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Romiplostim

(Nplate®)

Nplate®

Drug updated on 12/11/2024

Dosage FormInjection (subcutaneous; 125 mcg, 250 mcg, 500 mcg)
Drug ClassThrombopoietin receptor agonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
  • Indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

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Summary
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  • This summary is based on the review of six systematic review(s)/meta-analysis(es). [1-6]
  • Effectiveness in Persistent Immune Thrombocytopenia (ITP): Romiplostim and eltrombopag achieved higher platelet response rates, with Romiplostim ranking highest in sustaining platelet counts above 50 x 10^9/L. Avatrombopag showed the greatest platelet response (surface under the cumulative ranking curve (SUCRA) = 87.5) followed by recombinant human thrombopoietin (rhTPO) and eltrombopag.
  • Comparative Efficacy in Persistent ITP: Eltrombopag demonstrated superior efficacy relative to rituximab and rhTPO+rituximab, with a risk ratio (RR) of 4.56 and 4.18, respectively. Romiplostim also showed higher RR for platelet response compared to both rituximab and rhTPO+rituximab.
  • Efficacy in Chemotherapy-Induced Thrombocytopenia (CIT): thrombopoietin receptor agonists (TPO-RAs), including romiplostim, significantly reduced the incidence of grade 3 or 4 thrombocytopenia (RR = 0.69), with this reduction remaining statistically significant after Bonferroni correction (P = 0.008).
  • The incidence of thrombotic events was slightly higher in patients receiving TPO-RAs, such as romiplostim, with a pooled rate of 2.2% in ITP patients and a thrombotic risk ratio of 1.73, though this was not statistically significant (P = 0.113).
  • TPO-RAs, including romiplostim, showed no significant difference in the rates of adverse events (RR = 0.98) or serious adverse events (RR = 0.79) when compared to controls, with similar safety profiles observed across romiplostim, eltrombopag, and avatrombopag.