Subconjunctival adalimumab for treatment of dry eye disease in Sjögren’s syndrome

ABSTRACT Objective To describe the use of subconjuctival administration of the anti-tumor necrosis factor agent adalimumab for treatment of dry eye in patients with Sjögren’s syndrome, and to investigate conjunctival healing. Methods Prospective, nonrandomized, noncomparative interventional case series including consecutive patients with Sjögren’s syndrome and dry eye disease treated with subconjunctival adalimumab, who were refractory to conventional treatment. Patients with infectious ocular surface involvement or structural changes in the tear pathway or eyelids were excluded. Data recorded included age, sex, lissamine green staining pattern, Schirmer test results, intraocular pressure, conjunctival mobility, tear break up time and findings of biomicroscopic evaluation, following fluorescein dye instillation. The Ocular Surface Disease Index questionnaire validated for the Portuguese language was used for subjective assessment of patients. Results Eleven eyes of eight patients were studied. Mean patient age was 53±13.4 years. Patients were treated with subconjunctival injection of 0.03 mL of adalimumab and followed for 90 days thereafter. There were no statistically significant objective improvement (objective tests results; p>0.05) and no statistically significant changes in intraocular pressure (p=0.11). Questionnaire responses revealed a significant improvement in ocular symptoms (p=0.002). Conclusion Based on the Ocular Surface Disease Index questionnaire, subconjunctival administration of adalimumab improved dry eye symptoms. However, objective assessments failed to reveal statistically significant improvements.

摘要
研究目的：探讨结膜下注射抗肿瘤坏死因子制剂阿达木单抗（adalimumab）治疗干燥综合征（Sjögren’s syndrome）患者干眼症的临床应用效果，并观察结膜愈合情况。
研究方法：本研究为前瞻性、非随机、非对照介入性病例系列研究，纳入经常规治疗无效的干燥综合征合并干眼症的连续入组患者。排除合并感染性眼表病变、泪道或眼睑结构异常的患者。记录的临床指标包括患者年龄、性别、丽丝胺绿染色结果、Schirmer试验（Schirmer test）结果、眼压、结膜活动度、泪膜破裂时间，以及荧光素钠滴眼后的裂隙灯显微镜检查结果。采用经过葡萄牙语验证的眼表疾病指数（Ocular Surface Disease Index）问卷对患者进行主观症状评估。
研究结果：本研究共纳入8例患者的11只患眼。患者平均年龄为53±13.4岁。予以患者结膜下注射0.03 mL阿达木单抗，术后随访90天。客观检查指标未出现具有统计学意义的显著改善（客观检测结果；p>0.05），眼压亦未出现具有统计学意义的变化（p=0.11）。问卷调研结果显示患者眼部症状出现具有统计学意义的显著改善（p=0.002）。
研究结论：基于眼表疾病指数问卷结果，结膜下注射阿达木单抗可改善干眼症患者的眼部症状，但客观检查未发现具有统计学意义的病情改善。