The first biotherapy for patients with systemic lupus erythematosus is commercially launched in China

GSK announced today that Benlysta (belimumab), the world’s first biotherapy for patients with systemic lupus erythematosus (SLE), has been commercially launched in China. The announcement was made at the 2019 annual conference of Rheumatology and Immunology Physicians Committee of the Chinese Medical Doctor Association (CMDA). Benlysta is now available for treatment subject to a doctor’s prescription for more than 1 million SLE patients in China.

Fabio Landazabal, Senior Vice President of Emerging Markets at GSK, said: “A quarter of the world’s SLE patients are in China[1], most of whom are women at childbearing age of 15-45. As the only medicine specifically designed and developed for the treatment of SLE, Belimumab helps to reduce the long-term organ damage and delay the disease progression. We hope more patients with SLE will benefit from GSK’s innovative drug.”

SLE in China: large number of patients, early onset, severe organ damage

SLE is an autoimmune disease that can cause damage to multiple organs and tissues such as kidney, cardiovascular system, respiratory system, digestive system, blood system, blood vessels, and eyes[2], thus significantly increasing the risk of death[3]. Professor Xiaofeng Zeng, Director of the Department of Rheumatology and Immunology at Peking Union Medical College Hospital said: “Compared with the European and American situation, the age of onset among Chinese SLE patients is earlier and conditions are worse. Although SLE is a chronic disease, it can cause extensive organ damage even in the early stage of the disease.”

Research showed that about 40% of SLE patients suffered from organ damage in the first year[4], and 50% of them had irreversible organ damage within 5 years of onset[5]. The mortality rate of SLE patients was three times that of normal people in the same age group, and the risks of death caused by infection and kidney diseases rose by 5 times and 8 times respectively[6]. Among them, infection is the leading cause of death among SLE patients in China[7].

In order to effectively reduce the severe damage of SLE, the European League Against Rheumatism (EULAR) issued the 2019 update of recommendations for the management of SLE. According to the recommendations, treatment in SLE aims at remission of disease symptoms or low disease activity, prevention of flares and damage accrual, minimisation of drug side-effects, and improvement of quality of life[8].

However, it’s still a challenge for the therapeutic drugs currently available in China to meet the standards.

Targeted biotherapy: Offering patients a new option by ending an era of nearly 60 years when no new drug for SLE was available in China

Professor Xiaofeng Zeng said: “Conventional therapies for SLE were glucocorticoids, immunosuppressive agents and antimalarials, all of which targeted specific symptoms. Under conventional treatment, SLE patients suffered from double damage due to poor disease control and drug toxicity. Nearly 60% of SLE patients still have continuous disease activity or repeated recurrence[9]. Traditional SLE therapies had certain toxicity, and long-term high-dose use might induce or exacerbate infection, as well as adverse reactions such as liver damage, myelosuppression and fundus lesions[10]. Although the 10-year survival rate of SLE patients has improved, it remains urgent to better control disease activity, decrease disease recurrence, delay organ damage, reduce adverse drug reactions and improve the quality of life for these patients.”

Professor Zeng said: “We are very glad to see the approval for belimumab in China which will bring a new treatment option and hope to Chinese patients.  Targeting the pathway of B cells, belimumab inhibits proliferation and differentiation of B cells, induces apoptosis of autoreactive B cells, and reduces serum levels of autoantibodies, thus achieving the goal of treating SLE. The clinical trial targeting Chinese patients using  belimumab showed positive results. Research showed that in Asia, including Chinese adult patients with SLE, after 52 weeks of treatment with the combination of belimumab and standard therapy, patients’ SLE Responder Index (SRI) reached up to 57.8%, and the risk of severe relapses was reduced by 50%, with less dependence on steroids, stable response rates, and similar overall incidence of adverse reactions compared with placebo[11]. We hope that belimumab will help address poorly controlled diseases and lower the amount of steroids used by patients so as to reduce the long-term organ damage.”

According to the 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus, belimumab (1a/A) should be considered in extrarenal disease with inadequate control (ongoing disease activity or frequent flares) to first-line treatments (typically including combination of  hydroxychloroquine and prednisone with/without immunosuppressive agents), and inability to taper daily dose of glucocorticoids to acceptable levels.

At the upcoming second China International Import Expo (CIIE), GSK will showcase a variety of “first-in-class” innovative drugs, including belimumab, the world’s first targeted biotherapy for lupus erythematosus. GSK will take the opportunity of the CIIE to share its global innovations with China and deliver on its commitment of “in China, with China, for China.”

Fabio said: “GSK is committed to improving SLE disease treatment. Patients with SLE are brave and resilient in their journey fighting with the disease. As a responsible healthcare company, we’re conscious of their situation and committed to accelerating our steps and continuing with more clinical trials to help more patients to benefit from Belimumab.”

 

About GSK

GSK – a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

Media inquiry:

Chloe Yao (chloe.x.yao@gsk.com

 

Reference:


[1] Li M et al. Lupus. 2013 Oct;22(11):1192-9.

[2] Lee YH, Choi SJ, Ji JD, et al. Overall and cause-specific mortality in systemic lupus erythematosus: an updated meta-analysis. Lupus. 2016 Jun;25(7):727-34

[3] Caroline Gordon. Systemic Lupus Erythematosus. Oxford University Press. 2016

[4] Taraborelli M,et al. Lupus. 2017;26(11):1197-1204.

[5] Urowitz MB, Gladman DD, Ibanez D, et al. Arth Care and Res. 2012;64(1);132-7

[6] Caroline Gordon. Systemic Lupus Erythematosus. Oxford University Press. 2016

[7] Wang Z, Wang Y, Zhu R, et al. Long-term survival and death causes of systemic lupus erythematosus in China: a systemic review of observational studies. Medicine (Baltimore). 2015 May; 94(17): e794. doi:10.1097/MD.0000000000000794

[8] Antonis Fanouriakis, Myrto Kostopoulou, Alessia Alunno, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus [J]. BMJ. 2019, 78 (6): 736-745

[9] Zen M,et al. Clin Exp.Rheumatol. 2012;30(6):856-863.

[10]系统性红斑狼疮诊断及治疗指南,中华风湿病学杂志,2010,14(5):342-346