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Case report and review: Angiosarcoma with thrombocytopenia after total hip arthroplasty.

Total hip arthroplasty (THA) is a common treatment for osteoarthritis and is also performed for other conditions, such as secondary arthritis due to developmental dysplasia of the hip. Various THA types may be complicated by osteolysis and an inflammatory pseudotumor due to an adverse reaction to metal debris. Rarely, THA has been associated with malignant tumors, but their causality remains unclear. In this case report, we describe a female patient with developmental dysplasia of the hip. She had undergone left metal-on-polyethylene THA, acetabular revision of the THA, and left total knee art

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… Paroxysmal nocturnal hemoglobinuria tests were negative. Based on her laboratory results, autoimmune hemolytic anemia (AIHA), cold AIHA, idiopathic thrombocytopenic purpura (ITP), AIHA combined with ITP, and chronic disseminated intravascular coagulation (DIC) were considered possible. …

What are safe hemoglobin, neutrophil and platelet counts for people with hematological malignancies to participate in exercise and activities of daily living: a scoping review.

PurposeThe aim of this scoping review was to summarize the extent of the literature in relation to safe levels of platelet, hemoglobin and neutrophil count for people with hematological cancers to participate in exercise or activities of daily living (ADLs).MethodsA comprehensive search for this scoping review was completed in July 2024 across five databases: the Cochrane Library, Embase, PEDro, PubMed and OTSeeker. Original studies, reviews and expert opinion papers were included if they focused on people with active hematological cancer diagnoses or those undergoing treatment affecting bone

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… trial N = 42 (EG = 21; CG = 21) Age: EG: 41 ± 13 years (18–60) CG: 37 ± 11 years (18–55) Patient cohort: chronic myelogenous leukaemia, acute myeloid leukaemia, acute lymphocytic leukaemia, aplastic anaemia, myelodysplastic syndromes, myelofibrosis, waldenstrom macroglobulinemia, paroxysmal nocturnal hemoglobinuria … trial | N = 42 (EG = 21; CG = 21) Age: EG: 41 ± 13 years (18–60) CG: 37 ± 11 years (18–55) Patient cohort: chronic myelogenous leukaemia, acute myeloid leukaemia, acute lymphocytic leukaemia, aplastic anaemia, myelodysplastic syndromes, myelofibrosis, waldenstrom macroglobulinemia, paroxysmal nocturnal hemoglobinuria …

Monoclonal antibody and protein therapeutic formulations for subcutaneous delivery: high-concentration, low-volume vs. low-concentration, high-volume.

Biologic drugs are used to treat a variety of cancers and chronic diseases. While most of these treatments are administered intravenously by trained healthcare professionals, a noticeable trend has emerged favoring subcutaneous (SC) administration. SC administration of biologics poses several challenges. Biologic drugs often require higher doses for optimal efficacy, surpassing the low volume capacity of traditional SC delivery methods like autoinjectors. Consequently, high concentrations of active ingredients are needed, creating time-consuming formulation obstacles. Alternatives to tradition

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… The 100 mg/mL IV formulation was approved by the Food and Drug Administration (FDA) in 2018 and was administered every 8 weeks at a dose of 3,300 milligrams (33 mL) for the treatment of paroxysmal nocturnal hemoglobinuria. … Food and Drug Administration (FDA) approval of EMPAVELI™ (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH). 14 May 2021. https://investors.apellis.com/news-releases/news-release-details/apellis-announces-us-food-and-drug-administration-fda-approval . 78. …

Antibodies to watch in 2023.

