Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
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 .
Primary Immune Thrombocytopenia
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia|
- The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion. [ Time Frame: one year ] [ Designated as safety issue: Yes ]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/
- The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response. [ Time Frame: 3 months, one year, last follow-up ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||October 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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
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.