Objectives The aims of this study were to investigate the prevalence of dose reduction in patients with SLE treated with belimumab (BEL) in Spain, analyze 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 9 patients receiving subcutaneous BEL and in 6 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.

中文翻译：

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系统性红斑狼疮患者可以减少贝利尤单抗的剂量吗？

目的 本研究的目的是调查西班牙接受贝利尤单抗 (BEL) 治疗的 SLE 患者剂量减少的发生率，分析治疗方式，并确定对控制疾病活动的影响。方法对接受BEL治疗的SLE患者进行回顾性纵向和多中心研究。记录减少前后（6-12 个月）有关疾病活动、治疗和结果的数据，并进行比较。结果共纳入324例患者。 29 名患者（8.9%）的剂量减少。 9 名接受皮下 BEL 的患者和 6 名接受静脉注射 BEL 的患者的给药间隔增加。 16 名患者每次给药剂量减少。减量前状态为缓解 (2021 DORIS) 的患者为 15/26 (57.7%)，LLDAS 的患者为 23/26 (88.5%)。减少治疗后，分别有 2/24 名患者 (8.3%) 和 3/22 名患者 (13.6%) 在 6 个月和 12 个月时失去缓解（无统计学意义 [NS]）。至于 LLDAS，2/23 名患者 (8.7%) 和 2/21 名患者 (9.5%) 分别在 6 个月和 12 个月时失去状态 (NS)。尽管 12 个月就诊时 GC 的中位剂量较高（基线时为 5 [0.62–8.75] vs 2.5 [0–5]），但在 12 个月就诊时服用糖皮质激素 (GC) 的患者明显减少。结论 在相当大比例的患者中，BEL 的剂量可以减少，而疾病活动度没有相关变化（至少在短期内），并且大多数患者维持减少的剂量。然而，在某些患者中可能会观察到临床或血清学活性增加。因此，建议减少后采取更严格的后续行动。