scholarly journals The Efficacy of High-Dose Dexamethasone vs. Other Treatments for Newly Diagnosed Immune Thrombocytopenia: A Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Qirong Xiao ◽  
Bicun Lin ◽  
Hanyu Wang ◽  
Weiwu Zhan ◽  
Ping Chen
Keyword(s):  
Immune Thrombocytopenia ◽  
Meta Analysis ◽  
Treatment Options ◽  
Good Alternative ◽  
Quality Analysis ◽  
High Dose ◽  
Newly Diagnosed ◽  
High Dose Dexamethasone ◽  
Dexamethasone Group ◽  
Increased Risk

Objective: To compare the therapeutic efficacies of high dose dexamethasone, prednisone and rituximab in combination with dexamethasone for newly diagnosed ITP (Immune Thrombocytopenia, ITP) patients.Methods and results: Relevant publications for this study were obtained by searching PubMed, Embase, Cochrane, and CNKI (National Knowledge Infrastructure, CNKI) databases following the PRISMA guidelines. A total of, 15 publications were retrieved that contained sufficient data from 1,362 patients for high quality analysis of this study endpoints. Data analysis was carried out using Stata 11.0 software.The primary outcomes were OR (Overall Response, OR) at 1 month after intervention and SR at 6 and 12 months. The secondary outcomes were AEs and relapse. There were no differences in the OR, while the SR was higher at 6 months (p = 0.001) as well as 12 months (p < 0.001) in the rituximab + dexamethasone group. In addition, the incidences of AEs (p = 0.008) were also higher in the rituximab + dexamethasone group. Dexamethasone was superior to prednisone based on OR (p = 0.006). We found no differences in SR at 6 months between dexamethasone and prednisone but SR at 12 months was higher in the dexamethasone group (p = 0.014). The relapse rate was higher in the high dose dexamethasone group compared to the rituximab + dexamethasone group (p = 0.042).Conclusion: This demonstrated that new treatment options such as Rituximab + dexamethasone, could be a good alternative to traditional therapy in improving long-term response and reducing the rate of relapse. However, further studies are required on the increased risk of AEs associated with Rituximab + dexamethasone.

scholarly journals Immune Thrombocytopenia Associated with COVID-19 - Case Series

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 13-14
Author(s):  
Ramil Fatkhullin ◽  
Vasily Shuvaev
Keyword(s):  
Immune Thrombocytopenia ◽  
Meta Analysis ◽  
Case Series ◽  
Cervix Uteri ◽  
First Episode ◽  
High Dose ◽  
Platelet Response ◽  
Pulmonary Infiltrates ◽  
High Dose Dexamethasone ◽  
History Of

