Skip to main content
Top
Published in: Journal of Thrombosis and Thrombolysis 3/2014

01-04-2014

Prednisone versus high-dose dexamethasone for untreated primary immune thrombocytopenia. A retrospective study of the Japan Hematology & Oncology Clinical Study Group

Authors: Kana Sakamoto, Hideki Nakasone, Shigeharu Tsurumi, Ko Sasaki, Kinuko Mitani, Michiko Kida, Akira Hangaishi, Kensuke Usuki, Ayako Kobayashi, Ken Sato, Mariko Karasawa-Yamaguchi, Koji Izutsu, Yasushi Okoshi, Shigeru Chiba, Yoshinobu Kanda

Published in: Journal of Thrombosis and Thrombolysis | Issue 3/2014

Login to get access

Abstract

High-dose dexamethasone (HDD) has been shown to be an effective initial treatment for immune thrombocytopenia (ITP), but it is not clear whether HDD offers any advantages over conventional-dose prednisone (PSL). We retrospectively compared the efficacy and toxicity of HDD and PSL for newly diagnosed ITP. The response was evaluated according to the International Working Group (IWG) criteria. We analyzed data from 31 and 69 patients in the HDD and PSL groups, respectively. There were no significant differences in patient characteristics between the two groups except for the incidence of the eradication of Helicobacter pylori. The response rate was better in the HDD group (42.7 vs. 28.4 %), and this difference was statistically significant when adjusted for other factors including the eradication of H. pylori. In the HDD group, a response was achieved earlier (28 vs. 152 days in median) and steroids were more frequently discontinued at 6 months (64.5 vs. 37.7 %). Among patients who achieved a response, there was no significant difference in the incidence of loss of response. There were no significant differences in the rate of adverse events, transition to chronic ITP, and splenectomy. In conclusion, HDD might enable the early cessation of steroids without a loss of response.
Literature
2.
go back to reference Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN (2009) Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood 113:2386–2393PubMedCrossRef Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN (2009) Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood 113:2386–2393PubMedCrossRef
3.
go back to reference Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ (2010) International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 115:168–186PubMedCrossRef Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ (2010) International consensus report on the investigation and management of primary immune thrombocytopenia. Blood 115:168–186PubMedCrossRef
4.
go back to reference Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA (2011) The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 117:4190–4207PubMedCrossRef Neunert C, Lim W, Crowther M, Cohen A, Solberg L, Crowther MA (2011) The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 117:4190–4207PubMedCrossRef
5.
go back to reference Bellucci S, Charpak Y, Chastang C, Tobelem G (1988) Low doses v conventional doses of corticoids in immune thrombocytopenic purpura (ITP): results of a randomized clinical trial in 160 children, 223 adults. Blood 71:1165–1169PubMed Bellucci S, Charpak Y, Chastang C, Tobelem G (1988) Low doses v conventional doses of corticoids in immune thrombocytopenic purpura (ITP): results of a randomized clinical trial in 160 children, 223 adults. Blood 71:1165–1169PubMed
6.
7.
go back to reference George JN, Harake MA, Raskob GE (1994) Chronic idiopathic thrombocytopenic purpura. N Engl J Med 331:1207–1211PubMedCrossRef George JN, Harake MA, Raskob GE (1994) Chronic idiopathic thrombocytopenic purpura. N Engl J Med 331:1207–1211PubMedCrossRef
8.
go back to reference George JN, Woolf SH, Raskob GE, Wasser JS, Aledort LM, Ballem PJ, Blanchette VS, Bussel JB, Cines DB, Kelton JG, Lichtin AE, McMillan R, Okerbloom JA, Regan DH, Warrier I (1996) Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood 88:3–40PubMed George JN, Woolf SH, Raskob GE, Wasser JS, Aledort LM, Ballem PJ, Blanchette VS, Bussel JB, Cines DB, Kelton JG, Lichtin AE, McMillan R, Okerbloom JA, Regan DH, Warrier I (1996) Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American Society of Hematology. Blood 88:3–40PubMed
9.
go back to reference Mazzucconi MG, Francesconi M, Fidani P, Di Nucci G, Gandolfo GM, Afeltra A, Masala C, Di Prima M, Rocchi G, Resta S (1985) Treatment of idiopathic thrombocytopenic purpura (ITP). Results of a multicentric protocol. Haematologica 70:329–336PubMed Mazzucconi MG, Francesconi M, Fidani P, Di Nucci G, Gandolfo GM, Afeltra A, Masala C, Di Prima M, Rocchi G, Resta S (1985) Treatment of idiopathic thrombocytopenic purpura (ITP). Results of a multicentric protocol. Haematologica 70:329–336PubMed
