A Meta-Analysis on the Use of Intravenous Gamma Globulin and Corticosteroids in Children with Acute Immune Thrombocytopenic Purpura.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 4000-4000
Author(s):  
Mary N. Chua ◽  
Tintin Manuela ◽  
Jesus N. Sarol ◽  
Antonio D. Ligsay
Keyword(s):  
Platelet Count ◽  
Adverse Events ◽  
Immune Thrombocytopenic Purpura ◽  
Fixed Effects ◽  
Gamma Globulin ◽  
Treated Group ◽  
Risk Difference ◽  
Oral Steroid ◽  
Thrombocytopenic Purpura ◽  
Treatment Groups

Abstract To determine the difference in proportion of patients who achieved a rise in platelet count and to determine the risk difference of adverse events in patients with acute immune thrombocytopenic purpura treated with corticosteroids or gamma globulin (IVIG). Medline, EMBASE, Pediatric Hematology and Oncology, Pediatrics and Journal of Pediatrics (all up to 2005) and personal collections of the authors. Systematic search of articles utilizing a search strategy was performed to identify relevant articles according to prior inclusion and exclusion criteria. Fixed effects and random effects models were used to determine summary effect estimates. Difference in proportion of patients who achieved the desired platelet count and risk difference of adverse events between treatment groups. Analysis of 9 randomized controlled trials showed that IVIG produced an additional 12–14% increase in proportion of patients with platelet count >20 x 109/L and 15% increase in proportion of patients with platelet count >50 x 109/L on days 2 to 4. No significant differences were seen between the treatment groups on days 14 and 28 except for platelet count >50 x 109/L. More patients in oral steroid treated group had adverse events compared to IVIG treated group but no differences were noted in the parenteral treated group. IVIG is more effective compared to corticosteroids in raising the platelet count during the early part of treatment. IVIG and parenteral steroids shows less adverse events as compared to oral steroid.

Combination immunosuppressant therapy for patients with chronic refractory immune thrombocytopenic purpura

Blood ◽  
2010 ◽  
Vol 115 (1) ◽  
pp. 29-31 ◽  
Author(s):  
Donald M. Arnold ◽  
Ishac Nazi ◽  
Aurelio Santos ◽  
Howard Chan ◽  
Nancy M. Heddle ◽  
...  
Keyword(s):  
Platelet Count ◽  
Mycophenolate Mofetil ◽  
Adverse Events ◽  
Observational Study ◽  
Immune Thrombocytopenic Purpura ◽  
Treatment Options ◽  
Initial Response ◽  
Immunosuppressant Therapy ◽  
Thrombocytopenic Purpura ◽  
Refractory Itp

Abstract Treatment options for patients with chronic refractory immune thrombocytopenic purpura (ITP) are limited. Because combination immunosuppressant therapy appeared to be effective in ITP and other disorders, we used this approach in patients with particularly severe and refractory ITP. In this retrospective, observational study, we determined the response (platelet count above 30 × 109/L and doubling of baseline) among 19 refractory ITP patients. Treatment consisted of azathioprine, mycophenolate mofetil, and cyclosporine. The patients had failed a median of 6 prior treatments, including splenectomy (in all except 1). Of 19 patients, 14 (73.7%) achieved a response lasting a median of 24 months, after which time 8 (57.1%) relapsed. Of the 8 relapsing patients, 6 responded to additional treatments. Of the 14 patients who achieved an initial response, 2 (14.3%) remained in remission after eventually stopping all medications. Severe adverse events did not occur. Combination immunosuppressant therapy can produce a rise in the platelet count that is sometimes sustained in refractory ITP patients.

Efficacy and Safety of a New Intravenous Immunoglobulin Product in Patients with Chronic Immune Thrombocytopenic Purpura.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 1307-1307
Author(s):  
Tadeusz Robak ◽  
Abdulgabar Salama ◽  
Lidia Kovaleva ◽  
Yaroslava I. Vyhovska ◽  
Simon Davies ◽  
...  
Keyword(s):  
Platelet Count ◽  
Adverse Events ◽  
Intravenous Immunoglobulin ◽  
Primary Endpoint ◽  
Immune Thrombocytopenic Purpura ◽  
Efficacy And Safety ◽  
Platelet Response ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
Chronic Itp

