Core Viewpoint - The clinical trial results of QX002N (Lusacitinib) for treating ankylosing spondylitis (AS) show significant efficacy, indicating a potential new treatment option for AS patients [1][2] Group 1: Clinical Trial Overview - The Phase III clinical trial was led by Professor Zeng Xiaofeng from Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study design was a multi-center, randomized, double-blind, placebo-controlled trial with a treatment period of 48 weeks and a safety follow-up of 4 weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the Lusacitinib group was 40.4%, significantly higher than the placebo group's 18.9% (P<0.0001) [1] - The ASAS20 response rate for the Lusacitinib group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] Group 3: Imaging and Inflammation Assessment - MRI assessments showed that the spinal score for the Lusacitinib group changed by -8.1, while the sacroiliac joint score changed by -6.2, both significantly better than the placebo group's -1.4 and -2.3 [2] - These results provide objective imaging evidence that Lusacitinib effectively alleviates edema and inflammation in the spine and sacroiliac joints [2] Group 4: Safety Profile - The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Lusacitinib group was similar to that of the placebo group, with most TEAEs being mild to moderate [2] - The overall safety profile of Lusacitinib is considered good, supporting its potential as a new treatment option for AS patients [2] Group 5: Future Prospects - The company plans to accelerate the registration application process for Lusacitinib to seek early approval for market launch [2]
荃信生物-B：鲁塞奇塔单抗(QX002N)强直性脊柱炎III期临床研究成果亮相2025年ACR年会