You might have noticed, that I’ve been following the development of iguratimod very closely since 2012. Iguratimod is a disease modifying anti-rheumatic drug (DMARD); chemical formula: N-(3-Formamido-4-oxo-6-phenoxy-4H-chromen-7-yl)-methanesulfonamide. “Iguratimod is characterized by inhibitory effects on immunoglobulin production in B cells as well as inhibiting cytokine production. Its' mode of action comes by suppression of nuclear factor kappa B (NF-kB) activation.” It is approved for the treatment of rheumatoid arthritis in Japan as well as in China!
Rong Mu and colleagues presented the following study at the 2016 ACR Annual Meeting [#1622]: “Safety and Efficacy of Iguratimod in Patients with Active Rheumatoid Arthritis: A Multicenter, Single-Arm, Open-Label, Real World Study”. Conclusion: “Iguratimod was effective and well tolerated in active RA patients in this large sample phase IV clinical trial. No unexpected adverse drug reaction was found.” And let me add, I would have been surprised if this study showed any new data. But it confirms data from underpowered earlier studies. “1759 patients were enrolled in this study, among them 1751 were included in safety analysis, and 1597 patients were evaluated for efficacy.” 164 missing patients! That’s about 10%.
A second study by Lingshu Zhang and colleagues is about Sjoegren’s syndrome [#2666]: “Therapeutic Efficacy of Iguratimod in Patients with Primary Sjogren’s Syndrome”. Conclusion: “In subjects with pSS, IGU treatment resulted in clinically meaningful improvements in disease activity compared with conventional therapy. IGU affected B cell frequency and functions in pSS via inhibition of BAFF-R expression on B cells and inhibition of B cell antibody production.” The data supports the conclusion. I stumbled about the word meaningful, but as the ESSPRI is a patient reported index, I can live with the wording.
I see a potential for this drug on the world market, but I don’t see any commitment by the producers Eisai and Toyama Chemical to come to the international markets outside of East Asia.
Mu R. Safety and Efficacy of Iguratimod in Patients with Active Rheumatoid Arthritis: A Multicenter, Single-Arm, Open-Label, Real World Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/safety-and-efficacy-of-iguratimod-in-patients-with-active-rheumatoid-arthritis-a-multicenter-single-arm-open-label-real-world-study/. Accessed December 21, 2016.
Zhang L, Jiang W, Chu CQ, Liu Y. Therapeutic Efficacy of Iguratimod in Patients with Primary Sjogren’s Syndrome [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). http://acrabstracts.org/abstract/therapeutic-efficacy-of-iguratimod-in-patients-with-primary-sjogrens-syndrome/. Accessed December 21, 2016.