Increased numbers of COVID-19 infection make the study of its systemic manifestations more and more important. Despite of SARS-Cov-2 main clinical respiratory syndrome other clinical infection signs as immune thrombocytopenia without respiratory failure were identified. We have seen case series of patients with thrombocytopenia and active COVID-19 infection during present epidemic outbreak. Patient 1, female, 31 years old was admitted at our hospital with ecchymoses, epistaxis, gingival hemorrhage and metrorrhagia. There were also signs of COVID-19 infection - fever up to 40oC, short of breathes with room air. The pulmonary infiltrates about to 25% were revealed by CT scan. The CBC parameters were as follows: WBC 8.9x109/l, Hb 11,2 g/dl, PLT 3 x109/l by microscopy. The patient was treated with high-dose dexamethasone 40 mg QD for 4 days. The treatment resulted to stable complete platelet response as 189x109/l in fourteen days after start of therapy. At that time, the cancer in situ of cervix uteri there was revealed by gynecologic examination, that was successfully local treated. Patient 2, female 30 years old presented epistaxis, metrorrhagia, cutaneous and gingival hemorrhagic syndrome as previous patient. There were WBC 6.4x109/l, Hb 12,6 g/dl, PLT 3x109/l by microscopy in CBC. She had no respiratory signs and abnormality in pulmonary CT. The COVID-19 infection was identified by PCR and antibody screening. The patient also received high-dose dexamethasone 40 mg QD for 4 days and yielded of platelet elevation to 25x109/l with no hemorrhagic syndrome in five days of treatment. Patient 3, female 68 years old with chronic course of immune thrombocytopenia and resistance to glucocorticoid, after splenectomy and presence of HBsAg. All relapses of thrombocytopenia in this patient were associated with virus infection. The first episode was in 2009, patient was treated with glucocorticoid with no effect. The complete platelet response was achieved after splenectomy. The relapse occurred in 2015 and was associated with acute respiratory distress syndrome (probably H7N9 flu). There treatment with prednisone 1 mg/day resulted to complete platelet response. At present time, the COVID-19 infection on this patient manifested with 75% of pulmonary volume lesions. At the recovery (25% of pulmonary infiltrates) the relapse of immune thrombocytopenia with cutaneous bleeding occurred. In CBC there were WBC 5.9x109/l, Hb 15,1 g/dl, PLT 5x109/l by microscopy. Given that history of therapy we treated this patient with high-dose dexamethasone 40 mg QD for 4 days and romiplostime 2 mqg/kg. The complete resolution of hemorrhagic signs and platelet response (65x109/l) was reached in seven days of treatment. Discussion. The virus-associated thrombocytopenia is usual in common practice. In recent COVID-19 infection outcome meta-analysis (G. Lippi et al. Clinica Chimica Acta 506 (2020) 145-148) the platelet count was significantly lower in severe course of disease. The presence of platelet below the lower limit was associated with fivefold of risk of severe COVID-19 and was a factor of mortality. The platelet decline could be as sign of disease worsening at one hand and have an own risk of mortality by bleeding at other hand. There is a need for guideline to thrombocytopenia management in COVID-19 patients. Now we are continuing to search and include the patients with COVID-19 infection and thrombocytopenia in our study. Disclosures Shuvaev: Novartis:Honoraria, Speakers Bureau;BMS:Honoraria, Speakers Bureau;Pfizer:Honoraria, Speakers Bureau.

scholarly journals High-dose dexamethasone vs prednisone for treatment of adult immune thrombocytopenia: a prospective multicenter randomized trial

Blood ◽  
2016 ◽  
Vol 127 (3) ◽  
pp. 296-302 ◽  
Author(s):  
Yu Wei ◽  
Xue-bin Ji ◽  
Ya-wen Wang ◽  
Jing-xia Wang ◽  
En-qin Yang ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Immune Thrombocytopenia ◽  
High Dose ◽  
Newly Diagnosed ◽  
First Line ◽  
Multicenter Randomized Trial ◽  
High Dose Dexamethasone ◽  
Key Points ◽  
Line Management

Key Points HD-DXM is a preferred strategy to conventional prednisone as first-line management of newly diagnosed adult primary ITP.

Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults

Blood ◽  
2014 ◽  
Vol 123 (25) ◽  
pp. 3906-3908 ◽  
Author(s):  
David Gómez-Almaguer ◽  
Miguel A. Herrera-Rojas ◽  
José C. Jaime-Pérez ◽  
Andrés Gómez-De León ◽  
Olga G. Cantú-Rodríguez ◽  
...  
Keyword(s):  
Immune Thrombocytopenia ◽  
High Dose ◽  
Newly Diagnosed ◽  
High Dose Dexamethasone ◽  
Effective Combination ◽  
Key Points ◽  
Frontline Treatment

Key Points Eltrombopag/dexamethasone is a safe and effective combination for treating newly diagnosed ITP patients. This treatment may prove useful in achieving lasting responses without additional immunosuppression in some patients.

