Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA
Abstract: This phase 4, multicenter, open-label study was conducted to evaluate the safety, efficacy, and treatment satisfaction of switching to avatrombopag from another thrombopoietin receptor agonist (TPO-RA) in patients with immune thrombocytopenia (ITP). Adults who had received ≥90 days of trea...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-06-01
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| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2473952925001764 |
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| author | Michael D. Tarantino Kailash Mosalpuria Scott Kolodny Jessica Zhang Michael Vredenburg Brian D. Jamieson |
| author_facet | Michael D. Tarantino Kailash Mosalpuria Scott Kolodny Jessica Zhang Michael Vredenburg Brian D. Jamieson |
| author_sort | Michael D. Tarantino |
| collection | DOAJ |
| description | Abstract: This phase 4, multicenter, open-label study was conducted to evaluate the safety, efficacy, and treatment satisfaction of switching to avatrombopag from another thrombopoietin receptor agonist (TPO-RA) in patients with immune thrombocytopenia (ITP). Adults who had received ≥90 days of treatment with eltrombopag or romiplostim and had a response (2 platelet counts [PCs] ≥50 × 109/L) switched to avatrombopag with no protocol-defined washout period. The primary end point was the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs. Secondary end points were the proportion of patients who had a PC between ≥50 × 109/L and ≤200 × 109/L (days 15, 30, 60, and 90) and change from baseline in each domain of the self-administered Treatment Satisfaction Questionnaire for Medication (TSQM) to day 90. Among 60 enrolled patients, 58.3% experienced TEAEs and 10.0% experienced serious TEAEs (1 related to avatrombopag [thrombocytopenia that resolved]; 5 unrelated [1 unrelated death]). A PC ≥50 × 109/L to ≤200 × 109/L was reported for 51.7%, 31.7% (mean PC, 256.2 × 109/L [standard deviation, 176.7 × 109/L]), 55.0%, 60.0%, and 55.0% at baseline and on days 15, 30, 60, and 90, respectively. TSQM scores increased from baseline to day 90 across all domains (mean change: convenience, +13.5; effectiveness, +14.4; global satisfaction, +14.2; side effects, +8.3). There was no correlation between stable avatrombopag dose (day 90) and previous TPO-RA dose (high or low). Patients with ITP may safely switch from another TPO-RA to avatrombopag and maintain adequate PCs while experiencing improved treatment satisfaction. This trial was registered at www.ClinicalTrials.gov as #NCT04638829 |
| format | Article |
| id | doaj-art-de73d7eab7934f0180d067e583519adc |
| institution | OA Journals |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-de73d7eab7934f0180d067e583519adc2025-08-20T02:01:05ZengElsevierBlood Advances2473-95292025-06-019112733274310.1182/bloodadvances.2024015635Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RAMichael D. Tarantino0Kailash Mosalpuria1Scott Kolodny2Jessica Zhang3Michael Vredenburg4Brian D. Jamieson5Bleeding and Clotting Disorders Institute, Peoria, IL; Correspondence: Michael D. Tarantino, Bleeding & Clotting Disorders Institute, 427 W Northmoor Rd, Peoria, IL 61615;Nebraska Hematology Oncology Cancer Center, Lincoln, NESobi, Inc, Morrisville, NCSobi, Inc, Morrisville, NCSobi, Inc, Morrisville, NCSobi, Inc, Morrisville, NCAbstract: This phase 4, multicenter, open-label study was conducted to evaluate the safety, efficacy, and treatment satisfaction of switching to avatrombopag from another thrombopoietin receptor agonist (TPO-RA) in patients with immune thrombocytopenia (ITP). Adults who had received ≥90 days of treatment with eltrombopag or romiplostim and had a response (2 platelet counts [PCs] ≥50 × 109/L) switched to avatrombopag with no protocol-defined washout period. The primary end point was the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs. Secondary end points were the proportion of patients who had a PC between ≥50 × 109/L and ≤200 × 109/L (days 15, 30, 60, and 90) and change from baseline in each domain of the self-administered Treatment Satisfaction Questionnaire for Medication (TSQM) to day 90. Among 60 enrolled patients, 58.3% experienced TEAEs and 10.0% experienced serious TEAEs (1 related to avatrombopag [thrombocytopenia that resolved]; 5 unrelated [1 unrelated death]). A PC ≥50 × 109/L to ≤200 × 109/L was reported for 51.7%, 31.7% (mean PC, 256.2 × 109/L [standard deviation, 176.7 × 109/L]), 55.0%, 60.0%, and 55.0% at baseline and on days 15, 30, 60, and 90, respectively. TSQM scores increased from baseline to day 90 across all domains (mean change: convenience, +13.5; effectiveness, +14.4; global satisfaction, +14.2; side effects, +8.3). There was no correlation between stable avatrombopag dose (day 90) and previous TPO-RA dose (high or low). Patients with ITP may safely switch from another TPO-RA to avatrombopag and maintain adequate PCs while experiencing improved treatment satisfaction. This trial was registered at www.ClinicalTrials.gov as #NCT04638829http://www.sciencedirect.com/science/article/pii/S2473952925001764 |
| spellingShingle | Michael D. Tarantino Kailash Mosalpuria Scott Kolodny Jessica Zhang Michael Vredenburg Brian D. Jamieson Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA Blood Advances |
| title | Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA |
| title_full | Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA |
| title_fullStr | Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA |
| title_full_unstemmed | Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA |
| title_short | Safety, efficacy, and treatment satisfaction in adults with ITP who switched to avatrombopag from another TPO-RA |
| title_sort | safety efficacy and treatment satisfaction in adults with itp who switched to avatrombopag from another tpo ra |
| url | http://www.sciencedirect.com/science/article/pii/S2473952925001764 |
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