Benlysta (Belimumab) for Lupus Nephritis Gains Market Entry in China, Offering a Novel Targeted Therapy Option

ShanghaiApril 6, 2022PR Newswire -- Recently, GlaxoSmithKline (GSK) announced the official launch in China of Benlysta (generic name: Belimumab for Injection) for the treatment of lupus nephritis. The approval of this new indication for belimumab in China will break the current treatment困境 for lupus nephritis, providing patients with a new option for biologic targeted therapy.

GSK General Manager of Prescription Medicines and Vaccines in China, Qi Xin, stated: "GSK has been deeply involved in the lupus field for over a decade. Belimumab is the first drug globally and in China approved for the treatment of systemic lupus erythematosus and adult lupus nephritis. Lupus nephritis is one of the most common complications of systemic lupus erythematosus. The recent approval of belimumab for lupus nephritis will bring a new treatment option to patients in China. In the future, we will accelerate the introduction of more indications into China, bringing hope to lupus patients and their families."

Benlysta New Indication Launch: China's Lupus Nephritis Treatment Enters the Era of Biological Targeted Therapy

据统计，约40%-60% 的系统性红斑狼疮（SLE）患者起病初即有狼疮肾炎，且复发率高达33%-40%。^[1]10-20% of lupus nephritis patients can progress to end-stage renal disease within 5 years of diagnosis.^[2]、[3]Lupus nephritis is an important cause of death in SLE patients.^[4]。

Professor Xueqing Yu, principal investigator in China for the global BLISS-LN study and president of Guangdong Provincial People's Hospital, stated: "The previous treatment regimen for lupus nephritis based on steroids combined with immunosuppressants still has issues such as low renal response rates, high recurrence rates, and significant long-term drug toxicity. The biological targeted agent belimumab, combined with conventional therapy, can significantly improve renal response in patients with lupus nephritis, markedly reduce the risk of renal-related events/death in these patients, decrease recurrence, infections, and steroid dosage, and demonstrates good overall safety and tolerability, ultimately aiding in achieving the long-term treatment goals for lupus nephritis. We look forward to the launch of belimumab’s new indication, which will open up a new treatment model for patients."

Professor Zeng Xiaofeng, Director of the Department of Rheumatology and Immunology at Peking Union Medical College Hospital, stated: "The kidney is the most commonly affected organ in SLE. Poorly controlled lupus nephritis can lead to repeated flare-ups and cause more severe damage to the kidneys. Compared with traditional glucocorticoids and immunosuppressants, the greatest innovative value of biologic targeted therapies lies in their ability to selectively inhibit self-reactive lymphocytes while reducing the use of other drugs and the occurrence of adverse reactions. With the widespread application of precise targeted biologics such as belimumab, patients may have the potential to delay both renal and systemic organ damage caused by long-term, high-dose hormones and immunosuppressants."

Guidelines Recommendation: Improving Long-term Survival Rate and Quality of Life Becomes the Ultimate Goal of Lupus Nephritis Treatment

The "2019 Chinese Guidelines for the Diagnosis and Treatment of Lupus Nephritis" states: The ultimate goal of treating lupus nephritis is to improve long-term survival rates of both patients and kidneys, as well as enhance quality of life. 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 possible. Maintenance therapy should last for at least 3 years after achieving complete remission.

Professor Zeng Xiaofeng stated: "As a systemic autoimmune disease that affects multiple systems in the body, lupus can cause irreversible damage to vital organs such as the kidneys and may even be life-threatening. Therefore, the goal of treatment is not only to achieve clinical remission but also to emphasize reducing disease complications and drug toxic side effects while controlling the condition, thereby minimizing cumulative damage to tissues and organs and improving patients' long-term survival rates and quality of life. Long-term treatment with belimumab can reduce the frequency of lupus flares, lower disease activity, and particularly prevent long-term cumulative organ damage, thus improving patients' long-term survival rates and enhancing their quality of life."

Due to the less-than-ideal control of the disease, a considerable number of patients face the risk of recurrence. Each recurrence will cause more severe damage to kidney function, and many patients may even progress to renal failure, requiring dialysis or kidney transplantation. "The treatment of lupus nephritis requires more innovative drugs to improve efficacy, reduce recurrence, and delay or prevent patients from progressing to end-stage renal failure, thereby improving clinical outcomes for patients. The approval of Belimumab for lupus nephritis also reveals the future direction of treatment," introduced Professor Yu Xueqing.

Results from the BLISS-LN study, the largest and longest Phase 3 clinical trial globally for active lupus nephritis, have confirmed that compared with placebo, initiating belimumab during the induction phase demonstrated statistically significant differences across all four critical endpoints. These include primary renal response (PERR) at two years (104 weeks), complete renal response (CRR), time to renal-related events or death, and overall renal response (ORR) after two years. The 2021 KDIGO Guidelines recommend belimumab for the initial treatment of patients with active proliferative lupus nephritis.

References

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

[2] Yu Feng. Nature Reviews Nephrology. 2017;13:483–495

[3] Bertsias, G. K. et al. Ann. Rheum. Dis. 71, 1771–1782 (2012)

[4] Chinese Lupus Nephritis Diagnosis and Treatment Guidelines Writing Group. Chinese Lupus Nephritis Diagnosis and Treatment Guidelines [J]. Chinese Medical Journal, 2019, 99(44): 3441-3455.