Immune thrombocytopenia

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Initial therapy

Dexamethasone, high-dose

Regimen #1, Matschke et al. 2013

Phase III

Pre-dexamethasone

Pulsed dexamethasone

3-week cycle x 6 cycles

Regimen #2, Cheng et al. 2003

125 patients enrolled

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

Regimen #3, Mazzucconi et al. 2007 (monthly dexamethasone)

37 patients

28-day cycles x 6 cycles

Regimen #4, Mazzucconi et al. 2007 (every 2 week dexamethasone)

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
  3. Abstract: Hannes Müller-Beißenhirtz, Ilona Vester, Bernd Hertenstein, Lewin Eisele, Hildegard Lax, Claudia Ose, Ulrich Dührsen. A Randomized Trial Of Daily Prednisone Versus Pulsed Dexamethasone In Treatment Naïve Patients With Idiopathic Thrombocytopenic Purpura. Blood Nov 2013,122(21)325. link to abstract

Dexamethasone & Eltrombopag

Regimen

Pilot, <20 patients reported

One course

References

  1. Gómez-Almaguer D, Herrera-Rojas MA, Jaime-Pérez JC, Gómez-De León A, Cantú-Rodríguez OG, Gutiérrez-Aguirre CH, Tarín-Arzaga L, Hernández-Reyes J, Ruiz-Arguelles GJ. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. Blood. 2014 Jun 19;123(25):3906-8. Epub 2014 May 6. link to original article contains verified protocol PubMed

Dexamethasone & Rituximab

Regimen ("R+3Dex")

Retrospective

References

  1. Abstract: Allison Imahiyerobo, Micha Thompson, Marina Izak Karaev, Waleed Ghanima, James B Bussel. Rituximab Combined With Three Cycles Of High Dose Dexamethasone Provides a Long Term Response Rate Similar To That Of Splenectomy In Patients With Immune Thrombocytopenia (ITP) Of Duration Less Than 2 Years. Blood Nov 2013,122(21)2310. link to abstract

Prednisone (Sterapred)

Regimen #1, Matschke et al. 2013

Phase III

  • Prednisone (Sterapred) 1 mg/kg/day for 14 days, then tapered over 19 weeks with a goal of maintenance dosing less than 7.5 mg/day at the end of week 19

References

  1. Abstract: Hannes Müller-Beißenhirtz, Ilona Vester, Bernd Hertenstein, Lewin Eisele, Hildegard Lax, Claudia Ose, Ulrich Dührsen. A Randomized Trial Of Daily Prednisone Versus Pulsed Dexamethasone In Treatment Naïve Patients With Idiopathic Thrombocytopenic Purpura. Blood Nov 2013,122(21)325. link to abstract

Rho(D) immune globulin (RhoGAM)

Regimen

Randomized Phase II, <20 per arm

Note: this medication is only effective in RhD-positive patients. The approved dose it 50 μg/kg but there is some data to support a higher dose of 75 μg/kg.

Supportive medications:

Can be repeated if required to increase platelet count

References

  1. Bussel JB, Graziano JN, Kimberly RP, Pahwa S, Aledort LM. Intravenous anti-D treatment of immune thrombocytopenic purpura: analysis of efficacy, toxicity, and mechanism of effect. Blood. 1991 May 1;77(9):1884-93. link to original article PubMed
  2. Newman GC, Novoa MV, Fodero EM, Lesser ML, Woloski BM, Bussel JB. A dose of 75 microg/kg/d of i.v. anti-D increases the platelet count more rapidly and for a longer period of time than 50 microg/kg/d in adults with immune thrombocytopenic purpura. Br J Haematol. 2001 Mar;112(4):1076-8. link to original article contains verified protocol PubMed

Relapsed/Refractory

Dexamethasone, high-dose

Regimen, Andersen et al. 1994

10 patients

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

Dexamethasone & Rituximab

Regimen ("R+3Dex")

Retrospective

References

  1. Abstract: Allison Imahiyerobo, Micha Thompson, Marina Izak Karaev, Waleed Ghanima, James B Bussel. Rituximab Combined With Three Cycles Of High Dose Dexamethasone Provides a Long Term Response Rate Similar To That Of Splenectomy In Patients With Immune Thrombocytopenia (ITP) Of Duration Less Than 2 Years. Blood Nov 2013,122(21)2310. link to abstract

Eltrombopag (Promacta)

Regimen #1, Bussel et al. 2009

Phase III

  • Eltrombopag (Promacta) 50 mg (starting dose) PO once per day; 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.

Regimen #2, Cheng et al. 2010 (RAISE)

Phase III

Dose modifications:

  • Increase to 75 mg PO once per day allowed after day 22 for patients with platelet counts lower than 50,000 per μL
  • Decrease to 25 mg PO once per day required for platelets counts between 200,000 and 400,000 per μL
  • Drug was held for platelet count greater than 400,000 per μL, until platelet count dropped below 150,000 per μL

6-month course

Regimen #3, Saleh et al. 2012 (EXTEND)

Non-randomized

"Dose and schedule were individualized with the goal of achieving and maintaining platelets ≥ 50,000/μL and < 200,000/μL."

References

  1. 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. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. link to original article PubMedPubMed PMID:
  2. 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
  3. Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. Epub 2010 Aug 23. Erratum in: Lancet. 2011 Jan 29;377(9763):382. link to original article contains verified protocol PubMed
  4. Saleh MN, Bussel JB, Cheng G, Meyer O, Bailey CK, Arning M, Brainsky A; EXTEND Study Group. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia: results of the long-term, open-label EXTEND study. Blood. 2013 Jan 17;121(3):537-45. Epub 2012 Nov 20. link to original article contains verified protocol PubMed

Placebo

Regimen

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
  2. 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
  3. Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. Epub 2010 Aug 23. Erratum in: Lancet. 2011 Jan 29;377(9763):382. link to original article contains verified protocol PubMed

Rituximab (Rituxan)

Regimen, Godeau et al. 2008 & Patel et al. 2012

Phase II

Patients in Godeau et al. 2008 had "ITP lasting 6 or more months before inclusion; at least 1 previous treatment for ITP; and platelet count less than 30 × 109/L at inclusion" and were candidates for splenectomy."

Supportive medications (per Godeau et al. 2008):

4-week course

References

  1. Godeau B, Porcher R, Fain O, Lefrère F, Fenaux P, Cheze S, Vekhoff A, Chauveheid MP, Stirnemann J, Galicier L, Bourgeois E, Haiat S, Varet B, Leporrier M, Papo T, Khellaf M, Michel M, Bierling P. Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study. Blood. 2008 Aug 15;112(4):999-1004. link to original article contains verified protocol PubMed
  2. Patel VL, Mahévas M, Lee SY, Stasi R, Cunningham-Rundles S, Godeau B, Kanter J, Neufeld E, Taube T, Ramenghi U, Shenoy S, Ward MJ, Mihatov N, Patel VL, Bierling P, Lesser M, Cooper N, Bussel JB. Outcomes 5 years after response to rituximab therapy in children and adults with immune thrombocytopenia. Blood. 2012 Jun 21;119(25):5989-95. link to original article contains verified protocol PubMed

Romiplostim (Nplate)

Regimen, Kuter et al. 2008

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
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