Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia

被引：145

作者：

Gudbrandsdottir, Sif ^{[1
,2
]}

Birgens, Henrik Sverre ^{[3
]}

Frederiksen, Henrik ^{[4
]}

Jensen, Bjarne Anker ^{[3
]}

Jensen, Morten Krogh ^{[3
]}

Kjeldsen, Lars ^{[5
]}

Klausen, Tobias Wirenfeldt ^{[3
]}

Larsen, Herdis ^{[6
]}

Mourits-Andersen, Hans Torben ^{[7
]}

Nielsen, Claus Henrik ^{[2
]}

Nielsen, Ove Juul ^{[5
]}

Plesner, Torben ^{[8
]}

Pulczynski, Stanislaw ^{[9
]}

Rasmussen, Inge Helleberg ^{[10
]}

Ronnov-Jessen, Dorthe ^{[6
]}

Hasselbalch, Hans Carl ^{[1
]}

机构：

[1] Copenhagen Univ Hosp Roskilde, Dept Hematol, DK-4000 Roskilde, Denmark

[2] Rigshosp, Copenhagen Univ Hosp, Inst Inflammat Res, Dept Infect Dis & Rheumatol, DK-2100 Copenhagen, Denmark

[3] Copenhagen Univ Hosp Herlev, Dept Hematol, Herlev, Denmark

[4] Odense Univ Hosp, Dept Hematol, DK-5000 Odense, Denmark

[5] Rigshosp, Copenhagen Univ Hosp, Dept Hematol, DK-2100 Copenhagen, Denmark

[6] Viborg Hosp, Hematol Sect, Dept Internal Med, Viborg, Denmark

[7] Esbjerg Cent Hosp, Dept Hematol & Infect Dis, Esbjerg, Denmark

[8] Vejle Hosp, Dept Hematol, Vejle, Denmark

[9] Holstebro Hosp, Hematol Sect, Dept Internal Med, Holstebro, Denmark

[10] Aarhus Univ Hosp, Aalborg Hosp, Dept Hematol, Aalborg, Denmark

来源：

BLOOD | 2013年 / 121卷 / 11期

关键词：

PURPURA; ADULTS; THERAPY;

D O I：

10.1182/blood-2012-09-455691

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 <= 25x10(9)/L or <= 50x10(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 >= 50x10(9)/L) at 6 months follow-up, was reached in 58% of patients in the rituximab 1 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 1 dexamethasone group. There was an increased incidence of grade 3 to 4 adverse events in the rituximab 1 dexamethasone group (P = .04). In conclusion, rituximab 1 dexamethasone induced higher response rates and longer time to relapse than dexamethasone alone.

引用

页码：1976 / 1981

页数：6

共 15 条

[1] Rituximab in immune thrombocytopenia: transient responses, low rate of sustained remissions and poor response to further therapy in refractory patients [J].