Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent and chronic ITP in routine clinical practice in central and Eastern Europe : an analysis of the PLATON study
OBJECTIVES: The objective of this analysis was to assess the effectiveness and safety of romiplostim in the real-world by duration of primary immune thrombocytopenia (ITP): <3 ('newly diagnosed'), 3-12 ('persistent'), and >12 ('chronic') months.
METHODS: This was a post-hoc analysis of the PLATON single-arm, observational cohort study of adults from five Central and Eastern European countries receiving ≥1 romiplostim dose as second-line therapy, or where surgery was contraindicated. Durable (≥75% of measurements with ≥50 × 109 platelets/L during weeks 14-24) and overall platelet response (≥30 or ≥50 × 109 platelets/L at least once), rescue therapy, bleeding, discontinuation of other ITP medications, and adverse drug reactions (ADRs) were assessed.
RESULTS: Of 100 participants, 22.0% had newly diagnosed, 17.0% had persistent, and 61.0% had chronic ITP. Prior splenectomy was most frequently reported in chronic ITP (32.8%), prior bleeding was predominant in newly diagnosed patients (68.2%). Durable platelet response was achieved in 50.0% (95% confidence interval [CI]: 28.2-71.8%) of newly diagnosed, 35.3% (95% CI: 14.2-61.7%) of persistent, and 31.1% (95% CI: 19.9-44.3%) of chronic ITP patients. Overall platelet response was achieved in >80% across all strata. Safety was comparable across groups, with a low incidence of thrombotic ADRs and no bone marrow ADRs.
DISCUSSION: In this real-world study, platelet response to romiplostim was consistent across all strata of ITP duration. ADRs were infrequent and similar across ITP settings.
CONCLUSION: These findings support the utilization of romiplostim in patients with newly diagnosed and persistent ITP in accordance with recent guidelines and the recent romiplostim label extension.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:26 |
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| Enthalten in: |
Hematology (Amsterdam, Netherlands) - 26(2021), 1 vom: 09. Dez., Seite 497-502 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Skopec, Barbara [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 29.07.2021 Date Revised 24.04.2022 published: Print Citation Status MEDLINE |
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| doi: |
10.1080/16078454.2021.1948209 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM327840838 |
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| 100 | 1 | |a Skopec, Barbara |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Effectiveness and safety of romiplostim among patients with newly diagnosed, persistent and chronic ITP in routine clinical practice in central and Eastern Europe |b an analysis of the PLATON study |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.07.2021 | ||
| 500 | |a Date Revised 24.04.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a OBJECTIVES: The objective of this analysis was to assess the effectiveness and safety of romiplostim in the real-world by duration of primary immune thrombocytopenia (ITP): <3 ('newly diagnosed'), 3-12 ('persistent'), and >12 ('chronic') months | ||
| 520 | |a METHODS: This was a post-hoc analysis of the PLATON single-arm, observational cohort study of adults from five Central and Eastern European countries receiving ≥1 romiplostim dose as second-line therapy, or where surgery was contraindicated. Durable (≥75% of measurements with ≥50 × 109 platelets/L during weeks 14-24) and overall platelet response (≥30 or ≥50 × 109 platelets/L at least once), rescue therapy, bleeding, discontinuation of other ITP medications, and adverse drug reactions (ADRs) were assessed | ||
| 520 | |a RESULTS: Of 100 participants, 22.0% had newly diagnosed, 17.0% had persistent, and 61.0% had chronic ITP. Prior splenectomy was most frequently reported in chronic ITP (32.8%), prior bleeding was predominant in newly diagnosed patients (68.2%). Durable platelet response was achieved in 50.0% (95% confidence interval [CI]: 28.2-71.8%) of newly diagnosed, 35.3% (95% CI: 14.2-61.7%) of persistent, and 31.1% (95% CI: 19.9-44.3%) of chronic ITP patients. Overall platelet response was achieved in >80% across all strata. Safety was comparable across groups, with a low incidence of thrombotic ADRs and no bone marrow ADRs | ||
| 520 | |a DISCUSSION: In this real-world study, platelet response to romiplostim was consistent across all strata of ITP duration. ADRs were infrequent and similar across ITP settings | ||
| 520 | |a CONCLUSION: These findings support the utilization of romiplostim in patients with newly diagnosed and persistent ITP in accordance with recent guidelines and the recent romiplostim label extension | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Central and Eastern Europe | |
| 650 | 4 | |a Immune thrombocytopenia (ITP) | |
| 650 | 4 | |a TPO | |
| 650 | 4 | |a bleeding | |
| 650 | 4 | |a bleeding disorder | |
| 650 | 4 | |a real-world evidence | |
| 650 | 4 | |a romiplostim | |
| 650 | 4 | |a thrombocytopenia | |
| 650 | 4 | |a thrombopoietin receptor agonist | |
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| 650 | 7 | |a Receptors, Thrombopoietin |2 NLM | |
| 650 | 7 | |a Recombinant Fusion Proteins |2 NLM | |
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| 650 | 7 | |a romiplostim |2 NLM | |
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| 700 | 1 | |a Sninska, Zuzana |e verfasserin |4 aut | |
| 700 | 1 | |a Tzvetkov, Nikolai |e verfasserin |4 aut | |
| 700 | 1 | |a Ivanushkin, Vladlen |e verfasserin |4 aut | |
| 700 | 1 | |a Björklöf, Katja |e verfasserin |4 aut | |
| 700 | 1 | |a Hippenmeyer, Jane |e verfasserin |4 aut | |
| 700 | 1 | |a Mihaylov, Georgi |e verfasserin |4 aut | |
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