Abstract:
:After the patents of biopharmaceuticals have expired, based on specific regulatory approval pathways copied products ("biosimilars" or "follow-on biologics") have been launched in the EU. This article summarizes experiences with hematopoietic medicines, namely the epoetins (two biosimilars traded under five different brand names) and the filgrastims (two biosimilars, six brand names). Physicians and pharmacists should be familiar with the legal and pharmacological specialities of biosimilars: The production process can differ from that of the original, clinical indications can be extrapolated, glycoproteins contain varying isoforms, the formulation may differ from the original, and biopharmaceuticals are potentially immunogenic. Only on proof of quality, efficacy and safety, biosimilars are a viable option because of their lower costs.
journal_name
Am J Hematoljournal_title
American journal of hematologyauthors
Jelkmann Wdoi
10.1002/ajh.21805subject
Has Abstractpub_date
2010-10-01 00:00:00pages
771-80issue
10eissn
0361-8609issn
1096-8652journal_volume
85pub_type
杂志文章,评审abstract::Polycythemia vera (PCV) and multiple myeloma are both clonal disorders of hematopoietic stem cells. The simultaneous occurrence of these diseases in an individual patient is rare. A case of synchronous PCV and smoldering myeloma is presented and the literature is reviewed. The issues of clinical importance in this unu...
journal_title:American journal of hematology
pub_type: 杂志文章,评审
doi:10.1002/ajh.2830440311
更新日期:1993-11-01 00:00:00
abstract::Children with sickle cell anemia (SCA) and a primary overt stroke are at high risk of recurrent (secondary) stroke. Chronic transfusion therapy dramatically reduces but does not eliminate this high risk, and inevitably results in transfusion-related hemosiderosis. We previously reported the use of hydroxyurea/phleboto...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.21986
更新日期:2011-04-01 00:00:00
abstract::Fetal calf serum (FCS) is used as a component of the media for cells grown in culture. However, the high cost of FCS has stimulated a search for a possible alternative. Approximately 10% of human platelet concentrates prepared for clinical transfusions are outdated. Sera prepared from platelet concentrates were compar...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830170104
更新日期:1984-07-01 00:00:00
abstract::The content of peripheral blood B cells (B1+) was reduced in patients of multiple myeloma (MM) and not in those with benign monoclonal gammopathy (BMG) compared to normal donors (P less than 0.01). This observation correlated with the suppression of synthesis of normal immunoglobulin (Ig) in MM. Thus, cytokine activit...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830300208
更新日期:1989-02-01 00:00:00
abstract:DISEASE OVERVIEW:Approximately one-fourth of primary cutaneous lymphomas are B-cell derived and are generally classified into three distinct subgroups: primary cutaneous follicle center lymphoma (PCFCL), primary cutaneous marginal zone lymphoma (PCMZL), and primary cutaneous diffuse large B-cell lymphoma, leg type (PCD...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.25970
更新日期:2020-08-20 00:00:00
abstract::This analysis, using data from the bortezomib-melphalan-prednisone (VMP) arm of the Phase III VISTA study, investigated whether increased cumulative bortezomib dose could improve overall survival (OS) in transplant-ineligible patients with previously untreated multiple myeloma. Median cumulative bortezomib dose receiv...
journal_title:American journal of hematology
pub_type: 杂志文章,随机对照试验
doi:10.1002/ajh.23933
更新日期:2015-04-01 00:00:00
abstract::Lentiviral modification combined with ex vivo erythroid differentiation was used to stably inhibit RhAG expression, a critical component of the Rh(rhesus) membrane complex defective in the Rh(null) syndrome. The cultured red cells generated recapitulate the major alterations of native Rh(null) cells regarding antigen ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.23414
更新日期:2013-05-01 00:00:00
abstract::A 68-year-old previously well woman developed sudden onset of limb gangrene in association with liver dysfunction. An immediately acting inhibitor to factor V with some of the features of lupus anticoagulant was demonstrated. The patient required limb amputation within 2 weeks and activity of the anticoagulant seemed ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830420410
更新日期:1993-04-01 00:00:00
abstract::Leg ulcers are a well recognized complication of sickle cell disease that has been attributed to venous insufficiency. We studied 16 patients with sickle cell disease and active ulcers using venous pulse volume recordings and photoplethysmography (Doppler studies). Based on hemodynamic monitoring, all 16 patients exhi...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830370215
更新日期:1991-06-01 00:00:00
abstract::Disseminated intravascular coagulation (DIC) is a complex acquired coagulopathy resulting from excessive thrombin formation. Abnormal tissue factor (TF) expression is a major mechanism initiating DIC in many disorders, including obstetrical complications, sepsis, cancer, and trauma. Numerous laboratory tests are avail...