In this 14th installment of the annual Antibodies to Watch article series, we discuss key events in commercial monoclonal antibody therapeutics development that occurred in 2022 and forecast events that might occur in 2023. As of mid-November, 12 antibody therapeutics had been granted first approvals in either the United States or European Union (tebentafusp (Kimmtrak), faricimab (Vabysmo), sutimlimab (Enjaymo), relatlimab (Opdualag), tixagevimab/cilgavimab (Evusheld), mosunetuzumab (Lunsumio), teclistamab (TECVAYLI), spesolimab (SPEVIGO), tremelimumab (Imjudo; combo with durvalumab), nirsevim

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… IgG1λ2 | Cervical cancer | Regulatory review in China Adebrelimab | PD-L1; Humanized IgG4κ | Small cell lung cancer | Regulatory review in China Tagitanlimab | PD-L1; Humanized IgG1κ | Solid tumor indications | Regulatory review in China Crovalimab | Complement C5; Humanized IgG1κ | Paroxysmal nocturnal hemoglobinuria … It was also designed to have pH-dependent binding to the target. 75 In August 2022, Chugai announced that the NMPA accepted an application for regulatory approval of crovalimab for paroxysmal nocturnal hemoglobinuria (PNH) and granted priority review. …

Antibodies to watch in 2021.

In this 12th annual installment of the Antibodies to Watch article series, we discuss key events in antibody therapeutics development that occurred in 2020 and forecast events that might occur in 2021. The coronavirus disease 2019 (COVID-19) pandemic posed an array of challenges and opportunities to the healthcare system in 2020, and it will continue to do so in 2021. Remarkably, by late November 2020, two anti-SARS-CoV antibody products, bamlanivimab and the casirivimab and imdevimab cocktail, were authorized for emergency use by the US Food and Drug Administration (FDA) and the repurposed an

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… Soliris, which targets C5 was first approved by FDA in 2007 for paroxysmal nocturnal hemoglobinuria. A BLA for anti-IL-6 receptor satralizumab as a possible treatment for NMOSD was under review at FDA when Uplizna was approved for this indication. … , NCT02403323 ) Novartis Pharmaceuticals Corp. | Ianalumab (VAY736) | Human IgG1 | BLyS/BAFF/TACI/BCMA receptor | Phase 2/3 | Autoimmune hepatitis ( NCT03217422 ) Chugai Pharmaceutical, Hoffmann-La Roche | Crovalimab (SKY59, RG6107, RO7112689) | Humanized IgG1 | C5 | Phase 3 | Paroxysmal nocturnal hemoglobinuria …

Успешное уничтожение антител de novo HLA с помощью Daratumumumab в иммунопосредованных цитопенциях после пересадки аллогенетических стволовых клеток: отчет по делу.

Рефракторные иммуномедиаментированные цитопенции (КМК) после трансплантации стволовых клеток с аллогенетической гематопоиетической гематозностью (аллоХСТ) представляют собой сложное осложнение с ограниченными терапевтическими возможностями. Несмотря на то, что ранее существовавшие антитела лейкоцитов человека (ХЛА), в частности конкретные для доноров антитела (АДС), являются хорошо зарекомендовавшими себя факторами риска в случае отказа от трансплантации, клиническая значимость и механистическая роль антител de novo HLA, появившихся после трансплантации, по-прежнему плохо определены. Не провод

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… Flow cytometry showed a paroxysmal nocturnal hemoglobinuria clone in 13.68% of monocytes without clinical or laboratory hemolysis. Given refractoriness to immunosuppressive therapy, she proceeded to allo-HSCT. …

Impact of Mantle Cell Lymphoma Contamination of Autologous Stem Cell Grafts on Outcome after High-Dose Chemotherapy.

Novel predictive factors are needed to identify mantle cell lymphoma (MCL) patients at increased risk for relapse after high-dose chemotherapy and autologous hematopoietic stem cell transplantation (HDCT/Auto-HSCT). Although bone marrow and peripheral blood involvement is commonly observed in MCL and lymphoma cell contamination of autologous stem cell grafts might facilitate relapse after Auto-HSCT, prevalence and prognostic significance of residual MCL cells in autologous grafts are unknown. We therefore performed a multiparameter flow cytometry (MFC)-based measurable residual disease (MRD) a

