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Recombinant anti-D for prevention of maternal-foetal Rh(D) alloimmunization: a randomized multi-centre clinical trial
Mayekar RV, Paradkar GV, Bhosale AA, Sachan R, Beeram S, Anand AR, Mundle SR, Trivedi Y, Md R, Patole KP, et al
Obstet Gynecol Sci. 2020;63(3):315-322
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Abstract
Objective: To compare the efficacy and safety of recombinant anti-D (R-anti-D) with conventional polyclonal anti-D (Poly anti-D) in preventing maternal-fetal rhesus D (RhD) alloimmunization and to investigate the immunogenicity of R-anti-D. Methods: This was a randomized, open-label, multi-center clinical trial conducted in RhD-negative pregnant women who did not receive antenatal anti-D who delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline. The women were randomized in a 2:1 ratio to R-anti-D or Poly anti-D groups and were administered 300 mcg (IM) of the corresponding drug within 72 hours of delivery. ICT was performed 72 hours, 90 days, and 180 days after anti-D injection. Serum samples were collected to check for the development of antibodies against R-anti-D at days 90 and 180, using bridging enzyme-linked immunosorbent assay. The proportion of subjects who had positive ICT results at days 90 and 180 were compared between the groups using Fisher's exact test. Results: A total of 144 women were randomized to the R-anti-D group and 71 to the Poly anti-D group. Three women in the R-anti-D and none in the Poly anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against R-anti-D. Conclusion: The studied R-anti-D is comparable in efficacy to conventional Poly anti-D and is safe and non-immunogenic.Trial Registration: Clinical Trials Registry of India Identifier: Trial Registration: Clinical Trials Registry of India Identifier: CTRI/2017/03/008101.
PICO Summary
Population
RhD-negative pregnant women who did not receive antenatal anti-D and delivered RhD-positive babies and showed negative indirect Coombs tests (ICTs) at baseline (n= 215).
Intervention
Recombinant anti-D (300 mcg), (n= 144).
Comparison
Polyclonal anti-D (300 mcg), (n= 71).
Outcome
Three women in the Recombinant anti-D and none in the Polyclonal anti-D group had a positive ICT result at day 90. No woman in either group had positive ICT result at day 180. Both drugs were well tolerated with only 4 reports of adverse events in each group-all were mild, non-serious, and resolved without sequelae. No subject developed antibodies against Recombinant anti-D.
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Comparison between IV immune globulin (IVIG) and anti-D globulin for treatment immune thrombocytopenia: a randomized open-label study
Eghbali A, Azadmanesh P, Bagheri B, Taherahmadi H, Sadeghi Sedeh B
Fundamental & Clinical Pharmacology. 2016;30((4):):385-389. 385
Abstract
OBJECTIVE To compare the effect of IV immune globulin (IVIG) and anti-D globulin (anti-D) for treatment of immune thrombocytopenia (ITP) in children. METHODS A randomized, open-label, single center clinical trial was done in Amir-Kabir Hospital (Arak, Iran). The study was performed on 60 children with ITP, aged from 1 to 15 years. Patients were randomly assigned (1:1) to 50 mug/kg Anti-D or 1g/kg IVIG. Platelet counting was done at baseline, and 3 days, 7 days and 14 days after treatment termination. Safety assessment was done in all patients. RESULTS Anti-D caused a quicker response on the 3rd day of treatment (P <0.001). Both drugs caused a significant rise in number of platelets on the 7th and the 14th day of treatment. Compared to IVIG, except a significant drop in hemoglobin concentration (P < 0.001), anti-D had lower rate of side effects including fever (P < 0.05), allergy (P < 0.01), and headache (P < 0.001). CONCLUSION Our results showed that anti-D was associated with rapid rise of platelets compared to IVIG. In addition, anti-D treatment had acceptable safety profile. This article is protected by copyright. All rights reserved.
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High dose intravenous anti-D immune globulin is more effective and safe in Indian paediatric patients of immune thrombocytopenic purpura
Swain TR, Jena RK, Swain KP
Journal of Clinical and Diagnostic Research : Jcdr. 2016;10((12)):FC12-FC15.
Abstract
INTRODUCTION Immune Thrombocytopenia (ITP) is characterised by an autoimmune antibody-mediated destruction of platelets and impaired platelet production. Few controlled trials exist to guide management of patients with ITP in Indian scenario for which patients require an individualized approach. Anti-D (Rho (D) immune globulin) at a higher dose can prove to be a cost effective and safe alternative for Indian patients with ITP. AIM: To compare the safety and efficacy of higher dose (75mug/kg) intravenous Anti-D immune globulin against the standard dose of 50mug/kg for the management of ITP in Indian patients. MATERIALS AND METHODS One hundred and sixty four children with newly diagnosed ITP between 4-14 years were randomly selected for inclusion and were treated with 50mug/kg (standard dose) or 75mug /kg (higher dose) of Anti-D to compare the efficacy and safety of higher dose intravenous anti-D immune globulin. Efficacy of Anti-D was measured in terms of rate of response and median time to response for increase in platelet counts. Any adverse event was noted. A decrease in haemoglobin concentration suggested accompanying haemolysis. RESULTS Seventy one out of 84 patients treated with Anti-D at 75mug/kg produced complete response (85%) with median time of response being 2.5 days. On the contrary, 45 patients (70%) patients treated with 50mug/kg had complete response. However, there was no significant increase in haemolysis with higher dose. A significant correlation was found between dose and peak increase in platelet count measured at 7th day following administration. However, there was no relationship between the decrease in haemoglobin and the dose given, or between the increase in platelet count and fall in haemoglobin. CONCLUSION A 75mug/kg dose of Anti-D is more effective with acceptable side effect in comparison to 50mug dose for treatment of newly diagnosed Indian patients of ITP.
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Recombinant factor VIIa analog in the management of hemophilia with inhibitors: results from a multicenter, randomized, controlled trial of vatreptacog alfa
Lentz SR, Ehrenforth S, Abdul Karim F, Matsushita T, Weldingh KN, Windyga J, Mahlangu JN, adept2 investigators
Journal of Thrombosis & Haemostasis. 2014;12((8):):1244-53.
Abstract
BACKGROUND Vatreptacog alfa, a recombinant factor VIIa (rFVIIa) analog with three amino acid substitutions and 99% identity to native FVIIa, was developed to improve the treatment of hemophilic patients with inhibitors. OBJECTIVES To confirm the safety and assess the efficacy of vatreptacog alfa in treating bleeding episodes in hemophilic patients with inhibitors. PATIENTS AND METHODS In this international, multicenter, randomized, double-blind, active-controlled, crossover, confirmatory phase III trial (adept() 2) in patients with hemophilia A or B and inhibitors, bleeds were randomized 3 : 2 to treatment with vatreptacog alfa (one to three doses at 80 mug kg(-1) ) or rFVIIa (one to three doses at 90 mug kg(-1) ). Treatment failures after three doses of trial product (TP) were managed according to the local standard of care. RESULTS In the 72 patients enrolled, 567 bleeds were treated with TP. Both vatreptacog alfa and rFVIIa gave 93% effective bleeding control at 12 h. Vatreptacog alfa was superior to rFVIIa in secondary efficacy outcomes, including the number of doses used to treat a bleed and sustained bleeding control 24-48 h after the first dose. Eight patients (11%) developed antibodies against vatreptacog alfa, including four with cross-reactivity against rFVIIa and one with an in vitro neutralizing effect to vatreptacog alfa. CONCLUSIONS This large randomized controlled trial confirmed the well-established efficacy and safety profile of rFVIIa, and showed that vatreptacog alfa had similar or better efficacy than rFVIIa. However, because of the development of anti-drug antibodies, a positive benefit-risk profile is unlikely to be achieved with vatreptacog alfa. 2014 The Authors. Journal of Thrombosis and Haemostasis published by Wiley Periodicals, Inc. on behalf of International Society on Thrombosis and Haemostasis.
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Comparison of anti-D immunoglobulin, methylprednisolone, or intravenous immunoglobulin therapy in newly diagnosed pediatric immune thrombocytopenic purpura
Celik M, Bulbul A, Aydogan G, Tugcu D, Can E, Uslu S, Dursun M
Journal of Thrombosis and Thrombolysis. 2013;35((2):):228-33.