Abstract Background Intravenous immunoglobulin (IVIG) is an accepted treatment for immune thrombocytopenic purpura (ITP). A new liquid 10% human IgG preparation stabilized with proline at a pH of 4.8 (trade name: Privigen) was recently developed. It can be stored at room temperature and is therefore always ready to use. Here we report its efficacy and safety in patients with chronic ITP. Patients and Methods Fifty-seven patients with chronic ITP and a platelet count below 20 x 109/L were included in this open-label, single arm, multi-center Phase III trial. IVIG was given at a dose of 1 g/kg on 2 consecutive days at a maximum infusion rate of 4 mg/kg/min. A subset (56.1%) of the patients received premedication (acetaminophen or diphenhydramine) to avoid adverse events. The primary endpoint was the platelet response rate, defined as the percentage of patients showing an increase in platelet count to ≥50 x 109/L within 7 days of the first infusion. Secondary endpoints included platelet counts at specified time points, time to platelet response, duration of platelet response, and regression of hemorrhages at different bleeding sites. Safety was evaluated by the frequency and severity of adverse events. Results The primary endpoint, an increase in platelet counts to ≥50 x 109/L, was achieved by 81% of the subjects (95% CI: 69–89%). The highest median platelet count (149 x 109/L) was observed on day 8. Median time to response was 2.5 days, with 43% of subjects responding within 1 day. Median duration of platelet response (days with platelet count ≥ 50 x 109/L) was 15.4 days. Regression rates for various bleeding sites ranged from 78% to 100%. Regression of bleeding correlated with increases in platelet counts. Adverse events were reported in 52 (91%) subjects. The most common adverse event was headache (67%), the incidence and severity of which was attenuated by premedication with acetaminophen/diphenhydramine. There were 3 serious adverse events, one of which (aseptic meningitis) was considered related to the study medication. Conclusions The present study has shown the safety and significant efficacy of a novel, 10% liquid, ready for use IVIG preparation, in patients with chronic ITP. A rapid increase in platelet counts to a level where severe bleeding episodes become more unlikely was seen in the majority of patients, as expected with IVIG given at 1 g/kg on 2 consecutive days. The increase in platelet counts was associated with a regression of bleeding. Adverse events were generally mild to moderate in severity, corresponded to those expected with IVIG, and could be prevented with premedication.

scholarly journals Metastatic Breast Cancer with Extensive Osseous Metastasis Presenting with Symptomatic Immune Thrombocytopenic Purpura and Anemia: A Case Report and Review of the Literature

2015 ◽  
Vol 8 (2) ◽  
pp. 256-263 ◽  
Author(s):  
Jiaxin Niu ◽  
Teresa Goldin ◽  
Maurie Markman ◽  
Madappa N. Kundranda
Keyword(s):  
Breast Cancer ◽  
Platelet Count ◽  
Metastatic Breast Cancer ◽  
Immune Thrombocytopenic Purpura ◽  
English Literature ◽  
Metastatic Breast ◽  
Response To Therapy ◽  
Severe Thrombocytopenia ◽  
Thrombocytopenic Purpura ◽  
Immune Mediated

Background: Immune thrombocytopenic purpura (ITP) is a rare acquired bleeding disorder with an estimated incidence of 1 in 10,000 people in the general population. The association of ITP with breast cancer is an even rarer entity with very limited reports in the English literature. Case Presentation: We report a case of a 51-year-old female with no significant past medical history who presented with sudden onset of malaise, syncope, gingival bleed and epistaxis. She was found to have severe thrombocytopenia (platelet count 6,000/μl) and anemia (hemoglobin 7.2 g/dl). Her workup led to the diagnosis of metastatic ductal breast cancer with extensive bone metastasis. Bone marrow biopsy demonstrated myelophthisis which was initially thought to be consistent with her presentation of thrombocytopenia and anemia. Therefore, the patient was started on hormonal therapy for the treatment of her metastatic breast cancer. After 3 months of therapy, she did not improve and developed severe mucosal bleeding. Her clinical presentation was suspicious for ITP and immune-mediated anemia, and hence she was started on steroids and intravenous immunoglobulin. The patient had a dramatic response to therapy with normalization of her platelet count and hemoglobin within 2 weeks. Conclusion: To our knowledge, this is the first reported case of metastatic breast cancer presenting with symptomatic ITP and anemia, and both symptoms are postulated to be immune-mediated.

scholarly journals Anti-RH immunoglobulin therapy for human immunodeficiency virus-related immune thrombocytopenic purpura

Blood ◽  
1988 ◽  
Vol 71 (5) ◽  
pp. 1499-1502 ◽  
Author(s):  
E Oksenhendler ◽  
P Bierling ◽  
Y Brossard ◽  
C Schenmetzler ◽  
PM Girard ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Specific Interaction ◽  
Immunoglobulin Therapy ◽  
Thrombocytopenic Purpura ◽  
Immunodeficiency Virus

