Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Number of Participants Reported as Complete Responders to Golimumab
研究概览
简要总结
To asses the use of golimumab, a fully humanized anti-TNF Alpha monoclonal antibody, in juvenile idiopathic Arthritis-associated uveitis refractory to adalimumab.
详细描述
Background:
Uveitis is a potentially blinding complication of juvenile idiopathic arthritis (JIA). Treatment remains a substantial challenge, even though the use of tumor necrosis factor (TNF)-α-antagonists has improved visual outcomes substantially. Among these agents, adalimumab has been recently approved for the treatment of non-infectious uveitis and is thus the first biologic disease-modifying anti-rheumatic drug (bDMARD) approved for JIA-associated uveitis. However, some patients do not respond sufficiently or lose response over time. In these cases switching to another biologic DMARD is recommended. Recently golimumab, a fully humanized anti-TNF-α monoclonal antibody, demonstrated efficacy in a small case series, leading to uveitis inactivity in 4 of 7 patients Golimumab is approved for the treatment of polyarticular JIA.
Hypothesis:
Patients with JIA-associated uveitis failing treatment with adalimumab benefit from the treatment with golimumab.
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •JIA associated Uveitis
- •Treatment failure with adalimumab
排除标准
- •Uveitis due to other causes
- •Adalimumab Initiation because of non ocular reasons
研究组 & 干预措施
group 1
All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019
干预措施: Golimumab (Drug)
结局指标
主要结局
Number of Participants Reported as Complete Responders to Golimumab
时间窗: last follow up, up to 5 years
Response was classified as complete, partial, or none ("non-response", NR) at each timepoint separately." Complete response (CR) constituted achieving inactive uveitis, defined as 0+ cells in the AC (grade 0). Partial response (PR) was diagnosed in patients with improved uveitis, defined as a decrease in the level of inflammation, without achieving AC grade 0 status. Primary-NR was diagnosed in patients without change in SUN score and an entry grade of 3 or higher or in patients with worsening activity, defined as either a two-grade increase in inflammation or an increase in inflammation to grade 4. Relapse of uveitis was defined as active inflammation after at least 3 months of inactivity,
次要结局
- Best Corrected Visual Acuity (BCVA)(up to 5 years)
- Number of Patients With Ocular Discomfort(up to 5 years)
- Steroid Sparing Potential(Baseline, 12 Months Follow-Up)