Benlysta (Belimumab) Becomes First Biologic Approved in China for Lupus Nephritis

Shanghai, February 10, 2022 /PRNewswire/ -- Today, GSK announced that Benlysta (generic name: belimumab for injection) has been approved by the National Medical Products Administration (NMPA) for use in combination with standard therapy to treat adult patients with active lupus nephritis (LN). The approval of this lupus nephritis indication makes belimumab the...The First and Only in ChinaA biologic covering the indications of systemic lupus erythematosus and lupus nephritis. Thus, belimumab has been approved in China for three major indications: adult and pediatric systemic lupus erythematosus, and adult lupus nephritis.

Systemic Lupus Erythematosus (SLE) is an autoimmune disease that affects multiple systems throughout the body, among which Lupus Nephritis is one of the most severe complications of SLE. Approximately 40%-60% of patients with SLE have Lupus Nephritis at the onset of the disease, with a recurrence rate as high as 33%-40%. Each recurrence may lead to further aggravation of organ damage.^[1]About 20% of patients with lupus nephritis progress to end-stage renal disease (ESRD) within 10 years after diagnosis.^[1], the need for kidney dialysis or kidney transplantation is an important cause of death in SLE patients.^[2]。

National Clinical Research Center for Kidney Disease（Academician Liu Zhihong from the General Hospital of Eastern Theater Command stated: "The current treatment for lupus nephritis is mainly based on a regimen combining hormones with immunosuppressants, which has problems such as a low renal remission rate, high recurrence rate, and significant long-term drug toxicity. The recent approval of belimumab for the treatment of active lupus nephritis provides patients with a new therapeutic option. Based on the complex pathogenesis and high heterogeneity of lupus nephritis, combination therapies utilizing existing immunosuppressants and novel biologics are expected to bring innovative developments to the treatment of lupus nephritis patients, ultimately achieving personalized treatment."”

The "2019 Chinese Guidelines for the Diagnosis and Treatment of Lupus Nephritis" propose that improving long-term survival rates of both patients and kidneys, as well as enhancing quality of life, are the ultimate goals in treating lupus nephritis. The treatment of lupus nephritis requires continuous long-term therapy from induction to maintenance. Long-term maintenance with glucocorticoids should ideally be reduced to within 7.5 mg/day, and discontinued if conditions permit. Maintenance therapy should last for at least 3 years after achieving complete remission.

BLISS-LN Study is for Active Lupus NephritisThe world's largest scale and longest durationThe Phase 3 clinical trial enrolled a total of 448 patients and lasted for 2 years (104 weeks). This study aimed to evaluate the efficacy and safety of belimumab in treating adult patients with active lupus nephritis. The research data were published in the September 2020 issue of the New England Journal of Medicine. Compared with the placebo, the use of belimumab during the induction phase demonstrated statistically significant differences across all four primary endpoints. These included renal therapeutic response (PERR) at 2 years (104 weeks) of treatment, complete renal response (CRR) after 2 years of treatment, time to kidney-related events or death events, and overall renal response (ORR) after 2 years.

Global BLISS-LN Study Chief Investigator in China, Professor Xueqing Yu, President of Guangdong Provincial People's Hospital, stated: "With the continuous advancement in medical standards, the treatment for lupus nephritis has evolved from the use of hormones and immunosuppressants to precision-targeted therapies. The approval of belimumab for the lupus nephritis indication marks a significant breakthrough in the application of targeted treatments in this field. The latest results from the BLISS-LN study, on which the approval was based, demonstrate that initiating belimumab in combination with conventional therapy during the induction phase can achieve a reduction in steroid dosage within 24 weeks compared to conventional therapy alone."Less than or equal to"At the same time of 10mg/d, it significantly improved the renal response rate of lupus nephritis patients within two years, significantly reduced the risk of renal-related events/death in lupus nephritis patients, decreased recurrence, infection, and hormone dosage, which is conducive to achieving the ultimate long-term treatment goal for lupus nephritis. It is believed that with the progress of clinical trials, more inspiring clinical research data for both doctors and patients will emerge in the future."

Professor Zeng Xiaofeng, Director of the Rheumatology and Immunology Department at Peking Union Medical College Hospital, stated: "More than half of SLE patients experience kidney involvement."^[3]，The approval of belimumab for lupus nephritis this time is a significant piece of good news for SLE patients with lupus accompanied by kidney involvement to achieve early and whole-course organ protection. At the same time, it is expected to delay renal and extrarenal systemic organ damage caused by long-term/high-dose hormones and immunosuppressants, injecting momentum into the realization of 'double targets' in lupus treatment for doctors and patients, that is, achieving a low hormone dose in the short term.Less than or equal to7.5mg/d for disease activity control, long-term realization of delaying organ damage progression, and improving the long-term survival rate of both patients and kidneys."

As the world's first and only biologic covering both systemic lupus erythematosus and lupus nephritis indications, belimumab is a fully human monoclonal antibody administered intravenously. It targets and binds to soluble B lymphocyte stimulator, inhibiting B cell proliferation and differentiation, inducing apoptosis of autoreactive B cells, thereby reducing autoantibodies in serum to treat systemic lupus erythematosus and lupus nephritis. Moreover, due to its minimal impact on late-stage B cells, belimumab can effectively preserve patient immunity during treatment.^{[4],[5],[6],[7]} 。

GSK China Prescription Drugs and Vaccines General Manager Qi Xin stated: "Helping people do more, feel better, and live longer has always been our mission. GSK has been deeply involved in the field of systemic lupus erythematosus for a decade, benefiting from China's accelerated new drug approval and medical insurance-related policies. Belimumab has successfully been approved in China for three major indications: adult systemic lupus erythematosus, pediatric systemic lupus erythematosus, and lupus nephritis. Among these, the adult indication has been included in the national medical insurance, making it possible for more lupus patients to benefit from biologics. In the future, we will accelerate the introduction of more innovative products into China, such as intravenous and subcutaneous injection formulations of belimumab, bringing confidence and hope to more families affected by lupus."

References

[1]Wang Z, Wang Y, Zhu R, et al。Medicine, 2015, 94(17). e794

[2] Chinese Lupus Nephritis Diagnosis and Treatment Guidelines Writing Group. Chinese Lupus Nephritis Diagnosis and Treatment Guidelines[J]. Chinese Medical Journal.

[3] Xu Ningben. Clinical and Pathological Analysis of 402 Renal Biopsy Cases in Our Hospital from 2013 to 2017[J]. Medical Information, 2018, 31(07): 125-127.

[4] Stohl W & Hilbert DM. Nature Biotechnology.2012; 30(1):69-77

[5] Rahman A & Isenberg DA. N Engl J Med.2008;358:929-939.

[6] Mok CC & Lau CS. J Clin Pathol 2003;56:481–490.

[7] Cancro MP, et al. J. Clin. Invest.2009; 119:1066–1073.