Simcere invited leading domestic medical scientists in the treatment of rheumatoid arthritis to announce a phase IV clinical study result of a category 1.1 new drug Iremod (Iguratimod Tablets) on June 15, 2021. The press conference came after the results published in the Lancet Regional Health-Western Pacific, a sub-journal of the world’s top medical journal The Lancet, this March.
Scientists included Professor Li Zhanguo and Dr. Li Chun from Peking University People’s Hospital, Professor Jiang Dexun, Professor Wang Kuanting, Professor Zhao Miansong from sub-centers and Dr. Huang Qin, Senior Vice President of Simcere. They interpreted the results of the study on the press conference and answered questions from media journalists from all over the country.
This was a nationwide, multi-center, real-world study of Iguratimod in the treatment of Rheumatoid Arthritis (RA). The project was led by Peking University People’s Hospital and involved 48 hospitals in China. A total of 1,759 participants aged 18-85 with or without multiple comorbidities such as hypertension and diabetes were enrolled. The total treatment course was 24 weeks.
Results from the study showed that 71.9% of patients who received Iguratimod treatment reached primary efficacy endpoint -- ACR20 at 24 weeks, while the secondary endpoints of ACR50 and ACR70 response at 24 weeks were 47.4% and 24.0%, respectively. In terms of safety, the incidence of ≥ grade 3 adverse events was 3.4%. 0.7% (13/1751) of SAEs were related to Iguratimod.
Moreover, compared with previous studies, no new adverse reactions were observed in this large-sample study, which was one of the main conclusions of this study. The analysis of factors related to efficacy suggested that male patients and those with a shorter duration of disease showed better response to the treatment. The study, led by Professor Li Zhanguo, filled a gap in the large sample clinical data of Iremod in the Chinese population, providing new guidance and a basis for clinical medication.
Publication of this study in the journals under The Lancet has also highlighted the attention paid by international academic community to Iremod, as well as their recognition on China's RA clinical research.
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