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This study aims to describe the treatment patterns and clinical outcomes of treatment with eltrombopag in primary immune thrombocytopenia (ITP) patients treated with prior corticosteroid therapy.
This study will use secondary data provided by health care professionals (HCPs) for a sample of primary ITP patients, and primary data from a structured HCP survey. Data will be collected from HCPs working in various clinical centers across the United States (US), United Kingdom (UK), and Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eltrombopag Cohort | Adult patients diagnosed with primary ITP who initiated eltrombopag treatment between 01 January 2020 and 31 December 2024 following corticosteroid treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients Achieving an Initial Platelet Response Within 12 Weeks of Start of Treatment | Initial platelet response is defined as a platelet count ≥50 × 10^9/L. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Patients Achieving an Initial Complete Platelet Response Within 12 Weeks of Start of Treatment | Complete platelet response is defined as a platelet count of ≥100 × 10^9/L. | 12 weeks |
| Number and Percentage of Patients Achieving a Partial Platelet Response Within 12 Weeks of Start of Treatment |
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Inclusion criteria:
HCP inclusion criteria:
Patient-level inclusion criteria:
Exclusion criteria:
HCP exclusion criteria:
Patient-level exclusion criteria:
1. Diagnosis of Evans syndrome, secondary ITP, or non-immune thrombocytopenia.
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Adult patients diagnosed with primary ITP who were treated with eltrombopag following corticosteroid treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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Partial platelet response is defined as a platelet count of ≥30 × 10^9/L. |
| 12 weeks |
| Number and Percentage of Patients With No or Suboptimal Platelet Response Within 12 Weeks of Start of Treatment | No or suboptimal platelet response is defined as a platelet count of <30 × 10^9/L. | 12 weeks |
| Number and Percentage of Patients Achieving Clinically Meaningful Platelet Response Thresholds Within 12 Weeks of Start of Treatment | Clinically meaningful platelet response thresholds as indicated by a platelet count increase from a pretreatment value <30 × 10^9/L, and/or documentation of improvement in clinical symptoms such as bleeding. | 12 weeks |
| Time to Platelet Response | Platelet response is defined as a platelet count ≥50 ×10^9/L. | Up to 4 years and 6 months after treatment initiation |
| Platelet Counts at Eltrombopag Treatment Initiation | Day 1 |
| Platelet Counts at Eltrombopag Treatment Discontinuation | Up to 4 years and 6 months after treatment initiation |
| Number and Percentage of Patients With Bleeding Symptoms During Eltrombopag Treatment | Up to 4 years and 6 months after treatment initiation |
| Duration Between ITP Diagnosis and Eltrombopag Treatment Initiation | Up to 6 years prior to Day 1 of treatment |
| Number and Percentage of Patients With Concomitant Corticosteroid Treatment During Eltrombopag Treatment | Up to 4 years and 6 months after treatment initiation |
| Number and Percentage of Patients With Concomitant Corticosteroid Treatment Withdrawn During Eltrombopag Treatment | Up to 4 years and 6 months after treatment initiation |
| Time to Eltrombopag Treatment Discontinuation | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by Reason for Eltrombopag Initiation | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by Reason for Eltrombopag Discontinuation | Up to 4 years and 6 months after treatment initiation |
| Baseline Demographics | Up to 6 years prior to Day 1 of treatment |
| Number of Prior Corticosteroid Treatment Courses | Up to 6 years prior to Day 1 of treatment |
| Duration of Prior Corticosteroid Treatment Courses | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by Comorbidities | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by HCP-reported Reason for Eltrombopag Initiation | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by HCP-reported Factors Influencing Selection of Eltrombopag as Second-line Treatment | Factors influencing selection include platelet count, bleeding symptoms, comorbidities, prior treatment response, ease of administration, safety profile, guideline recommendation, and other. | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by Location of Eltrombopag Prescription | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by Type of Provider of Eltrombopag Treatment Initiation | Providers include general practitioner, immunologist, hematologist, internal medicine specialist, and other. | Day 1 |
| Number of Patients Categorized by Typical Duration Between ITP Diagnosis and Eltrombopag Initiation as Reported by the HCP | Typical duration between diagnosis and treatment initiation categorized as <3 months, 3-6 months, 6-12 months, >12 months. | Up to 6 years prior to Day 1 of treatment |
| Number of Patients by Corticosteroid Use During Eltrombopag Treatment as Reported by the HCP | Corticosteroid use categorized as never, rarely, sometimes, often, or always. | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by HCP-reported Indicators for Treatment Escalation or Discontinuation | Indicators for treatment escalation or discontinuation include lack of platelet response, bleeding symptoms, adverse events, stable response, patient preference, and other. | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by Common Reasons for Eltrombopag Discontinuation as Reported by the HCP | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by the HCP-reported Treatment Success With Eltrombopag | Treatment success categorized as rapid platelet increase, sustained response, bleeding control, minimal side effects, improved quality of life, and other. | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by Patient Characteristics Associated With Better Eltrombopag Response as Reported by the HCP | Patient characteristics include younger age, no comorbidities, early initiation post-diagnosis, prior corticosteroid response, and other | Up to 4 years and 6 months after treatment initiation |
| Number of Patients by Patient Characteristics Associated With Poor Eltrombopag Response as Reported by the HCP | Patient characteristics include multiple comorbidities, delayed initiation, prior treatment failure, and other. | Up to 4 years and 6 months after treatment initiation |
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |