Since
2012 I've been looking at iguratimod [1]. Iguratimod is a
conventional synthetic disease modifying anti-rheumatic drug
(csDMARD); 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 and RANKL production.
There
have been four studies presented at the EULAR 2020 Online Meeting and
one publication in Clinical Rheumatology.
K.
Katayama and colleagues presented [2]: „SAT0146 INHIBITION
OF RADIOGRAPHIC PROGRESSION BY IGURATINOD IN 116 JAPANESE RHEUMATOID
ARTHIRITIS PATIENTS DESPITE CONVENTIONAL SYNTHETIC DISEASE-MODIFYING
ANTIRHEUMATIC DRUGS
THERAPY“. The study looked at 116 patients after one year of
therapy; joint damage was evaluated by modified total Sharp scoring
(mTSS) and RA activity was measured by DAS28-ESR.
„Iguratimod suppressed not
only clinical activities but also joint destruction
in RA patients resistant to csDMARDs therapy.“
D.
Kobayashi and colleagues presented the following study [3]: „SAT0147
EFFICACY AND SAFETY OF IGURATIMOD AS FIRSTLINE DISEASE-MODIFYING
ANTIRHEUMATIC DRUG THERAPY FOR PATIENTS WITH RHEUMATOID ARTHRITIS“.
The prospective single-center study aimed at efficacy and safety of
iguratimod as a first-line DMARD in patients with rheumatoid
arthritis. Conclusion: „Our study indicates IGU is safe and
effective for DMARD naive RA patients. Starting treatment with IGU
might be a new and effective strategy for RA
patients
without previous use of a DMARD.“ Not much new information. The
results are congruent with former studies.
T.
Miyamoto and colleagues looked at RA patients with inadequate
response to adalimumab [4]: „AB0350 EFFICACY OF ADDING IGURATIMOD
THERAPY IN RHEUMATOID ARTHRITIS PATIENTS WHO HAD INADEQUATE RESPONSE
TO BIOLOGIC DMARDS“. The authors looked at 107 RA patients
receiving adalimumab plus methotrexate. The study is not blinded, no
placebo arm. Results: „Mean DAS28-ESR, SDAI, CDAI were
significantly decreased from the initiation of IGU treatment at 24
weeks (3.1→2.3, 7.1→2.7, 6.5→2.4), at 52 weeks (2.1, 2.4, 2.0).
Remission rates of DAS28-ESR, SDAI, CDAI were 69.2%, 68.2%, 70.1% at
24 weeks, 74.8%, 78.5%, 79.4% at 52 weeks.“ I hab´ve problems with
the statistics of this study. However the conclusion seems to be
correct: „IGU might be a new RA treatment option for aiming
remission in patients who had inadequate response to Bio.“
Y.
Mochida and colleagues looked at 190 elderly patient [5]: „EFFICACY
OF IGURATIMOD FOR RHEUMATOID ARTHRITIS IN
ELDERLY PATIENTS“. Conclusion: „From
the results of this study, the efficacy of IGU for elderly patients
was confirmed and did not show differences with non-elderly people.
IGU is an inexpensive drug with enough efficacy and thought to be
possible substitute for cases with insufficient reaction with other
DMARDs.“ Let's keep in mind: inexpensive drug.
And
there is the study of S. Mizutani and colleagues in Clinical
rheumatology [6]: „Clinical effectiveness of iguratimod based on
real-world data of patients with rheumatoid arthritis“. „Disease
activity scores in 177 RA patients treated using IGU were
retrospectively evaluated“. The authors concluded, that iguratimod
is effective for rheumatoid arthritis, especially with concomitant
methotrexate. „Since all serious adverse events were in the elderly
group in this study, sufficient monitoring for adverse events,
especially for elderly RA patients, is needed during iguratimod
therapy.“
Most
if not all studies presented in this blogpost or the preceding ones
would not meet the standards to apply for an approval by EMA or FDA,
but iguratimod is an inexpensive csDMARD used successfully in Japan.
So why isn't the drug made available in the rest of the world?
Links:
[1]
Iguratimod at the EULAR Meeting 2012
Iguratimod
at the EULAR Meeting 2013
Iguratimod
at the ACR 2013 Meeting
Iguratimod
at the EULAR 2014 Meeting
Iguratimod
at the ACR 2015 Meeting
https://rheumatologe.blogspot.com/2015/11/iguratimod-at-acr-2015-meeting-in-san.html
Iguratimod
at the EULAR 2017 Meeting
[2]
K. Katayama1, T. Okubo1, K. Yujiro2, R. Fukai3, T. Sato1, M. Yuichi4,
S. Abe4, H. Ito4. SAT0146 INHIBITION OF RADIOGRAPHIC PROGRESSION
BY
IGURATINOD IN 116 JAPANESE RHEUMATOID ARTHIRITIS PATIENTS DESPITE
CONVENTIONAL SYNTHETIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS THERAPY.
DOI: 10.1136/annrheumdis-2020-eular.1434
[3]
D. Kobayashi1,2, E. Hasegawa2,3, Y. Wada4, S. Ito2, A. Abe2, K.
Nakazono2, A. Murasawa2, I. Narita1, H. Ishikawa2. SAT0147 EFFICACY
AND SAFETY OF IGURATIMOD AS FIRSTLINE DISEASE-MODIFYING ANTIRHEUMATIC
DRUG THERAPY FOR PATIENTS WITH RHEUMATOID ARTHRITIS. DOI:
10.1136/annrheumdis-2020-eular.2691
[4]
T. Miyamoto1,2, K. Yamazaki1. AB0350 EFFICACY OF ADDING IGURATIMOD
THERAPY IN RHEUMATOID ARTHRITIS PATIENTS WHO HAD INADEQUATE RESPONSE
TO BIOLOGIC DMARDS. DOI: 10.1136/annrheumdis-2020-eular.459
[5]
Y. Mochida1, K. Harigane1, T. Shimazaki1, Y. Inaba2, A. Nagaoka2.
AB0351 EFFICACY OF IGURATIMOD FOR RHEUMATOID
ARTHRITIS
IN ELDERLY PATIENTS. DOI: 10.1136/annrheumdis-2020-eular.2639
[6]
Mizutani S, Kodera H, Sato Y, Nanki T, Yoshida S, Yasuoka H. Clinical
effectiveness of iguratimod based on real-world data of patients with
rheumatoid arthritis [published online ahead of print, 2020 Jun 6].
Clin Rheumatol. 2020;10.1007/s10067-020-05208-y.
doi:10.1007/s10067-020-05208-y
https://pubmed.ncbi.nlm.nih.gov/32506311/
.
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