FOIA Most patients who developed anti-romiplostim binding antibodies (18 of 25 [72%]) had 90% of platelet assessments showing a response. 2]). Peak platelet counts occur between days 12 and 14 with a decline to baseline by day 28. Following 4 weeks of home administration training pack training, the majority of patients were able to correctly reconstitute romiplostim (97.5%), deliver the proper dose (100%), and successfully administer the injection (100%).23 Data from the pediatric ICON2 trial found that 16% of children (n = 51) had received 1 dose of romiplostim at home.19, Initial phase 1 and phase 2 clinical trials of romiplostim in adult patients with chronic ITP demonstrated platelet responses within the targeted platelet range, 50 to 450 109/L, and at least twice the baseline platelet count, to various dosing cohorts ranging from 1 to 10 g/kg per week.24 Efficacy of romiplostim in splenectomized and nonsplenectomized adults was shown in 2 parallel phase 3 randomized trials, with 38% of splenectomized patients (n = 42) and 61% of nonsplenectomized subjects (n = 41) achieving a durable platelet response (platelet count >50 109/L for 6 of the last 8 weeks of therapy). and transmitted securely. Romiplostim is approved to treat: Thrombocytopenia (low platelet levels). 2014 Aug;39(4):376-82. doi: 10.1111/jcpt.12156. Learn more The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response. Would you like email updates of new search results? For data that were not normally distributed, the Box-Cox procedure23 was used to decide an appropriate transformation to normality. and transmitted securely. Hematopoietic syndrome of acute radiation syndrome: Infants, Children, and Adolescents: SubQ: 10 mcg/kg once; administer dose as soon as possible after suspected or confirmed exposure to radiation levels >2 (gray) Gy; do not delay romiplostim if CBC is not readily available. No patients withdrew due to adverse events. We examined the development of binding and neutralizing antibodies to romiplostim and TPO among pediatric patients with primary immune thrombocytopenia (ITP) in 5 clinical trials and a global postmarketing registry. These mutations impair secretion and reduce the activity of native TPO. The primary end point was correction of platelet count within 3 weeks. Epub 2012 May 14. As such, the ability to predict which patient was more likely to develop antibodies (either transient or persistent) appears to have limited clinical utility, given that no evidence shows that anti-romiplostim or anti-TPO binding antibodies influence clinical outcomes in pediatric patients. Conflict-of-interest disclosure: C.E.N. Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body's natural TPO and is designed to increase platelet counts in patients with chronic immune thrombocytopenia (ITP). Future research could help to address some of the gaps in knowledge about romiplostim, including ideal dosing strategies, extended indications, optimum timing of initiation, and cost evaluation. Dose for ITP control and the potential for treatment-free remission 1 Use the lowest dose of Nplate to achieve and maintain a platelet count 50 x 10 9 /L as necessary to reduce the risk for bleeding. . Lastly, although the effect of romiplostim is through interaction with the Mpl receptor, it did not inhibit the native role of TPO in megakaryocyte proliferation and could bind with Mpl, even in the presence of native TPO9 (Figure 2). For the postmarketing registry, immunogenicity data were evaluated for pediatric patients for whom spontaneous requests for antibody testing of blood samples were submitted during the period of interest. At follow-up, all patients had a decrease in reticulin grade, even 1 patient who continued on romiplostim therapy. Similar to findings from our previous analysis in adults, platelet counts and AEs provided no evidence that development of anti-romiplostim or anti-TPO antibodies was associated with reduced platelet response or increased romiplostim dose. Romiplostim is a once-weekly subcutaneous injection that has been shown to increase the platelet count, lessen bleeding, and reduce concurrent medication use in adults with ITP. 2021 May 10;12:624844. doi: 10.3389/fphar.2021.624844. Patients 19 and 21, who had experienced bleeding AEs, had platelet assessments showing no response after the first detection of anti-romiplostim binding antibodies (2% and 45%, respectively). A total of 217 patients (184 adults, 19 pediatric patients, and 14 