Rituximab Treatment in Childhood Chronic Immune Thrombocytopenic Purpura (ITP).

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4461-4461 ◽  
Author(s):  
Ji Yoon Kim ◽  
Kun Soo Lee ◽  
Hyoung Jin Kang ◽  
Hoon Kook ◽  
Hong Hoe Koo ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Medical Records ◽  
Conflicts Of Interest ◽  
Complete Response ◽  
Thrombocytopenic Purpura ◽  
Chronic Itp ◽  
New Treatment ◽  
Lost To Follow Up

Abstract Abstract 4461 Background Immune thrombocytopenic purpura (ITP) is characterized by mucocutaneous purpura and thrombocytopenia caused by circulating anti-platelet auto-antibodies. ITP is usually self-limited in children, but around 20% of patients will develop chronic ITP. The conventional treatments for children chronic ITP include intravenous immunoglobulin (IVIG), corticosteroid therapy, anti-D immune globulin, or splenectomy. Some children with chronic ITP are refractory to these treatments and nowadays begun to try new treatment agents such as rituximab. Rituximab as a monoclonal antibody to CD-20, has shown promising reports to these patients with refractory chronic ITP in adults groups and a few children groups. We investigated this study to evaluate the efficacy of rituximab for childhood chronic ITP in Korea. Methods We reviewed the questionnaires and medical records about the clinical progresses and results in thirteen children from eight clinical institutes, retrospectively. Complete response (CR) was considered if the platelet count was > 100,000/uL. Results Thirteen patients with chronic thrombocytopenia who had been treated with rituximab were investigated. Two patients were lost to follow-up after rituximab. Finally eleven patients were evaluated including one patient with Evans syndrome. Median age was 6.5 year (range, 0.5 ∼ 15.4). Median platelet count at baseline was 13,700/uL (3,000∼46,000). All patients had been treated with conventional therapy including IVIG and steroids. One had done splenectomy. Median follow-up duration was 2.8 years (1.1-5.9). Among 11 patients, CR was achieved in 3 patients (27%). Their platelet count prior to rituximab were < 10,000/uL. They were treated as the regimen of 375 mg/m2/dose weekly for 4 doses. Time from the first rituximab dose to achievement of complete response was 3.9, 4.9 and 5.7 weeks respectively. One patient who was relapsed 6months after the first course of rituximab was received second course of rituximab using the same regimen and achieved a new CR at 9.3 weeks after. There were no reports about severe complication or interruption of medication. Conclusions Therefore, we suggest that rituximab is effective treatment choice in childhood refractory chronic ITP and well tolerated. Disclosures: No relevant conflicts of interest to declare.

Successful Treatment of An Elderly Patient with Refractory Chronic Immune Thrombocytopenic Purpura with Combination Therapy of Rituximab and Corticosteroids: A Case Report

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4686-4686
Author(s):  
Yun Ling ◽  
Xiangshan Cao ◽  
Xinyu Qian
Keyword(s):  
Platelet Count ◽  
Combination Therapy ◽  
Immune Thrombocytopenic Purpura ◽  
Conflicts Of Interest ◽  
Response Duration ◽  
Autoimmune Disorder ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
Chronic Itp ◽  
Duration Of Response

