ELTROMBOPAG SAFETY AND EFFICACY IN OLDER THAN 65 YEARS OLD PRIMARY IMMUNE THROMBOCYTOPENIA PATIENTS IN CLINICAL PRACTICE
(Abstract release date: 05/19/16)
EHA Library. González-López T. 06/09/16; 132979; E1430
Dr. Tomás José González-López
Contributions
Contributions
Abstract
Abstract: E1430
Type: Eposter Presentation
Background
Eltrombopag is a a thrombopoietin receptor agonist (TPO-RA) approved for chronic primary immune thrombocytopenia (ITP) patients. However, ITP clinical practice in more than 65 years old patients could not reflect efficacy and safety of clinical trials results.
Aims
To evaluate the safety and efficacy results of eltrombopag in older than 65 years old patients in a real world setting
Methods
81 equal or more than 65 years old primary ITP patients from 23 Spanish centers who had been treated with eltrombopag and included in the Spanish Eltrombopag ITP Registry were retrospectively evaluated.
Results
-The median age of the whole cohort was 75 (IQR, 69-79) years. Our case series included 16 newly-diagnosed, 16 persistent and 49 chronic primary ITP patients [78 (IQR, 73-81), 78 (IQR, 74-85) and 73 (IQR, 68-76) median years, respectively]. There were 51 women and 30 men. 23% of patients had a Charlson Comorbidity Index score of 2 or more at diagnosis. The median time from ITP diagnosis to eltrombopag initiation was 36 (IQR, 4-47) months [1(IQR,0-1.25), 4(IQR,6-8) and 57(IQR, 22-73) months, for each of the groups]. The median number of therapies before starting eltrombopag was 2 (IQR, 1-3), including rituximab (18%), romiplostim (17%) and splenectomy (10%).-At the time of treatment start, 22 of 81 patients (27%) patients were receiving concomitant medication for primary ITP, mainly including corticosteroids (20%) or immunoglobulins (11%). 24 of 81 (30%) patients had bleeding symptomatology during the month preceding the starting eltrombopag. At eltrombopag initiation the median platelet count was 27 x 109/L (IQR, 7-26 x 109/L).-68 of 81 (84%) patients had a response (R) to eltrombopag treatment whilst 62 patients (76%) achieved a complete response (CR; platelet count >100 x 109/L). [R and CR rates were 94% and 87% in newly-diagnosed ITP; 75% and 68% in persistent ITP; 84% and 75% in chronic ITP]. Women reached 86% and 78% of R/CR while 80% and 73% of men. Responses were 91% in patients who received concomitant ITP medication at baseline and 64% in patients without other added treatments. The proportion of patients achieving a platelet response was quite similar regardless bleeding at starting eltrombopag (79% and 86% for patients with and without bleeding, respectively).-Of the 82 patients, 20 (24.4%) experienced one or more adverse events during treatment with eltrombopag. Adverse events were mainly grade 1–2 in severity. The commonest adverse effects reported during eltrombopag treatment were diarrhea and headache. Eight percent of patients (7 of 82) had hepatobiliary laboratory abnormalities (HBLAs). On the other hand, we observed seven deaths: three of them were caused by ITP severity (cerebral bleedings), two were due to progression of COPD (chronic obstructive pulmonary disease), one was a gram-negative sepsis and one patient suffered an arrhythmia related sudden death.-A subanalysis of primary ITP patients with more than 80 years (6 male and 14 female), revealed as high efficacy rates as younger patients (85% of CR with 75% of responses). This kind of patients are expected to be a very frail patients. Nevertheless, only 7 (35%) patients of this population reported adverse events.
Conclusion
Our case series describe the great efficacy and safety results observed with the use of eltrombopag in our more than 65 years old ITP patients. However more studies are needed to confirm the possible usefulness of TPO-RAs in this variety of primary ITP cases.
Session topic: E-poster
Keyword(s): Immune thrombocytopenia (ITP), Thrombopoietin (TPO)
Type: Eposter Presentation
Background
Eltrombopag is a a thrombopoietin receptor agonist (TPO-RA) approved for chronic primary immune thrombocytopenia (ITP) patients. However, ITP clinical practice in more than 65 years old patients could not reflect efficacy and safety of clinical trials results.
Aims
To evaluate the safety and efficacy results of eltrombopag in older than 65 years old patients in a real world setting
Methods
81 equal or more than 65 years old primary ITP patients from 23 Spanish centers who had been treated with eltrombopag and included in the Spanish Eltrombopag ITP Registry were retrospectively evaluated.