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… A prospective comparison of four techniques for diagnosis of paroxysmal nocturnal hemoglobinuria Int. J. Lab. Hematol. 2007 29 119 126 10.1111/j.1751-553X.2006.00838.x 17474884 50. Rawstron A. Böttcher S. Letestu R. Villamor N. Fazi C. Kartsios H. De Tute R. Shingles J. Ritgen M. Moreno C. …

ENHANZE® drug delivery technology: a novel approach to subcutaneous administration using recombinant human hyaluronidase PH20

ENHANZE® drug delivery technology is based on the proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20; Halozyme Therapeutics, Inc.) that facilitates the subcutaneous (SC) delivery of co-administered therapeutics. rHuPH20 works by degrading the glycosaminoglycan hyaluronan (HA), which plays a role in resistance to bulk fluid flow in the SC space, limiting large volume SC drug delivery, dispersion, and absorption. Co-administration of rHuPH20 with partner therapies can overcome administration time and volume barriers associated with existing SC therapeutic formulations, and has been

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… Alexion Pharmaceuticals is using the ENHANZE drug delivery technology to develop a next-generation SC formulation of ALXN1210 (ALXN1210 + rHuPH20, designated as ALXN1810), an investigational long-acting C5 complement inhibitor monoclonal antibody in development for the treatment of paroxysmal nocturnal hemoglobinuria …

Common drug review recommendations for orphan drugs in Canada: basis of recommendations and comparison with similar reviews in Quebec, Australia, Scotland and New Zealand.

BackgroundPublic payer reimbursement for non-oncology drugs in Canada, including orphan drugs, is based on recommendations by the Common Drug Review (CDR) (with the exception of Quebec). CDR has been criticized for negative recommendations for orphan drugs and contributing to delays in patient access to these drugs. However, it is unclear how CDR makes recommendations for orphan drugs and the role clinical and economic factors play in decision making. The objective of the present study was to analyze the basis for CDR orphan drug recommendations and to compare recommendations to those in other

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… cost-effectiveness d For these recommendations CDR included a condition of a substantial reduction in price or a drug cost that should not exceed the drug plan cost of a comparator therapy Drug | Disease | Recommendation (Date of decision) | ICUR b | Patient input | CDR comments Eculizumab | Paroxysmal nocturnal hemoglobinuria …

A Critical Appraisal of Extracorporeal Photopheresis as a Treatment Modality for Acute and Chronic Graft-Versus-Host Disease.

Although significant advances have been made in the biologic understanding of graft-versus-host disease (GVHD) and its treatment options, GVHD remains the single most challenging obstacle to the success of allogeneic hematopoietic cell transplantation (HCT) due to high risk of disabling morbidity and mortality. Extracorporeal photopheresis (ECP) has promising effects in controlling steroid-refractory GVHD, both acute and chronic, and it has been studied extensively. Its putative immunomodulatory mechanisms, while not immunosuppressive, position ECP as an attractive treatment strategy for GVHD

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… myelogenous leukemia; NHL: Non-Hodgkin’s lymphoma; MM: multiple myeloma; AA: aplastic anemia; ARDS: adult respiratory distress syndrome; ECP: extracorporeal photopheresis; AL: acute leukemia; MDS: myelodysplastic syndrome; MPD: myeloproliferative disease; SCA: sickle cell anemia; PNH, paroxysmal nocturnal hemoglobinuria …

Frequency of Topical Immunomodulatory and Immunosuppressive Therapies for Ocular Chronic Graft-versus-Host Disease.

