Treatment of Immune-Mediated Thrombocytopenia Purpura with Concurrent IVIg and Platelet Transfusion: A Retrospective Review of 40 Patients.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3972-3972
Author(s):  
Joseph E. Spahr ◽  
Neeraj Agarwal ◽  
George M. Rodgers
Keyword(s):  
Platelet Count ◽  
Side Effects ◽  
Retrospective Review ◽  
Combined Treatment ◽  
Age Groups ◽  
Optimal Dose ◽  
Active Bleeding ◽  
Bleeding Complications ◽  
Platelet Counts ◽  
Immune Mediated

Abstract Introduction: In January 2000, two patients with severe Immune-Mediated Thrombocytopenia (ITP) at our institution were successfully treated with prolonged infusions of IVIg and platelets. The dose of IVIg was 1 g/kg given by continuous infusion over 24 hours with concurrent platelets (1 pheresis unit every 8 hours). Based on these preliminary results, we evaluated this protocol in a larger series of 40 ITP patients. Methods: We performed an IRB-approved retrospective review of adult hospitalized patients with ITP treated with this regimen from January 2000 - December 2005. Patients with clinically significant thrombocytopenia and either active bleeding, need for anticoagulation, or requirement for a surgical procedure received the combined treatment. The subjects received IVIg and platelets as described above. Additional treatments, such as steroids, immunosupressives, or rituximab, as well as splenectomy were utilized at the discretion of the hematologist overseeing their care. Results: The average age of patients treated was 52 years. The majority of patients ranged from 20–80 years old, but 12.5% were older than 80 years. The average pretreatment platelet count was 10,000/μl, with an increase to 55,000/μl after 24 hours, and 69,000/μl after 48 hours. By 72 hours, the average platelet count had begun to decline, although the platelet count remained at an acceptable level (58,200/μl). After 24 hours, 62.7% of patients had a platelet count > 50,000/μl. Bleeding was controlled initially in all patients, and those requiring a procedure experienced no bleeding complications. Over half of the patients (52.5%) required additional treatments for recurrent or refractory ITP, and 32.5% of the patients underwent splenectomy. Six of the 21 patients requiring later retreatment (29%) received IVIg and platelets again in a similar fashion. The average retreatment platelet counts after 24 and 48 hours were 53,000/μl and 49,000/μl respectively, with clinical improvement in bleeding in all patients. No side effects of the combined treatment were noted. The response rates for the 3 IVIg products used were similar. Discussion: For ITP, IVIg and platelets are considered to be first line treatment for patients with very low platelet counts, active bleeding, or those requiring urgent procedures. There is limited literature on the optimal dose and schedule for administration of IVIg and platelets. Our approach for administration of IVIg and platelets concurrently was associated with minimal side effects, resolution of bleeding, ability to safely undergo procedures, and rapid restoration of adequate platelet counts. Additionally, elderly patients had equivalent benefit with no increased side effects, indicating that this regimen is appropriate and safe for patients of all age groups.

Imatinib Mesylate in Polycythemia Vera. A Heterogeneous Response Pattern but a Consistent Reduction in Phlebotomy Requirements.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4747-4747 ◽  
Author(s):  
Hans Hasselbalch
Keyword(s):  
Platelet Count ◽  
Side Effects ◽  
Polycythemia Vera ◽  
Response Pattern ◽  
Treatment Protocol ◽  
First Year ◽  
Minor Response ◽  
Platelet Counts ◽  
Cytotoxic Treatment

