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The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .
Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard regimen | Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab | ||
| Rheumatoid arthritis regimen | Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. | A complete response (CR) was defined as a platelet count >100 x 109/l and a response (R): by a platelet count >30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/ | one year |
| Measure | Description | Time Frame |
|---|---|---|
| The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response. | 3 months, one year, last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Primary ITP patients treated with standard or RA regimen were retrospectively included in the observationnal study.
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |