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

Sif Gudbrandsdottir; Henrik Sverre Birgens; Henrik Frederiksen; Bjarne Anker Jensen; Morten Krogh Jensen; Lars Kjeldsen; Tobias Wirenfeldt Klausen; Herdis Larsen; Hans Torben Mourits-Andersen; Claus Henrik Nielsen; Ove Juul Nielsen; Torben Plesner; Stanislaw Pulczynski; Inge Helleberg Rasmussen; Dorthe Rønnov-Jessen; Hans Carl Hasselbalch

doi:10.1182/blood-2012-09-455691

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

Sif Gudbrandsdottir, Henrik Sverre Birgens, Henrik Frederiksen, Bjarne Anker Jensen, Morten Krogh Jensen, Lars Kjeldsen, Tobias Wirenfeldt Klausen, Herdis Larsen, Hans Torben Mourits-Andersen, Claus Henrik Nielsen, Ove Juul Nielsen, Torben Plesner, Stanislaw Pulczynski, Inge Helleberg Rasmussen, Dorthe Rønnov-Jessen, Hans Carl Hasselbalch

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105 Citationer (Scopus)

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 ≤25x10⁹/L or ≤50x10⁹/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/m² 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 ≥50x10⁹/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. This study is registered at http://clinicaltrials.gov as NCT00909077.

Originalsprog	Engelsk
Tidsskrift	Blood
Vol/bind	121
Udgave nummer	11
Sider (fra-til)	1976-81
Antal sider	6
ISSN	0006-4971
DOI	https://doi.org/10.1182/blood-2012-09-455691
Status	Udgivet - 14 mar. 2013

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10.1182/blood-2012-09-455691

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Gudbrandsdottir, S., Birgens, H. S., Frederiksen, H., Jensen, B. A., Jensen, M. K., Kjeldsen, L., Klausen, T. W., Larsen, H., Mourits-Andersen, H. T., Nielsen, C. H., Nielsen, O. J., Plesner, T., Pulczynski, S., Rasmussen, I. H., Rønnov-Jessen, D., & Hasselbalch, H. C. (2013). Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia. Blood, 121(11), 1976-81. https://doi.org/10.1182/blood-2012-09-455691

Gudbrandsdottir, S, Birgens, HS, Frederiksen, H, Jensen, BA, Jensen, MK, Kjeldsen, L, Klausen, TW, Larsen, H, Mourits-Andersen, HT, Nielsen, CH, Nielsen, OJ, Plesner, T, Pulczynski, S, Rasmussen, IH, Rønnov-Jessen, D & Hasselbalch, HC 2013, 'Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia', Blood, bind 121, nr. 11, s. 1976-81. https://doi.org/10.1182/blood-2012-09-455691

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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 ≤25x109/L or ≤50x109/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/m2 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 ≥50x109/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. This study is registered at http://clinicaltrials.gov as NCT00909077.",

author = "Sif Gudbrandsdottir and Birgens, {Henrik Sverre} and Henrik Frederiksen and Jensen, {Bjarne Anker} and Jensen, {Morten Krogh} and Lars Kjeldsen and Klausen, {Tobias Wirenfeldt} and Herdis Larsen and Mourits-Andersen, {Hans Torben} and Nielsen, {Claus Henrik} and Nielsen, {Ove Juul} and Torben Plesner and Stanislaw Pulczynski and Rasmussen, {Inge Helleberg} and Dorthe R{\o}nnov-Jessen and Hasselbalch, {Hans Carl}",

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doi = "10.1182/blood-2012-09-455691",

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T1 - Rituximab and dexamethasone vs dexamethasone monotherapy in newly diagnosed patients with primary immune thrombocytopenia

AU - Gudbrandsdottir, Sif

AU - Birgens, Henrik Sverre

AU - Frederiksen, Henrik

AU - Jensen, Bjarne Anker

AU - Jensen, Morten Krogh

AU - Kjeldsen, Lars

AU - Klausen, Tobias Wirenfeldt

AU - Larsen, Herdis

AU - Mourits-Andersen, Hans Torben

AU - Nielsen, Claus Henrik

AU - Nielsen, Ove Juul

AU - Plesner, Torben

AU - Pulczynski, Stanislaw

AU - Rasmussen, Inge Helleberg

AU - Rønnov-Jessen, Dorthe

AU - Hasselbalch, Hans Carl

PY - 2013/3/14

Y1 - 2013/3/14

N2 - 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 ≤25x109/L or ≤50x109/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/m2 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 ≥50x109/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. This study is registered at http://clinicaltrials.gov as NCT00909077.

AB - 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 ≤25x109/L or ≤50x109/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/m2 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 ≥50x109/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. This study is registered at http://clinicaltrials.gov as NCT00909077.

U2 - 10.1182/blood-2012-09-455691

DO - 10.1182/blood-2012-09-455691

M3 - Journal article

C2 - 23293082

SN - 0006-4971

VL - 121

SP - 1976

EP - 1981

JO - Blood

JF - Blood

IS - 11

ER -

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

Abstract

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