Results
-The median age of the whole cohort was 75 (IQR, 69-79) years. Our case series included 16 newly-diagnosed, 16 persistent and 49 chronic primary ITP patients [78 (IQR, 73-81), 78 (IQR, 74-85) and 73 (IQR, 68-76) median years, respectively]. There were 51 women and 30 men. 23% of patients had a Charlson Comorbidity Index score of 2 or more at diagnosis. The median time from ITP diagnosis to eltrombopag initiation was 36 (IQR, 4-47) months [1(IQR,0-1.25), 4(IQR,6-8) and 57(IQR, 22-73) months, for each of the groups]. The median number of therapies before starting eltrombopag was 2 (IQR, 1-3), including rituximab (18%), romiplostim (17%) and splenectomy (10%).-At the time of treatment start, 22 of 81 patients (27%) patients were receiving concomitant medication for primary ITP, mainly including corticosteroids (20%) or immunoglobulins (11%). 24 of 81 (30%) patients had bleeding symptomatology during the month preceding the starting eltrombopag. At eltrombopag initiation the median platelet count was 27 x 109/L (IQR, 7-26 x 109/L).-68 of 81 (84%) patients had a response (R) to eltrombopag treatment whilst 62 patients (76%) achieved a complete response (CR; platelet count >100 x 109/L). [R and CR rates were 94% and 87% in newly-diagnosed ITP; 75% and 68% in persistent ITP; 84% and 75% in chronic ITP]. Women reached 86% and 78% of R/CR while 80% and 73% of men. Responses were 91% in patients who received concomitant ITP medication at baseline and 64% in patients without other added treatments. The proportion of patients achieving a platelet response was quite similar regardless bleeding at starting eltrombopag (79% and 86% for patients with and without bleeding, respectively).-Of the 82 patients, 20 (24.4%) experienced one or more adverse events during treatment with eltrombopag. Adverse events were mainly grade 1–2 in severity. The commonest adverse effects reported during eltrombopag treatment were diarrhea and headache. Eight percent of patients (7 of 82) had hepatobiliary laboratory abnormalities (HBLAs). On the other hand, we observed seven deaths: three of them were caused by ITP severity (cerebral bleedings), two were due to progression of COPD (chronic obstructive pulmonary disease), one was a gram-negative sepsis and one patient suffered an arrhythmia related sudden death.-A subanalysis of primary ITP patients with more than 80 years (6 male and 14 female), revealed as high efficacy rates as younger patients (85% of CR with 75% of responses). This kind of patients are expected to be a very frail patients. Nevertheless, only 7 (35%) patients of this population reported adverse events.
Conclusion
Our case series describe the great efficacy and safety results observed with the use of eltrombopag in our more than 65 years old ITP patients. However more studies are needed to confirm the possible usefulness of TPO-RAs in this variety of primary ITP cases.
Session topic: E-poster
Keyword(s): Immune thrombocytopenia (ITP), Thrombopoietin (TPO)
Abstract: E1430
Type: Eposter Presentation
Background
Eltrombopag is a a thrombopoietin receptor agonist (TPO-RA) approved for chronic primary immune thrombocytopenia (ITP) patients. However, ITP clinical practice in more than 65 years old patients could not reflect efficacy and safety of clinical trials results.
Aims
To evaluate the safety and efficacy results of eltrombopag in older than 65 years old patients in a real world setting
Methods
81 equal or more than 65 years old primary ITP patients from 23 Spanish centers who had been treated with eltrombopag and included in the Spanish Eltrombopag ITP Registry were retrospectively evaluated.
Results
-The median age of the whole cohort was 75 (IQR, 69-79) years. Our case series included 16 newly-diagnosed, 16 persistent and 49 chronic primary ITP patients [78 (IQR, 73-81), 78 (IQR, 74-85) and 73 (IQR, 68-76) median years, respectively]. There were 51 women and 30 men. 23% of patients had a Charlson Comorbidity Index score of 2 or more at diagnosis. The median time from ITP diagnosis to eltrombopag initiation was 36 (IQR, 4-47) months [1(IQR,0-1.25), 4(IQR,6-8) and 57(IQR, 22-73) months, for each of the groups]. The median number of therapies before starting eltrombopag was 2 (IQR, 1-3), including rituximab (18%), romiplostim (17%) and splenectomy (10%).-At the time of treatment start, 22 of 81 patients (27%) patients were receiving concomitant medication for primary ITP, mainly including corticosteroids (20%) or immunoglobulins (11%). 24 of 81 (30%) patients had bleeding symptomatology during the month preceding the starting eltrombopag. At eltrombopag initiation the median platelet count was 27 x 109/L (IQR, 7-26 x 109/L).-68 of 81 (84%) patients had a response (R) to eltrombopag treatment whilst 62 patients (76%) achieved a complete response (CR; platelet count >100 x 109/L). [R and CR rates were 94% and 87% in newly-diagnosed ITP; 75% and 68% in persistent ITP; 84% and 75% in chronic ITP]. Women reached 86% and 78% of R/CR while 80% and 73% of men. Responses were 91% in patients who received concomitant ITP medication at baseline and 64% in patients without other added treatments. The proportion of patients achieving a platelet response was quite similar regardless bleeding at starting eltrombopag (79% and 86% for patients with and without bleeding, respectively).-Of the 82 patients, 20 (24.4%) experienced one or more adverse events during treatment with eltrombopag. Adverse events were mainly grade 1–2 in severity. The commonest adverse effects reported during eltrombopag treatment were diarrhea and headache. Eight percent of patients (7 of 82) had hepatobiliary laboratory abnormalities (HBLAs). On the other hand, we observed seven deaths: three of them were caused by ITP severity (cerebral bleedings), two were due to progression of COPD (chronic obstructive pulmonary disease), one was a gram-negative sepsis and one patient suffered an arrhythmia related sudden death.-A subanalysis of primary ITP patients with more than 80 years (6 male and 14 female), revealed as high efficacy rates as younger patients (85% of CR with 75% of responses). This kind of patients are expected to be a very frail patients. Nevertheless, only 7 (35%) patients of this population reported adverse events.