patients with age missing in the data) for whom spontaneous requests for antibody testing of blood samples were submitted from May 2009 through May 2016 had immunogenicity results in the manufacturers postmarketing registry study. Reduction or discontinuation of concurrent therapy (eg, corticosteroids) occurred in 87% of patients given romiplostim compared with 38% receiving placebo.25 Further long-term open-label adult studies (n = 142) with romiplostim treatment showed an overall platelet count response (>50 109/L) in 87% of all patients.26 Lastly, the phase 3 long-term trial, describing up to 5 years of therapy and nearly 300 adult patients, noted median platelet counts of 50 to 200 109/L maintained by all patients at a median 92% of study visits.27. Romiplostim is indicated for children 1 year of age who have had ITP for 6 months and an insufficient response to corticosteroids, immunoglobulins, or splenectomy. This site needs JavaScript to work properly. To facilitate proper drug administration, the manufacturer provided a home administration training pack to eligible patients. McMillan R, Luiken GA, Levy R, Yelenosky R, Longmire RL. At the time the immunogenicity assay was validated using SPRIA and a bioassay platform, Amgen followed the published guidance for industry at that time.21,22 The screening assay cutoff point was statistically derived using the mean +3 standard deviation and removal of assay values that were outliers. (1) advertisement 2 DOSAGE AND ADMINISTRATION Initial dose of 1 mcg/kg once weekly as a subcutaneous injection. Administer Nplate as a once-weekly subcutaneous injection with dose adjustments based upon the platelet count response. The peptibody molecule has two identical single-chain subunits, each one is made up of 269 amino acid residues. 2016 Jan;95(2):239-44. doi: 10.1007/s00277-015-2556-z. Adverse events for the initial adult phase 3 studies were primarily rated as mild to moderate in severity. No obvious pattern of romiplostim dose increase was observed when immunogenicity to romiplostim or TPO was detected. Along a similar time course, in 2011, a second TPO-RA, eltrombopag, was approved for adults with chronic ITP who had insufficient response to corticosteroids, immunoglobulins, or splenectomy, and the label was expanded to children 1 year of age in 2016. After treatment, the samples were tested in corresponding romiplostim or TPO assays. The upper limit on the range of the expected values for the population was determined by calculating the upper bound of a 1-sided 95% prediction interval for the distribution of the assay values from 141 patients with ITP who were treatment naive for romiplostim. For patients who continued from the parent studies15-17 to the extension studies,18,19 data from both study phases were included in the analysis, but each patient was counted only once. Nine of 279 patients (3.2%) who had received romiplostim tested positive for anti-TPO binding antibodies; 8 (2.9%) had transient antibodies, and 1 (0.4%) had persistent antibodies. Accessibility Complete details are available at the https://wwwext.amgen.com/science/clinical-trials/clinical-data-transparency-practices/clinical-trial-data-sharing-request/. Romiplostim, a thrombopoietin mimetic, is efficacious as a second-line treatment for immune thrombocytopenia in children and for TRT in adult cancer patients. Data suggest that, following TPO-RA exposure, some individuals exhibit a reduction in levels of platelet antibodies,52 as well as improved regulatory T-cell number and function.53 A proportion of adult patients may be able to maintain a stable platelet count 50 109/L following the use of romiplostim. Transient and persistent anti-romiplostim binding antibodies, transient anti-TPO binding antibodies, and transient anti-romiplostim neutralizing antibodies were identified when the romiplostim dose was close to the median dose of 8 g/kg (Figure 3A-C), and all of the antibodies were persistently identified at lower romiplostim doses, in the 3 to 5 g/kg range (Figure 3D). We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). 2021 May 26;15:2243-2268. doi: 10.2147/DDDT.S299591. Epub 2011 Nov 14. Seven patients continued to receive romiplostim after anti-romiplostim neutralizing antibodies were detected; of those, 6 had a subsequent platelet response at 1 or more weekly measurements. The phase 1/2 pediatric clinical trial included assessment of pharmacokinetics.12 With weekly dosing, serum concentrations ranged from 16 to 51.1 pg/mL predose and from 17.7 to 274 pg/mL 2 days following a dose. Interpretation: Careers. For the 25 patients who developed postbaseline anti-romiplostim binding antibodies (either transient or persistent), median time to the first positive result was 67 weeks (Table 3). Total assay variance calculated by analysis of variance incorporated patient, day, and plate differences into the calculation of prediction limits, with inhibition of romiplostim-induced proliferation by 16.0% or inhibition of TPO-induced proliferation by 25.9% considered a sign of neutralizing activity. The full-text version of this article contains a data supplement. 2019 Apr 1;23(2):212-216. doi: 10.1188/19.CJON.212-216. Lancet. Subsequently, in a 24-week phase 3 randomized trial, children who had failed 1 additional therapy and continued to have a platelet count <30 109/L were eligible.20 A durable response, platelet count 50 109/L without rescue therapy in the previous 4 weeks for 6 of the final 8 study weeks, was exhibited by 52% of children in the treatment group compared with 10% in the placebo group (P = .002; odds ratio, 9.1; 95% confidence interval, 1.9-43.2). 8600 Rockville Pike Splenectomy has been successful in Wiskott-Aldrichassociated thrombocytopenia, but at the expense of increased infection risk. For patients with transient and persistent anti-romiplostim neutralizing antibodies and the 1 patient with transient anti-TPO neutralizing antibodies, platelet response was similar to that which occurs after detection of persistent anti-romiplostim or persistent anti-TPO binding antibodies, with an initial decrease followed by an increase in median platelet counts before the end of treatment (Figure 2C-D). Patients in the romiplostim group maintained a platelet response (50 109/L) for a median of 7 weeks (range, 0-11) compared with 0 weeks in the placebo group. 2015 Aug;2(8):e315-25. The development of anti-romiplostim neutralizing antibodies was unrelated to the romiplostim dose, and most patients who developed the antibodies (7 of 8 [88%]) had platelet response. sharing sensitive information, make sure youre on a federal Use of eltrombopag in the pediatric population is outlined in a 2018 review article6; this review will focus on romiplostim. 2022 Feb 14;7(1):48. doi: 10.1038/s41392-022-00904-4. No patients developed anti-TPO neutralizing antibodies in the adult ITP analysis20 compared with 1 (0.4%) patient in our pediatric ITP analysis. Al-Samkari H, Marshall AL, Goodarzi K, Kuter DJ. No treatment-emergent AEs of hypersensitivity were reported. The pilot data from the pediatric phase 1/2 study showed that treatment with romiplostim significantly reduced parental burden (24 17 vs 6 8, P = .0008) based on the Kids ITP Tool (KIT). The Nplate (romiplostim) dose calculator is provided to simplify the calculation of the correct dose and guide to the correct reconstitution and administration procedures. Romiplostim is a TPO receptor agonist that has been utilized successfully in the treatment of pediatric patients with immune thrombocytopenia. Romiplostim patients were also more likely to experience an overall platelet count response (4 platelet count responses between weeks 2 and 25), as well as any platelet response (platelet count 50 109/L). Expansion of off-label romiplostim use is being reported in children for ITP <6 months, neonatal thrombocytopenia, hereditary thrombocytopenias, and chemotherapy- and bone marrow transplant-associated thrombocytopenia. PMC In addition, romiplostim is well tolerated, making it an attractive option for the treatment of children. A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP) IRAS ID. When converted to weight-based dosing, the dosing range was between 1 and 10 g/kg.13. Amgen Inc. Trial registration: 2021 Jul;81(11):1285-1305. doi: 10.1007/s40265-021-01553-7. Romiplostim is a once-weekly subcutaneous injection that has been shown to increase the platelet count, lessen bleeding, and reduce concurrent medication use in adults with ITP. If platelet counts remained between 200 10 9 /L and 400 10 9 /L for 2 consecutive weeks, the dose was reduced by 1 g/kg on the next scheduled dosing day. Most bleeding adverse events occurred in the first 6 weeks of the treatment period, during the dose-escalation phase, and the platelet count was <30 109/L in >80% of these patients. A Review of Romiplostim Mechanism of Action and Clinical Applicability. Serum concentrations of romiplostim in pediatric patients with ITP were within the range observed in adult patients with ITP receiving the same dose range of romiplostim. Bussel JB, Soff G, Balduzzi A, Cooper N, Lawrence T, Semple JW. No patients tested positive for anti-TPO binding or neutralizing antibodies. Of the 8 patients who tested positive for anti-romiplostim neutralizing antibodies, 7 continued romiplostim after their first positive result with no rescue medication needed within 4 weeks of testing positive for anti-drug antibodies. Nplate is not indicated for the treatment of thrombocytopenia due to MDS or any cause of thrombocytopenia other than ITP. Of the 19 pediatric patients for whom spontaneous requests for antibody testing of blood samples were submitted from May 2009 through May 2016, 3 (15.8%) tested positive for anti-romiplostim binding antibodies; 1 (5.3%) of these patients tested positive for anti-romiplostim neutralizing antibodies. Therefore, alternative options for management of severe thrombocytopenia in these conditions would be of high value. Romiplostim is given as a subcutaneous injection once weekly. Early murine studies demonstrated that, compared with murine TPO, romiplostim resulted in similar megakaryocyte colony production, at higher concentrations (30 ng/mL compared with 1 ng/mL). the romiplostim prescribing information recommends a starting dose of 1 g/kg/week in both adults and children with itp. Two patients with myosin heavy chain-9related disorders have received romiplostim therapy. Baseline demographic and clinical characteristics were determined for the 284 patients (n = 25 and n = 259) who had received placebo or romiplostim only and patients who received both placebo and romiplostim. We review here the development of romiplostim with a focus on pediatric use. Bleeding occurred in 3 patients after detection of anti-TPO binding antibodies. ICH GCP. It is bound to and recycled by the neonatal fragment crystallizable (Fc) receptor (FcRn) on endothelial cells. In clinical practice, when a platelet response to romiplostim is not maintained in a patient, the recommendation is to search for causative factors, including development of anti-drug antibodies. The median romiplostim dose at which antibodies were first detected was 8 g/kg, the median cumulative romiplostim dose was 389 g/kg, and the median platelet count was 87 109/L. Durable platelet response rates with romiplostim by age were 38% (3/8) for 1 year to younger than 6 years, 56% (10/18) for 6 years to younger than 12 years, and 56% (9/16) for 12 years to younger than 18 years. In the trials, 25 of 280 (8.9%) patients developed anti-romiplostim binding antibodies. At the time of SPRIA validation, most companies, including Amgen, implemented the 50% reduction (a cutoff point that is more likely to detect an effective anti-drug antibody response) in the confirmatory step as the criteria to detect a sample that was positive for binding anti-drug antibodies.14 Detection limits were 400 ng/mL for anti-romiplostim antibodies and 200 ng/mL for anti-TPO antibodies. Houwerzijl EJ, Blom NR, van der Want JJ, et al.. Ultrastructural study shows morphologic features of apoptosis and para-apoptosis in megakaryocytes from patients with idiopathic thrombocytopenic purpura. Epub 2021 Oct 18. Romiplostim is an Fc-peptide fusion protein that binds to and activates the thrombopoietin (TPO) receptor, thereby increasing platelet production. In addition, romiplostim is well tolerated, making it an attractive option for the treatment of children. NPLATE (romiplostim) prescribing information (US). The dose of romiplostim was titrated to 4 g/kg/wk by the fifth wk of treatment, which . Anti-romiplostim neutralizing antibodies developed in 8 of 280 (2.9%) patients. The same was true for the efficacy end point of a platelet count 50 109/L and 20 109/L above baseline for 2 consecutive weeks (88% romiplostim vs 0% placebo, P = .0008). The platelet count was evaluated for patients with positive transient or persistent anti-romiplostim or anti-TPO antibodies at week 1, a week before and a week after an antibody-positive result, and at the end of treatment. Clipboard, Search History, and several other advanced features are temporarily unavailable. Given the importance of compressed therapy on outcomes, minimizing delays secondary to prolonged thrombocytopenia may provide an overall mortality benefit. Bussel JB, Soff G, Balduzzi A, Cooper N, Lawrence T, Semple JW. 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