Abstract Background. Imatinib targets the ATP-binding sites of the protein tyrosine kinase domains associated with Bcr-abl, platelet-derived growth factor receptors (PDGFR) and c-kit. Most recently imatinib has been to inhibit autonomous erythropoiesis in vitro in polycythemia vera (PV)(1). Several clinical studies have indicated that imatinib may reduce phlebotomy requirements (2,3), but only a few patients have been followed for longer periods on imatinib monotherapy (2,3). Aim of the study. To evaluate the safety and efficacy of long term monotherapy with imatinib in PV. Patients.Eight patients (median age 60 years, range 39–68) have been treated. Five of the patients were enrolled in a phase II treatment protocol and three patients have been treated off protocol. None of the patients in the protocol had received cytotoxic treatment whereas the three patients treated off protocol had been treated with hydroxyurea (HU) and PEG-Intron. Imatinib was given at an initial dose of 400 mg/day in all patients. Methods. The diagnosis of PV was made according to conventional criteria, including an increased red cell blood volume and a low plasma erythropoietin. All patients were negative for the Bcr-abl transcript. A complete response (CR) was defined as phlebotomy-free within the first year of treatment, lasting at least 6 mo together with a platelet count less than 600 x 109/l and absence of splenomegaly. A partial response (PR) was defined by phlebotomy-free within the first year of treatment, lasting at least 6 mo together with a platelet count more than 600 x 109/l and a palpable spleen but less than 50 % of the original size (2). A minor response (MR) was defined as a reduction in the need of phlebotomies of at least 50 % but no change in the platelet counts. Results. Four patients have been followed for 12 mo on a dose of 400 mg daily apart from short periods, when the dose had to be decreased to 100 mg/day and 300mg/day, respectively, due to temporary side effects. Responses were seen in all evaluable patients (7/7) (CR=1; PR=6). The PR’s in two of the patients were obtained when HU (n=1) or PEG-Intron (n=1) were added. A definite decline in the Ht within the first month (< 0.45) and a reduction in the need of phlebotomies were recorded in all evaluable patients whereas the leucocyte and platelet counts displayed a highly heterogeneous response pattern with unchanged and even rising platelet counts in 3 patients. The one patient with a CR displayed a reduction of spleen size and a decrease in the degree of bone marrow fibrosis after being treated for 12 mo. Almost complete alleviation of severe pruritus was noticed in one patient a few weeks after starting imatinib. One patient had to discontinue treatment after 1 week due to severe musculoskeletal pain. Otherwise the side effects were moderate and often transient. One of the patients noticed no side effects at all. Conclusions. Imatinib in PV is followed by a decrease in the Ht but highly heterogeneous leucocyte-and platelet responses in some patients when using 400 mg/day.Combinational therapy with HU or PEG-Intron seems safe and effective.

scholarly journals Treatment of Immune Thrombocytopenia (ITP) with Eltrombopag - Results of the 4 th Interim Analysis of the German Non-Interventional Trial RISA

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3150-3150
Author(s):  
Oliver Meyer ◽  
Rudolf Schlag ◽  
Thomas Stauch ◽  
Bastian Fleischmann ◽  
Marcel Reiser ◽  
...  
Keyword(s):  
Platelet Count ◽  
Interim Analysis ◽  
Receptor Agonist ◽  
Immune Thrombocytopenia ◽  
Bleeding Complications ◽  
Bleeding Events ◽  
Interventional Trial ◽  
Platelet Counts ◽  
Thrombopoietin Receptor ◽  
Thrombopoietin Receptor Agonist