Introduction: The purpose of the study was to evaluate the frequency of topical immunomodulatory and immunosuppressive therapies in patients with ocular chronic graft-versus-host disease (cGVHD) in consideration of inflammatory activity and systemic immunosuppressive therapies in a tertiary care university hospital setting. Methods: We included 95 adult patients (48 male, 47 female) with ocular chronic graft-versus-host disease (cGVHD) after alloHSCT (median age 49.5 years). Clinical ophthalmological findings and the grade of ocular cGVHD according to the NIH eye score and the German-Austrian-

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… | -Unspecified 3/95 | 3.2% Lymphomas 16/95 | | 16.8% | -Multiple myeloma and plasma cell myeloma 7/95 | 7.4% | -Other Non-Hodgkin lymphomas 9/95 | 9.5% Myelodysplastic syndromes: 15/95 | | 15.8% | -Primary myelofibrosis 3/95 | 3.2% | -Polycythaemia vera 1/95 | 1.05% | -Paroxysmal nocturnal hemoglobinuria …

Design and implementation of an Internet-Based cancer risk assessment tool: Use over 10 years.

BackgroundPrevention and early intervention can improve survival and quality of life across all cancers. Patient understanding of risk factors and associated actionable lifestyle changes and screening programs is not well understood by clinicians METHODS: An Internet-based tool, Reduce My Risk, was created in 2009 and made available on oncolink.org. Users voluntarily completed a survey regarding demographics and cancer risk factors, and received information about their cancer risk RESULTS: Twenty eight thousand and one surveys were completed from 2009 to 2019. Median age was 26 years (18-101);

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… pylori infection or ulcers | Have you ever been diagnosed with: Myelodysplastic syndrome (MDS) | No | 97% | 27,153 | | No | 100% | 27,960 | | Yes | 3% | 848 | | Yes | 0% | 41 | Have you ever been diagnosed with: Epstein Barr Virus (EBV) | Have you ever been diagnosed with: Paroxysmal nocturnal hemoglobinuria …

Using 5 consecutive years of NICE guidance to describe the characteristics and influencing factors on the economic evaluation of orphan oncology drugs.

OBJECTIVE: Orphan oncology drugs used in this article were defined by the type of disease treated by drugs, as drugs used to treat rare diseases with a prevalence of ≤ 500 per million people per year. In this article, our concern was to explore focus on the economic evaluation of the National Institute for Health and Care Excellence (NICE), when orphan oncology drugs were appraised for reimbursement, and provide advice and suggestions to decision-makers. METHODS: A retrospective study was used in this study. Thirty guidance were gathered as our subject by NICE from 2016 to 2020, excluded drug

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… Analysis of baseline characteristics, disease burden and long-term follow-up of 167 patients with Paroxysmal Nocturnal Hemoglobinuria at a single center in Brazil. Blood Cells Mol Dis. (2021) 92:102605. 10.1016/j.bcmd.2021.102605 12. Stafinski T, Glennie J, Young A, Menon D. …

Indications for haematopoietic cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe, 2022.

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… Paroxysmal nocturnal hemoglobinuria (PNH) The introduction of anti-complement therapy with eculizumab changed the natural history of the disease, and allo-HCT became generally not recommended for patients with haemolytic PNH for whom eculizumab is available. …

Evaluating nurse preferences for a novel on-body delivery system vs. manual syringes for large-volume subcutaneous drug administration: a survey study.

While nurses report challenges with the manual administration of large-volume subcutaneous drugs, these challenges and potential solutions are not captured in the literature. In this cross-sectional study, 45 nurses with experience administering large-volume subcutaneous biologics completed an 18-item survey about preferences for syringes vs. on-body delivery systems. 100% responded that an on-body delivery system seemed easy to learn and use and preferable to syringes. In a drug delivery scenario including comprehensive administration details and assuming equivalent safety and efficacy, 97.78

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… To date, it has been FDA-approved for the self-administration of pegcetacoplan (EMPAVELI ® ) for the treatment of paroxysmal nocturnal hemoglobinuria (Philpott 2023 ). Figure 2. Product X on-body delivery system (enFuse). …

Gene Expression Profiles Identify Biomarkers of Resistance to Decitabine in Myelodysplastic Syndromes.

