Florida Eye Research and Surgical Therapy Institute (FERST Eye Institute), Daytona Beach, Florida, USA.
Curr Eye Res. 2010 Dec;35(12):1057-62. doi: 10.3109/02713683.2010.511392. Epub 2010 Oct 7.
At least one-year follow-up of a case series of young Stevens-Johnson syndrome (SJS) patients with cicatrizing ocular surface disease and recurrent inflammation (SJS-RI) treated with systemic humanized monoclonal antibody (daclizumab).
Five patients (median age 16 yr; range 8-34 yr) with SJS, with recurrent inflammation refractory to conventional immunotherapy, were enrolled in a prospective non-randomized case series study. Inclusion criteria were patients with SJS and ocular cicatrizing inflammatory disease with severe visual impairment, using topical or systemic anti-inflammatory and/or immunomodulatory drugs without clinical improvement resulting in persistent inflammation (SJS-RI). Treatment with Daclizumab 1 mg/Kg (intravenous) was scheduled in three cycles. First cycle with concomitant immunotherapy: a total of 5 doses, with 14 days interval between them (total of this cycle: 10 weeks). Second cycle: interval was increased to 3 weeks; the patients received 2 doses (the second cycle had a total of 6 weeks). Third cycle: maintenance phase with 4 weeks interval between each application, until at least 12 months of the total follow up. After the first cycle (5th dose), the patients were kept with preservative-free lubricants and systemic doxycycline.
Control of ocular inflammation was observed at a median of 8 weeks (range 6-10 weeks) in all patients, with relapses in two patients at 20-36 weeks. Relapses were controlled with topical steroids at a median of 10 days, and within 2 weeks the steroids were tapered for both patients.
In this small case series, daclizumab demonstrated to play a beneficial role in the control of the inflammatory process of the recurrent inflammation in SJS, refractory to conventional immunomodulatory therapy.
对接受全身性人源化单克隆抗体(达珠单抗)治疗的患有瘢痕性眼表疾病和复发性炎症的年轻史蒂文斯-约翰逊综合征(SJS)患者的病例系列进行至少一年的随访。
本前瞻性非随机病例系列研究纳入了 5 名(中位年龄 16 岁;范围 8-34 岁)患有 SJS 的患者,这些患者存在复发性炎症,且对常规免疫治疗无效,他们患有 SJS 并伴有严重视力损害的眼表瘢痕性炎症,使用局部或全身性抗炎和/或免疫调节药物但没有临床改善,导致持续性炎症(SJS-RI)。达珠单抗 1 mg/Kg(静脉内)治疗计划分为三个周期。第一周期同时进行免疫治疗:总共 5 剂,每剂之间间隔 14 天(此周期共 10 周)。第二周期:间隔时间延长至 3 周;患者接受 2 剂(第二周期共 6 周)。第三周期:维持阶段,每次应用之间间隔 4 周,直到总随访时间至少达到 12 个月。在第一周期(第 5 剂)之后,患者继续使用不含防腐剂的润滑剂和全身性多西环素。
所有患者的眼部炎症均在中位 8 周(范围 6-10 周)得到控制,但有 2 名患者在 20-36 周时复发。在这两名患者中,复发时使用局部皮质类固醇治疗,中位时间为 10 天,并且在 2 周内逐渐减少这两名患者的皮质类固醇用量。
在这项小病例系列研究中,达珠单抗在控制复发性炎症的炎症过程中表现出有益作用,复发性炎症对常规免疫调节治疗无效。