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Simcere Unveils Latest Clinical Data of Iguratimod and Abatacept at EULAR

Release time:2021-06-10

The European Alliance of Associations for Rheumatology(EULAR)2021 Virtual Congress was held online from 2nd to 5th June (Central European Summer Time). This is a major event in the world rheumatology calendar. During this congress, two clinical studies conducted on Simcere’s innovative rheumatology drug Iremod® (Iguratimod Tablets) was included in EULAR's poster, and the latest clinical research data was released.

Iguratimod (IGU) alone demonstrated superior efficacy compared to Methotrexate (MTX) (POS0664)

Study cases: 895 

Efficacy results: IGU monotherapy and IGU+MTX were found to be superior to MTX at week 52 with a higher ACR20 response of 77.44%(230/297, P=0.0019) and 77.05%(235/305, P=0.0028) versus 65.87%(193/293).

Safety results: The incidence of adverse drug reactions (ADR) leading to study discontinuation were 11.45% (34/297), 8.53% (25/293) and 9.21% (28/305), respectively. There was no one death and no significant difference in all the safety indicators among the three arms.

PI:Chunde Bao,Renji Hospital of Shanghai Jiao Tong University School of Medicine

Comment by PI:

“This is a surprising yet inspiring discovery. Iremod, as a traditional synthetic DMARDs, has shown superior efficacy over methotrexate. It provides an important reference for selection of clinical drugs.

On the other hand, the combined treatment of Iguratimod with methotrexate has similar efficacy when compared with Iremod monotherapy. This may be due to the fact that the ACR20 of iguratimod monotherapy has reached 77.44%, which is a very high level. The addition of other drugs would have very limited improvement. The results suggest that for patients with early rheumatoid arthritis, Iremod monotherapy alone can achieve good therapeutic effect. Unless results of Iremod monotherapy are not satisfactory, it is not necessary to combine with other treatment drugs. "

IGU-based monotherapy and combined therapies are tolerant and effective for treating undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) (pos0647)

Study case: 313

Efficacy results:

The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment).

Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. The proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course

Safety results: 25.8% pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study.

PI: Qiang Shu, Qilu Hospital of Shandong University

Comment by PI:

"Early treatment is of great importance to RA patients. Although methotrexate (MTX) is regarded as an anchor drug for RA treatment, there is still much room for improvement in first-line regimen for RA. Our research suggests that treatment can be optimized based on the patient’s baseline characteristics. For example, patients with low disease activity and few adverse prognostic factors may start with Iremod monotherapy; while patients with high disease activity and poor prognostic factors may choose Iremod combined with methotrexate or other medications during initial therapy. This strategy can reduce possible safety risks or issues caused by over-treatment due to unnecessary drug combination, as well as ensure sufficient treatment intensity. On the other hand, for most early-stage ERA and UA patients with low disease activity, the initial application of Iguratimod monotherapy has good efficacy and safety. In conclusion, the initial application of Iremod-based therapy is effective and safe for RA patients at different stages." 

Furthermore, Orencia® (Abatacept Injection), an innovative drug jointly developed in China by Simcere and BMS, also released data on multiple international clinical studies during the EULAR conference in the form of posters, oral presentation and abstracts. The new data on using biomarkers to predict the prognosis of individual patient, and the application of Abatacept in rheumatoid arthritis-associated interstitial pneumonia (RA-ILD) have attracted widespread academic attention. 

For more details, please visit EULAR's official website: https://congress.eular.org/ 

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.