monitoring with biosimilars, a strategy to improve the efficacy of biologicals for treating inflammatory bowel diseases at an affordable cost. Dig Dis Basel Switz 35(1–2):61–68
    • (2017) Dig Dis Basel Switz , vol.35 , Issue.1-2 , pp. 61-68
    • Gils, A.1
  • 10
    • 33644931095 scopus 로고    scopus 로고
    • Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis
    • PID: 16508927
    • Wolbink GJ, Vis M, Lems W, Voskuyl AE, de Groot E, Nurmohamed MT et al (2006) Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum 54(3):711–715
    • (2006) Arthritis Rheum , vol.54 , Issue.3 , pp. 711-715
    • Wolbink, G.J.1    Vis, M.2    Lems, W.3    Voskuyl, A.E.4    de Groot, E.5    Nurmohamed, M.T.6
  • 11
  • 12
    • 84904063633 scopus 로고    scopus 로고
    • The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab
    • COI: 1:CAS:528:DC%2BC2cXhsFGhur3K, PID: 24041539
    • Ungar B, Chowers Y, Yavzori M, Picard O, Fudim E, Har-Noy O et al (2014) The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab. Gut 63(8):1258–1264
    • (2014) Gut , vol.63 , Issue.8 , pp. 1258-1264
    • Ungar, B.1    Chowers, Y.2    Yavzori, M.3    Picard, O.4    Fudim, E.5    Har-Noy, O.6
  • 13
    • 17644382690 scopus 로고    scopus 로고
    • Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis
    • COI: 1:CAS:528:DC%2BD2MXksFWru74%3D, PID: 15485995
    • Wolbink GJ, Voskuyl AE, Lems WF, de Groot E, Nurmohamed MT, Tak PP et al (2005) Relationship between serum trough infliximab levels, pretreatment C reactive protein levels, and clinical response to infliximab treatment in patients with rheumatoid arthritis. Ann Rheum Dis 64(5):704–707
    • (2005) Ann Rheum Dis , vol.64 , Issue.5 , pp. 704-707
    • Wolbink, G.J.1    Voskuyl, A.E.2    Lems, W.F.3    de Groot, E.4    Nurmohamed, M.T.5    Tak, P.P.6
  • 14
    • 84988311235 scopus 로고    scopus 로고
    • Long-term efficiency of infliximab in patients with ankylosing spondylitis: real life data confirm the potential for dose reduction
    • COI: 1:STN:280:DC%2BC2s3nvVansQ%3D%3D, PID: 27493791
    • Baraliakos X, Heldmann F, van den Bosch F, Burmester G, Gaston H, van der Horst-Bruinsma IE et al (2016) Long-term efficiency of infliximab in patients with ankylosing spondylitis: real life data confirm the potential for dose reduction. RMD Open 2(2):e000272
    • (2016) RMD Open , vol.2 , Issue.2
    • Baraliakos, X.1    Heldmann, F.2    van den Bosch, F.3    Burmester, G.4    Gaston, H.5    van der Horst-Bruinsma, I.E.6
  • 15
    • 84940649360 scopus 로고    scopus 로고
    • Comparing tapering strategy to standard dosing regimen of tumor necrosis factor inhibitors in patients with spondyloarthritis in low disease activity
    • COI: 1:CAS:528:DC%2BC28XptFWrsLk%3D, PID: 26178279
    • Plasencia C, Kneepkens EL, Wolbink G, Krieckaert CLM, Turk S, Navarro-Compán V et al (2015) Comparing tapering strategy to standard dosing regimen of tumor necrosis factor inhibitors in patients with spondyloarthritis in low disease activity. J Rheumatol 42(9):1638–1646
    • (2015) J Rheumatol , vol.42 , Issue.9 , pp. 1638-1646
    • Plasencia, C.1    Kneepkens, E.L.2    Wolbink, G.3    Krieckaert, C.L.M.4    Turk, S.5    Navarro-Compán, V.6
  • 16
    • 85057919675 scopus 로고    scopus 로고
    • Dose-tapering of TNF inhibitors in daily rheumatology practice enables the maintenance of clinical efficacy while improving cost-effectiveness
    • Aug 5 [cited 2017]; Available from
    • Pascual-Salcedo D, Plasencia C, Jurado T, Valle LG del, Sabina P, Diego C, et al. Dose-tapering of TNF inhibitors in daily rheumatology practice enables the maintenance of clinical efficacy while improving cost-effectiveness. J Pharmacovigil [Internet]. 2015 Aug 5 [cited 2017]; Available from: https://www.esciencecentral.org/journals/dosetapering-of-tnf-inhibitors-in-daily-rheumatology-practice-enables-the-maintenance-of-clinical-efficacy-while-improving-costeffectiveness-2329-6887-1000172.php?aid=58635