Abstract Abstract 4686 Immune thrombocytopenic purpura (ITP) is an autoimmune disorder. A corticosteroid, usually prednisone is often the first line treatment for ITP. However, the problem is that about 70 percent of adult patients experience a relapse after discontinuation of corticosteroids. And approximately 20–30% of patients with chronic ITP do not respond to corticosteroids therapy. Rituximab has been proven effective in refractory chronic ITP, but the timing of response is slower than expected, at least three months might be necessary to observe an effect. And the response duration to rituximab remains relatively short in some patients. So, sometimes it is necessary to use combination therapy including rituximab, according to different patient conditions. Here, we report an 82-year-old man with chronic ITP who had thrombocytopenia (platelet count <10 × 109/L) for more than 6 months and relapsed on a prednisone taper. He presented sustaining blood-tinged sputum, bleeding in skin and steroid-induced diabetes, the result of short-term prednisone. He didn't want splenectomy and other immune suppressive drugs. His blood glucose got control after insulin therapy. We gave the patient intravenous infusions of rituximab 375 mg/m2 weekly for 4 weeks combined with dexamethasone (10 mg intravenously weekly for 4 weeks). After first dose of dexamethasone followed by rituximab, within 24 hours his platelet count had increased to 65 × 109/L and bleeding symptoms were significantly improved. During the next 3-week period of treatment, his platelet counts fluctuated between 30 × 109/L and 60 × 109/L. And then the platelet count dropped back to a minimum of 19 × 109/L. Consider the slow responses to rituximab and prevention of bleeding, we still gave the patient maintenance therapy with 15mg prednisone daily and he had been no bleeding. Two months after starting rituximab and dexamethasone, his platelet counts began to gradually recover to normal. Although we need to further observe the patients's duration of response, this case suggests that combination therapy of rituximab and corticosteroids may be a promising treatment for refractory chronic ITP. Disclosures: No relevant conflicts of interest to declare.

Study on the Efficacy and Safety of IGIV3I Grifols (Human Intravenous Immunoglobulin) in Patients Diagnosed with Chronic Immune Thrombocytopenic Purpura.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3956-3956
Author(s):  
Antonio Julia ◽  
Lidia Kovaleva ◽  
Ignacio Alberca ◽  
Fernando Hernandez ◽  
Svetlana Loria ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Platelet Count ◽  
Intravenous Immunoglobulin ◽  
Immune Thrombocytopenic Purpura ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
Chronic Itp

Abstract Intravenous immunoglobulin (IVIG) products are considered a useful treatment in patients with chronic idiopathic/immune thrombocytopenic purpura (ITP) to prevent bleeding or prior to surgery, when platelet counts have to be rapidly increased. IGIV3I Grifols is a highly purified, unmodified human IgG product whose manufacturing process follows the same basic principles of Flebogamma® (another IVIG manufactured by Grifols in clinical use since 1992). The main differences between both processes are how purification steps are sequentially arranged, and the introduction of two specific steps to inactivate/remove any potential contaminating pathogen (solvent-detergent treatment and sequential nanofiltration through 35 and 20 nm pore size filters), as additional viral elimination steps to pasteurization, already present in Flebogamma®. An open prospective study was planned to investigate the efficacy and safety of IGIV3I Grifols in 20 adult patients with chronic ITP (at least 6 months after diagnosis). Twenty adult subjects were enrolled and 19 patients with chronic ITP in acute phase (platelet counts &lt;20x109/l) were treated. Patients received 0.4 g/kg body weight for 5 consecutive days. Efficacy endpoints were the proportion of patients who reached a platelet count ≥50x109/l, the time taken for the platelet count to reach the target level and the duration of response. Regression of haemorrhages was documented during the first 14 days of follow-up. Safety parameters including adverse events (AEs), laboratory determinations and vital signs were regularly monitored. The follow-up of patients ended 3 months after first dose of IGIV3I Grifols to determine any change in viral markers for HIV, HCV, HBV and HAV. Results from intention to treat (ITT) population (n=20) and per protocol (PP) population (n=19) are presented. A patient was withdrawn from the study because she did not present an immune idiopathic thrombocytopenic purpura. A total of 14 patients (ITT = 70%; PP = 74%) responded to the study drug. The median time to platelet response was ≥2.5 days and the median number of days in which the platelet count remained ≥50x109/l was ≥7.0 days. For 17 patients (ITT = 85%; PP = 89%) a regression of the bleeding episodes was reported on day 14. Eight out of 20 patients presented 21 AEs potentially related to the study drug (16 mild and 5 moderate). Headache and fever (6 cases each), hypertension (2), decreased blood pressure (2) or hypotension (1), blood pressure fluctuation (1), thrombocythaemia (1), bradycardia (1) and asthenia (1) were AEs potentially related to study drug. No patients experienced clinically significant abnormalities in the laboratory values (haematology and renal and hepatic functions) and no patients changed their virological markers during the follow-up of the study. The results show that IGIV3I Grifols is safe and adequate to achieve a safe platelet count in patients with refractory chronic ITP.

