93% of patients achieved any platelet response2,*
(n = 70/75)
Rapid onset as early as 7 days with median time to onset of 2.1 weeks1,3,†
(95% Cl: 1.1, 3.0)
Lasting stability (primary endpoint): 61% of patients achieved a response for ≥ 11 months (n = 46/75)1
*Platelet response was defined as a platelet count ≥ 50 x 109/L.2
†5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.3
CI, confidence interval.
Watch why Dr Steven Fein chooses Nplate® for second-line treatment in newly diagnosed/persistent ITP
Don’t wait—Choose Nplate® first when your ITP patient needs second-line treatment1
*This regimen includes reducing, withholding, and discontinuing Nplate® if/when platelet counts exceed certain levels. Of the 24 patients who achieved treatment‑free remission, 20 (83%) discontinued Nplate® based on this regimen during the 52-week treatment period; 4 patients (17%) tapered Nplate® at the end of the 52-week treatment period using a different dosage adjustment approach per the study protocol.1,2,4
†Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate® Prescribing Information).2
STUDY DESIGN & PATIENTS
The First Prospective Trial to Evaluate Treatment-Free Remission With Nplate®
Nplate® was studied in adult patients with newly diagnosed/persistent ITP
Nplate® was studied in a 52-week, open-label, single-arm, phase 2 trial of 75 adults with newly diagnosed/persistent ITP for ≤ 6 months who had an insufficient response (platelet count ≤ 30 x 109/L) to first-line ITP treatment, including corticosteroids.1-4,* The primary endpoint was the cumulative number of months in which a patient achieved a median platelet count ≥ 50 x 109/L. 1 The secondary endpoint was the rate of remission, defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months without any ITP treatment.1-4
Patients received Nplate® within 6 months of diagnosis, right after insufficient response to first-line treatment1-4
*First-line treatments could have also included immunoglobulins, anti-D immunoglobulin, or vinca alkaloids.1
†Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate® Prescribing Information).
ITP, Immune thrombocytopenia.
Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy.
Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate® is 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.
Nplate® is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate® should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate® should not be used in an attempt to normalize platelet counts.
References: 1. Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172(2):262-273. 2. Nplate® (romiplostim) prescribing information, Amgen. 3. Data on file, Amgen; Clinical Study Report 20080435; 2014. 4. Newland A, Godeau B, Priego V, et al. Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol. 2016;172(Suppl):1-4.