Conclusion
Our case series describe the great efficacy and safety results observed with the use of eltrombopag in our more than 65 years old ITP patients. However more studies are needed to confirm the possible usefulness of TPO-RAs in this variety of primary ITP cases.
Session topic: E-poster
Keyword(s): Immune thrombocytopenia (ITP), Thrombopoietin (TPO)
Type: Eposter Presentation
Background
Eltrombopag is a a thrombopoietin receptor agonist (TPO-RA) approved for chronic primary immune thrombocytopenia (ITP) patients. However, ITP clinical practice in more than 65 years old patients could not reflect efficacy and safety of clinical trials results.
Aims
To evaluate the safety and efficacy results of eltrombopag in older than 65 years old patients in a real world setting
Methods
81 equal or more than 65 years old primary ITP patients from 23 Spanish centers who had been treated with eltrombopag and included in the Spanish Eltrombopag ITP Registry were retrospectively evaluated.
Results
-The median age of the whole cohort was 75 (IQR, 69-79) years. Our case series included 16 newly-diagnosed, 16 persistent and 49 chronic primary ITP patients [78 (IQR, 73-81), 78 (IQR, 74-85) and 73 (IQR, 68-76) median years, respectively]. There were 51 women and 30 men. 23% of patients had a Charlson Comorbidity Index score of 2 or more at diagnosis. The median time from ITP diagnosis to eltrombopag initiation was 36 (IQR, 4-47) months [1(IQR,0-1.25), 4(IQR,6-8) and 57(IQR, 22-73) months, for each of the groups]. The median number of therapies before starting eltrombopag was 2 (IQR, 1-3), including rituximab (18%), romiplostim (17%) and splenectomy (10%).-At the time of treatment start, 22 of 81 patients (27%) patients were receiving concomitant medication for primary ITP, mainly including corticosteroids (20%) or immunoglobulins (11%). 24 of 81 (30%) patients had bleeding symptomatology during the month preceding the starting eltrombopag. At eltrombopag initiation the median platelet count was 27 x 109/L (IQR, 7-26 x 109/L).-68 of 81 (84%) patients had a response (R) to eltrombopag treatment whilst 62 patients (76%) achieved a complete response (CR; platelet count >100 x 109/L). [R and CR rates were 94% and 87% in newly-diagnosed ITP; 75% and 68% in persistent ITP; 84% and 75% in chronic ITP]. Women reached 86% and 78% of R/CR while 80% and 73% of men. Responses were 91% in patients who received concomitant ITP medication at baseline and 64% in patients without other added treatments. The proportion of patients achieving a platelet response was quite similar regardless bleeding at starting eltrombopag (79% and 86% for patients with and without bleeding, respectively).-Of the 82 patients, 20 (24.4%) experienced one or more adverse events during treatment with eltrombopag. Adverse events were mainly grade 1–2 in severity. The commonest adverse effects reported during eltrombopag treatment were diarrhea and headache. Eight percent of patients (7 of 82) had hepatobiliary laboratory abnormalities (HBLAs). On the other hand, we observed seven deaths: three of them were caused by ITP severity (cerebral bleedings), two were due to progression of COPD (chronic obstructive pulmonary disease), one was a gram-negative sepsis and one patient suffered an arrhythmia related sudden death.-A subanalysis of primary ITP patients with more than 80 years (6 male and 14 female), revealed as high efficacy rates as younger patients (85% of CR with 75% of responses). This kind of patients are expected to be a very frail patients. Nevertheless, only 7 (35%) patients of this population reported adverse events.
Conclusion
Our case series describe the great efficacy and safety results observed with the use of eltrombopag in our more than 65 years old ITP patients. However more studies are needed to confirm the possible usefulness of TPO-RAs in this variety of primary ITP cases.
Session topic: E-poster
Keyword(s): Immune thrombocytopenia (ITP), Thrombopoietin (TPO)
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