Belimumab, a new drug for systemic lupus erythematosus (SLE), has been proved effective in reducing hormone dependence in treatment and in obviously restraining the disease without causing safety problems, according to an international clinical multi-center research led by Professor Zhang Fengchun from the Department of Immunology and Rheumatology, PUMCH. The findings have been included in Annals of the Rheumatic Diseases, published online in January 2018. The new drug is now under consideration of the Center for Drug Evaluation, China Food and Drug Administration, and is expected to bring new hope to patients in China.

SLE is a serious autoimmune disease which causes severe clinical symptoms, organ injury and even death. For a long time, only glucocorticoid and immunosuppressive drugs are used clinically. And only a small range of immunosuppressive drugs are available: cyclophosphamide, azathioprine, mycophenolate mofetil and cyclosporine. And long-term use of them brings risks of myelosuppression, liver and kidney damage, infection and cancer.

Targeting B lymphocyte stimulator, Belimumab is the world’s first biological agent for SLE and has been approved by FDA. However, there had been no research on its effectiveness and safety among Asian groups. Professor Zhang’s team conducted a 52-week, 2:1 randomized double-blind parallel contrast study involving 677 patients from 49 centers in China, Japan and South Korea.

According to the results, the Belimumab group has a higher effectiveness (53.8%) than the placebo-controlled group (40.1%), and has a percentage of patients whose SRI points dropped ≥4 obviously higher than the placebo-controlled group. Meanwhile, the Belimumab group showed a 50% lower risk of the disease recurring; for patients who take >7.5mg Prednisolone/day at baseline period, Belimumab can significantly reduce the dependence on glucocorticoid and control the disease. In terms of side effects, there is no statistical difference between the two groups.