Treatment-free remission was a secondary endpoint defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months in the absence of any ITP treatment, and occurred in 32% (n = 24/75) of patients.1,2
The primary endpoint of the study (N = 75) was the cumulative number of months in which patients achieved a platelet response.2
*Nplate® was initiated following a platelet count ≤ 30 x 109/L at any time during the 4-week screening period. Nplate® was initiated within 6 months of ITP diagnosis.1,2
Nplate® was studied in a 52-week, open-label, single-arm, phase 2 trial of 75 adults with ITP for ≤ 6 months who had an insufficient response (platelet count ≤ 30 x 109/L) to first-line ITP treatment, including corticosteroids.1-4,*
Cumulative number of months in which a patient achieved a median platelet count ≥ 50 x 109/L2
Rate of remission, defined as maintaining every platelet count at ≥ 50 x 109/L for at least 6 months without any ITP treatment2
The lack of a placebo control group prevents determination of remission rates without Nplate®.2
*First-line treatments could have also included immunoglobulins, anti-D immunoglobulin, or vinca alkaloids.2
†Adjustments were made following the recommended dosage regimen (Section 2.1 of the Nplate® Prescribing Information).
TPO-RA, thrombopoietin receptor agonist.
received prior corticosteroid treatment
(n = 72/75)
median time from diagnosis to Nplate®
*Rituximab is not FDA-approved for use in ITP.5
of patients achieved
a platelet response1,*
(n = 70/75)
median time to onset, with
responses occurring as early
as week 1 of treatment1,6,†
(95% Cl: 1.1, 3.0)
*Platelet response was defined as a platelet count ≥ 50 x 109/L.1
†5.56%, 47.22%, and 61.11% of patients responded by weeks 1, 2, and 3, respectively.6
CI, confidence interval.
*32% of patients achieved treatment‑free remission.1,2
†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.1‑3
|ADVERSE EVENT||n (%)|
|BLEEDING EVENT||n (%)|
*Led to discontinuation of Nplate®.2
In 2019 the American Society of Hematology (ASH) and the International Consensus Report (ICR) released updates to their guidelines for ITP treatment. These updates are based on a critical review of relevant articles published over the last 10 years.7,8
Recent evidence suggests that ITP is often managed with prolonged steroid use, exposing patients to side effects that may have long-term implications.7
is preferred vs prolonged, continuous use
Delay splenectomy until after 1 year
Access the full ASH Guidelines.
in patients who achieve a response
even if platelet counts drop during taper
Delay splenectomy until ≥ 1 year to 2 years
Access the full ICR Guidelines.
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. Nplate® (romiplostim) prescribing information, Amgen. 2. 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. 3. 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. 4. Data on file, Amgen; Clinical Study Report 20080435; 2014. 5. RITUXAN® (rituximab) full Prescribing Information, Genentech, Inc. 6. Data on file, Amgen; Time to Onset, biostatistical analysis; 2019. 7. Provan D, Arnold DM, Bussel JB, et al. Updated International Consensus Report on the investigation and management of primary immune thrombocytopenia. Blood Adv. 2019;3(22):3780-3817. 8. Neunert C, Terrell DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv. 2019;3(23):3829-3866.