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      Updated international consensus report on the investigation and management of primary immune thrombocytopenia

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          Abstract

          Over the last decade, there have been numerous developments and changes in treatment practices for the management of patients with immune thrombocytopenia (ITP). This article is an update of the International Consensus Report published in 2010. A critical review was performed to identify all relevant articles published between 2009 and 2018. An expert panel screened, reviewed, and graded the studies and formulated the updated consensus recommendations based on the new data. The final document provides consensus recommendations on the diagnosis and management of ITP in adults, during pregnancy, and in children, as well as quality-of-life considerations.

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          International consensus report on the investigation and management of primary immune thrombocytopenia.

          Drew Provan, Roberto Stasi, Adrian Newland … (2010)
          Previously published guidelines for the diagnosis and management of primary immune thrombocytopenia (ITP) require updating largely due to the introduction of new classes of therapeutic agents, and a greater understanding of the disease pathophysiology. However, treatment-related decisions still remain principally dependent on clinical expertise or patient preference rather than high-quality clinical trial evidence. This consensus document aims to report on new data and provide consensus-based recommendations relating to diagnosis and treatment of ITP in adults, in children, and during pregnancy. The inclusion of summary tables within this document, supported by information tables in the online appendices, is intended to aid in clinical decision making.
          Article 0 comments Cited 396 times – based on 0 reviews     Review now
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            Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial.

            J Bussel, Jeffrey S Wasser, Gray R. Lyons … (2008)
            Chronic immune thrombocytopenic purpura (ITP) is characterised by accelerated platelet destruction and decreased platelet production. Short-term administration of the thrombopoiesis-stimulating protein, romiplostim, has been shown to increase platelet counts in most patients with chronic ITP. We assessed the long-term administration of romiplostim in splenectomised and non-splenectomised patients with ITP. In two parallel trials, 63 splenectomised and 62 non-splenectomised patients with ITP and a mean of three platelet counts 30x10(9)/L or less were randomly assigned 2:1 to subcutaneous injections of romiplostim (n=42 in splenectomised study and n=41 in non-splenectomised study) or placebo (n=21 in both studies) every week for 24 weeks. Doses of study drug were adjusted to maintain platelet counts of 50x10(9)/L to 200x10(9)/L. The primary objectives were to assess the efficacy of romiplostim as measured by a durable platelet response (platelet count > or =50x10(9)/L during 6 or more of the last 8 weeks of treatment) and treatment safety. Analysis was per protocol. These studies are registered with ClinicalTrials.gov, numbers NCT00102323 and NCT00102336. A durable platelet response was achieved by 16 of 42 splenectomised patients given romplostim versus none of 21 given placebo (difference in proportion of patients responding 38% [95% CI 23.4-52.8], p=0.0013), and by 25 of 41 non-splenectomised patients given romplostim versus one of 21 given placebo (56% [38.7-73.7], p<0.0001). The overall platelet response rate (either durable or transient platelet response) was noted in 88% (36/41) of non-splenectomised and 79% (33/42) of splenectomised patients given romiplostim compared with 14% (three of 21) of non-splenectomised and no splenectomised patients given placebo (p<0.0001). Patients given romiplostim achieved platelet counts of 50x10(9)/L or more on a mean of 13.8 (SE 0.9) weeks (mean 12.3 [1.2] weeks in splenectomised group vs 15.2 [1.2] weeks in non-splenectomised group) compared with 0.8 (0.4) weeks for those given placebo (0.2 [0.1] weeks vs 1.3 [0.8] weeks). 87% (20/23) of patients given romiplostim (12/12 splenectomised and eight of 11 non-splenectomised patients) reduced or discontinued concurrent therapy compared with 38% (six of 16) of those given placebo (one of six splenectomised and five of ten non-splenectomised patients). Adverse events were much the same in patients given romiplostim and placebo. No antibodies against romiplostim or thrombopoietin were detected. Romiplostim was well tolerated, and increased and maintained platelet counts in splenectomised and non-splenectomised patients with ITP. Many patients were able to reduce or discontinue other ITP medications. Stimulation of platelet production by romiplostim may provide a new therapeutic option for patients with ITP.
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              Pregnancy outcomes after maternal exposure to rituximab.

              Anna Farmer, Ariella Kelman, Eliza Chakravarty … (2011)
              Rituximab is a chimeric anti-CD20 monoclonal B cell-depleting antibody indicated for certain hematologic malignancies and active rheumatoid arthritis with inadequate response to tumor necrosis factor antagonists. Despite counseling to avoid pregnancy, women may inadvertently become pregnant during or after rituximab treatment. Using the rituximab global drug safety database, we identified 231 pregnancies associated with maternal rituximab exposure. Maternal indications included lymphoma, autoimmune cytopenias, and other autoimmune diseases. Most cases were confounded by concomitant use of potentially teratogenic medications and severe underlying disease. Of 153 pregnancies with known outcomes, 90 resulted in live births. Twenty-two infants were born prematurely; with one neonatal death at 6 weeks. Eleven neonates had hematologic abnormalities; none had corresponding infections. Four neonatal infections were reported (fever, bronchiolitis, cytomegalovirus hepatitis, and chorioamnionitis). Two congenital malformations were identified: clubfoot in one twin, and cardiac malformation in a singleton birth. One maternal death from pre-existing autoimmune thrombocytopenia occurred. Although few congenital malformations or neonatal infections were seen among exposed neonates, women should continue to be counseled to avoid pregnancy for ≤ 12 months after rituximab exposure; however, inadvertent pregnancy does occasionally occur. Practitioners are encouraged to report complete information to regulatory authorities for all pregnancies with suspected or known exposure to rituximab.
              Article 0 comments Cited 138 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Journal
                Title: Blood Advances
                Publisher: American Society of Hematology
                ISSN (Print): 2473-9529
                ISSN (Electronic): 2473-9537
                Publication date Created: November 26 2019
                Publication date (Print): November 26 2019
                Publication date (Electronic): November 26 2019
                Volume: 3
                Issue: 22
                Pages: 3780-3817
                Affiliations
                [1 ]Academic Haematology Unit, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom;
                [2 ]McMaster Centre for Transfusion Research, Department of Medicine and Department of Pathology and Molecular Medicine, McMaster University and Canadian Blood Services, Hamilton, ON, Canada;
                [3 ]Division of Hematology/Oncology, Department of Pediatrics, Weill Cornell Medicine, New York, NY;
                [4 ]St. George Hospital, NSW Health Pathology, University of New South Wales, Sydney, NSW, Australia;
                [5 ]Department of Haematology, Hammersmith Hospital, London, United Kingdom;
                [6 ]Seattle Cancer Care Alliance, University of Washington, Seattle, WA;
                [7 ]Departments of Research, Medicine and Oncology, Østfold Hospital Trust, Grålum, Norway;
                [8 ]Department of Hematology, Institute of Clinical Medicine, Oslo University, Oslo, Norway;
                [9 ]Centre de Référence des Cytopénies Auto-Immunes de l'Adulte, Service de Médecine Interne, CHU Henri Mondor, AP-HP, Université Paris-Est Créteil, Créteil, France;
                [10 ]Department of Hematology, Hospital Universitario de Burgos, Burgos, Spain;
                [11 ]Department of Haematology, Royal Manchester Children’s Hospital, Manchester, United Kingdom;
                [12 ]Department of Haematology, Qilu Hospital, Shandong University, Jinan, China;
                [13 ]Platelet Disorder Support Association, Cleveland, OH;
                [14 ]Royal London Hospital, Barts Health NHS Trust, London, United Kingdom;
                [15 ]Haematology Theme Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom;
                [16 ]Hematology Project Foundation, Affiliated to the Department of Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy;
                [17 ]Department of Haematology, University College London Hospital, Cardiometabolic Programme-NIHR UCLH/UCL BRC, London, United Kingdom;
                [18 ]Department of Blood Transfusion, Osaka University Hospital, Osaka, Japan;
                [19 ]Sir YK Pao Centre for Cancer and Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, NT, Hong Kong;
                [20 ]SC Ematologia, Azienda Sanitaria Universitaria Integrata, Trieste, Italy; and
                [21 ]Division of Hematology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
                Article
                DOI: 10.1182/bloodadvances.2019000812
                PMC ID: 6880896
                PubMed ID: 31770441
                SO-VID: 9e60ee2d-b19a-4116-a87e-0689e85005ae
                Copyright © © 2019
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