Abstract
This study aimed to evaluate the efficacy, cost, and effects of anti-D immunoglobulin (anti-D Ig), methylprednisolone, or intravenous immunoglobulin (IVIG) therapy on the development of chronic disease in children who are Rh-positive with diagnosed immune thrombocytopenic purpura (ITP). Children with newly diagnosed ITP and platelet count <20,000/mm(3) were prospectively randomized to treatment with anti-D Ig (50ug/kg), methylprednisolone (2mg/kg/day), or IVIG (0.4g/kg/day, 5days). Sixty children with a mean age of 6.7years were divided into three equal groups. No difference was observed between platelet counts before treatment and on day 3 of treatment. However, platelet counts at day 7 were lower in the methylprednisolone group than in the IVIG group (P=0.03). In the anti-D Ig group, hemoglobin and hematocrit levels were significantly lower at the end of treatment (P<0.05). Chronic ITP developed in 30% of the anti-D Ig group, 35% of the methylprednisolone group, and 25% of the IVIG group, but no significant difference was noted among the groups. The cost analysis revealed that the mean cost of IVIG was 7.4 times higher than anti-D Ig and 10.9 times higher than methylprednisolone. In the treatment of ITP in childhood, one 50ug/kg dose of anti-D Ig has similar effects to IVIG and methylprednisolone. Among patients who were treated with anti-D Ig, serious anemia was not observed, and the cost of treatment was less than that of IVIG treatment.
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A comparison of intravenous immunoglobulin (2g/kg totally) and single doses of anti-D immunoglobulin at 50ug/kg, 75ug/kg in newly diagnosed children with idiopathic thrombocytopenic purpura: Ankara hospital experience
Alioglu B, Ercan S, Tapci AE, Zengin T, Yazarli E, Dallar Y
Blood Coagulation & Fibrinolysis. 2013;24((5):):505-9.
Abstract
We conducted this prospective randomized trial of intravenous immunoglobulin (IVIG) treatment in children with newly diagnosed immune thrombocytopenic purpura (ITP) to compare the efficacy of IVIG to standard and higher doses of anti-D IVIG. Seventy-eight patients who were previously untreated and between the age of 1 and 18 years with newly diagnosed acute ITP and a platelet concentration less than 20x10/l were eligible for enrollment. In this study IVIG treatment was compared with two different doses of anti-D. Study patients were randomized to receive treatment according to one of the two single anti-D IVIG doses [50ug/kg (n=19) or 75ug/kg (n=20)] or 2g/kg (400mg/kg per day, 5 day) total dose of IVIG (n=39). There is a significant increase of 24th hour, 48th hour, 72nd hour, 7th day and 30th day platelet counts in IVIG (2g/kg, total dose) group compared to anti-D IVIG 50ug/kg and anti-D IVIG 75ug/kg groups. However, there were no difference between 24th hour, 48th hour, 72nd hour, 7th day and 30th day platelet counts across anti-D IVIG 50ug/kg and anti-D IVIG 75ug/kg groups. In conclusion, this study suggests that IVIG is well tolerated and significantly more effective than standard and high-dose anti-D IVIG for the treatment of newly diagnosed ITP in children. Apart from this, we believe that IVIG might be the first-line treatment of these patients. Regarding this issue further prospective studies comparing different IVIG treatment regimens with anti-D IVIG treatment regimens are needed.
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Standard-dose intravenous anti-D immunoglobulin versus intravenous immunoglobulin in the treatment of newly diagnosed childhood primary immune thrombocytopenia
Papagianni A, Economou M, Tragiannidis A, Karatza E, Tsatra I, Gombakis N, Athanassiadou-Piperopoulou F, Athanasiou-Metaxa M
Journal of Pediatric Hematology/Oncology. 2011;33((4):):265-9.
Abstract
BACKGROUND We conducted a study to evaluate the efficacy of intravenous (IV) anti-D against IV immunoglobulin (IVIG) in newly diagnosed immune thrombocytopenia (ITP) in children and to identify the clinical characteristics of the children most likely to benefit from one or the other treatment.PROCEDURE Children (6 mo to 14 y) with newly diagnosed ITP and a platelet count <20,000/µL were treated either with a single bolus dose of 50 µg/kg IV anti-D or with 0.8 to 1 g/kg IVIG in a randomized manner.RESULTS Twenty-five patients, mean age of 6.8 years, were treated either with IV anti-D (n=10) or with IVIG (n=15). Both drugs were equally efficient in raising the platelet count above 20,000/µL at 24 hours posttreatment. Children who presented with bleeding stage 1 or 2 (no mucosal bleeding) responded better to IVIG treatment, in terms of an increase in platelet count at 24 hours posttreatment (P=0.04). Hemoglobin drop was greater in the anti-D group (P=0.002).CONCLUSIONS A single bolus dose of 50 µg/kg of IV anti-D is a safe and effective first-line treatment in newly diagnosed ITP in childhood and mucosal bleeding is a poor prognostic factor for treatment with IVIG.