Rituximab Is an Alternative to Splenectomy in Adults with Chronic Immune Thrombocytopenic Purpura: Results of a Multicenter Prospective Phase 2 Study.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 478-478 ◽  
Author(s):  
Bertrand Godeau ◽  
Olivier Fain ◽  
Raphael Porcher ◽  
Francois Lefrere ◽  
Pierre Fenaux ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Single Stage ◽  
Phase 2 ◽  
Initial Value ◽  
Durable Response ◽  
Thrombocytopenic Purpura ◽  
Chronic Itp ◽  
One Year

Abstract Background : Rituximab, a monoclonal anti-CD20 antibody, is a promising therapeutic agent for adults with immune thrombocytopenic purpura (ITP). Pooling results of the published literature suggest that rituximab achieves an initial response in about 50 % of adults with chronic ITP, with a 25–40% rate of sustained response. However, heterogeneity of patient pre-treatment status, short follow up and bias due to retrospective studies limit the interpretation of the data. Objective : To assess the safety and efficacy of rituximab in adults with chronic ITP (duration ≥ 6 months) and platelet count ≤ 30x109/L candidate to splenectomy. Methods : a multicenter prospective open-label single arm phase 2 trial designed according to Fleming’s single stage procedure was conducted. After informed consent, non splenectomized adults received 4 weekly intravenous infusions of rituximab at a dose of 375 mg/m2. All other ITP treatments were stopped. Treatment success was defined as a platelet count ≥ 50 x109/L with at least a 2 fold increase of the initial value at one year after the first rituximab infusion. Patients who received another treatment during follow up were considered as non responders. A sample size of at least 56 patients was calculated by Fleming’s single-stage design to ensure 90 % power for proving lack of efficacy if the true complete response rate was below 25%. Results : Sixty consecutive patients (40F/20M) were included over a 21 months period. Mean age was 48 years (range 18–84). Mean ITP duration was 4.8 years. Mean platelet count at inclusion was 16±10x109/L. All but one patient, in whom reversible serum sickness disease was diagnosed after 2 infusions, received 4 infusions of rituximab. Fifteen other patients experienced transient side effects that did not lead to treatment discontinuation. No patient was lost to follow up. Success was achieved in 40 % (24/60 patients) (95 % confidence interval 28% to 52%) and was found significantly different from 25% (p=0.007). Among the 24 long term responders, platelet count at one year was ≥ 150x109/L in 18 and between 50 and 150 x109/L in 6. Two other patients (3%) had and incomplete response defined as a platelet count at one year between 30 and 50 x109/L but at least 2 fold the initial value. Thirty four (57%) patients failed to respond and amongst them, 18 have already undergone splenectomy. Conclusion: rituximab appears to be a safe and good splenectomy-sparing strategy in adults with chronic ITP leading to a significant and durable response in 40% of the cases.

Does treatment with intermittent infusions of intravenous anti-D allow a proportion of adults with recently diagnosed immune thrombocytopenic purpura to avoid splenectomy?