Abstract Background: Immune thrombocytopenia (ITP) is an acquired autoimmune disorder with increased platelet destruction and impaired platelet production. Patients present with bleeding complications of various severity. Another common symptom of ITP is fatigue, which can severely affect patient's quality of life. Eltrombopag (EPAG) is an oral thrombopoietin receptor agonist, which is proved to be effective and safe in the treatment of ITP. In Europe, it is approved for the therapy of patients who were diagnosed with ITP at least 6 months ago and who have not responded to other treatments. Here we present data from the 4 th interim analysis of the RISA study. Methods: RISA is a prospective multicenter non-interventional trial in Germany. It was launched in December 2015, and it will be continued until December 2023. In accordance with the inclusion criteria, adults with persisting or chronic pITP (primary ITP) have been enrolled. Patients with pre-treatment could only be included if it was terminated 4 weeks prior to the patient's consent to participate in the study. Exclusion criteria comprised pregnancy, hepatitis C infection and severe aplastic anaemia. Dosage of EPAG and treatment of patients follows the SmPC and the routine of treating physicians. According to the study protocol, patient questionnaires must be completed at 0,1,3,6,9,12,18 and 24 months. Fatigue is assessed using the FACIT-F score, which includes a score range from 0 to 52, with score values <30 indicating severe fatigue. Statistical elaboration is predominantly descriptive. Calculations of confidence intervals and significance values are performed only for explorative purposes. Results: Data cutoff for this 4 th interim analysis was 23.02.2021. 275 patients were enrolled. 261 of them received at least one dose of EPAG and completed one post baseline assessment. Mean duration of participation was 5.2 years. Mean±SD age was 62.7±17.6 years. 54.8% of the patients were female. Median (range) duration of ITP at baseline was 5.3 (0.0-44.9) years. Comorbidity was present in 80.5% of all patients. 79 (28.7%) patients completed all scheduled visits before data cutoff. Median treatment duration was 395.0 days. Treatment with EPAG was carried out at a median dosage of 50 mg daily. In 255 patients, baseline platelet counts were available. The proportion of patients with a platelet count ≥50x10 9/L was 30.6% at baseline. With EPAG treatment, it increased to 75.4% within the first month (N=224) and to 89.0% within 24 months (N=73) from baseline. 12.6% of the patients who completed at least one assessment visit after baseline were pre-treated with the thrombopoietin receptor agonist romiplostim. Within this subgroup as well, platelet counts responded well to EPAG treatment. In 35.6% of patients, at least one bleeding event had occurred in the 12 months prior to baseline. During EPAG therapy, the incidence of bleeding events per patient year was reduced from 1.40 before baseline to 0.60 and 0.13 within the first and second treatment year respectively. This corresponds to a relative reduction in bleeding events of 57% and 91% respectively. Over the entire two years treatment period, the average incidence of bleeding events per patient year accounted for 0.44, which is 69% below the incidence at baseline. Bleeding events were mostly of low severity. (Tab.) Median FACIT-F score was 37.0 at baseline (N=202; mean 36.0±11.0) and 42.5 after 24 months (N=48; mean 38.1±12.1). This difference was not statistically significant. According to exploratory calculations, severity of fatigue was not correlated to platelet count, hemoglobin concentration or incidence of bleeding events. Discussion: In line with previously published randomized controlled trials (Birocchi et al. Platelets 2021), this non-interventional study confirmed the effectiveness of EPAG in adults with persistent or chronic ITP in a routine care setting. During treatment with EPAG, the prevalence and severity of thrombocytopenia, as well as the incidence of bleeding events, decreased. We could also confirm that fatigue is a significant issue in patients with ITP. A FACIT-F score of 37.0 is comparable to average score values in cancer patients (Montan et al. Value Health 2018). Under treatment with EPAG, we observed a decrease in fatigue that was clinically relevant but not statistically significant. Further research is needed to explore possible additional effects of EPAG, for example on fatigue. Figure 1 Figure 1. Disclosures Meyer: Swedish Orphan Biovitrum: Consultancy, Honoraria; Grifols: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Stauch: Novartis: Honoraria, Research Funding; Amgen: Honoraria. Willy: Novartis Pharma: Current Employment.

scholarly journals Severe Thrombocytopenia Does Not Increase Bleeding Complications in Patients Undergoing Bronchoscopy

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4293-4293
Author(s):  
Lakshminarayanan Nandagopal ◽  
Muthu Veeraputhiran ◽  
Tania Jain ◽  
Ayman Soubani ◽  
Charles A. Schiffer
Keyword(s):  
Platelet Count ◽  
Renal Dysfunction ◽  
Platelet Transfusion ◽  
Conflicts Of Interest ◽  
Bleeding Complications ◽  
British Thoracic Society ◽  
Severe Thrombocytopenia ◽  
Platelet Counts ◽  
Number Of Patients ◽  
Platelet Transfusions

