Friday, June 19, 2020

Iguratimod at the EULAR 2020 Online Meeting


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 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/

.



No comments:

Post a Comment