Abstract The potential hazards of steroids in human immunodeficiency virus (HIV)- infected patients led us to evaluate the effectiveness and safety of anti-D and anti-c Ig in 17 adults with severe HIV-related immune thrombocytopenic purpura (platelet count less than 20 x 10(9)/L). The 14 Rh+ patients received 12 to 25 micrograms/kg of anti-D IgG intravenously on two consecutive days. A significant platelet rise above 50 x 10(9)/L was obtained in nine patients. Repeated boosters were performed in six cases and were effective in all cases. The 3 Rh- patients had a good response after they were given 20 mL x 2 of plasma containing potent anti-c antibodies. Therapy was well tolerated, and only one patient had significant hemolysis. These data suggest that anti-Rh IgG can be effective and safe in HIV-related thrombocytopenic purpura and that a specific interaction between the RBC antigens and the anti-Rh antibodies is required.

scholarly journals Quantitation of platelet-associated IgG by radial immunodiffusion

Blood ◽  
1981 ◽  
Vol 57 (4) ◽  
pp. 809-811 ◽  
Author(s):  
BS Morse ◽  
D Giuliani ◽  
M Nussbaum
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Radial Immunodiffusion ◽  
Thrombocytopenic Purpura ◽  
Platelet Counts ◽  
Normal Platelet ◽  
Serum Igg ◽  
Acute Itp ◽  
Igg Level

Abstract Platelet-associated IgG (PAIgG) was measured by a simple radial immunodiffusion technique using washed solubilized platelets and commercially available immunoplates. Subjects with normal platelet counts had PAIgG levels of 1.5--7.0 fg/platelet. Subjects with idiopathic immune thrombocytopenic purpura (ITP) had levels ranging from 5.7 to 70.5 fg/platelet. All patients with recurrent ITP and 85% of patients with acute ITP had elevated PAIgg. Elevated PAIgG was also found in 17% of patients with recovered ITP, 40% of patients with SLE and thrombocytopenia, 57% of patients with thrombocytopenia occurring during the course of septicemia, and 100% of patients with IgG myeloma in whom the serum IgG level was clearly elevated, regardless of the platelet count. The results are similar to reports that used more complex techniques.

Severe haematological complications during treatment with natalizumab

2012 ◽  
Vol 18 (11) ◽  
pp. 1644-1646 ◽  
Author(s):  
L Midaglia ◽  
M Rodriguez Ruiz ◽  
D Muñoz-García
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Progressive Multifocal Leukoencephalopathy ◽  
Immune Thrombocytopenic Purpura ◽  
Safety Profile ◽  
Temporal Relationship ◽  
Careful Monitoring ◽  
Thrombocytopenic Purpura ◽  
Immune Mediated ◽  
Immunosuppressant Treatment

The safety profile of natalizumab has been widely discussed due to several cases of progressive multifocal leukoencephalopathy, reported worldwide. Since the launch of natalizumab, 32 patients have been treated at our centre. In this context, we describe two cases (6.25%), one of immune-mediated acute haemolytic anaemia (IAHA) and another of immune thrombocytopenic purpura during treatment with natalizumab. The temporal relationship between drug administration and the nature of the haematological complications, confirmed with the serological findings in the case of the IAHA, suggests that natalizumab is the most probable cause for these adverse events. Although very uncommon, the haematological complications are severe enough to justify a close and careful monitoring for all patients with multiple sclerosis treated with an immunosuppressant treatment.

Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hemoglobinuria Following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 1242-1242
Author(s):  
Ann R. Gaines
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Immune Globulin ◽  
Mechanism Of Action ◽  
Intravenous Administration ◽  
Disseminated Intravascular Coagulation ◽  
Immune Thrombocytopenic Purpura ◽  
Package Insert ◽  
Thrombocytopenic Purpura ◽  
Intravascular Coagulation