Blood ◽  
2002 ◽  
Vol 99 (6) ◽  
pp. 1922-1927 ◽  
Author(s):  
Nichola Cooper ◽  
B. Michael R. Woloski ◽  
Erin M. Fodero ◽  
Maria Novoa ◽  
Melissa Leber ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Maintenance Treatment ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
L 14 ◽  
Lost To Follow Up ◽  
Primary Predictor ◽  
All Treatment

Abstract This study explored whether repeated infusions of intravenous anti-D could allow adults with recently diagnosed immune thrombocytopenic purpura (ITP) who had failed an initial steroid course to postpone and ultimately avoid splenectomy. Twenty-eight Rh+, nonsplenectomized adults with ITP diagnosed within 1 to 11 months and platelet counts 30 × 109/L (30 000/μL) or below were enrolled. Anti-D was infused whenever the platelet count decreased to 30 × 109/L (30 000/μL) or below. “Response” was defined as a platelet increase of more than 20 × 109/L (20 000/μL) to more than 30 × 109/L (30 000/μL) within 7 days of treatment. Patients were a median 3.5 months from ITP diagnosis at enrollment and had received a median of 2 previous therapies, including prednisone in 26 of 28 cases. They were followed for a median 26 months. A total of 93% responded to their initial infusion of anti-D, and 68% repeatedly responded with counts maintained above 30 × 109/L (30 000/μL) using anti-D alone. Currently, 12 (43%) of 28 patients have been off all treatment for more than 6 months without undergoing splenectomy, 6 maintaining counts above 100 × 109/L (100 000/μL). Seven continue on treatment, 8 underwent splenectomy, and 1 was lost to follow-up at 10 months. One patient discontinued anti-D because of toxicity. Patients with platelet counts at least 14 × 109/L (14 000/μL) at enrollment were more likely to discontinue treatment (P &lt; .05). Anti-D was an effective maintenance treatment for two thirds of Rh+, nonsplenectomized adults with ITP who had failed an initial steroid course. Intermittent infusions of intravenous anti-D allowed more than 40% of these adults to avoid splenectomy and to achieve stable platelet counts off all therapy, even after many months of treatment. Platelet count at study entry was the primary predictor of outcome.

Safety and Efficacy of Laparoscopic Splenectomy in Patients with Refractory Immune Thrombocytopenic Purpura. A Long-Term Survey

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4548-4548
Author(s):  
Nicola Cascavilla ◽  
Matteo Scaramuzzi ◽  
Michele Nobile ◽  
Matteo Dell’Olio ◽  
Antonietta Pia Falcone ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Laparoscopic Splenectomy ◽  
New Drugs ◽  
Thrombocytopenic Purpura ◽  
Safety And Efficacy ◽  
Haematological Response ◽  
Short And Long Term

Abstract Background: Despite the popularity of splenectomy has decreased dramatically in the past few years, the surgical approach remains the best therapy for patients with refractory Immune Thrombocytopenic Purpura (ITP) in terms of high and durable rate of response (Vesely et al, Ann Intern Med2004; 140: 112). The recent introduction of anti-CD20 antibodies and thrombopoietins of second generation such as AMG 531 and Eltrombopag may have a relevant role (Kuter et al, Lancet2008; 371: 362) but their long-term safety and efficacy have not been still established. In parallel with new drugs, there has been an evolution in the surgery of splenectomy as well (Dolan et al, Am J Hematol2008; 83: 93). Actually, the laparoscopic surgery is considered the standard approach and the ITP represents the most common indication in 50–80% of all the laparoscopic splenectomies. Methods: The aim of this study is to evaluate the long-term complete and partial haematological response (CR + PR), as well as the short and long-term complications, of 40 patients (30 females and 10 males; median age: 38 years - range 6–71) with unresponsive ITP after one or more medical approaches and underwent laparoscopic splenectomy at our Institution from 1999 through 2006. The 40 patients accounted for 22.2% of 181 patients diagnosed in those years. An abdominal CT scan to evaluate the presence of accessory spleens was performed in all cases. All patients received meningococcal, pneumococcal and haemophilus influenzae vaccine one week before splenectomy. For 4 or 5 days before splenectomy the patients were treated with high doses of intravenous Immunoglobulins. Anti-thrombotic prophylaxis was performed with low molecular weight heparin (LMWH) for 10 days and afterwards with cardioaspirin (ASA) if the platelet count exceeded 500x10E9/L. Results: No cases required conversion to laparotomic splenectomy. An accessory spleen was found in 2 patients (5%). Immediate haematological response rate was of 100%. At date, after a median follow-up of 78 months (range 28–112 months), 36 patients (90%) remain in CR or PR with a platelet count more than 50x10E9/L and 2 patients are taking ASA. Four patients (10%) relapsed; out of which, 2 patients have a platelet count less than 10x10E9/L. Short and long-term mortality rate was 0%. Immediate postoperative complications rate was 5%: we observed 2 cases of hemoperitoneum related to a trocar’s tube and to an active bleeding, respectively, both resolved with new laparoscopic approach. The mean postoperative hospital stay was 4,5 days (range 4–8). Neither cases of bacterial sepsis in the postoperative or during the follow-up time, nor cases of splenic-portal vein thrombosis (SPVT) and no cases of neoplasms occurred. Conclusions: Our experience suggests that laparoscopic splenectomy is an excellent approach to patients with refractory ITP in terms of safety, efficacy and costs. With respect to laparotomic splenectomy, the use of laparoscopy is likely to make the splenectomy even safer and therefore suitable for a larger number of patients. Undoubtedly there is a great expectation for the new drugs (Rodeghiero et al, Am J Hematol2008; 83: 91) and we agree that only controlled comparative clinical trials (Vianelli et al, Haematologica2005; 90: 72) will be able or not to say a final word and to challenge the role of splenectomy.

scholarly journals Demographics and Long-Term Outcome of Incident Immune Thrombocytopenic Purpura: A Twelve-Years Nationwide Population-Based Study in Taiwan

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3259-3259
Author(s):  
Bor-Sheng Ko ◽  
Grace Hui-Min Wu ◽  
Yu-Chiao Wang ◽  
Ming Yao ◽  
Churn-Shiouh Gau ◽  
...  
Keyword(s):  
General Population ◽  
Immune Thrombocytopenic Purpura ◽  
Population Based ◽  
Male Gender ◽  
Term Outcome ◽  
Thrombocytopenic Purpura ◽  
Long Term Outcome ◽  
Chronic Itp

Abstract Background and Objectives Immune thrombocytopenic purpura (ITP) is a rare disease, and the epidemiology and long-term outcome are still rarely characterized. This study is then aimed to provide a population-based assessment for the demographics and outcome about ITP in Taiwan, an island in Southeastern Asia with around 23 million inhabitants. Material and Methods This study used claims data from Taiwan's National Health Insurance Research Database (NHIRD). The database included information from a nationwide, mandatory-enrollment and single-payer healthcare system with more than 99% coverage rate in Taiwan since March, 1995. To address adequate medical history tracking and outcome follow-up, only those patients with the first ITP diagnosis from Jan 1st, 2001 to Dec 31st, 2012 were included. Incident ITP was identified first with ICD-9 codes; but those cases with codes for potential ITP-confounding diseases within 6 months from the first ITP code were excluded. Next, only those patients with meaningful pharmacological treatment or splenectomy within 3 months were included in the final analysis. Chronic ITP was defined for those with ICD-9 ITP codes and continuous drug exposure for more than 3 months, or with rituximab or splenectomy. Sex- and age-matched cohorts with 1:10 ratio were selected from Taiwan general population for survival comparison. Results Of the 30673 patients with ITP codes from Jan 1st, 2001 to Dec 31st, 2012, 11437 were identified as incident ITP. The mean age was 42.9+/-27.5 y/o, and 5445 (47.6%) cases had Charlson Comorbidity Index (CCI) score more than 2. The average incidence was 4.16 per 100,000 person-year, and the details are shown in Table 1. The incidence for female was higher than that for male (4.97 vs. 3.38 per 100,000 person-year), and the incidences across the age represented a U-shape distribution, with the highest ones in those aged 0-9 y/o and more than 70 y/o (7.21 and 13.3 per 100,000 person-year, respectively). Some geographic distribution of the incidences existed, with the highest in central part and the lowest in Eastern part of Taiwan (5.33 and 2.64 per 100,000 person-year, respectively). Secondary causes could be identified in 3560 (31.0%) cases, and malignant neoplasma (1743, 49.0%) were most frequently noted. Viral hepatitis B or C were found in 785 (22.1%) cases. Chronic ITP was diagnosed during follow-up in 29.1% (n=3324) of incident ITP patients. Those incident ITP patients aged 0-9 y/o (431/2169 vs. 2893/9268, p<0.001) or male gender (1118/4697 vs. 2206/6740, p<0.001) had a less chance to develop chronic ITP. As compared with the matched cohort from general population, the 10-yr survival rate was significantly inferior for all ITP patients, no matter in those aged below 20 y/o (96.9+/-0.5% vs. 98.8+/-0.1%, p<0.0001) or above 20 y/o (62.5+/-0.8% vs. 83.2+/-0.2%, p<0.0001), as in Figure 1. For chronic ITP, the disadvantaged 10-yr survival rates persisted (for age below 20 y/o: 96.5+/-1.0% vs. 98.6+/-0.2%, p<0.0001; for age above 20 y/o: 72.7+/-1.3% vs. 86.7+/-0.4%, p<0.0001, as in Figure 2). Elder age, male gender and high CCI scores predicted worse survival in multi-variate analysis. Conclusions This study is the largest population-based epidemiology report at nationwide scale till now. Not only the results can provide a valuable demographic description for ITP in Eastern Asia, but also they confirm an inferior long-term outcome for ITP patients, which necessitates more attention to their health care. SD: standard deviation Table 1. Table 1. Figure 2. Figure 2. Figure 3. Figure 3. Disclosures Tang: Novartis: Consultancy, Honoraria.

Rituximab Does Not Prevent Relapse in Patients with Thrombotic Thrombocytopenic Purpura

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3318-3318
Author(s):  
Goyal Jatinder ◽  
Jose L. O. Lima ◽  
Jill Adamski ◽  
Marisa Marques
Keyword(s):  
Thrombotic Thrombocytopenic Purpura ◽  
Medical Records ◽  
Conflicts Of Interest ◽  
Univariate Analysis ◽  
Laboratory Data ◽  
Delayed Response ◽  
Thrombocytopenic Purpura ◽  
Group 2 ◽  
Group 1

Abstract Abstract 3318 Objective: In the last decade, rituximab has been added to therapeutic plasma exchange (TPE) to treat patients with thrombotic thrombocytopenic purpura (TTP) who appear resistant to TPE. We sought to determine first if rituximab prevented TTP relapse. In addition, if relapse has occurred, we compared the rates of relapse of patients treated with TPE alone with those treated with a combination of TPE and rituximab. Methods: We retrospectively reviewed the medical records of all adult patients treated for TTP between 2003 and 2008 at our institution. TTP was defined as thrombocytopenia, hemolytic anemia and ADAMTS13 activity less than 10% due to an inhibitor. None of the patients had congenital TTP. Patient demographics, laboratory data, treatment characteristics and follow up details were collected from their electronic and apheresis' medical records. Kaplan-Meier curves were drawn for survival and Cox proportional hazards models were applied to look for independent predictors of relapse-free survival (RFS). Results: A total of 20 patients underwent TPE only (Group 1) as compared to 18 patients who also received rituximab during admission with TTP (Group 2). Table 1 shows that both groups were balanced at baseline for demographic and laboratory data. However, patients in group 2 had longer duration of hospital stay (p<0.0001), underwent more TPE procedures (p<0.0001) and took longer to achieve remission (p<0.0001). The mean follow up in group 1 was 77.5 (±22.4) months and in group 2 was 68.6 (±28.5) months. At follow-up, 5 patients from group 1 relapsed (25%) as compared with 6 patients from group 2 (35%) (p=0.50). The 1-year, 3-year and 5-year RFS rates were 95%, 85% and 74% for group 1, and 94%, 76% and 71%, respectively, for group 2 (p=0.53 using log rank test). On univariate analysis, only age at the time of treatment (p=0.05) and duration of follow-up after treatment (p=0.03) were predictors of relapse. However, on multivariate analysis, no independent predictors of relapse were identified. Conclusion: Rituximab does not prevent or reduce rates of relapse when used with TPE in patients with TTP. Since rituximab was added to patients later in their TPE course due to delayed response to treatment, it may yet have a role in decreasing the number of TPEs needed to achieve a response if it were started earlier during hospitalization for TTP. Disclosures: No relevant conflicts of interest to declare.

Short Term Treatment With Thrombopoietin-Receptor Agonists For Patients With Immune Thrombocytopenic Purpura (ITP) Before Splenectomy

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1086-1086 ◽  
Author(s):  
Yosef Kalish ◽  
Galia Spectre ◽  
David Varon
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Complete Blood Count ◽  
Conflicts Of Interest ◽  
Short Term Treatment ◽  
Thrombocytopenic Purpura ◽  
Thrombopoietin Receptor Agonists ◽  
Receptor Agonists ◽  
Short Course ◽  
Thrombopoietin Receptor

Abstract The thrombopoietin-receptor agonists (romiplostim and eltrombopag) were approved recently as treatments for patients with immune thrombocytopenic purpura (ITP). Splenectomy remains a common second line treatment for ITP with the highest remission rate compared with alternative therapies. It has been reported that splenectomy can be safely performed in patients with a platelet count of 40-50,000 per cubic millimeter but many patients do not reach these values. Intravenous immune globulins (IVIG) are often used before splenectomy in order to increase the platelet count before surgery. The aim of this study was to determine whether a short course of thrombopoietin-receptor agonists can be used as a reliable and safe treatment to increase the platelet count in patients with ITP before splenectomy. Between 2010 and 2012, fifteen patients with ITP, all refractory to steroids, were scheduled for splenectomy. Treatment with thrombopoietin-receptor agonists (romiplostim or eltrombopag) was started 3 weeks before splenectomy. Eight patients received eltrombopag at a dose of 50 mg/day orally until 3 days before splenectomy. For romiplostim, a subcutaneous injection of 3 mcg/kg was given weekly to 7 patients. The last injection was given one week before splenectomy. Complete blood count was repeated every week and the dose of romiplostim was adjusted (up to 10 mcg/kg or down to 1 mcg/kg) based on the platelet count increment. Response was defined as a platelet count of 50,000 or more per cubic millimeter. Mean platelet count before treatment was 11,000±8,000 cells per cubic millimeter. All patients, except one patient on romiplostim, responded to the treatment with a mean platelet count of 74± 25 cells per cubic millimeter on the day of splenectomy (p<0.01). Similar effect was noticed among responders of the two drugs. Four patients from the romiplostim group responded to a 3 mcg/kg dose. Two patients responded to increased doses of 7 and 10 and 10 mcg/kg. One patient did not respond to 10 mcg/kg of romiplostim but later responded to IVIG. The two drugs were well tolerated with no side effects except for mild liver function abnormalities in one patient in the eltrombopag group. No thromboembolic complications or excessive bleeding were reported for these patients. In summary, we report that a short course of thrombopoietin-receptors agonists can effectively and safely increase the platelet count in steroid resistant ITP patients before splenectomy. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Prognostic Factors for Immune Thrombocytopenic Purpura Remission after Laparoscopic Splenectomy: A Cohort Study

Medicina ◽  
2019 ◽  
Vol 55 (4) ◽  
pp. 112
Author(s):  
Kwiatkowska ◽  
Radkowiak ◽  
Wysocki ◽  
Torbicz ◽  
Gajewska ◽  
...  
Keyword(s):  
Platelet Count ◽  
Prognostic Factors ◽  
Immune Thrombocytopenic Purpura ◽  
Laparoscopic Splenectomy ◽  
Univariate Analysis ◽  
Multivariate Logistic Regression Model ◽  
Hemorrhagic Diathesis ◽  
Thrombocytopenic Purpura

