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.
Links:
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.
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