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      Leukemic mature B‐cell neoplasm observed during the treatment with romiplostim in patient with thrombocytopenia and liver cirrhosis

      case-report

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          Key Clinical Message

          We report here a new adverse event of romiplostim which is a protein analog of thrombopoietin. Leukemic mature B‐cell neoplasm was observed during the treatment of thrombocytopenia in a patient with liver cirrhosis. Their relationship was suggested clinically but the mechanism of leukemic expansion of lymphoma cells was not clarified.

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          Integrated analysis of long-term safety in patients with chronic immune thrombocytopaenia (ITP) treated with the thrombopoietin (TPO) receptor agonist romiplostim.

          Douglas Cines, Terry Gernsheimer, Jeffrey S Wasser … (2015)
          A safety analysis of pooled data from clinical studies of romiplostim, a thrombopoietin (TPO) receptor agonist, in which patients with immune thrombocytopaenia (ITP) received romiplostim, placebo, or medical standard of care (SOC) Rodeghiero et al. (Eur J Haematol 91:423-436, 2013), has been updated. Included are data from 14 trials spanning 2002-2011; placebo- and SOC-arm data are pooled. Most patients (n = 1059) were female (61 %) and Caucasian (85 %); 38 % had undergone splenectomy; 23 were children. Mean (SD) baseline platelet count was 20.6 (16.5) × 10(9)/L. Mean (SD) weekly dose of romiplostim was 4.2 (2.8) µg/kg; total exposure was 1520 patient-years. Overall, 921 patients received romiplostim only, 65 received placebo/SOC only, and 73 received placebo/SOC followed by romiplostim. Rates of haemorrhage (romiplostim, 205/100 patient-years; placebo/SOC, 263/100), thrombosis (both, 5.5/100 patient-years), haematological malignancy/myelodysplastic syndrome (romiplostim, 0.5/100 patient-years; placebo/SOC, 2.7/100), and non-haematological tumours (romiplostim, 2.2/100 patient-years; placebo/SOC, 3.6/100) were comparable among groups. Bone marrow reticulin was reported in 17 patients and collagen in one patient receiving romiplostim; one patient receiving placebo/SOC had reticulin reported. Three patients developed neutralizing antibodies to romiplostim, but not to endogenous TPO. This integrated analysis of the safety profile of romiplostim in patients with ITP is consistent with previously reported studies; no new safety concerns emerged.
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            Management of Thrombocytopenia in Chronic Liver Disease: Focus on Pharmacotherapeutic Strategies

            Raoel Maan, Robert J. de Knegt, Bart J Veldt (2015)
            Thrombocytopenia (platelet count <150 × 109/L) often complicates chronic liver disease, impeding optimal management of these patients. The prevalence of this manifestation ranges from 6 % among non-cirrhotic patients with chronic liver disease to 70 % among patients with liver cirrhosis. It has also been shown that the severity of liver disease is associated with both prevalence and level of thrombocytopenia. Its development is often multifactorial, although thrombopoietin is thought to be a major factor. The discovery of and ability to clone thrombopoietin led to new treatment opportunities for this clinical manifestation. This review discusses data on the three most important thrombopoietin receptor agonists: eltrombopag, avatrombopag, and romiplostim. Currently, only eltrombopag is approved for usage among patients with thrombocytopenia and chronic hepatitis C virus infection in order to initiate and maintain interferon-based antiviral treatment. Nevertheless, the optimal management of hematologic abnormalities among patients with chronic liver disease, and its risk for bleeding complications, is still a matter of discussion. Thrombocytopenia definitely contributes to hemostatic defects but is often counterbalanced by the enhanced presence of procoagulant factors. Therefore, a thorough assessment of the patient’s risk for thrombotic events is essential when the use of thrombopoietin receptor agonists is considered among patients with chronic liver disease and thrombocytopenia.
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              Romiplostim safety and efficacy for immune thrombocytopenia in clinical practice: 2-year results of 72 adults in a romiplostim compassionate-use program.

              Lionel Galicier, Philippe Bierling, Matthieu Mahévas … (2011)
              Romiplostim, a thrombopoietic agent with demonstrated efficacy against immune thrombocytopenia (ITP) in prospective controlled studies, was recently licensed for adults with chronic ITP. Only France has allowed romiplostim compassionate use since January 2008. ITP patients could receive romiplostim when they failed to respond to successive corticosteroids, intravenous immunoglobulins, rituximab, and splenectomy, or when splenectomy was not indicated. We included the first 80 patients enrolled in this program with at least 2 years of follow-up. Primary platelet response (platelet count ≥ 50 × 10(9)/L and double baseline) was observed in 74% of all patients. Long-term responses (2 years) were observed in 47 (65%) patients, 37 (79%) had sustained platelet responses with a median platelet count of 106 × 10(9)/L (interquartile range, 75-167 × 10(9)/L), and 10 (21%) were still taking romiplostim, despite a median platelet count of 38 × 10(9)/L (interquartile range, 35-44 × 10(9)/L), but with clinical benefit (lower dose and/or fewer concomitant treatment(s) and/or diminished bleeding signs). A high bleeding score and use of concomitant ITP therapy were baseline factors predicting romiplostim failure. The most frequently reported adverse events were: arthralgias (26%), fatigue (13%), and nausea (7%). Our results confirmed that romiplostim use in clinical practice is effective and safe for severe chronic ITP. This trial was registered at www.clinicaltrials.gov as #NCT01013181.
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                Author and article information

                Contributors
                Hideki Akiyama:
                ORCID: http://orcid.org/0000-0001-5788-8555
                hakiyama@nakanosogo.or.jp
                Journal
                Journal ID (nlm-ta): Clin Case Rep
                Journal ID (iso-abbrev): Clin Case Rep
                Journal ID (doi): 10.1002/(ISSN)2050-0904
                Journal ID (publisher-id): CCR3
                Title: Clinical Case Reports
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2050-0904
                Publication date (Electronic): 17 April 2018
                Publication date Collection: June 2018
                Volume: 6
                Issue: 6 ( doiID: 10.1002/ccr3.2018.6.issue-6 )
                Pages: 1087-1089
                Affiliations
                [ 1 ] Department of Medicine Nitobe Memorial Nakano General Hospital 4‐59‐16, Chuou Nakano Tokyo 164‐8607 Japan
                Author notes
                [*] [* ] Correspondence

                Hideki Akiyama, Department of Medicine, Nitobe Memorial Nakano General Hospital, 4‐59‐16, Chuou, Nakano, Tokyo 164‐8607, Japan. Tel: 81‐3‐3382‐1231; Fax: 81‐3‐3381‐4799; E‐mail: hakiyama@ 123456nakanosogo.or.jp

                Author information
                http://orcid.org/0000-0001-5788-8555
                Article
                Publisher ID: CCR31530
                DOI: 10.1002/ccr3.1530
                PMC ID: 5986044
                SO-VID: f3021cca-9cf9-4962-bcb7-8ec88a527875
                Copyright © © 2018 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Date received : 09 January 2018
                Date revision received : 27 February 2018
                Date accepted : 24 March 2018
                Page count
                Figures: 2, Tables: 0, Pages: 3, Words: 1584
                Categories
                Subject: Case Report
                Subject: Case Reports
                Custom metadata
                source-schema-version-number 2.0
                component-id ccr31530
                cover-date June 2018
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:version=5.4.0 mode:remove_FC converted:04.06.2018

                Keywords: cirrhosis,mature b‐cell neoplasm,romiplostim
                Data availability:
                Keywords: cirrhosis, mature b‐cell neoplasm, romiplostim

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