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.
PLATELET CONTROL
Overall and durable platelet response in non-splenectomized patients1,2
Patients in the control arm received placebo. Some patients in both arms were receiving concurrent
ITP medications at baseline and were allowed to continue receiving them.1,2
Patients maintained platelet counts ≥ 50 x 109/L throughout the 6-month pivotal trial4
Median weekly platelet counts in non-splenectomized patients2
Median weekly platelet count includes all patients, even those receiving rescue therapy. Error bars indicate the range from the first to the third quartiles.
Red line indicates platelet count of 50 x 109/L.2
*Defined as platelet count ≥ 50 x 109/L measured 1 week after the first dose. In patients who received placebo, 0% achieved this response.3
CONCURRENT/RESCUE THERAPIES
Concurrent or rescue ITP therapies
Non-splenectomized patients who reduced or discontinued* concurrent ITP therapies1,2
n = number of patients receiving concurrent ITP medication baseline.2
Changes could be made to concurrent ITP therapies (corticosteroids, azathioprine, or danazol) during the first 12 weeks of study when platelet counts were > 100 x 109/L.2
Non-splenectomized patients receiving rescue therapy1,2
Rescue therapies included corticosteroids, intravenous immunoglobulin (IVIG), platelet transfusions, and anti-D immunoglobulin and were permitted for bleeding, for wet purpura, or if the patient was at immediate risk for hemorrhage.1
*Discontinuation was defined as discontinuation of all therapies for patients receiving multiple concomitant baseline therapies.1
Watch why Dr Steven Fein chooses Nplate® for second-line treatment in adults with chronic ITP
PLATELET CONTROL
Overall and durable platelet response
Patients in the control arm received placebo. Some patients in both arms were receiving concurrent
ITP medications at baseline and were allowed to continue receiving them.1
Patients maintained platelet counts ≥ 50 x 109/L throughout the 6-month pivotal trial2
Median weekly platelet counts in splenectomized patients2
Median weekly platelet count includes all patients, even those receiving rescue therapy. Error bars indicate the range from the first to the third quartiles.
Red line indicates platelet count of 50 x 109/L.2
*Defined as platelet count ≥ 50 x 109/L measured 1 week after the first dose. In patients who received placebo, 0% achieved this response.3
CONCURRENT/RESCUE THERAPIES
Concurrent or rescue ITP therapies
Splenectomized patients who reduced or discontinued* concurrent ITP therapies1,2
n = number of patients receiving concurrent ITP medication baseline.2
Changes could be made to concurrent ITP therapies (corticosteroids, azathioprine, or danazol) during the first 12 weeks of study when platelet counts were > 100 x 109/L.2
Splenectomized patients receiving rescue therapy1,2
Rescue therapies included corticosteroids, intravenous immunoglobulin (IVIG), platelet transfusions, and anti-D immunoglobulin and were permitted for bleeding, for wet purpura, or if the patient was at immediate risk for hemorrhage.1
*Discontinuation was defined as discontinuation of all therapies for patients receiving multiple concomitant baseline therapies.1
Watch why Dr Terry Gernsheimer and Dr Michael Tarantino choose Nplate® for second-line treatment following relapse after splenectomy in adults with chronic ITP
STUDY DESIGN FOR THE TWO PHASE 3 PIVOTAL TRIALS
Nplate® was studied vs placebo in 2 parallel, double-blind, 24-week, phase 3 trials in patients with adult chronic immune thrombocytopenia (ITP). One trial enrolled splenectomized patients (n = 63), the other enrolled non-splenectomized patients (n = 62).1,2
Pivotal trials endpoint definitions1,2
Primary Endpoint:
Durable platelet response
Secondary Endpoint:
Overall platelet response
When a timely and efficacious response matters, Nplate® restores stability for 8 out of 10 patients†
See the adult chronic ITP pooled safety data
*Prior ITP treatments in both study groups included corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, and azathioprine. (Rituximab is not FDA-approved for use in ITP.)5
†Based on overall platelet response (88%) in non-splenectomized patients.1
PLATELET CONTROL
STUDY DESIGN
TREATMENT DURATION
1 to 277 weeks (mean: 110 weeks).
period6Nplate® or placebo/standard-of-care (SOC)
trialsPrior Nplate® patients:
continued on their same dose*
Prior placebo/SOC patients:
started on Nplate® 1 mcg/kg/wk*
On Nplate® until end of
study or discontinuation
Study enrollment and completion6
TREATMENT PERIOD | # of patients |
---|---|
> 24 weeks | 271 patients (93%) |
> 48 weeks | 242 patients (83%) |
> 96 weeks | 117 patients (40%) |
> 144 weeks | 93 patients (32%) |
> 192 weeks | 53 patients (18%) |
> 240 weeks | 23 patients (8%) |
291 patients received at least one dose of Nplate® during the rolling enrollment period6
200 patients completed the study6
*Given as a once-weekly subcutaneous injection. Patients who had been off Nplate® for 24 weeks or who had not previously received Nplate® initiated therapy at 1 mcg/kg. Dose adjustments were allowed to maintain platelet counts ≥ 50 x 109/L.1 The recommended starting dose for Nplate® is 1 mcg/kg and the maximum weekly dose is 10 mcg/kg. Please see Nplate® full Prescribing Information for complete dosing instructions, including guidelines for dose adjustments.6
ITP, immune thrombocytopenia.
500,000+ Served Worldwide7
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. Nplate® (romiplostim) prescribing information, Amgen. 2. Kuter DJ, Bussel JB, Lyons RM, et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenia purpura: a double-blind randomised controlled trial. Lancet. 2008;371(9610):395-403. 3. Data on file, Amgen; Onset of Response; 2018. 4. Data on file, Amgen; Duration of Response; 2017. 5. RITUXAN® (rituximab) full Prescribing Information, Genentech, Inc. 6. Kuter DJ, Bussel JB, Newland A, et al. Long-term treatment with romiplostim in patients with chronic immune thrombocytopenia: safety and efficacy. Br J Haematol. 2013;161(3):411-423. 7. Data on file, Amgen; Number of patients treated with Nplate® from launch through to June 2023; Updated 2023.