Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial

@article{Kuter2008EfficacyOR,
  title={Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial},
  author={David J Kuter and James B Bussel and Roger M. Lyons and Vinod Pullarkat and Terry Gernsheimer and Francis Mark Senecal and Louis M Aledort and James N. George and Craig Kessler and Miguel A. Sanz and Howard A. Liebman and Frank Thomas Slovick and J. T. M. Wolf and Emmanuelle Bourgeois and Troy H. Guthrie and Adrian Newland and Jeffrey S Wasser and Solomon Hamburg and Carlos Grande and François Lefr{\`e}re and Alan Eli Lichtin and Michael D Tarantino and Howard R. Terebelo and Jean-François Viallard and Francis J. Cuevas and Ronald S. Go and David H Henry and Robert L Redner and Lawrence Rice and Martin Roelof Schipperus and D Matthew Guo and Janet L. Nichol},
  journal={The Lancet},
  year={2008},
  volume={371},
  pages={395-403}
}
BACKGROUND Chronic immune thrombocytopenic purpura (ITP) is characterised by accelerated platelet destruction and decreased platelet production. Short-term administration of the thrombopoiesis-stimulating protein, romiplostim, has been shown to increase platelet counts in most patients with chronic ITP. We assessed the long-term administration of romiplostim in splenectomised and non-splenectomised patients with ITP. METHODS In two parallel trials, 63 splenectomised and 62 non-splenectomised… 
Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP.
TLDR
In conclusion, romiplostim increased platelet counts in most patients for up to 156 weeks without tachyphylaxis and had an acceptable safety profile.
Romiplostim for the treatment of chronic immune thrombocytopenia in adult Japanese patients: a double-blind, randomized Phase III clinical trial
TLDR
In conclusion, romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP.
Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial
TLDR
Eltrombopag is an effective treatment for managment of thrombocytopenia in chronic ITP and a dose increase to 75 mg is explored, and platelet counts generally returned to baseline values within 2 weeks after the end of treatment.
Romiplostim: a breakthrough treatment for the management of immune thrombocytopenic purpura
  • A. Newland
  • Medicine
    European journal of haematology. Supplementum
  • 2009
TLDR
Romiplostim provides a valid treatment option that may bring about a change in the way that patients with ITP are treated in the future and appears to be generally well tolerated.
Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study
TLDR
Eltrombopag is effective for management of chronic immune thrombocytopenia, and could be particularly beneficial for patients who have not responded to splenectomy or previous treatment, and should be balanced with the potential risks associated with eltrom bopag treatment.
New Drug Romiplostim in Chronic Immune Thrombocytopenic Purpura
TLDR
Based on the findings from this review, romiplostim administration has been associated with a durable platelet response in these patients with refractory chronic ITP and has been found to be generally well tolerated.
Complete remission of refractory immune thrombocytopenia (ITP) with a short course of Romiplostim
TLDR
The normalisation of platelet counts in a previously refractory ITP patient with a very short course of romiplostim is reported, which shows no evidence of myelodysplasia but increased number of megakaryocytes consistent with peripheral consumption.
Combination of romiplostim and rituximab: effective therapy of severe immune thrombocytopenia
TLDR
Two patients with severe ITP that were successfully treated with a combination of romiplostim and rituximab are described, revealing high-titer anti-platelet antibodies in the serum and increased numbers of megakaryocytes in the bone marrow.
The Effectiveness and Safety of the Thrombopoetin Agonist Romiplostim in the Treatment of Adults with Chronic Idiopathic Thrombocytopenic Purpura
TLDR
The new addition of romiplostim in the treatment of chronic ITP in these studies were effective in raising platelet counts while having only mild to moderate side effects in the majority of the patients.
Eltrombopag for the treatment of chronic immune thrombocytopenia
TLDR
Eltrombopag has shown safety and efficacy in three double-blind randomized placebo-controlled multicenter studies, and a dose-dependent platelet increase to over 50 × 109/l was achieved in 58–60% of the patients.
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References

SHOWING 1-10 OF 40 REFERENCES
Treatment options for chronic idiopathic (immune) thrombocytopenic purpura.
TLDR
The hypothesis is that prolonged maintenance therapy with a nontoxic regimen may increase the percentage of patients who will experience a spontaneous remission from thrombocytopenia, thereby avoiding an invasive and permanent surgical procedure, splenectomy, and its potentially life-threatening sequelae.
Long-term dosing of AMG 531 in thrombocytopenic patients with immune thrombocytopenic purpura : 2-year update
TLDR
Most patients have been able to maintain a safe platelet count and to decrease or discontinue concurrent corticosteroid therapy, and individualized weekly doses of AMG 531 provide a therapeutic option for ITP.
Long-Term Dosing of AMG 531 Is Effective and Well Tolerated in Thrombocytopenic Patients with Immune Thrombocytopenic Purpura.
TLDR
Individualized weekly doses of AMG 531 may provide a therapeutic option in ITP, potentially enabling patients to taper off long-term corticosteroid therapy and has been generally well tolerated in this ongoing study.
Very low dose danazol in idiopathic thrombocytopenic purpura and its role as an immune modulator.
TLDR
Very low dose danazol regimen produced a significant increase in the CD4 without affecting the B cells, however, the excellent-good responder patients showed no significant change in theCD4 lymphocytes.
AMG 531, a thrombopoiesis-stimulating protein, for chronic ITP.
TLDR
AMG 531 caused no major adverse events and increased platelet counts in patients with ITP, and increases in the platelet count were dose-dependent.
Intravenous Anti-D Treatment of Immune Thrombocytopenic Purpura: Experience in 272 Patients
TLDR
Intervention of intravenous anti-D therapy in 261 non-splenectomized patients treated at the New York Hospital-Cornell Medical Center over the period from 1987 to 1994 is reported, finding that HIV+ patients show no adverse effects on hemoglobin decrease or HIV disease progression.
Maintenance treatment of adults with chronic refractory immune thrombocytopenic purpura using repeated intravenous infusions of gammaglobulin.
TLDR
Intravenous infusion of gammaglobulin is an effective although expensive maintenance therapy for adults with ITP and is useful in patients who have not responded to splenectomy.
Management of Adult Patients with Persistent Idiopathic Thrombocytopenic Purpura Following Splenectomy
TLDR
The efficacy of the different treatments for achieving a durable complete response is assessed and agents that may be most promising for further study are cyclophosphamide, azathioprine, and rituximab.
An open‐label, unit dose‐finding study of AMG 531, a novel thrombopoiesis‐stimulating peptibody, in patients with immune thrombocytopenic purpura
TLDR
Patients tolerated AMG 531 well at the doses tested and no anti‐AMG or antithrombopoietin antibodies were detected; doses equivalent to ≥1 μg/kg increased platelet counts.
Splenectomy for adult patients with idiopathic thrombocytopenic purpura: a systematic review to assess long-term platelet count responses, prediction of response, and surgical complications.
TLDR
Although the risk of surgery is an important consideration, splenectomy provides a high frequency of durable responses for adult patients with ITP and the ability to predict who will respond, and the frequency of surgical complications all remain uncertain.
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