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Efficacy and safety of biosimilar Peg-filgrastim after autologous stem cell transplant in myeloma and lymphoma patients: a comparative study with biosimilar Filgrastim, Lenograstim, and originator Peg-filgrastim.

Data about biosimilar Peg-filgrastim (bioPEG) in autologous stem cell transplant (ASCT) are still scarce. The aim of this study has been to assess efficacy and safety of bioPEG among lymphoma and myeloma patients undergoing ASCT, comparing these data with historical controls receiving other G-CSFs. Furthermore, an economic evaluation has been included to estimate the savings by using bioPEG. This is a prospective cohort study comparing lymphoma and myeloma patients undergoing ASCT and receiving bioPEG (n = 73) with three historical consecutive cohorts collected retrospectively who received oth

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… Since the implementation of a biosimilar approval pathway in 2005, several biosimilars including somatotropins, filgrastim, epoietins, and infliximab have been approved in Europe, on the basis of demonstrating comparable quality, safety, and efficacy to the originator products [ 6 ]. …

Sarcoidosis and autoimmunity: In the depth of a complex relationship.

Sarcoidosis is a chronic granulomatous disease that can virtually affect any organ. Its etiology is unknown, although it has been proposed that environmental or biological agents can act as triggers, ultimately leading to chronic inflammation in genetically predisposed individuals. The main component of sarcoid inflammation is represented by an exaggerated T- lymphocytic cellular response to a putative antigen that could not be efficiently cleared in the patient. However, several clinical and immunological observations, such as the association of sarcoidosis to autoimmune diseases or the prese

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… Finally, the third-line therapy comprises anti-tumor necrosis factor-α (TNF-α) antibodies, such as infliximab or adalimumab ( 3 ). …

The Interplay between Immune System and Microbiota in Osteoporosis.

Osteoporosis is a disease characterized by low bone mass and alterations of bone microarchitecture, with an increased risk of fractures. It is a multifactorial disorder that is more frequent in postmenopausal women but can be associated to other diseases (inflammatory and metabolic diseases). At present, several options are available to treat osteoporosis trying to block bone reabsorption and reduce the risk of fracture. Anyway, these drugs have safety and tolerance problems in long-term treatment. Recently, gut microbiota has been highlighted to have strong influence on bone metabolism, becom

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… In this contest, TNF antagonists (infliximab and adalimumab), used as conventional treatment for inflammatory bowel diseases, appear to have beneficial effects on bone metabolism, increasing bone formation. …

Sarcopenia in Older Adults with Hematologic Malignancies: A Comprehensive Review of Epidemiology, Prognosis, and Interventions.

Hematologic malignancies, including leukemias, lymphomas, and multiple myeloma, are diseases of older adults (age ≥ 60 years). Treatment decisions in older adults with cancer are heavily influenced by patient fitness: the ability of an individual patient to tolerate the off-target effects of anti-cancer therapy. Sarcopenia, defined as low muscle mass and strength, is increasingly recognized as an important marker of fitness. Furthermore, sarcopenia is known to be modifiable with nutrition and exercise interventions in older adults without cancer, but such evidence is limited for patients with

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… Anti-inflammatory agents trialed thus far include IL-6 inhibitors (Clazakizumab [ 158 ]), TNF-alpha inhibitors (Infliximab [ 159 ]), non-steroidal anti-inflammatory drugs (NSAIDS) [ 160 ], and corticosteroids [ 150 , 161 ]. …

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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… . ≤0.00915 events/infusion with Hizentra®). 71 Treatment-emergent adverse events (TEAEs), particularly viral and non-viral upper respiratory tract infections, were also found to be higher with IV administration of CT-P13, an infliximab biosimilar, compared with SC administration in a randomized Phase …

Medication-Related Osteonecrosis of the Jaw: A Systematic Review of Case Reports and Case Series.

Medication-related osteonecrosis of the jaw (MRONJ) is a rare condition, typically seen in patients receiving antiresorptive or antiangiogenic drugs. This study aims to synthesize reports and case series of MRONJ regarding sociodemographic and clinical characteristics and to evaluate the effectiveness of the treatments applied. Following PRISMA guidelines, a search for case reports and case series was carried out in the PubMed-Medline database until March 2024. A total of 88 articles were included in this review, in a total of 151 cases. The key findings reveal that females were the most affec

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… Primary Reconstruction Plate for Mandibular Medication-Related Osteonecrosis | [ 57 ] CR | 2017 | Gianfranco Favia; Angela Tempesta; Luisa Limongelli; Vito Crincoli; Florenzo Iannone; Giovanni Lapadula; Eugenio Maiorano | A Case of Osteonecrosis of the Jaw in a Patient with Crohn’s Disease Treated with Infliximab … A Case of Osteonecrosis of the Jaw in a Patient with Crohn’s Disease Treated with Infliximab. Am. J. Case Rep. 2017;18:1351–1356. doi: 10.12659/AJCR.905355. 59. Favia G., Tempesta A., Limongelli L., Crincoli V., Piattelli A., Maiorano E. …

Biological therapy in systemic lupus erythematosus, antiphospholipid syndrome, and Sjögren's syndrome: evidence- and practice-based guidance.