    • (2015) J Pharmacovigil [Internet]
    • Pascual-Salcedo, D.1    Plasencia, C.2    Jurado, T.3    del Valle, L.G.4    Sabina, P.5    Diego, C.6
  • 17
    • 84979582245 scopus 로고    scopus 로고
    • Stopping tumor necrosis factor inhibitor treatment in patients with established rheumatoid arthritis in remission or with stable low disease activity: a pragmatic multicenter, open-label randomized controlled trial
    • COI: 1:CAS:528:DC%2BC28Xht1ehtL3E
    • Ghiti Moghadam M, Vonkeman HE, Ten Klooster PM, Tekstra J, van Schaardenburg D, Starmans-Kool M et al (2016) Stopping tumor necrosis factor inhibitor treatment in patients with established rheumatoid arthritis in remission or with stable low disease activity: a pragmatic multicenter, open-label randomized controlled trial. Arthritis Rheumatol Hoboken NJ 68(8):1810–1817
    • (2016) Arthritis Rheumatol Hoboken NJ , vol.68 , Issue.8 , pp. 1810-1817
    • Ghiti Moghadam, M.1    Vonkeman, H.E.2    Ten Klooster, P.M.3    Tekstra, J.4    van Schaardenburg, D.5    Starmans-Kool, M.6
  • 18
    • 77954973766 scopus 로고    scopus 로고
    • Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study
    • COI: 1:CAS:528:DC%2BC3cXhtVSltbfI, PID: 20360136
    • Tanaka Y, Takeuchi T, Mimori T, Saito K, Nawata M, Kameda H et al (2010) Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis 69(7):1286–1291
    • (2010) Ann Rheum Dis , vol.69 , Issue.7 , pp. 1286-1291
    • Tanaka, Y.1    Takeuchi, T.2    Mimori, T.3    Saito, K.4    Nawata, M.5    Kameda, H.6
  • 20
    • 84946601256 scopus 로고    scopus 로고
    • 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
    • Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, et al. (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 1–7
    • (2015) Expert Opin Biol Ther , pp. 1-7
    • Nikiphorou, E.1    Kautiainen, H.2    Hannonen, P.3    Asikainen, J.4    Kokko, A.5    Rannio, T.6
  • 21
    • 84976339013 scopus 로고    scopus 로고
    • Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases
    • PID: 27266338
    • Gentileschi S, Barreca C, Bellisai F, Biasi G, Brizi MG, Stefano RD et al (2016) Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases. Expert Opin Biol Ther 16(10):1311–1312
    • (2016) Expert Opin Biol Ther , vol.16 , Issue.10 , pp. 1311-1312
    • Gentileschi, S.1    Barreca, C.2    Bellisai, F.3    Biasi, G.4    Brizi, M.G.5    Stefano, R.D.6
  • 22
    • 85027468124 scopus 로고    scopus 로고
    • Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice [Internet]
    • [cited Feb 16] Available from
    • Tweehuysen L, van den Bemt B.J.F., van Ingen I.L., de Jong A.J.L., van der Laan W.H., van den Hoogen F.H.J., den Broeder A.A. Clinical and immunogenicity outcomes after switching treatment from innovator infliximab to biosimilar infliximab in rheumatic diseases in daily clinical practice [Internet]. ACR Meeting Abstracts. [cited 2017 Feb 16] Available from: http://acrabstracts.org/abstract/clinical-and-immunogenicity-outcomes-after-switching-treatment-from-innovator-infliximab-to-biosimilar-infliximab-in-rheumatic-diseases-in-daily-clinical-practice/
    • (2017) ACR Meeting Abstracts
    • Tweehuysen, L.1    van den Bemt, B.J.F.2    van Ingen, I.L.3    de Jong, A.J.L.4    van der Laan, W.H.5    van den Hoogen, F.H.J.6    den Broeder, A.A.7
  • 23
    • 85018173560 scopus 로고    scopus 로고
    • Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study
    • Benucci M, Gobbi FL, Bandinelli F, Damiani A, Infantino M, Grossi V et al (2016) Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study. Immunol Res 23
    • (2016) Immunol Res , vol.23
    • Benucci, M.1    Gobbi, F.L.2    Bandinelli, F.3    Damiani, A.4    Infantino, M.5    Grossi, V.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.