Nplate® is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient 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.
CHANGE IN HRQoL DOMAINS
Non-splenectomized patients
ITP Patient Assessment Questionnaire (ITP-PAQ) mean change scores from baseline for non-splenectomized patients (n = 61)1,*,†
Splenectomized patients
ITP Patient Assessment Questionnaire (ITP-PAQ) mean change scores from baseline for splenectomized patients (n = 58)1,*,†
Pooled data
Mean ITP-PAQ score change from baseline to week 24 comparing Nplate® (n = 84) vs placebo (n = 41) in all patients1,*,†
*Placebo comparison may limit real-world comparison.1
†Length of disease may influence the change in quality of life.1
‡Overall quality of life was one of the domains and not a composite endpoint of the other domains.1,2
ITP, immune thrombocytopenia.
ITP-PAQ
Questionnaire Assessing HRQoL Domains and the Impact of ITP on a Patient’s Functioning and Well-being2
These data come from an analysis of a secondary descriptive endpoint from the pivotal trials that examined the change from baseline of scores from a validated Patient Reported Outcome (PRO) instrument over a 24-week period.2
Click on the buttons below to see the questions that were asked within the ITP-PAQ
Activity2
In the past 4 weeks, ...
5-point scale from extremely to not at all.
Bother2
In the past 4 weeks, ...
*5-point scale from all the time to never.
†7-point scale from extremely to not at all.
Fatigue/sleep2,*
In the past 4 weeks, how often did ITP or its treatments...
*5-point scale from all the time to never.
Fear2,*
In the past 4 weeks,...
*5-point scale from extremely fearful to not at all fearful.
Fertility (subscale under women’s reproductive health)2,*,†
*5-point scale from extremely to not at all.
†Questions completed by women only.
Menstrual symptoms (subscale under women’s reproductive health)2,*,†
Thinking about your last period, ...
*5-point scale from extremely to not at all.
†Questions completed by women only.
Overall quality of life (QoL)2,*
In the past 4 weeks, ...
*7-point scale from extremely to not at all.
†4-point scale from strongly agree to strongly disagree.
Psychological2
In the past 4 weeks, ...
*5-point scale from all the time to never.
†5-point scale from extremely to not at all.
Social activity2
In the past 4 weeks, ...
*5-point scale from all the time to never.
†5-point scale from extremely to not at all.
Symptoms2,*
In the past 4 weeks, how often did you…
*5-point scale from all the time to never.
Women's reproductive health2
See Fertility and Menstrual symptoms.
Work2,*
Since you were diagnosed, ...
*5-point scale from extremely to not at all, with a not applicable option.
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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.
Please see full Prescribing Information and Medication Guide.
References: 1. George JN, Mathias SD, Go RS, et al. Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo-controlled trials. Br J Haematol. 2009;144:409-415. 2. Mathias SD, Bussel JB, George JN, McMillan R, Okano GJ, Nichol JL. A disease-specific measure of health-related quality of life for use in adults with immune thrombocytopenia purpura: its development and validation. Health Qual Life Outcomes. 2007;5:11. 3. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.