Abstract：
OBJECTIVE: 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).
CONCLUSIONS: 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.
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).
CONCLUSIONS: 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：本研究的目的是调查西班牙使用贝利木单抗（BEL）治疗的SLE患者剂量减少的患病率，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和多中心研究。疾病活动数据，记录治疗前后（6-12个月）的治疗和结果，他们被比较了。
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BEL的患者和6例接受静脉BEL的患者的给药间隔增加。16名患者的每次给药剂量减少。15/26患者（57.7%）的预复位状态为缓解（2021DORIS），23/26患者（88.5%）为LLDAS。还原后,2/24患者（8.3%）和3/22患者（13.6%）在6个月和12个月时失去缓解，分别（无统计学意义[NS]）。至于LLDAS，2/23患者（8.7％）和2/21患者（9.5％）在6个月和12个月时失去状态，分别（NS）。在12个月的访视中服用糖皮质激素（GC）的患者明显减少，尽管在12个月访视时GC的中位剂量较高(5[0.62-8.75]vs基线时2.5[0-5]).
结论：在相当大比例的患者中，可以减少BEL的剂量，而疾病活动没有相关变化-至少在短期内是这样。和大多数保持减少的剂量。然而,在某些患者中可能观察到临床或血清学活性增加。因此,建议采取更严格的减少后跟进措施。
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。疾病活动数据，记录治疗前后（6-12个月）的治疗和结果，他们被比较了。
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BEL的患者和6例接受静脉BEL的患者的给药间隔增加。16名患者的每次给药剂量减少。15/26患者（57.7%）的预复位状态为缓解（2021DORIS），23/26患者（88.5%）为LLDAS。还原后,2/24患者（8.3%）和3/22患者（13.6%）在6个月和12个月时失去缓解，分别（无统计学意义[NS]）。至于LLDAS，2/23患者（8.7％）和2/21患者（9.5％）在6个月和12个月时失去状态，分别（NS）。在12个月的访视中服用糖皮质激素（GC）的患者明显减少，尽管在12个月访视时GC的中位剂量较高(5[0.62-8.75]vs基线时2.5[0-5]).
结论：在相当大比例的患者中，可以减少BEL的剂量，而疾病活动没有相关变化-至少在短期内是这样。和大多数保持减少的剂量。然而,在某些患者中可能观察到临床或血清学活性增加。因此,建议采取更严格的减少后跟进措施。
