Advanced search
Publication Cover
Modern Rheumatology Volume 29, 2019 - Issue 2
Journal homepage
718
Views
31
CrossRef citations to date
0
Altmetric
Original Article

Safety and effectiveness of iguratimod in patients with rheumatoid arthritis: Final report of a 52-week, multicenter postmarketing surveillance study

Tsuneyo MimoriDepartment of Rheumatology and Clinical Immunology, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Correspondence[email protected]
,
Masayoshi HarigaiDivision of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women’s Medical University, Tokyo, Japan;
,
Tatsuya AtsumiDepartment of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University Graduate School of Medicine, Hokkaido, Japan;
,
Takao FujiiDepartment of Rheumatology and Clinical Immunology, Wakayama Medical University, Wakayama, Japan;
,
Masataka KuwanaDepartment of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan;
,
Hiroaki MatsunoMatsuno Clinic for Rheumatic Diseases, Toyama, Japan;
,
Shigeki MomoharaHakkeikai Incorporated Medical Institution, Shizuoka, Japan; ;Department of Orthopaedic Surgery, Keio University, Tokyo, Japan;
,
Syuji TakeiGraduate School of Medical and Dental Sciences, Comprehensive Child Health and Development Medicine, Kagoshima University, Kagoshima, Japan;
,
Naoto TamuraDepartment of Internal Medicine and Rheumatology, Juntendo University Faculty of Medicine, Tokyo, Japan;
,
Yoshinari TakasakiJuntendo University Koshigaya Hospital, Juntendo University Faculty of Medicine, Saitama, Japan;
,
Kazuhiko YamamotoLaboratory for Autoimmune Diseases, RIKEN Center for Integrative Medical Sciences, Kanagawa, Japan;
,
Satoshi IkeuchiFrontier PMS Section, Neurology Medical Department, Medical HQs, Eisai Co., Ltd., Tokyo, Japan;
,
Satoru KushimotoPost-Marketing Surveillance Group, Data Science and Administration Department, Toyama Chemical Co., Ltd., Tokyo, Japan;
&
Takao KoikeSapporo Medical Center NTT EC, Hokkaido, Japan
 show all
Pages 314-323 | Received 02 Feb 2018, Accepted 29 Mar 2018, Published online: 27 Apr 2018

References

  • Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69:631–7.
  • 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;76:960–77.
  • Pincus T, Gibson KA, Castrejón I. Update on methotrexate as the anchor drug for rheumatoid arthritis. Bull Hosp Jt Dis. 2013;71(1):S9–S19.
  • Kohno M, Aikawa Y, Tsubouchi Y, Hashiramoto A, Yamada R, Kawahito Y, et al. Inhibitory effect of T-614 on tumor necrosis factor-alpha induced cytokine production and nuclear factor-kappaB activation in cultured human synovial cells. J Rheumatol. 2001;28:2591–6.
  • Tanaka K, Aikawa Y, Kawasaki H, Asaoka K, Inaba T, Yoshida C. Pharmacological studies on 3-formylamino-7-methylsulfonylamino-6-phenoxy-4H-1-benzopyran-4-one (T-614), 4th communication: Inhibitory effects on the production of interleukin-1 and interleukin-6. J Pharmacobiodyn. 1992;11:649–55.
  • Yamamoto M, Urata N, Yamamoto T, Aikawa Y, Funaki J, Tanaka K. Effect of a disease-modifying antirheumatic drug iguratimod (T-614) on inflammatory cytokine production (in Japanese). Jpn Pharmacol Ther. 2007;35:551–9.
  • 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;17:1–9.
  • Aikawa Y, Yamamoto M, Yamamoto T, Morimoto K, Tanaka K. An anti-rheumatic agent T-614 inhibits NF-κB activation in LPS-and TNFα-stimulated THP-1 cells without interfering with IκBα degradation. Inflamm Res. 2002;51:188–94.
  • Lü LJ, Bao CD, Dai M, Teng JL, Fan W, Du F, et al. Multicenter, randomized, double-blind, controlled trial of treatment of active rheumatoid arthritis with T-614 compared with methotrexate. Arthritis Rheum. 2009;61:979–87.
  • 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 dose of methotrexate: a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2013;23:430–9.
  • 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 a post-marketing surveillance study of 2679 patients in Japan. Mod Rheumatol. 2017;27:755–65.
  • Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. Pharmaceuticals and Medical Devices Safety Information No. 302. 2013. Available from: https://www.pmda.go.jp/files/000153314.pdf [last accessed 20 Jun 2017].
  • ICH Harmonised Tripartite Guideline. Clinical safety data management: definitions and standards for expedited reporting E2A. 1994. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf [last accessed 16 Mar 2017].
  • ICH Harmonised Tripartite Guideline. Post-approval safety data management: definitions and standards for expedited reporting E2D. 2003. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2D/Step4/E2D_Guideline.pdf [last accessed 16 Mar 2017].
  • Biopharmaceutical testing and related analytical methods [In Japanese]. 2012. Available from: http://www.pmda.go.jp/drugs/2012/P201200067/48029700_22400AMX00731000_K100_1.pdf [last accessed 26 Jul 2017] .
  • Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009;35:745–57.
  • Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009;68:954–60.
  • Bénichou C. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990;11:272–6.
  • Naughton CA. Drug-induced nephrotoxicity. Am Fam Physician. 2008;78:743–50.
  • Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Postmarketing surveillance of safety and effectiveness of etanercept in Japanese patients with rheumatoid arthritis. Mod Rheumatol. 2011;4:343–51.
  • Yamada T, Nakajima A, Inoue E, Tanaka E, Taniguchi A, Momohara S, et al. Incidence of malignancy in Japanese patients with rheumatoid arthritis. Rheumatol Int. 2011;31:1487–92.
  • Inoue E, Yamanaka H, Hara M, Tomatsu T, Kamatani N. Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28-C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407–9.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Order Reprints Request Corporate Permissions

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

Request Academic Permissions

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.

Related research

People also read lists articles that other readers of this article have read.

Recommended articles lists articles that we recommend and is powered by our AI driven recommendation engine.

Cited by lists all citing articles based on Crossref citations.
Articles with the Crossref icon will open in a new tab.