Article date: July 2016
By: Xia Chen, Qian Zhao, Yong Hou, Ji Jiang, Wen Zhong, Wenxiang Wang, Xuejing Yao, Lin Li, Jianmin Fang, Fengchun Zhang, Pei Hu in Volume 82, Issue 1, pages 41-52
Aim
RCT‐18 is a recombinant fusion protein that interferes with the selection and survival of mature B‐lymphocytes by inhibiting B‐lymphocyte stimulator and a proliferation‐inducing ligand.
Methods
This single blind, randomized, placebo controlled, clinical pharmacological study explored the short term efficacy and safety of RCT‐18 in 21 rheumatoid arthritis (RA) patients with three different dosing regimens. The pharmacological behaviour of RCT‐18 was also characterized through a six level biomarker cascade approach to identify potential predictors for clinical responses.
Results
Nine out of 10 patients (>80%) experienced moderate to good EULAR response at the end of 3 months with once or twice weekly doses of 180 mg RCT‐18, whereas weekly administration of 360 mg RCT‐18 or placebo, however, only resulted in moderate improvement in one patient in each group. Absence of IgM‐type rheumatoid factor reduction, recovery of IgM 2 weeks after drug cessation, lack of decrease in the count of CD27(+) B‐lymphocytes and a DAS28 change from baseline <6 in 4–6 weeks after the treatment initiation may indicate poor clinical response. No anti‐drug antibody of RCT‐18 was detected. The active treatments were well tolerated, although more mild to moderate infections were reported in patients receiving RCT‐18.
Conclusion
The study results support further development of RCT‐18 in RA patients and provide important information for future dose selection.
DOI: 10.1111/bcp.12908
View this article