I’ve been
following the development of iguratimod very closely since 2012 [1]. 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![2]
There had
been four abstracts on iguratimod at the 2017 EULAR Annual Meeting in Madrid.
K. Tokunaga
and colleagues looked at [3]: “COMPARISON OF EFFICACY BETWEEN COMBINATION THERAPY
WITH IGURATIMOD [IGU] AND SULFASALAZINE [SSZ] WITH METHOTREXATE IN JAPANESE
PATIENTS WITH RHEUMATOID ARTHRITIS: PROPENSITY SCORE ANALYSIS”. Luckily the
study excluded DMARDs like tacrolimus and bucillamine, which aren’t approved worldwide
for rheumatoid arthritis. In results we read: “The remission rates of DAS28-CRP
in the following year was 77.2% (44/57 patients) and 71.7% (38/53 patients;
P=0.52) in the IGU and SSZ groups, respectively.” Conclusions: “Combination
therapy with IGU or SSZ and methotrexate for rheumatoid arthritis did not show
a significant difference in disease activity. Further studies are needed.“
According to this study iguratimod fits into the group of csDMARDs like methotrexate,
leflunomide, sulfasalazine, azathioprine.
Y. Hirano
and colleagues presented [4]: “LONG-TERM OUTCOME OF IGURATIMOD, CONVENTIONAL SYNTHETIC
DISEASE-MODIFYNG ANTI-RHEUMATIC DRUD DEVELOPED IN JAPAN, IN JAPANESE PATIENTS
WITH RHEUMATOID ARTHRITIS IN REAL-WORLD CLINICAL SETTING”. “82% of patients had
factors influencing to prescribing IGU and intolerance of dose escalation of
MTX was 1st reason (23.3%), old age over 80 years old was 2nd reason (16.7%)
and economical reason was 3rd (14.2%)”. In conclusions the authors hinted t: “Although
biological DMARDs is effective in RA patients, the cost is very expensive. IGU
is comparative cheap (¥9,200/month) and suitable for RA patients with
economical difficulties.” ¥9,200 is a little less than 75 €.
T. Suto and
colleagues also presented long term data [5]: “EFFICACY AT THREE YEARS OF DAILY
CLINICAL USE OF IGURATIMOD IN PATIENTS WITH RHEUMATOID ARTHRITIS”. “The
survival rate at 3 years was 49.3%, and 8 patients discontinued the IGU
therapies due to insufficient response, 12 patients due to adverse events such as
exanthema, pneumonitis or hepatic disorder, and other patients based on their requests.”
Conclusions: “We assessed middle-term outcome of the clinical use of iguratimod
therapy in RA patients. The low DAS28-CRP and low usage rate of prednisolone at
the initiation of IGU were significant factors of clinical remission
achievement at 3 years.”
Iguratimod
could be a useful addition to existing csDMARDs, but would have to be evaluated
in randomized controlled studies. Maybe a pharmaceutical firm in Europe or the
US should buy the patent for the non-Asian market and evaluate iguratimod in
studies that are needed to get EMA or FDA approval. Otherwise only Japanese and
Chinese patients will have access to iguratimod.
Links and
References:
[3] DOI:
10.1136/annrheumdis-2017-eular.6157
[4] DOI:
10.1136/annrheumdis-2017-eular.4852
[5] DOI:
10.1136/annrheumdis-2017-eular.6040
.
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