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系统性红斑狼疮患者的贝利尤单抗剂量可以降低吗?

Can the dose of belimumab be reduced in patients with systemic lupus erythematosus?

作者信息

Rua-Figueroa Iñigo, Altabás-González Irene, Mouriño Coral, Roberts Karen, Hernández-Martín Andrea, Casafont-Solé Ivette, Font-Urgelles Judit, Román-Ivorra Jose A, de la Rubia Navarro Marta, Galindo-Izquierdo Maria, Salman-Monte Tarek C, Narváez Javier, Vidal-Montal Paola, García-Villanueva Maria Jesús, Garrote-Corral Sandra, Blazquez-Canamero Maria Angeles, Fernandez-Cid Carlos Marras, Piqueras-García Maria, Martínez-Barrio Julia, Sánchez-Lucas Marina, Cortés-Hernández Josefina, Penzo Eleonora, Calvo-Alén Jaime, de Dios Juan Ramón, Alvarez-Rodríguez Belén, Vasques-Rocha Margarida, Tomero Eva, Menor-Almagro Raul, Gandía Myriam, Gómez-Puerta José A, Frade-Sosa Beatriz, Ramos-Giráldez Consuelo, Trapero-Pérez Carmen, Diez Elvira, Moriano Clara, Muñoz-Jiménez Alejandro, Pego-Reigosa José María

机构信息

Department of Rheumatology, Hospital Universitario Doctor Negrín, Las Palmas de Gran Canaria, Spain.

Department of Rheumatology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain.

出版信息

Rheumatology (Oxford). 2025 Mar 1;64(3):1220-1224. doi: 10.1093/rheumatology/keae270.

Abstract

OBJECTIVES

The aims of this study were to investigate the prevalence of dose reduction in patients with SLE treated with belimumab (BEL) in Spain, analyse treatment modalities, and determine impact on control of disease activity.

METHODS

Retrospective longitudinal and multicentre study of SLE patients treated with BEL. Data on disease activity, treatments and outcomes were recorded before and after reduction (6-12 months), and they were compared.

RESULTS

A total of 324 patients were included. The dose was reduced in 29 patients (8.9%). The dosing interval was increased in nine patients receiving subcutaneous BEL and in six patients receiving intravenous BEL. The dose per administration was reduced in 16 patients. Pre-reduction status was remission (2021 DORIS) in 15/26 patients (57.7%) and LLDAS in 23/26 patients (88.5%). After reduction, 2/24 patients (8.3%) and 3/22 patients (13.6%) lost remission at 6 months and 12 months, respectively [not statistically significant (NS)]. As for LLDAS, 2/23 patients (8.7%) and 2/21 patients (9.5%) lost their status at 6 and 12 months, respectively (NS). Significantly fewer patients were taking glucocorticoids (GCs) at their 12-month visit, although the median dose of GCs was higher at the 12-month visit (5 [0.62-8.75] vs 2.5 [0-5] at baseline).

CONCLUSION

Doses of BEL can be reduced with no relevant changes in disease activity-at least in the short term-in a significant percentage of patients, and most maintain the reduced dose. However, increased clinical or serologic activity may be observed in some patients. Consequently, tighter post-reduction follow-up is advisable.

摘要

目的

本研究旨在调查西班牙接受贝利尤单抗(BEL)治疗的系统性红斑狼疮(SLE)患者中剂量减少的发生率,分析治疗方式,并确定对疾病活动控制的影响。

方法

对接受BEL治疗的SLE患者进行回顾性纵向多中心研究。记录剂量减少前后(6 - 12个月)的疾病活动、治疗及结果数据,并进行比较。

结果

共纳入324例患者。29例患者(8.9%)剂量减少。9例接受皮下注射BEL的患者和6例接受静脉注射BEL的患者给药间隔延长。16例患者每次给药剂量减少。剂量减少前,26例患者中有15例(57.7%)处于缓解状态(2021年DORIS标准),26例患者中有23例(88.5%)达到低疾病活动状态(LLDAS)。剂量减少后,分别有2/24例患者(8.3%)和3/22例患者(13.6%)在6个月和12个月时失去缓解状态[无统计学意义(NS)]。至于LLDAS,分别有2/23例患者(8.7%)和2/21例患者(9.5%)在6个月和12个月时失去该状态(NS)。在12个月随访时服用糖皮质激素(GCs)的患者显著减少,尽管12个月随访时GCs的中位剂量高于基线时(5 [0.62 - 8.75] 对比基线时的2.5 [0 - 5])。

结论

在相当比例的患者中,至少在短期内,BEL剂量可以减少且疾病活动无相关变化,并且大多数患者维持减少后的剂量。然而,部分患者可能会出现临床或血清学活动增加。因此,建议在剂量减少后进行更密切的随访。

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