PMID- 29611761
OWN - NLM
STAT- MEDLINE
DCOM- 20190503
LR  - 20190503
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 29
IP  - 2
DP  - 2019 Mar
TI  - Safety and effectiveness of iguratimod in patients with rheumatoid arthritis: 
      Final report of a 52-week, multicenter postmarketing surveillance study.
PG  - 314-323
LID - 10.1080/14397595.2018.1460230 [doi]
AB  - OBJECTIVES: We evaluated the long-term (52 weeks) safety and effectiveness of 
      iguratimod (IGU) in patients with rheumatoid arthritis (RA). METHODS: This 
      multicenter, prospective, observational study included all evaluable RA patients 
      who received IGU since its market launch in 2012. We evaluated adverse events 
      (AEs); adverse drug reactions (ADRs); ADRs of special interest, including liver 
      and renal dysfunctions, interstitial lung disease, gastrointestinal and blood 
      disorders, and infection; and change in Disease Activity Score 28-C-reactive 
      protein (DAS28-CRP) at week 52. RESULTS: Safety and effectiveness were analyzed 
      in 2666 and 1614 patients, respectively. The incidences of AEs, serious AEs, 
      ADRs, and serious ADRs were 46.92, 7.35, 38.26, and 4.58%, respectively. The 
      incidence of ADRs peaked at approximately 4 weeks of treatment. Subsequently, the 
      ADR incidence did not increase over time. Improvement of RA activity was shown up 
      to week 52. CONCLUSION: Long-term treatment with IGU in patients with RA resulted 
      in a tolerable safety profile and an improvement in RA activity. IGU could be 
      considered a useful treatment option for patients with RA.
FAU - Mimori, Tsuneyo
AU  - Mimori T
AD  - a Department of Rheumatology and Clinical Immunology, Graduate School of Medicine 
      , Kyoto University , Kyoto , Japan.
FAU - Harigai, Masayoshi
AU  - Harigai M
AD  - b Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases , 
      Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - c Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine , 
      Hokkaido University Graduate School of Medicine , Hokkaido , Japan.
FAU - Fujii, Takao
AU  - Fujii T
AD  - d Department of Rheumatology and Clinical Immunology , Wakayama Medical 
      University , Wakayama , Japan.
FAU - Kuwana, Masataka
AU  - Kuwana M
AD  - e Department of Allergy and Rheumatology , Nippon Medical School Graduate School 
      of Medicine , Tokyo , Japan.
FAU - Matsuno, Hiroaki
AU  - Matsuno H
AD  - f Matsuno Clinic for Rheumatic Diseases , Toyama , Japan.
FAU - Momohara, Shigeki
AU  - Momohara S
AD  - g Hakkeikai Incorporated Medical Institution , Shizuoka , Japan.
AD  - h Department of Orthopaedic Surgery , Keio University , Tokyo , Japan.
FAU - Takei, Syuji
AU  - Takei S
AD  - i Graduate School of Medical and Dental Sciences, Comprehensive Child Health and 
      Development Medicine , Kagoshima University , Kagoshima , Japan.
FAU - Tamura, Naoto
AU  - Tamura N
AD  - j Department of Internal Medicine and Rheumatology , Juntendo University Faculty 
      of Medicine , Tokyo , Japan.
FAU - Takasaki, Yoshinari
AU  - Takasaki Y
AD  - k Juntendo University Koshigaya Hospital, Juntendo University Faculty of Medicine 
      , Saitama , Japan.
FAU - Yamamoto, Kazuhiko
AU  - Yamamoto K
AD  - l Laboratory for Autoimmune Diseases , RIKEN Center for Integrative Medical 
      Sciences , Kanagawa , Japan.
FAU - Ikeuchi, Satoshi
AU  - Ikeuchi S
AD  - m Frontier PMS Section, Neurology Medical Department , Medical HQs, Eisai Co., 
      Ltd. , Tokyo , Japan.
FAU - Kushimoto, Satoru
AU  - Kushimoto S
AD  - n Post-Marketing Surveillance Group, Data Science and Administration Department , 
      Toyama Chemical Co., Ltd. , Tokyo , Japan.
FAU - Koike, Takao
AU  - Koike T
AD  - o Sapporo Medical Center NTT EC , Hokkaido , Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20180427
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Chromones)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Sulfonamides)
RN  - 4IHY34Y2NV (iguratimod)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/administration & dosage/adverse effects
MH  - Arthritis, Rheumatoid/diagnosis/*drug therapy
MH  - *Chromones/administration & dosage/adverse effects
MH  - Drug Monitoring/methods
MH  - Drug-Related Side Effects and Adverse Reactions/*diagnosis
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - *Sulfonamides/administration & dosage/adverse effects
MH  - Time
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Iguratimod
OT  - long-term effects
OT  - postmarketing surveillance study
OT  - rheumatoid arthritis
OT  - safety
EDAT- 2018/04/04 06:00
MHDA- 2019/05/06 06:00
CRDT- 2018/04/04 06:00
PHST- 2018/04/04 06:00 [pubmed]
PHST- 2019/05/06 06:00 [medline]
PHST- 2018/04/04 06:00 [entrez]
AID - 10.1080/14397595.2018.1460230 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2019 Mar;29(2):314-323. doi: 10.1080/14397595.2018.1460230. Epub 
      2018 Apr 27.