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8.
Immunoglobulin anti-D for treatment of chronic ITP in children
Iacobini M, Duse M, Antonetti L, Smacchia MP, Schiavetti A
Pediatric Blood & Cancer. 2010;55((7):):1435
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9.
A single dose of anti-D immunoglobulin raises platelet count as efficiently as intravenous immunoglobulin in newly diagnosed immune thrombocytopenic purpura in Korean children
Son DW, Jeon IS, Yang SW, Cho SH
Journal of Pediatric Hematology/Oncology : Official Journal of the American Society of Pediatric Hematology/Oncology. 2008;30((8):):598-601.
Abstract
OBJECTIVE The aim of this study is to compare the efficacy and safety of a single dose of anti-D immunoglobulin (anti-D) at 50 mug/kg to intravenous immunoglobulin (IVIG) in Korean children with acute immune thrombocytopenic purpura (ITP). METHODS We performed this study prospectively by randomly administering 2 consecutive doses of IVIG at a dose of 1. 0 g/kg/dor a single dose of anti-D at 50 microg/kg to children upon initial diagnosis of acute ITP. The platelet count and adverse events, including hemoglobin concentration, were then serially evaluated, and the responses were compared. RESULTS The likelihood of having a platelet count greater than 20x10/mm after 3 days of treatment in the IVIG and anti-D group was 93% and 92%, respectively. In addition, hemoglobin concentration in the anti-D group had declined more than that of the IVIG group (1. 49 g/dL vs. 0. 80 g/dL, P=0. 014) 3 days after treatment. Fever, chills, and headache occurred less frequently in the anti-D group than the IVIG group, however, this difference was not statistically significant (25% vs. 45%, P=0. 494). CONCLUSIONS A single dose of 50 microg/kg of anti-D raised platelet count as efficiently as IVIG in newly diagnosed cases of ITP in Korean children. Although 50 microg/kg of anti-D had a greater effect on the hemoglobin concentration than IVIG, the adverse effects were found to be acceptable, and no serious events were observed.
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10.
Intravenous immune globulin versus intravenous anti-D immune globulin for the treatment of acute immune thrombocytopenic purpura
Shahgholi E, Vosough P, Sotoudeh K, Arjomandi K, Ansari S, Salehi S, Faranoush M, Ehsani MA
Indian Journal of Pediatrics. 2008;75((12):):1231-5.
Abstract
OBJECTIVE The purpose of this study was to compare the efficacy and side effects of intravenous immunoglobulin (IVIG) with intravenous anti-D immunoglobulin for treatment of newly diagnosed acute childhood Idiopathic thrombocytopenic purpura (ITP). METHODS Children (6 months to 14 years) with newly diagnosed acute ITP and platelet count below 20,000/ microL were randomized to receive single dose intravenous 75 microg/kg anti-D or 1g/kg IVIG for two consecutive days (total dose 2 g/kg). Response rate defined as a platelet count over 20,000 / microL 72 hours after initial treatment. RESULTS Eighty one patients (52 male and 29 female) with mean age of 5 years and 3 months randomly divided in anti-D group (n=42) and IVIG group (n=39). Mean baseline (pretreatment) platelet counts were 15406 / microL and 15230/ microL in anti-D and IVIG group, respectively. The response rate in IVIG group (98%) was more significant than anti-D group (76%); (P = 0. 017). After 7 days the platelet counts of all patients in IVIG group were more than 20,000/ microL while in anti-D group 12% had platelet counts below 20,000/ microL. CONCLUSION In acute childhood ITP, initial treatment with IVIG (2g/Kg in divided dose) increased platelet count more rapidly and more significant than intravenous anti-D (single dose of 75 microg/kg) within the first 72 hours.