Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients--a Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- relapse
研究概览
简要总结
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus
详细描述
Pemphigus is a severe autoimmune skin disease traditionally treated with systemic corticosteroids and immunosuppressants. Recent studies have highlighted the superior efficacy of rituximab combined with systemic corticosteroids, establishing this combination as a first-line treatment for pemphigus patients.
Currently, the administration protocols for rituximab in pemphigus patients often refer to the dosage used for rheumatoid arthritis: two intravenous infusions of 500 mg or 1000 mg spaced two weeks apart, with an additional 500 mg infusion after 6 to 9 months if necessary. Recently, several studies have reported successful treatment of pemphigus using low-dose (single 500 mg dose) or ultra-low-dose (single 200 mg dose) rituximab.
As an optimal dosage regimen for pemphigus has yet to be established, we conducted a retrospective cohort study to evaluate the efficacy of different rituximab dosages and explore the optimal dosing strategy for the treatment of pemphigus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
- •follow-up for at least 6 months after initiation of rituximab therapy
排除标准
- •Previous use of rituximab for other indications
- •concomitant use of other biological agents within 6 months (e.g. Dupilumab,IL-17,FcRn)
- •with a diagnosis of other variants of pemphigus besides PV and PF
研究组 & 干预措施
Group A
one dose of 500mg RTX
Group B
two doses of 500mg RTX
Group C
two doses of 1000mg RTX
结局指标
主要结局
relapse
时间窗: week 4, 8, 12, 24, 36, 48 after treatment
according to Pemphigus S2 Guideline，patient who has achieved disease control appears ≥3 new lesions/month that do not heal spontaneously within 1 week, or patient's established lesions extend
disease control
时间窗: week 4, 8, 12, 24, 36, 48 after treatment
according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
adverse evert
时间窗: week 4, 8, 12, 24, 36, 48 after treatment
次要结局
- serum anti-Dsg1 and Dsg3 autoantibody levels(week 4, 8, 12, 24, 36, 48 after treatment)
- dose of glucocorticoids(week 4, 8, 12, 24, 36, 48 after treatment)
- immunoglobulin levels(week 4, 8, 12, 24, 36, 48 after treatment)
- peripheral CD19+ cell counts(week 4, 8, 12, 24, 36, 48 after treatment)
- Concomitant medication(week 4, 8, 12, 24, 36, 48 after treatment)