贝利尤单抗对合并关节和皮肤表现的系统性红斑狼疮患者的早期及晚期反应和糖皮质激素节省效应：来自贝利尤单抗真实世界研究-关节和皮肤（BeRLiSS-JS）的结果
Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study-Joint and Skin (BeRLiSS-JS).
作者信息
Zen Margherita, Gatto Mariele, Depascale Roberto, Regola Francesca, Fredi Micaela, Andreoli Laura, Franceschini Franco, Urban Maria Letizia, Emmi Giacomo, Ceccarelli Fulvia, Conti Fabrizio, Bortoluzzi Alessandra, Govoni Marcello, Tani Chiara, Mosca Marta, Ubiali Tania, Gerosa Maria, Bozzolo Enrica P, Canti Valentina, Cardinaletti Paolo, Gabrielli Armando, Tanti Giacomo, Gremese Elisa, De Marchi Ginevra, De Vita Salvatore, Fasano Serena, Ciccia Francesco, Pazzola Giulia, Salvarani Carlo, Negrini Simone, Di Matteo Andrea, De Angelis Rossella, Orsolini Giovanni, Rossini Maurizio, Faggioli Paola, Laria Antonella, Piga Matteo, Cauli Alberto, Scarpato Salvatore, Rossi Francesca Wanda, De Paulis Amato, Brunetta Enrico, Ceribelli Angela, Selmi Carlo, Prete Marcella, Racanelli Vito, Vacca Angelo, Bartoloni Elena, Gerli Roberto, Zanatta Elisabetta, Larosa Maddalena, Saccon Francesca, Doria Andrea, Iaccarino Luca
机构信息
Rheumatology Unit, Department of Medicine-DIMED, University of Padova, Via Giustiniani, 2, 35128 Padova, Italy.
ASST Spedali Civili di Brescia, Department of Clinical and Experimental Sciences, Rheumatology and Clinical Immunology, 25123 Brescia, Italy.
出版信息
J Pers Med. 2023 Apr 20;13(4):691. doi: 10.3390/jpm13040691.
AIM
To assess the efficacy of belimumab in joint and skin manifestations in a nationwide cohort of patients with SLE.
METHODS
All patients with skin and joint involvement enrolled in the BeRLiSS cohort were considered. Belimumab (intravenous, 10 mg/kg) effectiveness in joint and skin manifestations was assessed by DAS28 and CLASI, respectively. Attainment and predictors of DAS28 remission (<2.6) and LDA (≥2.6, ≤3.2), CLASI = 0, 1, and improvement in DAS28 and CLASI indices ≥20%, ≥50%, and ≥70% were evaluated at 6, 12, 24, and 36 months.
RESULTS
DAS28 < 2.6 was achieved by 46%, 57%, and 71% of patients at 6, 12, and 24 months, respectively. CLASI = 0 was achieved by 36%, 48%, and 62% of patients at 6, 12, and 24 months, respectively. Belimumab showed a glucocorticoid-sparing effect, being glucocorticoid-free at 8.5%, 15.4%, 25.6%, and 31.6% of patients at 6, 12, 24, and 36 months, respectively. Patients achieving DAS-LDA and CLASI-50 at 6 months had a higher probability of remission at 12 months compared with those who did not ( = 0.034 and = 0.028, respectively).
CONCLUSIONS
Belimumab led to clinical improvement in a significant proportion of patients with joint or skin involvement in a real-life setting and was associated with a glucocorticoid-sparing effect. A significant proportion of patients with a partial response at 6 months achieved remission later on during follow-up.
目的
评估贝利尤单抗对全国范围内系统性红斑狼疮（SLE）患者关节和皮肤表现的疗效。
方法
纳入BeRLiSS队列中所有有皮肤和关节受累的患者。分别通过28关节疾病活动度评分（DAS28）和系统性红斑狼疮皮肤综合评估指数（CLASI）评估贝利尤单抗（静脉注射，10mg/kg）对关节和皮肤表现的有效性。在6、12、24和36个月时评估DAS28缓解（<2.6）、低疾病活动度（LDA，≥2.6且≤3.2）、CLASI = 0、1以及DAS28和CLASI指数改善≥20%、≥50%和≥70%的达成情况及预测因素。
结果
在6、12和24个月时，分别有46%、57%和71%的患者实现DAS28 < 2.6。在6、12和24个月时，分别有36%、48%和62%的患者实现CLASI = 0。贝利尤单抗显示出糖皮质激素节省效应，在6、12、24和36个月时，分别有8.5%、15.4%、25.6%和31.6%的患者无需使用糖皮质激素。与未达到的患者相比，在6个月时达到DAS-LDA和CLASI-50的患者在12个月时缓解的可能性更高（分别为P = 0.034和P = 0.028）。
结论
在现实生活中，贝利尤单抗使相当一部分有关节或皮肤受累的患者临床症状得到改善，并与糖皮质激素节省效应相关。相当一部分在6个月时部分缓解的患者在后续随访中实现了缓解。
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