Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study

Sun, Fangfang; Wu, Huaxiang; Wang, Zitao; Wu, Tong; Wu, Xue; Chen, Jie; Zhang, Danting; Bao, Chunde; Shen, Nan; Wu, Lijun; Zhu, Jing; Ye, Shuang

doi:10.3390/biomedicines11030962

Open AccessArticle

Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study

by

Fangfang Sun

^1,†

,

Huaxiang Wu

^2,†,

Zitao Wang

²,

Tong Wu

³,

Xue Wu

⁴,

Jie Chen

¹,

Danting Zhang

¹,

Chunde Bao

¹,

Nan Shen

¹,

Lijun Wu

^4,5,*,

Jing Zhu

^3,* and

Shuang Ye

¹

Department of Rheumatology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai 201112, China

²

Department of Rheumatology, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China

³

Department of Rheumatology, Sichuan Provincial People’s Hospital, University of Electronic Science and Technology of China, Chengdu 610072, China

⁴

Department of Rheumatology, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, China

⁵

Xinjiang Clinical Research Center for Rheumatoid Arthritis, Urumqi 830001, China

^*

Authors to whom correspondence should be addressed.

^†

These authors contributed equally to this work.

Biomedicines 2023, 11(3), 962; https://doi.org/10.3390/biomedicines11030962

Submission received: 29 January 2023 / Revised: 6 March 2023 / Accepted: 16 March 2023 / Published: 21 March 2023

(This article belongs to the Special Issue Molecular Mechanisms of Chronic Pain and New Therapeutic Strategies)

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Abstract

Objective: The effectiveness and safety of belimumab in Chinese lupus patients with different disease activities were investigated in a real-world setting. Method: Patients who received 10 mg/kg belimumab intravenously on weeks 0, 2, and 4, and then every 4 weeks on a background of standard-of-care (SoC) therapy and had a follow-up of more than 6 months were enrolled from four centers in China. They were stratified according to the Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score at baseline as the moderate/severe (SELENA-SLEDAI > 6) or mild subgroups (SELENA-SLEDAI ≤ 6). Attainment of the Lupus Low Disease Activity State (LLDAS) or remission on treatment was analyzed in all patients. The SLE Responder Index 4 (SRI-4) and SELENA-SLEDAI Flare Index (SFI) were evaluated for patients with moderate/severe disease and mild disease, respectively. Patients in the control arm with SoC alone from previous metformin lupus trials were selected by propensity score matching (PSM) as the reference group. Results: 224 SLE patients with a mean follow-up of 11.7 months receiving belimumab were enrolled in this observational study, of which 126 and 98 were in the moderate/severe and mild subgroup, respectively. At 12 months, 54.76% of the patients attained LLDAS and 28.57% attained remission. Lower daily prednisone at baseline were independently associated with 12-month LLDAS. Further, 87% of the subgroup with moderate/severe disease achieved SRI-4 at 12 months and a high SLEDAI at baseline was its predictive factor. For the mild subgroup, a reduced flare rate was observed compared with PSM reference (17.5%, vs. 38.6%, p = 0.021). Infection events, particularly viral infections and pneumonia were recorded in 7 and 6 patients, respectively. Conclusion: Our real-world data supported the effectiveness and safety of belimumab in Chinese lupus patients.

Keywords: systemic lupus erythematosus (SLE); SLE Responder Index 4 (SRI-4); Lupus Low Disease Activity State (LLDAS); remission; disease flare

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MDPI and ACS Style

Sun, F.; Wu, H.; Wang, Z.; Wu, T.; Wu, X.; Chen, J.; Zhang, D.; Bao, C.; Shen, N.; Wu, L.; et al. Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study. Biomedicines 2023, 11, 962. https://doi.org/10.3390/biomedicines11030962

AMA Style

Sun F, Wu H, Wang Z, Wu T, Wu X, Chen J, Zhang D, Bao C, Shen N, Wu L, et al. Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study. Biomedicines. 2023; 11(3):962. https://doi.org/10.3390/biomedicines11030962

Chicago/Turabian Style

Sun, Fangfang, Huaxiang Wu, Zitao Wang, Tong Wu, Xue Wu, Jie Chen, Danting Zhang, Chunde Bao, Nan Shen, Lijun Wu, and et al. 2023. "Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study" Biomedicines 11, no. 3: 962. https://doi.org/10.3390/biomedicines11030962

APA Style

Sun, F., Wu, H., Wang, Z., Wu, T., Wu, X., Chen, J., Zhang, D., Bao, C., Shen, N., Wu, L., Zhu, J., & Ye, S. (2023). Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study. Biomedicines, 11(3), 962. https://doi.org/10.3390/biomedicines11030962

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Effectiveness and Safety of Belimumab in Chinese Lupus Patients: A Multicenter, Real-World Observational Study

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