Abstract Introduction Prophylactic platelet transfusions are often performed prior to bronchoscopy or broncho-alveolar lavage (BAL) to prevent bleeding in thrombocytopenic patients. There is a paucity of data to validate this approach, with a platelet transfusion threshold of <50,000/mm3 largely based on expert opinion. We conducted a retrospective study on the incidence of bleeding complications in thrombocytopenic patients undergoing bronchoscopy. Methods We identified 150 consecutive patients with platelet counts <100,000/mm3 who underwent bronchoscopy and/or BAL from January 2009 to May 2014 at our institution. Bronchoscopies performed in patients with frank hemoptysis and trans-bronchial lung biopsy procedures were excluded. Patient characteristics, underlying diagnosis, platelet count prior to bronchoscopy, administration of platelet transfusions and bronchoscopy details were recorded. Factors affecting bleeding risk including presence of renal dysfunction (defined as BUN >30 and/or Cr>2.0) and coagulation studies (PT, PTT, INR) were identified. The British Thoracic Society guidelines1 were used to categorize bleeding as a result of bronchoscopy. Data were analyzed using descriptive statistics. Results The median age was 59 years (range 27-90), with two-thirds of patients (63%) being male. One hundred and seventeen (78%) patients had underlying malignancy and 55 (37%) had thrombocytopenia related to malignancy. Fellows and residents under the supervision of a bronchoscopy certified attending performed all but 4 of the bronchoscopies. Infection (40%) was the primary indication for bronchoscopy with BAL performed in 127 (85%) patients. Fifty-eight of 89 (65%) patients with baseline platelet counts <50,000/mm3 received prophylactic transfusions compared to 8% of those with platelet counts >50,000/mm3. The platelet count did not rise to >50,000//mm3 in many transfused patients. Seventy patients (47%) had counts <50,000/mm3 and eighty patients (53%) had counts >50,000/mm3 at the time of bronchoscopy. 49% were receiving immunosuppressive medications, 45% had renal dysfunction and 8% had INR >1.5. Bloody lavage that resolved spontaneously without continuous suctioning (Grade 0) was observed in 9 (6%) patients. Bleeding that required continuous suctioning but then resolved spontaneously (Grade 1) was noted in 1 patient with a platelet count of 61,000/mm3. Of 10 total bleeding events, 7 occurred in patients who were intubated. Two additional patients with platelet counts of 30,000/mm3 and 53,000/mm3 had diffuse alveolar hemorrhage, which was present before bronchoscopy. “Old” blood and blood clots were observed in 6 patients. Discussion The low incidence of bleeding complications from bronchoscopy +/- BAL even in patients with platelet counts <30,000/mm3 (3 episodes in 31 patients, all grade 0) demonstrates that bronchoscopy can be safely done in severely thrombocytopenic patients. Adopting a lower threshold for prophylactic transfusions could save a considerable number of platelet units and translate into significant cost savings and decreased risk of transfusion-related complications. Table 1 Platelet count, transfusion history and bleeding complications during bronchoscopy Platelet count at the time of bronchoscopy Number (n) and percentage (%) of patients who underwent bronchoscopy Number of patients who received prior platelet transfusion Bleeding during bronchoscopy n % 0-15,000/mm3 9 6% (9/150) 5 Grade 0=1 pt 16-29 22 15% 16 Grade 0=2 pts 30-39 17 11% 9 Grade 0=1 pt 40-49 22 15% 9 Grade 0=3 pts 50-75 44 29% 14 Grade 1=1 pt 76-100 36 24% 10 Grade 0=2 pts Total 150 63 Grade 0=9 pts, Grade 1=1 pt. 1.Du Rand IA, Blaikley J, Booton R, et al. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013:68 Suppl 1:i1-i44 Disclosures No relevant conflicts of interest to declare.

scholarly journals Rapid response to mycophenolate mofetil in combination with romiplostim in a case of severe refractory immune thrombocytopenia post COVID-19 vaccination

2021 ◽  
Author(s):  
snigdha nutalapati ◽  
gerhard hildebrandt
Keyword(s):  
Platelet Count ◽  
Mycophenolate Mofetil ◽  
Immune Thrombocytopenia ◽  
Rapid Response ◽  
Active Bleeding ◽  
Immune Mediated ◽  
Refractory Itp ◽  
Count Recovery

Vaccine mediated immune mediated thrombocytopenia (ITP) is an exceedingly rare. We present a 25-year-old female who developed severe refractory ITP with multiple active bleeding sites post second dose of COVID vaccination. She was treated with a combination of Romiplostim and Mycophenolate mofetil that resulted in rapid platelet count recovery.

scholarly journals Increased FVIII and Anti-Phospholipid Antibodies Do Not Modify the Clinical Course of Chronic Immune Thrombocytopenia

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5013-5013
Author(s):  
Meet Kumar ◽  
Maitryee Bhattyacharyya ◽  
Shyamali Datta
Keyword(s):  
Platelet Count ◽  
Lupus Anticoagulant ◽  
Immune Thrombocytopenia ◽  
Clinical Course ◽  
Conflicts Of Interest ◽  
Age Groups ◽  
Platelet Counts ◽  
Bleeding Score ◽  
Chronic Immune Thrombocytopenia

Abstract INTRODUCTION: Immune thrombocytopenia is a heterogenous disease with majority patients having a mild bleeding phenotype and one-fourth being asymptomatic. Bleeding episodes are usually seen in patients with platelet counts typically <30,000/cumm. There is no study till date to identify patients with platelet count <30,000/cumm and at high risk for bleeding. Although patients who harbor anti phospholipid antibodies have a higher risk of arterial and venous thrombosis, it is not known whether presence of acquired thrombophilia modifies the clinical course of bleeding in low platelet count ITP patients. We evaluated the role of FVIII and lupus anticoagulant in modifying the clinical course of such patients. MATERIALS AND METHODS: Patients of all age groups with persistent and chronic immune thrombocytopenia were eligible for study enrolment. Patients with acute ITP and secondary ITP were excluded. Eligible patients were evaluated with baseline parameters, ITP bleeding score (ITP-BAT, version 1.0 by IWG on ITP) at baseline and then at every visit and FVIII and lupus anticoagulant at baseline and repeat at six months.Patients were called for monthly scheduled visits if platelet counts were >30,000/cummand more frequently at lower platelet counts. Patients with any evidence of underlying infection or raised c-reactive protein and procalcitonin were deferred evaluation.All patients were treated as per institutional protocol to avoid treatment bias. Patients were followed up for one year. We finally calculated the average bleeding scores of all patients at different platelet counts (for eg. average of skin, mucosal and organ bleeding scores of all patients that had platelet counts <10,000/cumm, 10-30,000/cumm etc) and analysed it with FVIII and anti-phospholipid antibody levels. RESULTS: A total of 45 patients were enrolled with M:F=1:3.2. Median age of patients is 28years (3-72 years). Two patients were excluded (both progressed to SLE) and another two were lost to follow-up. Median duration from ITP diagnosis to study enrolment was 62.4months (8-590 months). Median follow-up of all patients was 14.2 months (13.2-16.4 months). Nine patients had persistent and 32 patients had chronic ITP. ITP-BAT could differentiate intensity of bleeding at different platelet counts by means of bleeding scores (Table 1). Correlation of bleeding scores with prothrombotic markers could not establish a disease course modifying relationship between the two (Table 2). CONCLUSION: Presence of high FVIII and anti phosphoilipid antibodies donot modify the bleeding risks in patients with ITP and low platelet counts. Table 1Platelet count (x109/cumm)Total episodesAverage bleeding scoreP value<1014S2.4 M1.4 O0 0.00210-3015S1.4 M0.9 O030-6018S0.3 M0.1 O0>600S0 M0 O0 Table 2 Platelet count <10,000/cumm Platelet count 10-30,000/cumm N Av BS P= N Av BS P= FVIII>150 5 S2.5M1.1O0 0.02 6 S1.1M0.8O0 0.1 FVIII<150 9 S2M0.7O0 11 S1.4M0.6O0 LA1:LA2>2 1 S2.2M1.5O0 0.03 S1.1M0.8O0 0.2 LA1:LA2<1 12 S2.6M1.2O0 S1.2M0.6O0 Table 3 Platelet count 30-60,000/cumm Av BS P= FVIII>150 4 S0.9M0.1O0 0.2 FVIII<150 11 S0.3M0.1O0 LA1:LA2>2 Nil LA1:LA2<1 9 S1.1M0.4O0 Disclosures No relevant conflicts of interest to declare.

Clinical features of heparin-induced thrombocytopenia including risk factors for thrombosis

2005 ◽  
Vol 94 (07) ◽  
pp. 132-135 ◽  
Author(s):  
Beate Farner ◽  
Hartmut Kroll ◽  
Thomas Kohlmann ◽  
Theodore E. Warkentin ◽  
Petra Eichler ◽  
...  
Keyword(s):  
Risk Factors ◽  
Platelet Count ◽  
Arterial Thrombosis ◽  
Trauma Surgery ◽  
Considerable Proportion ◽  
Functional Assay ◽  
Heparin Induced Thrombocytopenia ◽  
Platelet Counts ◽  
Immune Mediated ◽  
Orthopedic Trauma Surgery

SummaryImmune mediated heparin induced thrombocytopenia (HIT) is a prothrombotic adverse effect of heparin. However, only a subgroup of patients with HIT develops thromboembolic complications. We aimed to identify risk factors for developing HITassociated thrombosis. We analyzed a registry of patients with clinical suspicion of HIT who tested positive using a sensitive functional assay. Patient information was obtained by a standardized questionnaire. By multivariate analysis the association of age, gender, type of patient population, and magnitude of the platelet count decline with the frequency, type (venous or arterial), and temporal pattern of thrombotic events was assessed. In 408 HIT patients we observed predominance of venous thrombosis (2.4:1), with 40% of patients developing a pulmonary embolism. However, in the subgroup of post-cardiovascular surgery patients there was predominance of arterial thrombosis (1:8.5). The type of arterial thrombosis (limb artery thrombosis > thrombotic stroke > myocardial infarction) was the converse of that observed with typical atherothrombotic clots in non-HIT populations. In 59.8% of patients HIT-related thrombosis manifested either on the same day a platelet count decrease >50% was documented (26.3%) or before the decrease in platelet counts (33.5%).The most important risk factors for thrombosis were orthopedic/trauma surgery and the magnitude of platelet count decrease. HIT-associated thrombosis occurs in a considerable proportion of patients before platelet counts decrease by more than 50%.

scholarly journals Propofol for endotracheal intubation in neonates: a dose-finding trial

2020 ◽  
Vol 105 (5) ◽  
pp. 489-495 ◽  
Author(s):  
Ellen H.M. de Kort ◽  
Sandra A. Prins ◽  
Irwin K.M. Reiss ◽  
Sten P. Willemsen ◽  
Peter Andriessen ◽  
...  
Keyword(s):  
Side Effects ◽  
Endotracheal Intubation ◽  
Primary Outcome ◽  
Age Groups ◽  
Optimal Dose ◽  
Individual Variability ◽  
Sedative Effect ◽  
Dose Finding ◽  
Starting Dose ◽  
Effective Sedation

ObjectiveTo find propofol doses providing effective sedation without side effects in neonates of different gestational ages (GA) and postnatal ages (PNA).Design and settingProspective multicentere dose-finding study in 3 neonatal intensive care units.PatientsNeonates with a PNA <28 days requiring non-emergency endotracheal intubation.InterventionsNeonates were stratified into 8 groups based on GA and PNA. The first 5 neonates in every group received a dose of 1.0 mg/kg propofol. Based on sedative effect and side effects, the dose was increased or decreased in the next 5 patients until the optimal dose was found.Main outcome measuresThe primary outcome was the optimal single propofol starting dose that provides effective sedation without side effects in each age group.ResultsAfter inclusion of 91 patients, the study was prematurely terminated because the primary outcome was only reached in 13% of patients. Dose-finding was completed in 2 groups, but no optimal propofol dose was found. Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%). Propofol-induced hypotension occurred in 59% of patients. Logistic regression analyses showed that GA and PNA did not predict effective sedation or the occurrence of hypotension.ConclusionsEffective sedation without side effects is difficult to achieve with propofol and the optimal dose in different age groups of neonates could not be determined. The sedative effect of propofol and the occurrence of hypotension are unpredictable and show large inter-individual variability in the neonatal population.

scholarly journals COVID-19 vaccination in patients with immune thrombocytopenia

2021 ◽  
Author(s):  
Chantal Visser ◽  
Maurice Swinkels ◽  
Erik van Werkhoven ◽  
F. Nanne Nanne Croles ◽  
Heike Susanne Noordzij-Nooteboom ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenia ◽  
De Novo ◽  
Rescue Therapy ◽  
Bleeding Event ◽  
Autoimmune Disorder ◽  
Bleeding Complications ◽  
Close Monitoring ◽  
Healthy Controls ◽  
Platelet Counts

Immune thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by low platelet count and increased bleeding risk. COVID-19 vaccination has been described as risk factor for de novo ITP, but the effects of COVID-19 vaccination in patients with ITP are unknown. Our aims were to investigate the effects of COVID-19 vaccination in ITP patients on platelet count, bleeding complications and ITP exacerbation (any of: ≥50% decline in platelet count; or nadir platelet count &lt;30x109/L with &gt;20% decrease from baseline; or use of rescue therapy). Platelet counts of ITP patients and healthy controls were collected immediately before, 1 and 4 weeks after first and second vaccination. Linear mixed-effects modelling was applied to analyze platelet counts over time. We included 218 ITP patients (50.9% female, mean age 55 years and median platelet count of 106x109/L) and 200 healthy controls (60.0% female, mean age 58 years and median platelet count of 256x109/L). Platelet counts decreased by 6.3% after vaccination. We observed no difference in decrease between the groups. Thirty ITP patients (13.8%, 95%CI 9.5%-19.1%) had an exacerbation and 5 (2.2%, 95%CI 0.7%-5.3%) suffered from a bleeding event. Risk factors for ITP exacerbation were platelet count &lt;50x109/L (OR 5.3, 95%CI 2.1-13.7), ITP treatment at time of vaccination (OR 3.4, 95%CI 1.5-8.0) and age (OR 0.96 per year, 95%CI 0.94-0.99). Our study highlights safety of COVID-19 vaccination in ITP patients and importance of close monitoring platelet counts in a subgroup of ITP patients. ITP patients with exacerbation responded well on therapy.

scholarly journals Initial Experience with Thrombopoetin Receptor Agonists (TRA) in 5 Patients with Refractory HIV-Associated Immune Thrombocytopenic Purpura (ITP)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5014-5014
Author(s):  
Mark Kowalczyk ◽  
Paul G. Rubinstein ◽  
David M Aboulafia
Keyword(s):  
Myocardial Infarction ◽  
Platelet Count ◽  
Viral Load ◽  
Cd4 Count ◽  
Sustained Response ◽  
Bleeding Complications ◽  
Lumbar Spine Surgery ◽  
Hiv Viral Load ◽  
Platelet Counts ◽  
Post Surgery

Abstract Introduction: In the pre-highly active anti-retroviral therapy (HAART) era, ITP was a relatively common hematologic abnormality, which was seen in as many as 30% of patients infected with HIV. With the advent of HAART, the incidence of HIV-associated ITP has been reduced substantially, with some epidemiological studies showing contemporary rates as low as 1 to 3% (Vannappagari, Platelets 2011). In cases where HAART does not lead to adequate improvement in platelet counts, next lines of therapy have traditionally consisted of corticosteroids, including dexamethasone and prednisone, intravenous immunoglobulin (IVIG), anti-Rho(D) immune globulin, rituximab and, in the current era, more sparingly, splenectomy. When platelet counts remain persistently <20 x 109/L despite medical and surgical interventions, patients with ITP retain a heightened risk of bleeding complications (Frederiksen, Br J Haematol 2014). The TRAs eltrombopag (Promacta®) and romiplostim (Nplate®) are effective in 59% to 88% of ITP cases in patient without HIV, and loss of response while on continued therapy is uncommon. The agents’ use in treatment of refractory HIV-associated ITP has not, however, been sufficiently studied or reported. Methods: Herein we perform a retrospective chart review of 5 patients with HIV-related ITP treated from 2009-2014. All 5 patients with HIV-associated ITP had failed at least two lines of ITP therapy before they received a TRA (table). Mean age was 34 years (18-47), 3 males and 2 females. 4 patients had CD4+ counts >200 cells/ µL, viral loads < 40 copies/mL, and platelet counts ≤20 x 109/L before starting TRA therapy. Results: Each patient responded to TRA use with a mean pre-treatment platelet count of 15 x 109/L, and this increased to a mean of 110 x 109/L 6 weeks following treatment initiation. 2 of the patients have maintained a sustained response with adequate platelet counts 3 years after discontinuing TRA therapy. 1 patient succumbed to a myocardial infarction while on eltrombopag and 1 patient, while on romiplostim, expired from complications of a presumed pulmonary embolus after undergoing lumbar spine surgery. Abstract 5014. Table: Characteristics of HIV-related ITP patients given TRA Case Nadir CD4+ count (cells/µL) /HIV viral load (copies/mL) HAART Regimen CD4+ count (cells/µL) /HIV viral load (copies/mL) at time of use of TPA Platelet count pre-TRA treatment Lines of ITP treatment before TRA TRA (dose where response was observed and sustained) 6 month f/u platelet count Sustained Response after stopping TRA (duration) Case 1 261/ 5,000 Atripla® 340 / <40 20 x 109/L 1. Pred + IVIG 2.Rituximab + Dex Romiplostim (4µg/kg) 158 x 109 /L Yes (3 years) Case 2 a 284/ 74,743 Atripla® 300/ <40 2 x 109/L 1. Pred 2. Pulse Dex 3.Rituximab + Dex 4. IVIG Romiplostim, then Eltrombopag (50mg) N/A N/A Case 3 261/ 5,000 Atripla® >300 / <40 13 x 109/L 1. Pred + IVIG 2.Rituximab + Dex Romiplostim (2µg/kg) 128 x 109 /L Yes (3 years) Case 4 100/ 100,000 Zidovudine + Epivir + Nevirapine 180 / <40 39 x 109/L 1. IVIG 2. Pred 3. Rituximab Romiplostim (3µg/kg) 52 x 109 /Lb N/A Case 5 100/ 2,400 Truvada + darunavir + detravirine + raltegravir + ritonavir >200 / 54,000 13 x 109/L 1. Anti-Rho(D) 2. IVIG 3. Rituximab 4. Pulse Dex 5. Pred 6.Rituximab + Dex Eltrombopag (50mg) 48 x 109 /Lc No aPatient expired prior to 6 month f/u due to myocardial infarction bPatient sustained response for 2 weeks after discontinuation of TRA cPatient to be reinitiated on maintenance therapy due to lack of compliance Abbreviations: efavirenz, tenofovir, and disoproxil fumarate (Atripla®); prednisone (Pred) dexamethasone (Dex); follow-up clinic visit (f/u) Discussion: Due to insufficient evidence, a definitive association between TRA use and the two patients who suffered thrombotic events remains speculative. Nonetheless, these events emphasize the importance of using these TRAs cautiously during periods of heightened risk of thrombosis such as post-surgery and during periods of immobility, or in patients with risk factors for thrombotic complications. While HIV-associated ITP remains an important clinical problem in the era of widespread HAART use, the availability of both romiplostim and eltrombopag give medical providers additional options in treating this disease. Further experience is needed, however, to better determine the effectiveness and, most importantly, the safety of these drugs in the context of HIV-associated ITP. Disclosures No relevant conflicts of interest to declare.

