Sen H Nida, Sangave Amit, Hammel Keri, Levy-Clarke Grace, Nussenblatt Robert B
Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, MD 20892, USA.
Can J Ophthalmol. 2009 Jun;44(3):e9-e12. doi: 10.3129/i09-061.
This study aimed to evaluate the possible safety and effectiveness of infliximab in patients with active scleritis.
Prospective, nonrandomized, open-label pilot study (Protocol No. 04-EI-0065).
Five patients with active anterior scleritis.
This single-centre, pilot study of infliximab for the treatment of active anterior scleritis was conducted at the National Eye Institute, National Institutes of Health, between 2003 and 2007. Scleritis patients with active disease who had used at least 1 conventional immunosuppressive agent in the past were included. Primary outcome was a 2-step decrease in scleral inflammation within 14 weeks. Patients received infliximab (5 mg/kg) at baseline, at weeks 2 and 6, and every 4 weeks through week 30, after which the infusion interval was increased (week 36, 48).
All patients met the primary outcome by achieving quiescence of their active scleritis by week 14 with no additional immunosuppressives. However, after 14 weeks 1 patient developed new-onset intraocular inflammation that did not respond to reinduction and was terminated from the study. Side effects attributable to infliximab included ear infection with transient decreased hearing, urinary tract infection, lower respiratory tract infection, and facial rash in 1 patient and urinary tract infection, diarrhea, upper respiratory tract infection, nasal congestion and headache, mouth sores, head tremor, and occasional numbness and tingling in extremities in another patient, all of which resolved spontaneously or with appropriate treatment.
Infliximab may be considered as a viable option in treating patients with active scleritis; however, patients should be monitored closely for potentially serious side effects.
本研究旨在评估英夫利昔单抗治疗活动性巩膜炎患者的潜在安全性和有效性。
前瞻性、非随机、开放标签的试点研究（方案编号04-EI-0065）。
5例活动性前巩膜炎患者。
2003年至2007年期间，在美国国立卫生研究院国立眼科研究所进行了这项单中心英夫利昔单抗治疗活动性前巩膜炎的试点研究。纳入过去至少使用过1种传统免疫抑制剂的活动性疾病巩膜炎患者。主要结局是在14周内巩膜炎症减轻两级。患者在基线时、第2周和第6周接受英夫利昔单抗（5mg/kg）治疗，在第30周之前每4周接受一次治疗，之后延长输注间隔时间（第36周、48周）。
所有患者在第14周时均达到主要结局，活动性巩膜炎静止，无需额外使用免疫抑制剂。然而，14周后，1例患者出现新发眼内炎症，对再次诱导治疗无反应，退出研究。英夫利昔单抗所致的副作用包括1例患者出现耳部感染伴短暂听力下降、尿路感染、下呼吸道感染和面部皮疹，另1例患者出现尿路感染、腹泻、上呼吸道感染、鼻塞和头痛、口腔溃疡、头部震颤以及四肢偶尔麻木和刺痛，所有这些副作用均自行缓解或经适当治疗后缓解。
英夫利昔单抗可被视为治疗活动性巩膜炎患者的一种可行选择；然而，应密切监测患者是否出现潜在的严重副作用。