Background and Objectives: Laparoscopic splenectomy (LS) has become the gold standard for patients with immune thrombocytopenic purpura (ITP). The total remission rate after splenectomy is 70%–90%, of which 66% is long-term. Despite this high response rate, some patients do not benefit from surgery. It is therefore important to try to identify risk factors for an unsatisfactory clinical response. The aim of this study was to assess long-term outcomes of LS for ITP and identify factors associated with increased disease remission rates. Materials and Methods: We retrospectively studied consecutive patients with ITP undergoing LS in a tertiary referral surgical center prospectively recorded in a database. Inclusion criteria were: Elective, laparoscopic splenectomy for diagnosed ITP, and complete follow-up. The cohort was divided into two groups—Group 1 (G1) patients with ITP remission after splenectomy and Group 2 (G2) patients without remission. There were 113 G1 patients and 52 G2 patients. Median follow-up was 9.5 (IQR: 5–15) years. Results: In univariate analysis, patient’s age, body mass index (BMI), preoperative platelet count, the need for platelet transfusions, and presence of hemorrhagic diathesis were shown to be statistically significant factors. Next, we built a multivariate logistic regression model using factors significant in univariate analysis. Age <41 years (odds ratio (OR) 4.49; 95% CI: 1.66–12.09), BMI <24.3 kg/m2 (OR: 4.67; 95% CI: 1.44–15.16), and preoperative platelet count ≥97 × 103/mm3 (OR: 3.50; 95% CI: 1.30–9.47) were shown to be independent prognostic factors for ITP remission after LS. Conclusion: The independent prognostic factors for ITP remission after LS revealed in our study are: age <41 years, BMI <24.3 kg/m2, and preoperative platelet count ≥97 × 103/mm3. Duration of the ITP and the time of treatment are not related to remission after LS.

Rituximab efficacy and safety in adult splenectomy candidates with chronic immune thrombocytopenic purpura: results of a prospective multicenter phase 2 study

Blood ◽  
2008 ◽  
Vol 112 (4) ◽  
pp. 999-1004 ◽  
Author(s):  
Bertrand Godeau ◽  
Raphael Porcher ◽  
Olivier Fain ◽  
François Lefrère ◽  
Pierre Fenaux ◽  
...  
Keyword(s):  
Immune Thrombocytopenic Purpura ◽  
Phase 2 ◽  
Open Label ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
Chronic Immune Thrombocytopenic Purpura ◽  
Chronic Itp ◽  
Phase 2 Trial ◽  
Phase 2 Study

Abstract Whether rituximab could effectively and safely avoid splenectomy for adults with chronic immune thrombocytopenic purpura (ITP) remains unresolved. A multicenter, prospective, open-label, single-arm, phase 2 trial was conducted to assess rituximab safety and efficacy in adult splenectomy candidates with chronic ITP. Sixty patients with chronic (≥ 6 months) ITP and platelet counts less than 30 × 109/L received a weekly intravenous infusion of rituximab (375 mg/m2) for 4 weeks. All other ITP treatments were stopped. A good response was defined as a platelet count 50 × 109/L or more, with at least a doubling of the initial value at 1 and 2 years after the first rituximab infusion. Patients who required another treatment during follow up were considered nonresponders. Sixteen patients experienced transient side effects that necessitated treatment discontinuation for only 1. Good 1-year responses were obtained in 40% of the patients (24/60 [95% confidence interval: 28%-52%]). At 2 years, 33.3% (20/60 patients) had good responses and 6.7% (4/60) had sustained platelet counts of 30 × 109/L or more without treatment. Thirty-six (60%) patients failed to respond; 25 underwent splenectomy. Based on these results, rituximab was an apparently safe and effective splenectomy-avoiding option in some adults with chronic ITP. This trial is registered at http://clinicaltrials.gov as NCT00225875.

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