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阿达木单抗和英夫利昔单抗治疗幼年特发性关节炎相关葡萄膜炎的长期安全性和疗效。

Longterm Safety and Efficacy of Adalimumab and Infliximab for Uveitis Associated with Juvenile Idiopathic Arthritis.

机构信息

From the Department of Woman and Child Health, University of Padua, Padua; G. Pini Institute for Rheumatology; Fondazione Istituto Di Ricovero e Cura a Carattere Scientifico (IRCCS) Cà Granda, Ospedale Maggiore Policlinico, Milan; Department of Ophthalmology, Sapienza University; Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome; Institute for Maternal and Child Health IRCCS "Burlo Garofolo," Trieste; Anna Meyer Children's Hospital, and Department of Internal Medicine, Rheumatology, Transition Clinic, University of Florence, Florence; G. Gaslini Children's Hospital, Genoa; Department of Pediatrics, A. Perrino Hospital, Brindisi; Department of Neurosciences and Sense Organs, University of Bari, Bari; Ospedale Infantile Regina Margherita, University of Torino, Torino; Ophthalmology Unit, University Hospital Borgo Trento, Verona; IRCCS Fondazione Policlinico San Matteo, Pavia, Italy.

V. Cecchin, MD, Assistant Professor, Department of Woman and Child Health, University of Padua; M.E. Zannin, MD, Department of Woman and Child Health, University of Padua; D. Ferrari, MD, Assistant Professor, Department of Woman and Child Health, University of Padua; I. Pontikaki, MD, Assistant Professor, G. Pini Institute for Rheumatology, Milan; E. Miserocchi, MD, Assistant Professor, G. Pini Institute for Rheumatology; M.P. Paroli, MD, Assistant Professor, Department of Ophthalmology, Sapienza University; C. Bracaglia, MD, Assistant Professor, Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù; D.P. Marafon, MD, Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù; S. Pastore, MD, Rheumatology Unit, Institute for Maternal and Child Health IRCCS "Burlo Garofolo"; F. Parentin, MD, Assistant Professor, Ophthalmology Unit, Institute for Maternal and Child Health IRCCS "Burlo Garofolo"; G. Simonini, MD, Associate Professor, Rheumatology Unit, Anna Meyer Children's Hospital, University of Florence; C. De Libero, MD, Ophthalmology Unit, Anna Meyer Children's Hospital, University of Florence; F. Falcini, MD, Associate Professor, Rheumatology Unit, Transition Clinic, University of Florence; A. Petaccia, MD, Assistant Professor, Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico; G. Filocamo, MD, Assistant Professor, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico; R. De Marco, MD, Assistant Professor, Ophthalmology Unit, G. Gaslini Children's Hospital; F. La Torre, MD, Assistant Professor, Department of Pediatrics, A. Perrino Hospital; S. Guerriero, MD, Associate Professor, Department of Neurosciences and Sense Organs, University of Bari; S. Martino, MD, Associate Professor, Ospedale Infantile Regina Margherita, University of Torino; F. Comacchio, MD, Assistant Professor, Ophthalmology Unit, Department of Neurological, Neuropsychological, Morphological and Movement Sciences, Verona University Medical School, and University Hospital Borgo Trento; V. Muratore, MD, Assistant Professor, Department of Pediatrics, IRCCS Fondazione Policlinico San Matteo; G. Martini, MD, PhD, Assistant Professor, Department of Woman and Child Health, University of Padua; F. Vittadello, Department of Woman and Child Health, University of Padua; F. Zulian, MD, Associate Professor, Rheumatology Unit, Department of Woman and Child Health, University of Padua.

出版信息

J Rheumatol. 2018 Aug;45(8):1167-1172. doi: 10.3899/jrheum.171006. Epub 2018 Apr 15.

Abstract

OBJECTIVE

Anti-TNF-α agents have significantly changed the management of juvenile idiopathic arthritis (JIA). We evaluated the safety and efficacy of adalimumab (ADA) and infliximab (IFX) for the treatment of JIA-associated uveitis in patients treated for ≥ 2 years.

METHODS

Patients with JIA-associated uveitis treated with IFX and ADA were managed by a standardized protocol and data were entered in the ORCHIDEA registry. At baseline, all patients were refractory to standard immunosuppressive treatment or were corticosteroid-dependent. Data recorded every 3 months were uveitis course, number/type of ocular flares and complications, drug-related adverse events (AE), and treatment switch or withdrawal. Data of patients treated for ≥ 2 years were analyzed by descriptive statistics.

RESULTS

Up to December 2014, 154 patients with ≥ 24 months followup were included in the study. Fifty-nine patients were treated with IFX and 95 with ADA. Clinical remission, defined as the absence of flares for > 6 months on treatment, was achieved in 69 patients (44.8%), with a better remission rate for ADA (60.0%) as compared to IFX (20.3%; p < 0.001). A significant reduction of flares was observed in all patients without difference between the 2 treatment modalities. The number of new ocular complications decreased in both groups but was lower for ADA (p = 0.015). No serious AE were recorded; 16.4% of patients experienced 35 minor AE and the incidence rate was lower with ADA than with IFX.

CONCLUSION

At the 2-year followup, ADA showed a better efficacy and safety profile than IFX for the treatment of refractory JIA-associated uveitis.

摘要

目的

抗 TNF-α 制剂显著改变了幼年特发性关节炎(JIA)的治疗方法。我们评估了阿达木单抗(ADA)和英夫利昔单抗(IFX)治疗 JIA 相关葡萄膜炎的安全性和疗效,这些患者的治疗时间≥2 年。

方法

采用标准化方案治疗 JIA 相关葡萄膜炎的 IFX 和 ADA 治疗患者,并在 ORCHIDEA 注册登记处录入数据。基线时,所有患者对标准免疫抑制治疗均耐药或依赖皮质激素。每 3 个月记录一次的数据包括葡萄膜炎病程、眼部发作的次数/类型和并发症、药物相关不良事件(AE)、治疗转换或停药。≥2 年的患者数据采用描述性统计分析。

结果

截至 2014 年 12 月,154 例患者的随访时间≥24 个月,纳入本研究。59 例患者接受 IFX 治疗,95 例患者接受 ADA 治疗。ADA 组(60.0%)的临床缓解率(无疾病活动期>6 个月)优于 IFX 组(20.3%)(p<0.001),69 例患者(44.8%)达到缓解。两种治疗方式均显著减少了发作次数,ADA 组无新发眼部并发症,IFX 组有 2 例(p=0.015)。未记录严重 AE;16.4%的患者出现 35 例轻微 AE,ADA 组的发生率低于 IFX 组。

结论

在 2 年随访时,ADA 治疗 JIA 相关葡萄膜炎的疗效优于 IFX,安全性更好。

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