Myelodysplastic syndrome (MDS) is a clonal hematopoietic stem cell disease characterized by inefficient hematopoiesis and the potential development of acute leukemia. Among the most notable advances in the treatment of MDS is the hypomethylating agent, decitabine (5-aza-2'deoxycytidine). Although decitabine is well known as an effective method for treating MDS patients, only a subset of patients respond and a tolerance often develops, leading to treatment failure. Moreover, decitabine treatment is costly and causes unnecessary toxicity. Therefore, clarifying the mechanism of decitabine resista

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… . | 1 | 2 | 3 | 4 Sex | Female | Male | Male | Female Age (years) | 46 | 73 | 74 | 61 Weight (kg) | 60 | 66 | 76 | 55 Height (m) | 1.56 | 1.6 | 1.63 | 1.47 BMI (kg/m 2 ) | 24.7 | 25.8 | 28.6 | 25.5 Underlying disease | History of allogeneic HSCT due to aplastic anemia, paroxysmal nocturnal hemoglobinuria …

Diagnostic, Clinical and Post-SARS-CoV-2 Scenarios in Cancer Patients with SARS-CoV-2: Retrospective Analysis in Three German Cancer Centers.

Oncologists face challenges in the management of SARS-CoV-2 infections and post-SARS-CoV-2 cancer treatment. We analyzed diagnostic, clinical and post-SARS-CoV-2 scenarios in patients from three German cancer centers with RT-PCR confirmed SARS-CoV-2 infection. Sixty-three patients with SARS-CoV-2 and hematologic or solid neoplasms were included. Thirty patients were initially asymptomatic, 10 of whom developed COVID-19 symptoms subsequently. Altogether 20 (32%) patients were asymptomatic, 18 (29%) had mild, 12 (19%) severe and 13 (20%) critical courses. Lymphocytopenia increased risk of severe

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… M, male; F, female; n , number; B-NHL, B-cell non-hodgkin lymphoma; T-NHL, T-cell NHL; ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; PNH, paroxysmal nocturnal hemoglobinuria. …

Antibodies to watch in 2022.

In this 13th annual installment of the annual 'Antibodies to Watch' article series, we discuss key events in commercial antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. Regulatory review of antibody therapeutics that target the SARS-CoV-2 coronavirus proceeded at an unprecedented pace in 2021, resulting in both emergency use authorizations and full approvals for sotrovimab, regdanvimab, REGEN-COV2, as well as others, in numerous countries. As of November 1, a total of 11 antibody therapeutics had been granted first approvals in either the Un

Pharmacotherapy of Generalized Myasthenia Gravis with Special Emphasis on Newer Biologicals.

Myasthenia gravis (MG) is a chronic, fluctuating, antibody-mediated autoimmune disorder directed against the post-synaptic neuromuscular junctions of skeletal muscles, resulting in a wide spectrum of manifestations ranging from mild to potentially fatal. Given its unique natural course, designing an ideal trial design for MG has been wrought with difficulties and evidence in favour of several of the conventional agents is weak as per current standards. Despite this, acetylcholinesterases and corticosteroids have remained the cornerstones of treatment for several decades with intravenous immuno

A prospective phase 2 clinical trial of a C5a complement inhibitor for acute GVHD with lower GI tract involvement.

Involvement of lower gastrointestinal tract (LGI) occurs in 60% of patients with graft-versus-host-disease (GVHD). Complement components C3 and C5 are involved in GVHD pathogenesis. In this phase 2a study, we evaluated the safety and efficacy of ALXN1007, a monoclonal antibody against C5a, in patients with newly diagnosed LGI acute GVHD receiving concomitant corticosteroid. Twenty-five patients were enrolled; one was excluded from the efficacy analysis based upon negative biopsy. Most patients (16/25, 64%) had acute leukemia; 52% (13/25) had an HLA-matched unrelated donor; and 68% (17/25) rece

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… Effect of eculizumab on hemolysis and transfusion requirements in patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2004;350:552–9. doi: 10.1056/NEJMoa031688. 39. Levine JE, Braun TM, Harris AC, Holler E, Taylor A, Miller H, et al. …