Systemic lupus erythematosus (SLE), antiphospholipid syndrome (APS), and Sjögren's syndrome (SS) are heterogeneous autoimmune diseases. Severe manifestations and refractory/intolerance to conventional immunosuppressants demand other options, namely biological drugs, and small molecules. We aimed to define evidence and practice-based guidance for the off-label use of biologics in SLE, APS, and SS. Recommendations were made by an independent expert panel, following a comprehensive literature review and two consensus rounds. The panel included 17 internal medicine experts with recognized practice

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… The short-term use of infliximab was successful in an open-label study with moderately active SLE patients ( 105 ). However, patients with lupus arthritis (n=5) maintained clinical response for less than 2 months after the last infusion. … Adverse events and efficacy of TNF-alpha blockade with infliximab in patients with systemic lupus erythematosus: Long-term follow-up of 13 patients . Rheumatology ( 2009 ) 48 ( 11 ): 1451–4 . doi: 10.1093/rheumatology/kep270 19748965 106 Furie RA Aroca G Cascino MD Garg JP Rovin BH Alvarez A . …

Autoimmune Rheumatic Diseases and Vascular Function: The Concept of Autoimmune Atherosclerosis.

Autoimmune rheumatic diseases (AIRDs) with unknown etiology are increasing in incidence and prevalence. Up to 5% of the population is affected. AIRDs include rheumatoid arthritis, system lupus erythematosus, systemic sclerosis, and Sjögren's syndrome. In patients with autoimmune diseases, the immune system attacks structures of its own body, leading to widespread tissue and organ damage, which, in turn, is associated with increased morbidity and mortality. One third of the mortality associated with autoimmune diseases is due to cardiovascular diseases. Atherosclerosis is considered the main un

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… Body mass index and clinical response to infliximab in rheumatoid arthritis Arthritis Rheum. 2010 63 359 364 10.1002/art.30136 21279992 26. García-Poma A. Segami M.I. Mora C.S. Ugarte-Gil M.F. Terrazas H.N. Rhor E.A. García E. Ramos M.P. Alva M. Castañeda I. … Infliximab improves vascular stiffness in patients with rheumatoid arthritis Ann. Rheum. Dis. 2008 68 1277 1284 10.1136/ard.2007.086157 18930987 PMC2703705 112. González L.A. Toloza S.M. Alarcón G.S. Impact of Race and Ethnicity in the Course and Outcome of Systemic Lupus Erythematosus Rheum. Dis. …

Revitalizing T cells: breakthroughs and challenges in overcoming T cell exhaustion.

T cell exhaustion is a prevalent phenomenon in chronic infections and tumor microenvironments, severely compromising the effectiveness of antitumor and antiviral immunity. In recent years, there has been significant progress in understanding the underlying mechanisms of T cell exhaustion, including external factors and intrinsic cellular changes that drive this dysfunctional state. Key external factors such as persistent antigen exposure, immune checkpoint signaling, and the cytokine milieu, as well as intrinsic changes such as altered metabolic processes, epigenetic modifications, and transcr

Combined Administration of Bisphosphonates, Chemotherapeutic Agents, and/or Targeted Drugs Increases the Risk for Stage 3 Medication-Related Osteonecrosis of the Jaw: A 4-Year Retrospective Study.

OBJECTIVES: Patients with stage 3 medication-related osteonecrosis of the jaw (MRONJ) suffer from severe complications. Chemotherapeutic agents and targeted drugs are considered to be associated with the development of MRONJ. However, little is known regarding the association of those agents with stage 3 MRONJ. The purpose of this study is to analyze the comprehensive medication history of patients with advanced-stage MRONJ (stage 2 and stage 3) and evaluate the possible risk factors for stage 3 MRONJ. Patients and Methods. Sixty patients with advanced-stage MRONJ were involved in this retrosp

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… A case of osteonecrosis of the jaw in a patient with Crohn’s disease treated with infliximab. The American journal of case reports. 2017;18:1351–1356. doi: 10.12659/AJCR.905355. 7. Yarom N., Shapiro C. L., Peterson D. E., et al. …

Current State of Knowledge on Primary Sjögren's Syndrome, an Autoimmune Exocrinopathy.

Primary Sjögren's syndrome (pSS) is a chronic systemic autoimmune rheumatic disease characterized by lymphoplasmacytic infiltration of the salivary and lacrimal glands, whereby sicca syndrome and/or systemic manifestations are the clinical hallmarks, associated with a particular autoantibody profile. pSS is the most frequent connective tissue disease after rheumatoid arthritis, affecting 0.3-3% of the population. Women are more prone to develop pSS than men, with a sex ratio of 9:1. Considered in the past as innocent collateral passive victims of autoimmunity, the epithelial cells of the saliv

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… With regard to biological therapies, infliximab, etanercept, belimumab and tocilizumab have failed to demonstrate a favourable effect on exocrine glandular function in their respective RCTs. …

Bispecific Antibodies in Hematologic Malignancies in the Outpatient and Community Settings.