10.
go back to reference Portielje JE, Westendorp RG, Kluin-Nelemans HC, Brand A (2001) Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood 97:2549–2554PubMedCrossRef Portielje JE, Westendorp RG, Kluin-Nelemans HC, Brand A (2001) Morbidity and mortality in adults with idiopathic thrombocytopenic purpura. Blood 97:2549–2554PubMedCrossRef
11.
go back to reference Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G (2003) Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med 349:831–836PubMedCrossRef Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G (2003) Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med 349:831–836PubMedCrossRef
12.
go back to reference Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D’Alfonso G, Mandelli F, Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA) Thrombocytopenia Working Party (2007) Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood 109:1401–1407PubMedCrossRef Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D’Alfonso G, Mandelli F, Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA) Thrombocytopenia Working Party (2007) Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood 109:1401–1407PubMedCrossRef
13.
go back to reference Borst F, Keuning JJ, van Hulsteijn H, Sinnige H, Vreugdenhil G (2004) High-dose dexamethasone as a first- and second-line treatment of idiopathic thrombocytopenic purpura in adults. Ann Hematol 83:764–768PubMedCrossRef Borst F, Keuning JJ, van Hulsteijn H, Sinnige H, Vreugdenhil G (2004) High-dose dexamethasone as a first- and second-line treatment of idiopathic thrombocytopenic purpura in adults. Ann Hematol 83:764–768PubMedCrossRef
14.
go back to reference Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R (2010) Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood 115:2755–2762PubMedCrossRef Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R (2010) Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood 115:2755–2762PubMedCrossRef
15.
go back to reference Gray RJ (1988) A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 16:1141–1154CrossRef Gray RJ (1988) A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 16:1141–1154CrossRef
16.
go back to reference Scrucca L, Santucci A, Aversa F (2007) Competing risk analysis using R: an easy guide for clinicians. Bone Marrow Transplant 40:381–387PubMedCrossRef Scrucca L, Santucci A, Aversa F (2007) Competing risk analysis using R: an easy guide for clinicians. Bone Marrow Transplant 40:381–387PubMedCrossRef
17.
go back to reference Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 48:452–458 Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 48:452–458
18.
go back to reference Apostolidis J, Tsandekidi M, Kousiafes D, Pagoni M, Mitsouli C, Karmiris T, Bakiri M, Karakasis D, Harhalakis N, Nikiforakis E (2001) Short-course corticosteroid-induced pulmonary and apparent cerebral aspergillosis in a patient with idiopathic thrombocytopenic purpura. Blood 98:2875–2877PubMedCrossRef Apostolidis J, Tsandekidi M, Kousiafes D, Pagoni M, Mitsouli C, Karmiris T, Bakiri M, Karakasis D, Harhalakis N, Nikiforakis E (2001) Short-course corticosteroid-induced pulmonary and apparent cerebral aspergillosis in a patient with idiopathic thrombocytopenic purpura. Blood 98:2875–2877PubMedCrossRef
19.
go back to reference Andersen JC (1994) Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med 330:1560–1564PubMedCrossRef Andersen JC (1994) Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med 330:1560–1564PubMedCrossRef
20.
go back to reference Arnold DM, Dentali F, Crowther MA, Meyer RM, Cook RJ, Sigouin C, Fraser GA, Lim W, Kelton JG (2007) Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med 146:25–33PubMedCrossRef Arnold DM, Dentali F, Crowther MA, Meyer RM, Cook RJ, Sigouin C, Fraser GA, Lim W, Kelton JG (2007) Systematic review: efficacy and safety of rituximab for adults with idiopathic thrombocytopenic purpura. Ann Intern Med 146:25–33PubMedCrossRef
21.
go back to reference Cooper N, Stasi R, Cunningham-Rundles S, Feuerstein MA, Leonard JP, Amadori S, Bussel JB (2004) The efficacy and safety of B-cell depletion with anti-CD20 monoclonal antibody in adults with chronic immune thrombocytopenic purpura. Br J Haematol 125:232–239PubMedCrossRef Cooper N, Stasi R, Cunningham-Rundles S, Feuerstein MA, Leonard JP, Amadori S, Bussel JB (2004) The efficacy and safety of B-cell depletion with anti-CD20 monoclonal antibody in adults with chronic immune thrombocytopenic purpura. Br J Haematol 125:232–239PubMedCrossRef
