SAFETY AND EFFICACY OF RITUXIMAB IN ADULT IMMUNE THROMBOCYTOPENIA
(Abstract release date: 05/19/16)
EHA Library. Biagiotti C. 06/09/16; 134987; PB2087
Dr. Caterina Biagiotti
Contributions
Contributions
Abstract
Abstract: PB2087
Type: Publication Only
Background
Immune thrombocytopenia is characterized by immune-mediated destruction and suboptimum production of platelets. Despite the absence of supporting evidence, the anti-CD20 chimeric monoclonal antibody rituximab has been effectively used off-label in the treatment of patients with primary immune thrombocytopenia (pITP).
Aims
The aim of this analysis is to describe our experience with Rituximab in patients affected by chronic ITP.
Methods
In this monocentric analysis we retrospectively evaluated 43 adult patients affected by chronic ITP resistant to 2 or more lines of therapy that were treated with four weekly infusions of 375 mg/mq rituximab to asses safety and efficacy.
Results
Of 43 patients treated with Rituximab, 39 were retrospectively evaluated. 20 F, 19 M. Median age was 60 years (range 29-91 years) and median platelets value at start treatment was 16.000/μl (range 5.000-40.000). 24/39 (62%) showed an initial response, 17/39 (44%) patients obtained complete response (CR) and 7/39 (18%) showed partial response (R). Of those achieving an overall response 4 (17%) patients relapsed, median time to relapse was 30 months (range 8-45). Of these 4 patients relapsed, 3 received re-treatment with four weekly infusions of 375 mg/mq rituximab and 2 patients achieved a complete response, one was no-responder. With a median follow-up of 22 months (range 2-95 months), 17/24 patients (71%) showed a lasting response out of treatment, of these 15 patients maintained a complete response with a median platelets count of 156.000/μl (100.000-362.000/μl) and 2 patients was in partial response. 7 patients underwent further line of therapy (6 treated with TPO-mimetics and 1 with splenectomy) During the follow-up, no opportunistic or severe infectious complications were observed.
Conclusion
In our limited experience these data confirm, over a long period of observation, the efficacy and safety of Rituximab treatment in the management of patients with resistant ITP and Rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. Further investigations and specific clinical trials are warrented.
Session topic: E-poster
Keyword(s): Bleeding disorder, Immune therapy, ITP, Rituximab
Type: Publication Only
Background
Immune thrombocytopenia is characterized by immune-mediated destruction and suboptimum production of platelets. Despite the absence of supporting evidence, the anti-CD20 chimeric monoclonal antibody rituximab has been effectively used off-label in the treatment of patients with primary immune thrombocytopenia (pITP).
Aims
The aim of this analysis is to describe our experience with Rituximab in patients affected by chronic ITP.
Methods
In this monocentric analysis we retrospectively evaluated 43 adult patients affected by chronic ITP resistant to 2 or more lines of therapy that were treated with four weekly infusions of 375 mg/mq rituximab to asses safety and efficacy.
Results
Of 43 patients treated with Rituximab, 39 were retrospectively evaluated. 20 F, 19 M. Median age was 60 years (range 29-91 years) and median platelets value at start treatment was 16.000/μl (range 5.000-40.000). 24/39 (62%) showed an initial response, 17/39 (44%) patients obtained complete response (CR) and 7/39 (18%) showed partial response (R). Of those achieving an overall response 4 (17%) patients relapsed, median time to relapse was 30 months (range 8-45). Of these 4 patients relapsed, 3 received re-treatment with four weekly infusions of 375 mg/mq rituximab and 2 patients achieved a complete response, one was no-responder. With a median follow-up of 22 months (range 2-95 months), 17/24 patients (71%) showed a lasting response out of treatment, of these 15 patients maintained a complete response with a median platelets count of 156.000/μl (100.000-362.000/μl) and 2 patients was in partial response. 7 patients underwent further line of therapy (6 treated with TPO-mimetics and 1 with splenectomy) During the follow-up, no opportunistic or severe infectious complications were observed.
Conclusion
In our limited experience these data confirm, over a long period of observation, the efficacy and safety of Rituximab treatment in the management of patients with resistant ITP and Rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. Further investigations and specific clinical trials are warrented.