scholarly journals Romiplostim, Low-Dose Rituximab and High-Dose Dexamethasone Combination in Newly Diagnosed Immune Thrombocytopenia: Another "Total Therapy" Pilot Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1014-1014
Author(s):  
Perla R. R. Colunga-Pedraza ◽  
Mónica Bustillos Muñoz ◽  
Fernando De La Garza ◽  
Andres Gomez-De Leon ◽  
Edgar Ulises Coronado-Alejandro ◽  
...  
Keyword(s):  
Immune Thrombocytopenia ◽  
Low Dose ◽  
Initial Response ◽  
High Dose ◽  
Newly Diagnosed ◽  
Front Line ◽  
High Dose Dexamethasone ◽  
Line Therapy ◽  
Total Therapy

Abstract Background: Primary immune thrombocytopenia (ITP) is an acquired autoimmune disorder that results from accelerating platelet clearance, destruction, and production. Front-line therapy for newly diagnosed ITP includes corticosteroids, intravenous immune globulin, or anti-D immunoglobulin. However, after these single-agent therapies, relapses will occur in half of patients. We previously reported the safety, feasibility, and efficacy of the combination of dexamethasone, low-dose rituximab, and the thrombopoietin receptor agonist (TPO-Ra) eltrombopag as front-line treatment in newly diagnosed ITP. Romiplostim, another TPO-Ra is approved by the FDA for patients with chronic ITP. However, the safety, tolerability, and efficacy of romiplostim combined with low-dose rituximab, and high-dose dexamethasone in newly diagnosed ITP remain unknown. Objective: Our primary objectives were safety, and tolerability. Secondary objectives were initial response and relapse incidence. Methods: An open-label, single-arm study was performed in Hospital Universitario "Dr. José Eleuterio González" in Monterrey, Mexico (Clinical trials.gov NCT04588194). Eligible patients were newly diagnosed ITP patients, treatment-naïve, ≥18 years, with a platelet count ≤30×10 9/L. Patients were excluded if they had an active infection, pregnancy, or malignant disease. The treatment regimen was romiplostim (2 mcg/kg weekly, four doses), low-dose rituximab (100 mg weekly, four doses) and high-dose dexamethasone (40 mg PO, days 1-4). Dexamethasone was allowed up to 3 cycles. Partial (PR) and complete responses (CR) were defined as an increase in platelet counts ≥30×10 9/L (at least a doubling of the baseline count) and ≥100×10 9/L, respectively. Results: We included ten consecutive patients. The median age was 34.5 years (range, 17-63). Seven patients were men (70%). The median platelet account at diagnosis was 6x10 9/L (range 0-23), and median follow-up was 180 days (range 30-270). The median number of romiplostim doses was 3.5 (range 1-4), and three (30%) patients required dose adjustment due to thrombocytosis. All but one patient achieved response (CR or PR) at a median of 7 days (range 7-28). Five patients (50%) achieved CR at 28 days of treatment, and four patients (40%) PR. No significant adverse effects have occurred during treatment; one patient presented grade 1 myalgia and the other a grade 2 soft tissue infection. Five patients (50%) relapsed during follow-up. Recently, four (40%) patients remain in CR and three (30%) in PR. Conclusion: The combination of romiplostim, low-dose rituximab, and high-dose dexamethasone was safe and effective. This "total therapy" approach was associated with minimum side effects and rapid initial response. Prospective validation in a larger sample is needed. Figure 1 Figure 1. Disclosures Gomez-Almaguer: Janssen: Honoraria, Speakers Bureau; Roche: Honoraria, Speakers Bureau; Bristol-Myers-Squibb: Honoraria, Speakers Bureau; Takeda: Honoraria, Speakers Bureau. OffLabel Disclosure: Romiplostim in firs-line therapy for immune thrombocytopenia

High-dose dexamethasone compared with prednisone for previously untreated primary immune thrombocytopenia: a systematic review and meta-analysis

2016 ◽  
Vol 3 (10) ◽  
pp. e489-e496 ◽  
Author(s):  
Siraj Mithoowani ◽  
Kathleen Gregory-Miller ◽  
Jennifer Goy ◽  
Matthew C Miller ◽  
Grace Wang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Immune Thrombocytopenia ◽  
Meta Analysis ◽  
High Dose ◽  
High Dose Dexamethasone ◽  
Primary Immune Thrombocytopenia