22.
go back to reference Garcia-Chavez J, Majluf-Cruz A, Montiel-Cervantes L, Esparza MG, Vela-Ojeda J, Group MHS (2007) Rituximab therapy for chronic and refractory immune thrombocytopenic purpura: A long-term follow-up analysis. Ann Hematol 86:871–877PubMedCentralPubMedCrossRef Garcia-Chavez J, Majluf-Cruz A, Montiel-Cervantes L, Esparza MG, Vela-Ojeda J, Group MHS (2007) Rituximab therapy for chronic and refractory immune thrombocytopenic purpura: A long-term follow-up analysis. Ann Hematol 86:871–877PubMedCentralPubMedCrossRef
23.
go back to reference Stasi R, Pagano A, Stipa E, Amadori S (2001) Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood 98:952–957PubMedCrossRef Stasi R, Pagano A, Stipa E, Amadori S (2001) Rituximab chimeric anti-CD20 monoclonal antibody treatment for adults with chronic idiopathic thrombocytopenic purpura. Blood 98:952–957PubMedCrossRef
24.
go back to reference Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL (2006) AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med 355:1672–1681PubMedCrossRef Bussel JB, Kuter DJ, George JN, McMillan R, Aledort LM, Conklin GT, Lichtin AE, Lyons RM, Nieva J, Wasser JS, Wiznitzer I, Kelly R, Chen CF, Nichol JL (2006) AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP. N Engl J Med 355:1672–1681PubMedCrossRef
25.
go back to reference Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM (2007) Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med 357:2237–2247PubMedCrossRef Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM (2007) Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med 357:2237–2247PubMedCrossRef
26.
go back to reference Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M (2009) Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet 373:641–648PubMedCrossRef Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M (2009) Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet 373:641–648PubMedCrossRef
27.
go back to reference Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB (2011) Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet 377:393–402PubMedCrossRef Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB (2011) Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet 377:393–402PubMedCrossRef
28.
go back to reference Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL (2009) Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood 113:2161–2171PubMedCrossRef Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL (2009) Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood 113:2161–2171PubMedCrossRef
29.
go back to reference Khellaf M, Michel M, Quittet P, Viallard JF, Alexis M, Roudot-Thoraval F, Cheze S, Durand JM, Lefrère F, Galicier L, Lambotte O, Panelatti G, Slama B, Damaj G, Sebahoun G, Gyan E, Delbrel X, Dhedin N, Royer B, Schleinitz N, Rossi JF, Mahévas M, Languille L, Bierling P, Godeau B (2011) Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood 118:4338–4345PubMedCrossRef Khellaf M, Michel M, Quittet P, Viallard JF, Alexis M, Roudot-Thoraval F, Cheze S, Durand JM, Lefrère F, Galicier L, Lambotte O, Panelatti G, Slama B, Damaj G, Sebahoun G, Gyan E, Delbrel X, Dhedin N, Royer B, Schleinitz N, Rossi JF, Mahévas M, Languille L, Bierling P, Godeau B (2011) Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program. Blood 118:4338–4345PubMedCrossRef
30.
go back to reference Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL (2008) Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet 371:395–403PubMedCrossRef Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL (2008) Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet 371:395–403PubMedCrossRef
Metadata
Title
Prednisone versus high-dose dexamethasone for untreated primary immune thrombocytopenia. A retrospective study of the Japan Hematology & Oncology Clinical Study Group
Authors
Kana Sakamoto
Hideki Nakasone
Shigeharu Tsurumi
Ko Sasaki
Kinuko Mitani
Michiko Kida
Akira Hangaishi
Kensuke Usuki
Ayako Kobayashi
Ken Sato
Mariko Karasawa-Yamaguchi
Koji Izutsu
Yasushi Okoshi
Shigeru Chiba
Yoshinobu Kanda
Publication date
01-04-2014
Publisher
Springer US
Published in
Journal of Thrombosis and Thrombolysis / Issue 3/2014
Print ISSN: 0929-5305
Electronic ISSN: 1573-742X
DOI
https://doi.org/10.1007/s11239-013-0939-3

Other articles of this Issue 3/2014

Journal of Thrombosis and Thrombolysis 3/2014 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine