title: Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia.
abstract: In this study, we report the results from the largest cohort to date of newly diagnosed adult immune thrombocytopenia patients randomized to treatment with dexamethasone alone or in combination with rituximab. Eligible were patients with platelet counts ≤25×10(9)/L or ≤50×10(9)/L with bleeding symptoms. A total of 133 patients were randomly assigned to either dexamethasone 40 mg/day for 4 days (n = 71) or in combination with rituximab 375 mg/m(2) weekly for 4 weeks (n = 62). Patients were allowed supplemental dexamethasone every 1 to 4 weeks for up to 6 cycles. Our primary end point, sustained response (ie, platelets ≥50×10(9)/L) at 6 months follow-up, was reached in 58% of patients in the rituximab + dexamethasone group vs 37% in the dexamethasone group (P = .02). The median follow-up time was 922 days. We found longer time to relapse (P = .03) and longer time to rescue treatment (P = .007) in the rituximab + dexamethasone group. There was an increased incidence of grade 3 to 4 adverse events in the rituximab + dexamethasone group (P = .04). In conclusion, rituximab + dexamethasone induced higher response rates and longer time to relapse than dexamethasone alone. This study is registered at http://clinicaltrials.gov as NCT00909077.
authors.affiliation: Department of Hematology, Copenhagen University Hospital Roskilde, Roskilde, Denmark. sif.gudbrandsdottir@gmail.com
authors.forename: Sif
authors.initials: S
authors.lastname: Gudbrandsdottir
authors.forename: Henrik Sverre
authors.initials: HS
authors.lastname: Birgens
authors.forename: Henrik
authors.initials: H
authors.lastname: Frederiksen
authors.forename: Bjarne Anker
authors.initials: BA
authors.lastname: Jensen
authors.forename: Morten Krogh
authors.initials: MK
authors.lastname: Jensen
authors.forename: Lars
authors.initials: L
authors.lastname: Kjeldsen
authors.forename: Tobias Wirenfeldt
authors.initials: TW
authors.lastname: Klausen
authors.forename: Herdis
authors.initials: H
authors.lastname: Larsen
authors.forename: Hans Torben
authors.initials: HT
authors.lastname: Mourits-Andersen
authors.forename: Claus Henrik
authors.initials: CH
authors.lastname: Nielsen
authors.forename: Ove Juul
authors.initials: OJ
authors.lastname: Nielsen
authors.forename: Torben
authors.initials: T
authors.lastname: Plesner
authors.forename: Stanislaw
authors.initials: S
authors.lastname: Pulczynski
authors.forename: Inge Helleberg
authors.initials: IH
authors.lastname: Rasmussen
authors.forename: Dorthe
authors.initials: D
authors.lastname: Rønnov-Jessen
authors.forename: Hans Carl
authors.initials: HC
authors.lastname: Hasselbalch
mesh_terms: D000328:Adult; D017668:Age of Onset; D000368:Aged; D000465:Algorithms; D058846:Antibodies, Monoclonal, Murine-Derived / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D012008:Recurrence; D000069283:Rituximab; D016896:Treatment Outcome
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000069283:Rituximab; D003907:Dexamethasone