Background Axial spondyloarthritis (axSpA) is a chronic inflammatory disease, which includes AS and nr-axSpA. Anti-TNF-α agents, such as Yisaipu (Yisaipu) are frequently used in nr-axSpA patients in China, but the related data is limited.
Objectives The aim of this research is to assess the efficacy and safety of Yisaipu in the treatment of patients with nr-axSpA in China.
Methods The inclusion of study population consisted of 150 patients who met the ASAS criteria for axial SpA but not the modified New York radiographic criteria for AS, had a score of ≥4 on the BASDAI or a score of ≥2.1 on the ASDAS-CRP and had been treated unsuccessfully with ≥1 NSAIDs for 4-week. Patients were assigned to receive Yisaipu (made in China) 50 mg/week and continued background NSAID treatment for 24 weeks (open-label study). At week 24, the primary efficacy end point was the improvement of ASDAS-CRP. Secondary end points included ASAS 20, ASAS 40, ASAS 5/6, ASAS partial remission and BASDAI. Safety was evaluated during scheduled visits.
Results 123 patients with active nr-axSpA were enrolled between April 19, 2014, and July 10, 2015. The mean age of the 123 nr-SpA patients was (25.3±5.9) years. The ASDAS-CRP and BASDAI decrease from 2.7±0.9 to 0.7±0.4, from 4.5±1.5 to 0.9±0.8, respectively between weeks 0 and 24. The patients achieved the ASDAS-CRP<2.1 was 96.7%. ASDAS-CRP major and important improvement were achieved by 41.4%, 79.8%, respectively at weeks 24. ASAS 20, ASAS 40, ASAS5/6 and ASAS partial remission were achieved by 75.0%, 54.8%, 64.5%, 89.3%, respectively at weeks 24. Yisaipu-treatment was associated with statistically significant improvements in all parameters, including BASFI, BASMI, PGA, PhGA, ESR and CRP concentrations. Most adverse events in the open-label phase were mild or moderate in severity.
Conclusions Yisaipu was effective and well-tolerated during the 24-week study period and was associated with a significant improvement in the signs and symptoms of active nr-axSpA.
Disclosure of Interest None declared