Abstract
We conducted a 52-week clinical study of iguratimod in 394 Japanese patients with rheumatoid arthritis to evaluate the long-term safety of the drug. Iguratimod was administered orally at a daily dose of 25 mg for the first 4 weeks and 50 mg for the subsequent 48 weeks. Some of the patients continued the treatment for 100 weeks for their benefit. The cumulative incidence of adverse events for 100 weeks was 97.6%. The cumulative incidence of adverse reactions was 65.3%; unfavorable symptoms and signs (excluding abnormal laboratory data changes) accounted for 33.2% of the reactions, and abnormal laboratory data changes accounted for 50.4%. The continued treatment rate was 66.8% at week 28 and 53.6% at week 52. For reference, the American College of Rheumatology (ACR) 20 response rate was calculated for the patients who had assessable disease activity, who did not violate the study protocol, and who continued the study treatment at weeks 28 and 52. The rate was 46.9% at week 28 and 41.0% at week 52. To use iguratimod safely for a long time, patients should be observed closely for adverse reactions such as increased hepatic enzymes.
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K Tanaka T Shimotori S Makino Y Aikawa T Inaba C Yoshida et al. (1992) ArticleTitlePharmacological studies of the new antiinflammatory agent 3-formylamino-7-methylsulfonylamino-6-phenoxy-4H-1-benzopyran-4-one. 1st communication: antiinflammatory, analgesic and other related properties Arzneimittelforschung 42 935–44 Occurrence Handle1418059 Occurrence Handle1:CAS:528:DyaK38XlsVejs7c%3D
K Tanaka T Shimotori Y Taniguchi M Eguchi C Abe (1993) ArticleTitlePharmacological studies on T-614, a novel anti-inflammatory agent: effect on type II collagen-induced arthritis in DBA/1J mice and spontaneous arthritis in MRL/l mice Int J Immunother 9 69–78 Occurrence Handle1:CAS:528:DyaK3sXmtFKqsLw%3D
K Tanaka T Yamamoto Y Aikawa K Kizawa K Muramoto H Matsuno et al. (2003) ArticleTitleInhibitory effects of an anti-rheumatic agent T-614 on immunoglobulin production by cultured B cells and rheumatoid synovial tissues engrafted into SCID mice Rheumatology (Oxf) 42 1365–71 Occurrence Handle10.1093/rheumatology/keg381 Occurrence Handle1:CAS:528:DC%2BD3sXos1antbY%3D
M Kohno Y Aikawa Y Tsubouchi A Hashiramoto R Yamada Y Kawahito et al. (2001) ArticleTitleInhibitory effect of T-614 on tumor necrosis factor-alpha induced cytokine production and nuclear factor-kappaB activation in cultured human synovial cells J Rheumatol 28 2591–6 Occurrence Handle11764202 Occurrence Handle1:CAS:528:DC%2BD38Xht12iuw%3D%3D
Y Aikawa M Yamamoto T Yamamoto K Morimoto K Tanaka (2002) ArticleTitleAn anti-rheumatic agent T-614 inhibits NF-kappaB activation in LPS- and TNF-alpha-stimulated THP-1 cells without interfering with IkappaBalpha degradation Inflamm Res 51 188–94 Occurrence Handle12058956 Occurrence Handle10.1007/PL00000291 Occurrence Handle1:CAS:528:DC%2BD38XjtlWhtLc%3D
JC Edwards G Cambridge (2001) ArticleTitleSustained improvement in rheumatoid arthritis following a protocol designed to delete B lymphocytes Rheumatology (Oxf) 40 201–11
S De Vita F Zaja S Sacco A Dde Candia R Fanin G Ferraccioli (2002) ArticleTitleEfficacy of selective B cell blockade in the treatment of rheumatoid arthritis; evidence for a pathogenetic role of B cells Arthritis Rheum 46 2029–33 Occurrence Handle12209504 Occurrence Handle10.1002/art.10467 Occurrence Handle1:CAS:528:DC%2BD38XmvFOqtLw%3D
DT Felson JJ Anderson M Boers C Bombardier M Chernoff B Fried et al. (1993) ArticleTitleThe American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials Arthritis Rheum 36 729–40 Occurrence Handle8507213 Occurrence Handle1:STN:280:ByyB1c3os1c%3D
DT Felson JJ Anderson M Boers C Bombardier D Furst C Goldsmith et al. (1995) ArticleTitleAmerican College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis Arthritis Rheum 38 727–35 Occurrence Handle7779114 Occurrence Handle1:STN:280:ByqB1MfgsFI%3D
T Inoue S Kawai T Azuma T Asai S Kondoh (1997) ArticleTitleProposed standard of clinical trial for antirheumatic drug/therapy by the Drug Evaluation Committee of Japan Rheumatism Foundation The RYUMACHI 37 516–20
FC Arnett SM Edworthy DA Bloch DJ McShane JF Fries NS Cooper et al. (1988) ArticleTitleThe American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis Arthritis Rheum 31 315–24 Occurrence Handle3358796 Occurrence Handle1:STN:280:BieC1M3nt1Q%3D
T Pincus JA Summey SA Soraci SuffixJr KA Wallston NP Hummon (1983) ArticleTitleAssessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire Arthritis Rheum 26 1346–53 Occurrence Handle6639693 Occurrence Handle1:STN:280:BiuD2M3mt1Q%3D
http://www.meddramsso.com/NewWeb2003/index.htm
M Hara T Abe S Sugawara M Mizushima K Hoshi S Irimajiri (2007) ArticleTitleEfficacy and safety of iguratimod compared with placebo and salazosulfapyridine in active rheumatoid arthritis: a controlled, multicentre, double-blind, parallel-group study Modern Rheumatology 17 1–9
H Tateishi R Ogawa T Nakamura N Murata S Tanaka (2003) ArticleTitleEvaluation of long-term safety and efficacy of leflunomide in Japanese patients with rheumatoid arthritis (in Japanese) J New Remedies Clinics 52 IssueID7 932
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Hara, M., Abe, T., Sugawara, S. et al. Long-term safety study of iguratimod in patients with rheumatoid arthritis. Mod Rheumatol 17, 10–16 (2007). https://doi.org/10.1007/s10165-006-0543-x
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DOI: https://doi.org/10.1007/s10165-006-0543-x