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Rheumatoid Arthritis

Factors influencing physician decisions to discontinue treatment after onset of liver dysfunction: Post-hoc analysis of an all-case post-marketing surveillance study of iguratimod

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Pages 633-639 | Received 20 Feb 2019, Accepted 25 Jul 2019, Published online: 12 Aug 2019

References

  • Smolen JS, Landewé R, Bijlsma J, Burmester G, Chatzidionysiou K, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017;76(6):960–77.
  • Subcommittee on Development of Guidelines for the Use of Methotrexate in the Treatment of Rheumatoid Arthritis., editors. Japan College of Rheumatology Guideline for the Use of Methotrexate in Patients with Rheumatoid Arthritis. Tokyo: Yodosha; 2016.
  • Hara M, Abe T, Sugawara S, Mizushima Y, Hoshi K, Irimajiri S, et al. Efficacy and safety of iguratimod compared with placebo and salazosulfapyridine in active rheumatoid arthritis: a controlled, multicenter, double-blind, parallel-group study. Mod Rheumatol. 2007;17(1):1–9.
  • Hara M, Abe T, Sugawara S, Mizushima Y, Hoshi K, Irimajiri S, et al. Long-term safety study of iguratimod in patients with rheumatoid arthritis. Mod Rheumatol. 2007;17(1):10–6.
  • Mimori T, Harigai M, Atsumi T, Fujii T, kuwana M, Matsuno H, et al. Safety and effectiveness of iguratimod in patients with rheumatoid arthritis: Final report of a 52-week, multicenter postmarketing surveillance study. Mod Rheumatol. 2018;27:1–10.
  • Mimori T, Harigai M, Atsumi T, Fujii T, Kuwana M, Matsuno H, et al. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of post-marketing surveillance study of 2679 patients in Japan. Mod Rheumatol. 2017;27(5):755–65.
  • ICH Harmonized Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting E2A step 4. [dated 1994 Oct 27]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf [last accessed 30 Jul 2019]
  • ICH Harmonized Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting E2D step 4. [dated 2003 Nov 12]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf [last accessed 30 Jul 2019]
  • Japanese Committee for clinical laboratory standards. Common reference intervals for standardized clinical laboratory test in Japan. [updated 2014 Mar 31]. Available from: http://www.jccls.org/techreport/public_comment_201405_p.pdf [last accessed 30 Jul 2019]
  • Ishiguro N, Yamamoto K, Katayama K, Kondo M, Sumida T, Mimori T, et al. Concomitant iguratimod therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate: a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2013;23(3):430–9.
  • Salliot C, van der Heijde D. Long-term safety of methotrexate monotherapy in patients with rheumatoid arthritis: a systematic literature research. Ann Rheum Dis. 2009;68(7):1100–4.
  • Amos RS, Pullar T, Bax DE, Situnayake D, Capell HA, McConkey B. Sulphasalazine for rheumatoid arthritis: toxicity in 774 patients monitored for one to 11 years. Br Med J (Clin Res Ed). 1986;293(6544):420–3.
  • Yamanaka H, Inoue E, Tanaka E, Nakajima A, Taniguchi A, Terai C, et al. Influence of methotrexate dose on its efficacy and safety in rheumatoid arthritis patients: evidence based on the variety of prescribing approaches among practicing Japanese rheumatologists in a single institute-based large observational cohort (IORRA). Mod Rheumatol. 2007;17(2):98–105.
  • Rodriguez-Rodriguez L, Jover-Jover JA, Fontsere O, Peña-Blanco RC, León L, Fernández-Gutierrez B, Abásolo L. Leflunomide discontinuation in rheumatoid arthritis and influence of associated disease-modifying anti-rheumatic drugs: a survival analysis. Scand J Rheumatol. 2013;42(6):433–6.
  • Abasolo L, Leon L, Rodriguez-Rodriguez L, Tobias A, Rosales Z, Maria Leal J, et al. Safety of disease-modifying antirheumatic drugs and biologic agents for rheumatoid arthritis patients in real-life conditions. Semin Arthritis Rheum. 2015;44(5):506–13.
  • Katchamart W, Trudeau J, Phumethum V, Bombardier C. Efficacy and toxicity of methotrexate (MTX) monotherapy versus MTX combination therapy with non-biological disease-modifying antirheumatic drugs in rheumatoid arthritis: a systematic review and meta-analysis. Ann Rheum Dis. 2009;68(7):1105–12.
  • Strand V, Miller P, Williams SA, Saunders K, Grant S, Kremer J. Discontinuation of Biologic Therapy in Rheumatoid Arthritis: Analysis from the Corrona RA Registry. Rheumatol Ther. 2017;4(2):489–502.
  • Yazici Y, Sokka T, Kautiainen H, Swearingen C, Kulman I, Pincus T. Long term safety of methotrexate in routine clinical care: discontinuation is unusual and rarely the result of laboratory abnormalities. Ann Rheum Dis. 2005; 64(2):207–11.