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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Guangdong Provincial Dermatology Hospital | OTHER_GOV |
| Chinese Academy of Medical Sciences | OTHER |
| West China Hospital |
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | one dose of 500mg RTX | ||
| Group B | two doses of 500mg RTX | ||
| Group C | two doses of 1000mg RTX |
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| Measure | Description | Time Frame |
|---|---|---|
| relapse | 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 | week 4, 8, 12, 24, 36, 48 after treatment |
| disease control | according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal | week 4, 8, 12, 24, 36, 48 after treatment |
| adverse evert | week 4, 8, 12, 24, 36, 48 after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| dose of glucocorticoids | According to the clinical glucocorticoid dosage record | week 4, 8, 12, 24, 36, 48 after treatment |
| immunoglobulin levels | week 4, 8, 12, 24, 36, 48 after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| OTHER |
| Second Xiangya Hospital of Central South University | OTHER |
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| Concomitant medication | According to the clinical medication record | week 4, 8, 12, 24, 36, 48 after treatment |
| serum anti-Dsg1 and Dsg3 autoantibody levels | week 4, 8, 12, 24, 36, 48 after treatment |
| peripheral CD19+ cell counts | week 4, 8, 12, 24, 36, 48 after treatment |
| D007154 | Immune System Diseases |