Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis

Modern Rheumatology
Tsutomu TakeuchiYoshihiro Nambu

Abstract

To demonstrate the pharmacokinetic equivalence of CT-P13 and its innovator infliximab (IFX) in Japanese patients with rheumatoid arthritis (RA), and to compare the efficacy and safety of these drugs, administered for 54 weeks. In a randomized, double-blind, parallel-group, multicenter study, 3 mg/kg of CT-P13 or IFX, in combination with methotrexate (MTX) (6-16 mg/week), was administered for 54 weeks to Japanese active RA patients with an inadequate response to MTX, to demonstrate the pharmacokinetic equivalence, based on the area under the curve (AUC(τ)) (weeks 6-14) and C(max) (week 6) of these drugs, and to compare their efficacy and safety. The CT-P13-to-IFX ratios (90% confidence intervals) of the geometric mean AUC(τ) and C(max) values in patients negative for antibodies to infliximab at week 14 were 111.62% (100.24-124.29%) and 104.09% (92.12-117.61%), respectively, demonstrating the pharmacokinetic equivalence of these drugs. In the full analysis set, CT-P13 and IFX showed comparable therapeutic effectiveness, as measured by the American College of Rheumatology, Disease Activity Score in 28 joints, the European League Against Rheumatism, and other efficacy criteria, at weeks 14 and 30. The incidence of adverse events wa...Continue Reading

References

Feb 1, 1980·Arthritis and Rheumatism·J F FriesH R Holman
Feb 1, 2000·Biologicals : Journal of the International Association of Biological Standardization·E Griffiths
Feb 20, 2014·Annals of the Rheumatic Diseases·Gerd-Rudiger BurmesterRoy M Fleischmann
Dec 18, 2014·MAbs·Soon Kwan JungShin Jae Chang

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Citations

Sep 24, 2015·Expert Review of Gastroenterology & Hepatology·Walter ReinischSilvio Danese
Sep 15, 2015·Alimentary Pharmacology & Therapeutics·K PapamichaelN Vande Casteele
Apr 28, 2016·Biologicals : Journal of the International Association of Biological Standardization·Jürgen Braun, Alex Kudrin
Mar 11, 2016·Annals of the Rheumatic Diseases·Thomas DörnerGerd R Burmester
Sep 22, 2016·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Hannah A Blair, Emma D Deeks
Oct 25, 2016·Clinical Gastroenterology and Hepatology : the Official Clinical Practice Journal of the American Gastroenterological Association·Shomron Ben-HorinPeter Laszlo Lakatos
Jan 11, 2017·Expert Opinion on Drug Safety·J Braun, J Kay
Sep 2, 2016·Therapeutic Advances in Gastroenterology·Joanna SieczkowskaJaroslaw Kierkus
Mar 18, 2017·Current Opinion in Rheumatology·Stanley Cohen, Jonathan Kay
Jun 3, 2017·Expert Review of Clinical Immunology·Dae Hyun Yoo
May 31, 2017·The British Journal of Dermatology·N GonzalezG Han
Nov 28, 2017·Journal of Comparative Effectiveness Research·Dae Hyun Yoo
Aug 31, 2018·Biological & Pharmaceutical Bulletin·Masahiro TsudaKazuo Matsubara
Oct 20, 2018·International Journal of Rheumatic Diseases·Prasan Deep RathLyndon Llamado
Jul 31, 2018·Journal of Clinical Rheumatology : Practical Reports on Rheumatic & Musculoskeletal Diseases·Valderilio Feijó AzevedoHeather E Jones
Apr 11, 2017·Current Medicinal Chemistry·Laszlo GulacsiPeter L Lakatos
Aug 14, 2019·Expert Opinion on Biological Therapy·Ahmad Albshesh, Shomron Ben-Horin
Mar 3, 2020·Expert Opinion on Drug Safety·Kelly A ReynoldsJashin J Wu
Sep 4, 2017·Annals of the Rheumatic Diseases·Jonathan KayUNKNOWN Task Force on the Use of Biosimilars to Treat Rheumatological Diseases
Sep 6, 2019·Clinical Rheumatology·Carmen Tze Kwan HoUNKNOWN Hong Kong Society of Rheumatology
Mar 20, 2018·Dermatology and Therapy·Jose-Manuel CarrascosaRobert Strohal
Nov 18, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Hyoun-Ah KimKichul Shin
Nov 14, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Vibeke StrandJohn D Isaacs
Sep 15, 2017·Rheumatology·Hendrik Schulze-Koops, Alla Skapenko
Jun 15, 2017·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Vibeke StrandLisa Marshall
Sep 19, 2018·Therapeutic Innovation & Regulatory Science·Ryuji Uozumi, Chikuma Hamada
Feb 9, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Sascha GerdesMarc A Radtke
Jan 25, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Sascha GerdesMarc A Radtke
Feb 13, 2020·American Journal of Clinical Dermatology·Kelly A ReynoldsJashin J Wu
Oct 13, 2020·Critical Reviews in Biotechnology·Muhammad Safwan AkramAli K Yetisen
Feb 19, 2021·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Conor Hanrahan, Todd Lee

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