Session topic: E-poster
Keyword(s): Bleeding disorder, Immune therapy, ITP, Rituximab
Abstract: PB2087
Type: Publication Only
Background
Immune thrombocytopenia is characterized by immune-mediated destruction and suboptimum production of platelets. Despite the absence of supporting evidence, the anti-CD20 chimeric monoclonal antibody rituximab has been effectively used off-label in the treatment of patients with primary immune thrombocytopenia (pITP).
Aims
The aim of this analysis is to describe our experience with Rituximab in patients affected by chronic ITP.
Methods
In this monocentric analysis we retrospectively evaluated 43 adult patients affected by chronic ITP resistant to 2 or more lines of therapy that were treated with four weekly infusions of 375 mg/mq rituximab to asses safety and efficacy.
Results
Of 43 patients treated with Rituximab, 39 were retrospectively evaluated. 20 F, 19 M. Median age was 60 years (range 29-91 years) and median platelets value at start treatment was 16.000/μl (range 5.000-40.000). 24/39 (62%) showed an initial response, 17/39 (44%) patients obtained complete response (CR) and 7/39 (18%) showed partial response (R). Of those achieving an overall response 4 (17%) patients relapsed, median time to relapse was 30 months (range 8-45). Of these 4 patients relapsed, 3 received re-treatment with four weekly infusions of 375 mg/mq rituximab and 2 patients achieved a complete response, one was no-responder. With a median follow-up of 22 months (range 2-95 months), 17/24 patients (71%) showed a lasting response out of treatment, of these 15 patients maintained a complete response with a median platelets count of 156.000/μl (100.000-362.000/μl) and 2 patients was in partial response. 7 patients underwent further line of therapy (6 treated with TPO-mimetics and 1 with splenectomy) During the follow-up, no opportunistic or severe infectious complications were observed.
Conclusion
In our limited experience these data confirm, over a long period of observation, the efficacy and safety of Rituximab treatment in the management of patients with resistant ITP and Rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. Further investigations and specific clinical trials are warrented.
Session topic: E-poster
Keyword(s): Bleeding disorder, Immune therapy, ITP, Rituximab
Type: Publication Only
Background
Immune thrombocytopenia is characterized by immune-mediated destruction and suboptimum production of platelets. Despite the absence of supporting evidence, the anti-CD20 chimeric monoclonal antibody rituximab has been effectively used off-label in the treatment of patients with primary immune thrombocytopenia (pITP).
Aims
The aim of this analysis is to describe our experience with Rituximab in patients affected by chronic ITP.
Methods
In this monocentric analysis we retrospectively evaluated 43 adult patients affected by chronic ITP resistant to 2 or more lines of therapy that were treated with four weekly infusions of 375 mg/mq rituximab to asses safety and efficacy.
Results
Of 43 patients treated with Rituximab, 39 were retrospectively evaluated. 20 F, 19 M. Median age was 60 years (range 29-91 years) and median platelets value at start treatment was 16.000/μl (range 5.000-40.000). 24/39 (62%) showed an initial response, 17/39 (44%) patients obtained complete response (CR) and 7/39 (18%) showed partial response (R). Of those achieving an overall response 4 (17%) patients relapsed, median time to relapse was 30 months (range 8-45). Of these 4 patients relapsed, 3 received re-treatment with four weekly infusions of 375 mg/mq rituximab and 2 patients achieved a complete response, one was no-responder. With a median follow-up of 22 months (range 2-95 months), 17/24 patients (71%) showed a lasting response out of treatment, of these 15 patients maintained a complete response with a median platelets count of 156.000/μl (100.000-362.000/μl) and 2 patients was in partial response. 7 patients underwent further line of therapy (6 treated with TPO-mimetics and 1 with splenectomy) During the follow-up, no opportunistic or severe infectious complications were observed.
Conclusion
In our limited experience these data confirm, over a long period of observation, the efficacy and safety of Rituximab treatment in the management of patients with resistant ITP and Rituximab used off-label may remain a valid option for treating persistent or chronic ITP in adults. Further investigations and specific clinical trials are warrented.
Session topic: E-poster
Keyword(s): Bleeding disorder, Immune therapy, ITP, Rituximab
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