journal_title:American journal of hematology
pub_type: 杂志文章,评审
doi:10.1002/(sici)1096-8652(199809)59:1<65::aid-ajh13>
更新日期:1998-09-01 00:00:00
abstract::Retroviral-mediated gene transfer into hematopoietic stem cells provides the only means of stable transduction of these cells and their progeny for use with a variety of potentially therapeutic genes. Expression of the Moloney amphotropic retroviral receptor-pit-2 or GLVR-2-is critical to the recognition and entry of ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/(sici)1096-8652(199908)61:4<243::aid-ajh4>
更新日期:1999-08-01 00:00:00
abstract::Eight patients with severe chronic autoimmune thrombocytopenic purpura (AITP) refractory to high-dose intravenous immunoglobulin (IVIgG) and/or oral prednisone were treated with one to three infusions of high-dose methylprednisolone (HDMP) (15 mg/kg/day). The mean platelet count before treatment was 12 +/- 10 x 10(9)/...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830480416
更新日期:1995-04-01 00:00:00
abstract::Although large vessel thrombi are occasionally reported in patients with homozygous sickle cell disease, the role of intravascular coagulation in typical pain crises is controversial. Therefore, we studied 24 sickle cell patients during and between episodes of pain crisis, using several sensitive tests of hemostasis. ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830230403
更新日期:1986-12-01 00:00:00
abstract::Acute leukemias of ambiguous lineage (ALAL) comprise acute undifferentiated leukemias (AUL) and mixed-phenotype acute leukemias (MPAL). In the revised fourth edition of the World Health Organization (WHO) classification provided further refinements to the diagnostic criteria for ALAL. Molecular characterization of MPA...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.25771
更新日期:2020-06-01 00:00:00
abstract::Heparin, employed clinically for more than 50 years, is still a widely used anticoagulant. Unfortunately, some patients given this agent develop thrombocytopenia and thrombosis. Because this side effect can have catastrophic consequences, it is imperative that all clinicians caring for patients who receive heparin hav...
journal_title:American journal of hematology
pub_type: 杂志文章,评审
doi:10.1002/ajh.20490
更新日期:2006-01-01 00:00:00
abstract::The fat embolism syndrome is an important complication of patients with sickle cell hemoglobinopathies because of severe morbidity and mortality. Our recent experience with three cases that survived with intensive supportive care and prompt use of transfusion stimulates this review. A high index of suspicion, prompt u...
journal_title:American journal of hematology
pub_type: 杂志文章,评审
doi:10.1002/ajh.20348
更新日期:2005-05-01 00:00:00
abstract::Duvelisib (IPI-145), an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-δ and -γ, was evaluated in a Phase 1 study in advanced hematologic malignancies, which included expansion cohorts in relapsed/refractory (RR) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and treatment-naïve (TN) CLL...
journal_title:American journal of hematology
pub_type: 杂志文章,多中心研究
doi:10.1002/ajh.25243
更新日期:2018-11-01 00:00:00
abstract::The -117(G-->A)A gamma hereditary persistence of fetal hemoglobin (Greek HPFH) and beta zero 39-thal mutations are rather frequent in Sardinia so that their interaction is to be expected. Characterization of eight compound heterozygotes for these defects indicated that HPFH was linked to haplotype VII and beta zero 39...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830490402
更新日期:1995-08-01 00:00:00
abstract::Among a cohort of 142 patients with Hodgkin disease (HD), pathologic stages (PS) IA through IVB, 84 remained in complete remission (CR) at least 3 years after the completion of initial protocol therapy. Eight of these patients subsequently developed a recurrence of HD and were defined as having a late relapse. The dis...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830100106
更新日期:1981-01-01 00:00:00
abstract::The association of T-cell large granular lymphocyte (LGL) leukemia and rheumatoid arthritis is well described and it is now recognized that these patients and patients with Felty's syndrome represent different aspects of a single disease process. Most patients have rheumatoid arthritis at the time of diagnosis of LGL ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/(sici)1096-8652(199803)57:3<253::aid-ajh14
更新日期:1998-03-01 00:00:00
abstract::We describe a 25-year-old black woman who presented with a long history of anemia requiring transfusions during childhood and adolescence. Molecular analysis revealed her to be a compound heterozygote for the sickle mutation and the approximately 22.7 kb deletion associated with hemoglobin Kenya. This patient's clinic...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830410413
更新日期:1992-12-01 00:00:00
abstract::We aimed to determine the survival benefits of chemotherapy (CT) added to radiotherapy (RT) in different risk groups of patients with early-stage extranodal nasal-type NK/T-cell lymphoma (ENKTCL), and to investigate the risk of postponing RT based on induction CT responses. A total of 1360 patients who received RT wit...