Abstract The Food and Drug Administration (FDA) licensed Rho(D) immune globulin intravenous (anti-D IGIV) in March 1995 for treatment of immune thrombocytopenic purpura (ITP). The presumed mechanism of action of anti-D IGIV is extravascular hemolysis of anti-D-sensitized RBCs by splenic macrophages. Although seemingly inconsistent with this mechanism of action, acute hemoglobinemia and hemoglobinuria have been reported and are listed in the professional package insert for anti-D IGIV as possible adverse events. Through November 30, 2004, FDA received 6 reports of disseminated intravascular coagulation (DIC) associated with “acute hemolysis” (or similar terms) following anti-D IGIV treatment for ITP (Gaines AR. Disseminated intravascular coagulation associated with acute hemoglobinemia or hemoglobinuria following Rho(D) immune globulin intravenous administration for immune thrombocytopenic purpura. Blood.2005, 106(5):in press). All patients were clinically stable and were initially discharged home following anti-D IGIV administration. All were subsequently hospitalized for signs and symptoms of acute hemolysis or DIC. The mean decrease between pretreatment and nadir posttreatment hemoglobin levels was 5.8 g/dL (range: 3.0 to 9.6 g/dL); 4 patients received 2 to > 5 units of packed RBCs. Four patients whose baseline serum creatinine levels were within normal limits developed renal insufficiency; 2 of those patients underwent dialysis. The pediatric patient was subsequently discharged from the hospital without sequelae. However, all 5 adult patients remained hospitalized and died 3 to 10 days after anti-D IGIV administration. Attending or consulting physicians assessed that acute hemolysis and/or DIC caused or contributed to each death. Data from previously reported cases further suggested that previous uneventful administration of anti-D IGIV does not preclude the development of acute hemolysis upon subsequent administration of anti-D IGIV. These cases suggested that patients treated with anti-D IGIV for ITP who experience acute hemoglobinemia or hemoglobinuria be monitored for the development of DIC. To increase our knowledge about the seemingly rare but potentially serious complication of DIC following anti-D IGIV treatment for ITP, physicians and other health care professionals are encouraged to submit serious adverse event reports to the anti-D IGIV manufacturer or to FDA. Contact information for reporting adverse events to the manufacturer of any FDA-approved product is generally available in the professional package insert or on manufacturer- or distributor-sponsored web sites. Alternatively, adverse events can be reported directly to FDA through its adverse event reporting system, MedWatch, by Internet at http://www.fda.gov/medwatch, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; or by mail at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787.

Treatment Patterns and Splenectomy Failure Rates in Patients with Chronic Immune Thrombocytopenic Purpura in Canada: A Retrospective Chart Review

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 4565-4565
Author(s):  
Joseph Mikhael ◽  
Alan Tinmouth ◽  
Tazmin Merali ◽  
Mo Amin ◽  
Wendy Lam
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenic Purpura ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Initial Therapy ◽  
Second Line ◽  
First Line ◽  
Bleeding Events ◽  
Thrombocytopenic Purpura ◽  
Line Therapy

Abstract Background: In clinical practice there is little consensus on treating patients with chronic immune thrombocytopenic purpura (ITP) beyond first line therapy with steroids. Objectives: Describe the demographic and disease characteristics of adult ITP patients who receive treatment; Obtain the treatment approach for patients with ITP beyond first line treatment with steroids, with an emphasis on splenectomy; and Evaluate adverse bleeding outcomes associated with ITP. Methods: A retrospective chart review of ITP patients after initial therapy with steroids was conducted. Ten physicians (oncologists and hematologists) were recruited from across Canada and each physician provided at least 5 ITP cases for review. A total of 51 cases were reviewed and patients (> 18 years old) were required to have had more than 1 course of steroids as treatment to be eligible. Results: The average age of patients at diagnosis was 42 (range 3 to 82 years); 37 (73%) of the patients were female, and 37 (73%) were Caucasian. The median platelet count upon presentation was 5×109/L. Median lines of therapy after initial therapy was 3 (range 0 to 6). Second line therapies varied, but most commonly patients underwent splenectomy (43%), followed by continued steroid treatment (16%), steroids plus IV Ig (16%), IV Ig alone (14%), immunosuppressant alone (2%), and anti-D plus steroids (2%). Of the patients reviewed, 40 (78%) eventually underwent splenectomy. Of the 40 splenectomized patients, 27 were splenectomized within the first year of diagnosis and 35 underwent splenectomy during the first 5 years. In addition, 62 of the splenectomies were laparoscopic, and the median hospital stay for all procedures was 5 days (range 1 to 60 days). Immediate failure of splenectomy occurred in 18% of patients, and the one- and five- year relapse/failure rates (defined as platelet count < 30×109/L) were 38% and 55%, respectively. Other therapies following splenectomy included IV Ig, azathioprine, cyclosporine, danazol, mycophenolate, rituximab, vincristine, cyclophosphamide, and anti-D. Only 6% of IV Ig use was for chronic maintenance therapy and 74% of use was for urgent therapy. A total of 61 bleeding events occurred, of which 10 were major (upper GI, mouth, rectal, and nose). Major bleeding events required hospitalization of the patient with an average length of stay of 5 days (range 2 to 14 days). Conclusions: Notwithstanding several limitations, the retrospective chart review suggests that there is wide variation in long-term therapy for patients with chronic ITP in Canada. Splenectomy was the most widely used second line therapy, although 18% of the patients were non-responders and the five-year relapse/failure rate was 55%.

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.

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