PMID- 27919207
OWN - NLM
STAT- MEDLINE
DCOM- 20180411
LR  - 20220310
IS  - 1439-7609 (Electronic)
IS  - 1439-7595 (Linking)
VI  - 27
IP  - 5
DP  - 2017 Sep
TI  - 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.
PG  - 755-765
LID - 10.1080/14397595.2016.1265695 [doi]
AB  - OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod 
      (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing 
      surveillance study was conducted. An interim analysis at week 24 was performed. 
      METHODS: This study included all RA patients who received IGU following its 
      introduction to the market. All adverse events (AEs) and adverse drug reactions 
      (ADRs) were collected. Effectiveness was evaluated by the change in Disease 
      Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. 
      RESULTS: Safety was analyzed in 2679 patients. The overall incidences of AEs, 
      ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most 
      commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial 
      lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use 
      and comorbid conditions associated with respiratory disease were identified as 
      risk factors for serious infections. Pulmonary alveolar hemorrhage and increased 
      international normalized ratio of prothrombin time were observed with concomitant 
      use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. 
      CONCLUSION: Although a safety concern was identified with concomitant use of IGU 
      and warfarin, this real-world study showed no other new safety concerns and 
      similar effectiveness to clinical trials. IGU is a new therapeutic option for RA 
      patients.
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 Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
FAU - Atsumi, Tatsuya
AU  - Atsumi T
AD  - c Division of Rheumatology, Endocrinology and Nephrology , 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 Department of Pediatric Rheumatology, Faculty of Medicine , School of Health 
      Sciences, Medical Center for Children, Kagoshima University , Kagoshima , Japan.
FAU - Tamura, Naoto
AU  - Tamura N
AD  - j Department of Internal Medicine and Rheumatology, Faculty of Medicine , 
      Juntendo University , Tokyo , Japan.
FAU - Takasaki, Yoshinari
AU  - Takasaki Y
AD  - k Faculty of Medicine , Juntendo University Koshigaya Hospital, Juntendo 
      University , Saitama , Japan.
FAU - Ikeuchi, Satoshi
AU  - Ikeuchi S
AD  - l Frontier PMS Section, Neurology Medical Department , Medical Division, Eisai 
      Co, Ltd , Tokyo , Japan.
FAU - Kushimoto, Satoru
AU  - Kushimoto S
AD  - m Post-Marketing Surveillance Group, Data Science and Administration Department , 
      Toyama Chemical Co, Ltd , Tokyo , Japan , and.
FAU - Koike, Takao
AU  - Koike T
AD  - n Sapporo Medical Center NTT EC , Hokkaido , Japan.
LA  - eng
PT  - Journal Article
DEP - 20161221
PL  - England
TA  - Mod Rheumatol
JT  - Modern rheumatology
JID - 100959226
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Chromones)
RN  - 0 (Glucocorticoids)
RN  - 0 (Sulfonamides)
RN  - 4IHY34Y2NV (iguratimod)
RN  - 9007-41-4 (C-Reactive Protein)
SB  - IM
EIN - Mod Rheumatol. 2017 Sep;27(5):v. PMID: 28332887
MH  - Adult
MH  - Antirheumatic Agents/administration & dosage/adverse effects
MH  - *Arthritis, Rheumatoid/diagnosis/drug therapy/epidemiology
MH  - C-Reactive Protein/analysis
MH  - *Chromones/administration & dosage/adverse effects
MH  - Drug Monitoring/methods
MH  - Drug Therapy, Combination/methods
MH  - Female
MH  - *Glucocorticoids/administration & dosage/adverse effects
MH  - Humans
MH  - Japan/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/methods
MH  - Risk Factors
MH  - *Sulfonamides/administration & dosage/adverse effects
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Iguratimod
OT  - Post-marketing surveillance
OT  - Rheumatoid arthritis
OT  - Safety
EDAT- 2016/12/07 06:00
MHDA- 2018/04/12 06:00
CRDT- 2016/12/07 06:00
PHST- 2016/12/07 06:00 [pubmed]
PHST- 2018/04/12 06:00 [medline]
PHST- 2016/12/07 06:00 [entrez]
AID - 10.1080/14397595.2016.1265695 [doi]
PST - ppublish
SO  - Mod Rheumatol. 2017 Sep;27(5):755-765. doi: 10.1080/14397595.2016.1265695. Epub 
      2016 Dec 21.