journal_title:American journal of hematology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1002/ajh.25878
更新日期:2020-09-01 00:00:00
abstract::In 2010, the Food and Drug Administration (FDA) added a black box warning to anti-D immune globulin (Rho(D) immune globulin, anti-D) for immune thrombocytopenia (ITP) to warn of the complications related to severe hemolysis. The objective of this retrospective medical record review was to examine recent trends in anti...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.22261
更新日期:2012-03-01 00:00:00
abstract::Peripheral serotonin (5-HT) has been involved in adverse cardiac remodeling and valve fibrosis. The peripheral levels of 5-HT mainly depend on its release from activated platelets and degradation by monoamine oxidase A (MAO-A). The SERAOPI study investigated the relationship between arterial serotoninergic system, deg...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.23855
更新日期:2015-01-01 00:00:00
abstract::Therapies engineered to prolong clotting factor protein circulation time, manipulate the balance of pro-coagulant and anti-coagulant proteins, or introduce new genetic material to enable endogenous factor protein production dominate the clinical trial landscape of hemophilia. The availability of clotting factor concen...
journal_title:American journal of hematology
pub_type: 杂志文章,评审
doi:10.1002/ajh.26018
更新日期:2021-01-01 00:00:00
abstract::ABO incompatibility is commonly observed in stem cell transplantation and its impact in this setting has been extensively investigated. HLA-mismatched unrelated donors (MMURD) are often used as an alternative stem cell source but are associated with increased transplant related complications. Whether ABO incompatibili...
journal_title:American journal of hematology
pub_type: 杂志文章,多中心研究
doi:10.1002/ajh.24771
更新日期:2017-08-01 00:00:00
abstract::We examined inter- and intraobserver reproducibility and concordance between histological diagnosis and independently collected clinical findings in a large series of patients with the major subtypes of myeloproliferative neoplasms (MPNs) and controls. Seven hematopathologists reviewed 272 bone marrow biopsies includi...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.23554
更新日期:2013-12-01 00:00:00
abstract::Ticlopidine-induced aplastic anemia (TIAA) is considered very uncommon. We present two new cases, and we review 55 additional cases from the literature. The first case concerns a 70-year-old man who developed severe aplastic anemia 7 weeks after treatment with 500 mg of ticlopidine daily. The patient sustained a sever...
journal_title:American journal of hematology
pub_type: 杂志文章,meta分析,评审
doi:10.1002/ajh.10150
更新日期:2002-09-01 00:00:00
abstract::Although numerous publications have described the chromosome abnormalities in B-cell non-Hodgkin lymphoma and their significance, sparse literature exists pertaining to the chromosome abnormalities in T-cell lymphoma. We did cytogenetic analyses in 21 cases of peripheral T-cell lymphoma (PTCL). Chromosomally abnormal ...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.2830350205
更新日期:1990-10-01 00:00:00
abstract::Thrombocytopenia is a poor prognostic indicator in the myelodysplastic syndromes (MDS). Treatment options for patients with symptomatic thrombocytopenia are limited. Danazol, an attenuated androgen, may have some efficacy in increasing the platelet count of patients with MDS. We retrospectively reviewed 33 patients wi...
journal_title:American journal of hematology
pub_type: 杂志文章
doi:10.1002/ajh.10209
更新日期:2002-11-01 00:00:00