4,494
Views
48
CrossRef citations to date
0
Altmetric
Original Article

Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab

, , , , , , & show all
Pages 237-245 | Received 16 Mar 2016, Accepted 06 Jun 2016, Published online: 01 Sep 2016

References

  • Takeuchi T, Yamanaka H, Tanaka Y, Sakurai T, Saito K, Ohtsubo H, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2015;25(6):817–24.
  • Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, et al. 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. 2013;72:1613–20.
  • Committee on Rheumatologic Care. American College of Rheumatology Position Statement. February 2015.
  • Yoo DH, Prodanovic N, Jaworski J, Miranda P, Ramiterre EB, Lanzon A, et al. Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13 [abstract]. Arthritis Rheumatol. 2013;65(12):3319.
  • Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727–35.
  • Felson DT, Anderson JJ, Lange MLM, Wells G, and Lavalley MP. Should improvement in rheumatoid arthritis clinical trials be defined as fifty percent or seventy percent improvement in core set measures, rather than twenty percent? Arthritis Rheum. 1998;41:1564–70.
  • Prevoo MLL, van’t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, and van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44–8.
  • van Riel PLCM, van Gestel AM, and van de Putte LBA. Development and validation of response criteria in rheumatoid arthritis: steps towards an international consensus on prognostic markers. Br J Rheumatol. 1996;35(Suppl 2):4–7.
  • Smolen JS, Breedveld FC, Schiff MH, Kalden JR, Emery P, Eberl G, et al. A simplified disease activity index for rheumatoid arthritis for use in clinical practice. Rheumatology (Oxford). 2003;42:244–57.
  • Aletaha D, Nell VPK, Stamm T, Uffmann M, Pflugbeil S, Machold K, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2005;7:R796–806.
  • Fries JF, Spitz P, Kraines RG, and Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137–45.
  • Westhovens R, Yocum D, Han J, Berman A, Strusberg I, Geusens P, et al. The safety of infliximab, combined with background treatments, among patients with rheumatoid arthritis and various comorbidities: a large, randomized, placebo-controlled trial. Arthritis Rheum. 2006;54(4):1075–86.
  • Takeuchi T, Tatsuki Y, Nogami Y, Ishiguro N, Tanaka Y, Yamanaka H, et al. Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis. Ann Rheum Dis. 2008;67:189–94.
  • Penn I. Malignancies associated with immunosuppressive or cytotoxic therapy. Surgery. 1978;83(5):492–502.
  • Penn I. Cancer following cyclosporine therapy. Transplant Proc. 1987;19(1):2211–13.
  • Kinlen L. Immunosuppressive therapy and acquired immunological disorders. Cancer Res. 1992;52(19 Suppl):5474s–6s.
  • Jones M, Symmons D, Finn J, and Wolfe F. Does exposure to immunosuppressive therapy increase the 10 year malignancy and mortality risks in rheumatoid arthritis? A matched cohort study. Br J Rheumatol. 1996;35(8):738–45.
  • Bendtzen K, Geborek P, Svenson M, Larsson L, Kapetanovic MC, and Saxne T. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab. Arthritis Rheum. 2006;54:3782–9.
  • Wolbink GJ, Vis M, Lems W, Voskuyl AE, de Groot E, Nurmohamed MT, et al. Development of antiinfliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis. Arthritis Rheum. 2006;54:711–15.
  • Krintel SB, Grunert VP, Hetland ML, Johansen JS, Rothfuss M, Palermo G, et al. 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. Rheumatology. 2013;53:299–307.
  • Ducourau E, Mulleman D, Paintaud G, Miow Lin DC, Lauféron F, Ternant D, et al. Antibodies toward infliximab are associated with low infliximab concentration at treatment initiation and poor infliximab maintenance in rheumatic diseases. Arthritis Res Ther. 2011;13:R105.
  • Brodszky V, Baji P, Balogh O, and Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ. 2014;15(Suppl 1):S65–71.