Department of Internal Medicine, Inflammation-Immunopathology-Biotherapy Department (DHU i2B), Assistance Publique - Hôpitaux de Paris, Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine, 75012 Paris, France; Sorbonne Universités, UMPC University Paris 06, INSERM U938, Centre de Recherche Saint-Antoine (CRSA), Paris, France.
Univ. Lille, INSERM U995 - LIRIC - Lille Inflammation Research International Center, F-59000 Lille, France; INSERM, U995, F-59000 Lille, France; CHU Lille, Département de Médecine Interne et Immunologie Clinique, F-59000 Lille, France; Centre National de Référence Maladies Systémiques et Auto-immunes Rares (Sclérodermie Systémique), F-59000 Lille, France.
Autoimmun Rev. 2018 Jun;17(6):582-587. doi: 10.1016/j.autrev.2017.12.010. Epub 2018 Apr 7.
To describe safety and efficacy of rituximab in patients with systemic sclerosis.
We included 13 patients with systemic sclerosis treated with rituximab and pooled with 40 additional patients from the literature. SSc rituximab untreated patients were matched to rituximab treated ones.
Thirteen patients who received rituximab and 26 rituximab-untreated patients were included. In comparison to 26 patients who did not received rituximab, FVC changes were not significantly different, whereas DLCO improved in 13 patients who received rituximab (0 [-4; 4] vs loss of -7 [-19; 0]; p=0.05). Considering 7 rituximab treated and 14 untreated diffuse SSc, FVC was improved during the 24 [12; 46] months of follow up in dSSc who received rituximab (gain of 12 [7.5:14] % vs loss of 1.5 [-16.8; 2.5], (p=0.003)). Pooled analysis of 53 patients (40 literature patients and 13 from personal series) showed significant improvement of median mRSS from 18 [8; 32] at baseline to 9 [4; 18] at M6 (p=0.007), 13 [8; 18] at M12 (p=0.008) and 10 [4; 16] at the last follow-up (p=0.0002). FVC increased from 71% [66; 80] at baseline to 84% [75; 90] at M12 (p=0.001). DLCO increased from 58% [39; 65] at M0 to 63% [53; 78] at M12 (p=0.04).
Our personal data and pooled literature analysis suggest the efficacy of rituximab in the subset of diffuse SSc in particular in skin and interstitial disease involvements. The safety of rituximab seems to be reasonable and similar to previous data in other autoimmune diseases.
描述利妥昔单抗治疗系统性硬化症的安全性和疗效。
我们纳入了 13 例接受利妥昔单抗治疗的系统性硬化症患者，并与文献中的 40 例额外患者进行了汇总。未接受利妥昔单抗治疗的 SSc 患者与接受利妥昔单抗治疗的患者进行了匹配。
共纳入 13 例接受利妥昔单抗治疗和 26 例未接受利妥昔单抗治疗的患者。与未接受利妥昔单抗治疗的 26 例患者相比，FVC 变化无显著差异，而接受利妥昔单抗治疗的 13 例患者的 DLCO 改善（0 [-4; 4] 与损失-7 [-19; 0]；p=0.05）。在考虑 7 例接受利妥昔单抗治疗的弥漫性系统性硬化症和 14 例未接受利妥昔单抗治疗的弥漫性系统性硬化症后，接受利妥昔单抗治疗的弥漫性系统性硬化症患者在 24 [12; 46] 个月的随访中 FVC 得到改善（增加 12 [7.5:14]%，损失 1.5 [-16.8; 2.5]%，（p=0.003））。53 例患者（40 例文献患者和 13 例来自个人系列）的汇总分析显示，mRSS 中位数从基线的 18 [8; 32] 显著改善至 6 个月时的 9 [4; 18]（p=0.007）、12 个月时的 13 [8; 18]（p=0.008）和最后一次随访时的 10 [4; 16]（p=0.0002）。FVC 从基线时的 71% [66; 80] 增加到 12 个月时的 84% [75; 90]（p=0.001）。DLCO 从基线时的 58% [39; 65] 增加到 12 个月时的 63% [53; 78]（p=0.04）。
我们的个人数据和汇总文献分析表明，利妥昔单抗在弥漫性系统性硬化症亚组中具有疗效，特别是在皮肤和间质疾病受累方面。利妥昔单抗的安全性似乎合理，与其他自身免疫性疾病的先前数据相似。
