Short-term clinical observation of Belimumab in the treatment of systemic lupus erythematosus#br#
XU Lei1 ZHU Yun2 ZHANG Hao1
1.Graduate School of Clinical Medicine, Weifang Medical University, Shandong Province, Weifang 261053, China;
2.Department of Rheumatology and Immunology, Weifang People’s Hospital, Shandong Province, Weifang 261041, China
Abstract:Objective To evaluate the efficacy and safety of Belimumab in the treatment of systemic lupus erythematosus(SLE). Methods A total of 42 patients who were diagnosed with SLE from the Department of Rheumatology and Immunology, Weifang People’s Hospital from September 2019 to August 2020 were selected. According to the treatment regimen, patients were divided into SoC (stand of care) group (21 cases) and Belimumab group (21 cases) (standard treatment + Belimumab). The clinical efficacy, complement, immunoglobulin G (IgG) levels were compared between the two groups, hormone dose, disease activity index (SLEDAI), and, adverse events were compared between the two groups. Results After treatment, the total effective rate of Belimumab group was higher than that of SoC group, and the difference was statistically significant (P < 0.05). C3 and C4 in the two groups were higher than before treatment, and IgG was lower than before treatment. Complement C3 and C4 in Belimumab group were higher than SoC group, and IgG was lower than SoC group, with statistical significance (P < 0.05); there was no significant difference in hormone dose between the two groups (P > 0.05), SLEDAI score of the two groups was lower than before treatment, and Belimumab group was lower than SoC group, the differences were statistically significant (P < 0.05); there was no significant difference in the total incidence of adverse reactions between the two groups (P > 0.05). Conclusion Belizumab can improve the therapeutic effect in patients with systemic lupus erythematosus and is safe.
[1] Kiriakidou M,Ching CL. Systemic Lupus Erythematosus [J]. Ann Intern Med,2020,172(11):ITC81-ITC96.
[2] 贺成美,张奉春.贝利木单克隆抗体:治疗系统性红斑狼疮的新型靶向药物[J].协和医学杂志,2020,11(2):130-134.
[3] Frodlund M,Reid S,Wetter?觟 J,et al. The majority of Swedish systemic lupus erythematosus patients are still affected by irreversible organ impairment:factors related to damage accrual in two regional cohorts [J]. Lupus,2019,28(10):1261-1272.
[4] Steri M,Orrù V,Idda ML,et al. Overexpression of the Cytokine BAFF and Autoimmunity Risk [J]. N Engl J Med,2017,376(17):1615-1626.
[5] Navarra SV,Guzmán RM,Gallacher AE,et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus:a randomised,placebo-controlled,phase 3 trial [J]. The Lancet,2011,377(9767):721-731.
[6] Furie R,Petri M,Zamani O,et al. A phase Ⅲ,randomized,placebo-controlled study of belimumab,a monoclonal antibody that inhibits B lymphocyte stimulator,in patients with systemic lupus erythematosus [J]. Arthritis Rheum,2011,63(12):3918-3930.
[7] van Vollenhoven RF,Navarra SV,Levy RA,et al. Long-term safety and limited organ damage in patients with systemic lupus erythematosus treated with belimumab:a Phase Ⅲ study extensio [J]. Rheumatology (Oxford),2020, 59(2):281-291.
[8] Aringer M,Costenbader K,Daikh D,et al. 2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus [J]. Arthritis Rheumatol,2019,71(9):1400-1012.
[9] Gladman DD,Iba?觡ez D,Urowitz MB. Systemic lupus erythematosus disease activity index 2000[J]. J Rheumatol,2002,29(2):288-291.
[10] 中华医学会风湿病学分会,国家皮肤与免疫病临床医学研究中心,中国系统红斑狼疮研究协作组.2020中国系统性红斑狼疮诊疗指南[J].中华内科杂志,2020,59(3):172-185.
[11] Sun C,Molineros JE,Looger LL,et al. High-density genotyping of immune-related loci identifies new SLE risk variants in individuals with Asian ancestry [J]. Nat Genet,2016,48(3):323-330.
[12] Saulep-Easton D,Vincent FB,Quah PS,et al. The BAFF receptor TACI controls IL-10 production by regulatory B cells and CLL B cells [J]. Leukemia,2016,30(1):163-172.
[13] Nakayamada S,Tanaka Y. BAFF-and APRIL-targeted therapy in systemic autoimmune diseases [J]. Inflamm Regen,2016,36:6.
[14] Stohl W,Schwarting A,Okada M,et al. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus:A Fifty-Two-Week Randomized,Double-Blind,Placebo-Controlled Study [J]. Arthritis Rheumatol,2017,69(5):1016-1027.
[15] Furie R,Rovin BH,Houssiau F,et al. Two-Year,Randomized,Controlled Trial of Belimumab in Lupus Nephritis [J]. N Engl J Med,2020,383(12):1117-1128.
[16] Zhang F,Bae SC,Bass D,et al. A pivotal phase Ⅲ,randomised,placebo-controlled study of belimumab in patients with systemic lupus erythematosus located in China,Japan and South Korea [J]. Ann Rheum Dis,2018,77(3):355-363.
[17] Gatto M,Saccon F,Zen M,et al. Early Disease and Low Baseline Damage as Predictors of Response to Belimumab in Patients With Systemic Lupus Erythematosus in a Real-Life Setting [J]. Arthritis Rheumatol,2020,72(8):1314-1324.
[18] Iaccarino L,Andreoli L,Bocci EB,et al. Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting.Results of a large,multicentric,nationwide study [J]. J Autoimmun,2018,86:1-8.
[19] Reátegui-Sokolova C,Rodríguez-Bellido Z,Gamboa-Cárdenas RV,et al. Remission and low disease activity state prevent hospitalizations in systemic lupus erythematosus patients [J]. Lupus,2019,8(11):1344-1349.
[20] Kang I,Quan T,Nolasco H,et al. Defective control of latent Epstein-Barr virus infection in systemic lupus erythematosus [J]. J Immunol,2004,172(2):1287-1294.
[21] Morand EF,Mosca M. Treat to target,remission and low disease activity in SLE [J]. Best Pract Res Clin Rheumatol,2017,31(3):342-350.
[22] Basta F,Fasola F,Triantafyllias K,et al. Systemic Lupus Erythematosus (SLE) Therapy:The Old and the New [J]. Rheumatol Ther,2020,7(3):433-446.
[23] Wilhelm TR,Magder LS,Petri M. Remission in systemic lupus erythematosus:durable remission is rare [J]. Ann Rheum Dis,2017,76:547-553.
[24] Tani C,Vagelli R,Stagnaro C,et al. Remission and low disease activity in systemic lupus erythematosus:an achievable goal even with fewer steroids?Real-life data from a monocentric cohort [J]. Lupus Sci Med,2018,5(1):e000234.
[25] 季兰岚,张卓莉.系统性红斑狼疮达标之路:《2019年欧洲抗风湿病联盟系统性红斑狼疮管理指南》解读[J].协和医学杂志,2020,11(3):283-288.