Schallhorn Julie M, McGee Selina, Nau Jeffrey, Macsai Marian, Gibson Andrea, Blemker Gretchen, Hendrix Laura H, Massaro-Giordano Mina
Department of Ophthalmology and Francis I, Proctor Foundation, University of California, San Francisco, CA, USA.
BeSpoke Vision, Edmond, OK, USA.
Clin Ophthalmol. 2023 Mar 3;17:725-734. doi: 10.2147/OPTH.S403953. eCollection 2023.
We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID).
Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment-subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥10 mm STS improvement.
Of the 891 participants, 31 reported comorbid AID. In all models, the treatment-subgroup interaction terms were not significant (p>0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and -9.3 for EDS and difference for proportion of subjects with ≥10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82-84%), graded as mild by 98% of subjects.
OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients.
我们在两项随机试验中，对自我报告患有自身免疫性疾病（AID）的干眼症（DED）受试者，评估OC-01（酒石酸伐尼克兰溶液）鼻喷雾剂（VNS）的治疗效果。
对ONSET-1和ONSET-2试验中报告有AID病史的受试者进行事后亚组分析，这些受试者来自综合的OC-01 VNS 0.03或0.06毫克组以及赋形剂对照组（VC）。比较OC-01 VNS组和VC组从基线到28天的麻醉后泪液分泌试验评分（STS，毫米）和眼干评分（EDS）的平均变化。使用协方差分析模型中从基线STS和EDS的平均变化的治疗亚组交互项，以及在实现≥10毫米STS改善比例的逻辑回归模型中，评估有和没有AID的受试者的治疗效果一致性。
在891名参与者中，31人报告患有合并AID。在所有模型中，治疗亚组交互项均无统计学意义（p>0.05），表明OC-01 VNS在有和没有AID的受试者中治疗效果一致。在患有AID的受试者中，STS的治疗差异为11.8毫米，EDS为-9.3，STS改善≥10毫米的受试者比例差异为61.1%。最常见的不良事件是打喷嚏（82-84%），98%的受试者将其评为轻度。
OC-01 VNS在改善患有AID的受试者的泪液分泌和患者报告的症状方面表现出一致性，与关键的ONSET-1和2试验结果一致。有必要进行进一步研究，结果可能会进一步支持在AID患者中使用OC-01 VNS治疗DED。