Low-Dose Rituximab and High-Dose Dexamethasone As Front-Line Therapy in Adult Patients with Primary Immune Thrombocytopenia

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 3332-3332
Author(s):  
David Gomez-Almaguer ◽  
Luz C. Tarin-Arzaga ◽  
Brizio Moreno-Jaime ◽  
Jose C. Jaime-Pérez ◽  
Adrián A. Ceballos-López ◽  
...  
Keyword(s):  
Platelet Count ◽  
Immune Thrombocytopenia ◽  
Low Dose ◽  
Complete Response ◽  
High Dose ◽  
Newly Diagnosed ◽  
Front Line ◽  
High Dose Dexamethasone ◽  
Line Therapy ◽  
Primary Immune Thrombocytopenia

Abstract Abstract 3332 Introduction Corticosteroids are the initial standard therapy for primary immune thrombocytopenia (ITP). A short course of high-dose dexamethasone as initial therapy is an alternative to prednisone with high initial responses, but about half of the patients relapse. Low dose rituximab has been used in the treatment of relapsed ITP, showing a similar activity to the standard dose. The aim of this prospective study was to evaluate the efficacy, safety and response duration of low-dose rituximab plus short pulses of high-dose dexamethasone as front-line therapy in newly diagnosed ITP adults. Methods Patients ≥18 years old with newly diagnosed received dexamethasone, 40 mg/day/i.v. for 4 consecutive days (+1, +2, +3, +4), rituximab was administered at a fixed dose of 100 mg as an i.v. infusion weekly for 4 consecutive doses (days +1, +8+, +15 and +22). The use of rescue therapy was allowed, using the same schedule of dexamethasone, before day 30, but only if the platelet count was < 20×109/L. A complete blood cell count was performed at enrollment, weekly for the first 28 days, monthly until month 6 and then every 3 months. The degree of response was defined as follows: a complete response (CR) was a platelet count ≥ 100 × 109/L; a complete sustained response (CSR) was considered if it was maintained for six months. Partial response (PR) was defined as a platelet level between 50 and 100 × 109/L; an overall response (OR) was defined as partial or complete response. Patients with a platelet count <30 × 109/L were considered non-responders (NR). Time-to-response (TTR) and time-to-complete response (TCR) were also assessed, as well as the safety profile and side effects incidence according to the National Cancer Institute Common Toxicity Criteria version 3.0. Results Twenty-one consecutive patients were enrolled from December 2009 to December 2011 (17 women and 4 men); median age was 51 years (range, 18–82). The median platelet count at baseline was 5.19 × 109/L (range, 0.3–24.2 × 109/L). Patients were followed for a median of 12 months (range, 1–25). At day +28, sixteen patients (76.2%) had CR, three patients had PR (14.3%), with the OR being 90.5%. At month six, 16 of 21 patients (76.2%) had achieved CSR. Seven patients received a second course of dexamethasone (one at day +8 and six at day+15) (Table 1). The median duration of response was 12 months (range, 7–25 months). The median time to reach TTR and TCR was 8 days (range, 4–28). Partial response was achieved in two patients who were further treated with danazol and prednisone, being subsequently splenectomized. The relapse rate was 15.8%. The 6- and 12- month cumulative RFS were both 84%; the 6- and 12-month cumulative TFS probabilities were 94% and 87%, respectively (Fig. 1). Overall, combination therapy in our group was well tolerated with a lower incidence of adverse effects during infusion in this trial according to the data reported in previous studies. Conclusions The combination of low-dose rituximab and high-dose dexamethasone as front-line therapy for adults with ITP was effective and safe with a high OR rate and a low incidence of relapse. These data need to be confirmed in a prospective randomized clinical trial including a sample size with enough power to reach statistically significant conclusions. Disclosures: No relevant conflicts of interest to declare.

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