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

• Published in: Modern rheumatology 2019-03, Vol.29 (2), p.314-323
• Main Authors: Mimori, Tsuneyo, Harigai, Masayoshi, Atsumi, Tatsuya, Fujii, Takao, Kuwana, Masataka, Matsuno, Hiroaki, Momohara, Shigeki, Takei, Syuji, Tamura, Naoto, Takasaki, Yoshinari, Yamamoto, Kazuhiko, Ikeuchi, Satoshi, Kushimoto, Satoru, Koike, Takao
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antirheumatic Agents - administration & dosage; Antirheumatic Agents - adverse effects; Arthritis, Rheumatoid - diagnosis; Arthritis, Rheumatoid - drug therapy; Chromones - administration & dosage; Chromones - adverse effects; Drug Monitoring - methods; Drug-Related Side Effects and Adverse Reactions - diagnosis; Female; Humans; Iguratimod; Immunosuppressive Agents - administration & dosage; Immunosuppressive Agents - adverse effects; long-term effects; Male; Middle Aged; postmarketing surveillance study; Product Surveillance, Postmarketing; Prospective Studies; rheumatoid arthritis; safety; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Time; Treatment Outcome
• ISSN: 1439-7595; 1439-7609
• DOI: 10.1080/14397595.2018.1460230

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. Trial registration: ClinicalTrials.gov identifier: NCT01850966.