Hemostatic Challenges In Patients Treated with Eltrombopag

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 2511-2511 ◽  
Author(s):  
Michael D. Tarantino ◽  
Patrick F. Fogarty ◽  
Bhabita Mayer ◽  
Sandra Y. Vasey ◽  
Andres Brainsky
Keyword(s):  
Clinical Trials ◽  
Platelet Count ◽  
Research Funding ◽  
Bleeding Complications ◽  
Blood Products ◽  
Invasive Procedures ◽  
Platelet Counts ◽  
Chronic Itp ◽  
Number Of Patients ◽  
Before And After

Abstract Abstract 2511 Introduction: Chronic immune thrombocytopenia (ITP) is an autoimmune disease in which antiplatelet-antibodies induce platelet destruction and impair platelet production, resulting in chronically low platelet counts. Patients with chronic ITP may require invasive procedures associated with bleeding (hemostatic challenges) that cannot be undertaken if the platelet count is unacceptably low. Eltrombopag is an oral, nonpeptide, thrombopoietin receptor (TPO-R) agonist developed to increase platelet counts in various conditions associated with thrombocytopenia; its use may facilitate undertaking invasive procedures in patients with chronic ITP, reducing the need for additional supportive requirements including cellular blood products. Methods: Across the eltrombopag ITP clinical trials, information about hemostatic challenges was collected retrospectively (TRA100773A and B) and prospectively (REPEAT, RAISE, EXTEND). Basic demographic information, platelet counts before and after the procedures, type of procedure, need for additional treatment to increase platelet counts (one week before and after the intervention), use of blood products, and where possible, assessment of bleeding and bleeding complications were recorded. For the purpose of this analysis, minor invasive procedures (eg, dental cleaning, endoscopy, bone marrow biopsy) were distinguished from major invasive procedures (splenectomy, laparotomy, hip replacement, aortic aneurysm repair, arthroplasty). Results: Seventy-seven patients underwent 120 invasive procedures while enrolled in clinical trials with eltrombopag. The median age of patients undergoing invasive procedures was 54 years; the median duration of treatment at the time of all procedures was 131 days. 112 invasive procedures were performed in patients while receiving eltrombopag, compared to 8 procedures among patients while receiving placebo. 65 (54%) were considered to be major and 55 (46%) were considered to be minor. The median platelet count closest to minor or major invasive procedures in patients receiving eltrombopag was higher than in those receiving placebo (Table). For minor procedures, rescue ITP medication was required in 9/52 (17%) procedures in patients treated with eltrombopag and in 1/3 (33%) procedures in patients receiving placebo. For major procedures, rescue ITP medication was required in 14/60 (23%) procedures in patients treated with eltrombopag and 3/5 (60%) procedures in patients receiving placebo. One bleeding complication was reported in an eltrombopag-treated patient with colon cancer who, on the first post-operative day after a colectomy, experienced a pulmonary embolism requiring anticoagulation and had an intra-abdominal hemorrhage on post-operative day 2. Conclusions: No difference in use of periprocedural blood products between groups was discernable, possibly due to the low frequency of bleeding events reported. Although the number of patients who did not undergo procedures due to thrombocytopenia was not captured, data from 77 patients undergoing 120 invasive procedures suggest that by achieving a sustained platelet increase in patients with chronic ITP, eltrombopag facilitates the undertaking of medical and surgical procedures associated with bleeding. Disclosures: Tarantino: GlaxoSmithKline, Novo Nordisk, Talecris, Baxter, Cangene: Honoraria, Research Funding, Speakers Bureau. Fogarty: GlaxoSmithKline: Honoraria, Research Funding. Mayer: GlaxoSmithKline: Employment, Equity Ownership. Vasey: GlaxoSmithKline: Employment. Brainsky: GlaxoSmithKline: Employment.

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