2,481
Views
1
CrossRef citations to date
0
Altmetric
Rheumatoid Arthritis

Effectiveness, safety, and methotrexate dose-tapering pattern over two years of treatment with adalimumab and ≥12 mg/week methotrexate for early rheumatoid arthritis: Results of the HAWK postmarketing surveillance study in Japan

, , , , , & show all
Pages 424-433 | Received 26 Mar 2019, Accepted 01 Jul 2019, Published online: 22 Jul 2019

References

  • Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T, et al. The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1316–22.
  • Yamanaka H, Sugiyama N, Inoue E, Taniguchi A, Momohara S. Estimates of the prevalence of and current treatment practices for rheumatoid arthritis in Japan using reimbursement data from health insurance societies and the IORRA cohort (I). Mod Rheumatol. 2014;24(1):33–40.
  • Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014;73(3):492–509.
  • Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2012;64(5):625–39.
  • Kameda H, Fujii T, Nakajima A, Koike R, Sagawa A, Kanbe K, et al. Japan College of Rheumatology guideline for the use of methotrexate in patients with rheumatoid arthritis. Mod Rheumatol. 2019;29(1):31–40.
  • Visser K, Katchamart W, Loza E, Martinez-Lopez JA, Salliot C, Trudeau J, et al. Multinational evidence-based recommendations for the use of methotrexate in rheumatic disorders with a focus on rheumatoid arthritis: integrating systematic literature research and expert opinion of a broad international panel of rheumatologists in the 3E Initiative. Ann Rheum Dis. 2009;68(7):1086–93.
  • Combe B, Lula S, Boone C, Durez P. Effects of biologic disease-modifying anti-rheumatic drugs on the radiographic progression of rheumatoid arthritis: a systematic literature review. Clin Exp Rheumatol. 2018;36(4):658–67.
  • Kavanaugh A, van Vollenhoven RF, Fleischmann R, Emery P, Sainsbury I, Florentinus S, et al. Testing treat-to-target outcomes with initial methotrexate monotherapy compared with initial tumour necrosis factor inhibitor (adalimumab) plus methotrexate in early rheumatoid arthritis. Ann Rheum Dis. 2018;77(2):289–92.
  • Pharmaceuticals and Medical Devices Agency, Japan. FY 2008 list of approved products: new drugs. Available from: https://www.pmda.go.jp/files/000153061.pdf [last accessed 25 Sep 2018].
  • Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of 7740 patients. Mod Rheumatol. 2014;24(3):390–8.
  • Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol. 2012;22(4):498–508.
  • Pharmaceuticals and Medical Devices Agency, Japan. New drugs approved in FY 2012. Available from: https://www.pmda.go.jp/files/000228228.pdf [last accessed 25 Sep 2018].
  • Takeuchi T, Yamanaka H, Ishiguro N, Miyasaka N, Mukai M, Matsubara T, et al. Adalimumab, a human anti-TNF monoclonal antibody, outcome study for the prevention of joint damage in Japanese patients with early rheumatoid arthritis: the HOPEFUL 1 study. Ann Rheum Dis. 2014;73(3):536–43.
  • Nakashima Y, Miyahara H, Kondo M, Fukuda T, Harada H, Haraguchi A, et al. Impact of methotrexate dose on efficacy of adalimumab in Japanese patients with rheumatoid arthritis: results from registered data analyses. Mod Rheumatol. 2017;27(1):15–21.
  • Favalli EG, Becciolini A, Biggioggero M, Bertoldi I, Crotti C, Raimondo MG, et al. The role of concomitant methotrexate dosage and maintenance over time in the therapy of rheumatoid arthritis patients treated with adalimumab or etanercept: retrospective analysis of a local registry. Drug Des Devel Ther. 2018;12:1421–9.
  • Burmester GR, Kivitz AJ, Kupper H, Arulmani U, Florentinus S, Goss SL, et al. Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial. Ann Rheum Dis. 2015;74(6):1037–44.
  • Kaeley GS, Evangelisto AM, Nishio MJ, Goss SL, Liu S, Kalabic J, et al. Methotrexate dosage reduction upon adalimumab initiation: clinical and ultrasonographic outcomes from the randomized noninferiority MUSICA Trial. J Rheumatol. 2016;43(8):1480–9.
  • Manders SH, van de Laar MA, Rongen-van Dartel SA, Bos R, Visser H, Brus HL, et al. Tapering and discontinuation of methotrexate in patients with RA treated with TNF inhibitors: data from the DREAM registry. RMD Open. 2015;1(1):e000147.
  • Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T, et al. Effect of methotrexate plus adalimumab on the achievement of rheumatoid arthritis therapeutic goals: post hoc analysis of Japanese patients (MELODY study). Rheumatol Ther. 2016;3(1):129–41.
  • Tanaka Y, Mimori T, Yamanaka H, Nakajima R, Morita K, Kimura J, et al. Effectiveness and safety of initiating adalimumab plus ≥12 mg/week methotrexate with adjustable dosing in biologic-naive patients with early rheumatoid arthritis: HAWK study postmarketing surveillance in Japan. Mod Rheumatol. 2019;29(4):572–580.
  • Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012;64(5):640–7.
  • Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Hiramatsu K, et al. Adalimumab discontinuation in patients with early rheumatoid arthritis who were initially treated with methotrexate alone or in combination with adalimumab: 1 year outcomes of the HOPEFUL-2 study. RMD Open. 2016;2(1):e000189.
  • Manders SH, Kievit W, Adang E, Jansen TJ, Stolk JN, Visser H, et al. Effectiveness of TNF inhibitor treatment with various methotrexate doses in patients with rheumatoid arthritis: results from clinical practice. Ann Rheum Dis. 2015;74(3):e24.
  • Conway R, Carey JJ. Risk of liver disease in methotrexate treated patients. World J Hepatol. 2017;9(26):1092–100.