Immune thrombocytopenia

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Initial therapy

Dexamethasone, high-dose

Regimen #1, Cheng et al. 2003

Levels of Evidence: 125 patients enrolled

• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4

4-day course; patients who had an initial response, but whose platelets dropped below 30,000 within 6 months received:

• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
• Prednisone (Sterapred) 15 mg PO once per day starting on day 5, "with gradual tapering"

Regimen #2, Mazzucconi et al. 2007 (monthly dexamethasone)

Levels of Evidence: 37 patients

• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4
• Patients who had platelet counts of ≤20 x 10⁹/L between cycles received Prednisone (Sterapred) 0.25 mg/kg PO once per day "between courses"

28-day cycles x 6 cycles

Regimen #3, Mazzucconi et al. 2007 (every 2 week dexamethasone)

Levels of Evidence: 95 patients

• Dexamethasone (Decadron) 40 mg PO/IV once per day on days 1 to 4
  • Patients <15 years old received Dexamethasone (Decadron) 20 mg/m2 (maximum dose: 40 mg per day) PO/IV once per day on days 1 to 4
• Patients who had platelet counts of ≤30 x 10⁹/L between cycles and/or who had bleeding related to thrombocytopenia received Dexamethasone (Decadron) 0.035 mg/kg PO once per day "between courses"

14-day cycles x 4 cycles

References

1. Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. link to original article contains verified protocol PubMed content property of HemOnc.org
2. 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. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. Epub 2006 Oct 31. link to original article contains verified protocol PubMed

Relapsed/Refractory

Dexamethasone, high-dose

Regimen, Andersen et al. 1994

Level of Evidence: 10 patients

• Dexamethasone (Decadron) 40 mg PO once per day on days 1 to 4

28-day cycles x 6 cycles

References

1. Andersen JC. Response of resistant idiopathic thrombocytopenic purpura to pulsed high-dose dexamethasone therapy. N Engl J Med. 1994 Jun 2;330(22):1560-4. link to original article contains verified protocol PubMed

Placebo

Regimen

Level of Evidence: Phase III

No treatment; used as a comparator arm and here for reference purposes only.

References

1. 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 Jr, 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. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article PubMed

Romiplostim (Nplate)

Regimen, Kuter et al. 2008

Level of Evidence: Phase III

• Romiplostim (Nplate) 1 mcg/kg (starting dose) SC once per week, with doses titrated per algorithm described in Kuter et al. 2008

References

1. 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 Jr, 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. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article contains verified protocol PubMed

Eltrombopag (Promacta)

Regimen, Bussel et al. 2009

Level of Evidence: Phase III

• Eltrombopag (Promacta) 50 mg (starting dose, route not specified) once daily; the eltrombopag dose could be increased from 50 mg to 75 mg after 3 weeks in patients whose platelet counts were less than 50 000 per μL. Treatment was discontinued in patients who attained a platelet count greater than 200 000 per μL.

References

1. Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. link to original article contains verified protocol PubMed