Bispecific antibodies (BsAbs) are novel antitumor agents that simultaneously engage tumor-associated antigens with CD3 on endogenous effector T cells, leading to cancer cell death. The immune-mediated toxicity rates associated with BsAbs are considerably lower than those seen with CAR T-cell therapy. Hence, widespread utilization of BsAb products in outpatient and community settings will allow greater and more homogeneous access and thus improve patient outcomes. In this review, we discuss the unique toxicities associated with BsAbs currently approved by the U.S. Food and Drug Administration a

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… Other immunomodulatory agents such as antitumor necrosis factor inhibitors like infliximab, adalimumab, and certolizumab could further be utilized. JAK‐STAT inhibitors, such as ruxolitinib and itacitinib, have also demonstrated efficacy in CRS. …

Аутоиммунные заболевания связаны с повышенным нейродегенеративным и цереброваскулярным риском, в то время как системное кортикостероидное воздействие свидетельствует об ограниченной нейродегенеративной и скромной сосудистой связи.

Системные аутоиммунные заболевания (СИД), характеризующиеся хроническим периферийным воспалением и частой сосудистой коморбидностью, все чаще связаны с неблагоприятными результатами центральной нервной системы (СНС); однако сравнительные данные по различным АИД и разъяснения роли сосудистого бремени, провокационной деятельности и иммуномодуляционной терапии по-прежнему ограничены. Используя Глобальную сеть сотрудничества TriNetX, мы провели ряд ретроспективных экспериментов, совпадающих с оценками, для взрослых в возрасте от 50 до 85 лет в целях количественной оценки заболевания Паркинсона (PD

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… Crohn’s disease (infliximab): male AD was higher in treated cohorts (p = 0.037); PD/TIA/ischemic stroke were ∼null; females showed a non-significant trend in the opposite direction. …

Platelet Transfusion for Patients with Cancer: An Update.

BackgroundPlatelet transfusion is essential for preventing and treating hemorrhage in oncology patients and can markedly improve quality of life and survival. However, access to platelet concentrates is often limited by global shortages and logistical constraints, especially in low-resource settings.SummaryMaintaining product quality requires stringent donor screening, pathogen-reduction technologies, and optimized storage conditions to preserve hemostatic function and reduce adverse reactions. Common transfusion-related complications (e.g., alloimmunization, non-hemolytic reactions, and circu

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… If platelet counts remain <50 × 10 9 /L after 24–72 h of steroids, adjunctive therapies (such as infliximab or rituximab) and TPO-RAs like eltrombopag may be considered [ 80 ]; persistent, steroid‐refractory cases often necessitate permanent discontinuation of immunotherapy. …

Внеклеточные нуклеотиды являются посредником в вирусных инфекциях центральной нервной системы: ключи от нейроинфламмации и нейродегенерации.

Недавний рост инфекционных заболеваний, затрагивающих центральную нервную систему, вызвал обеспокоенность по поводу их роли в нейроинфламмации и нейродегенерации. Вирусные патогены или их продукты могут вторгаться в центральную нервную систему и вызывать повреждения, ведущие к менингиту, энцефалиту, менингоэнцефалиту, миелиту или постинфекционным демиелинизирующим заболеваниям. Хотя изначально нейроинфламмация имеет защитную функцию, хроническое воспаление может способствовать развитию нейродегенеративных заболеваний. Такие механизмы, как агрегация белков и клеточные расстройства, связаны с ко

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… Indeed, TNF-α signaling was closely involved in memory loss and brain inflammation in human and mouse adult brain tissue infected with ZIKV (Figueiredo et al., 2019), and TNF-α blockade by its monoclonal antibody Infliximab was enough to prevent ZIKV-induced cognitive and motor impairment in Swiss mice …

COVID-19 Infections and Clinical Outcomes in Patients with Multiple Myeloma in New York City: A Cohort Study from Five Academic Centers.

Patients with multiple myeloma have a compromised immune system, due to both the disease and antimyeloma therapies, and may therefore be particularly susceptible to COVID-19. Here, we report outcomes and risk factors for serious disease in patients with multiple myeloma treated at five large academic centers in New York City in the spring of 2020, during which it was a global epicenter of the SARS-CoV-2 pandemic. Of 100 patients with multiple myeloma (male 58%; median age 68) diagnosed with COVID-19, 75 were admitted; of these, 13 patients (17%) were placed on invasive mechanical ventilation,

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… Nine patients received treatment with IL-6 inhibitors, tocilixumab or sarilumab, and 1 patient was treated with the IL-1 inhibitor anakinra and the TNF-alpha inhibitor infliximab. …

Cost-effectiveness of pneumococcal vaccination strategies for the elderly in Korea.

BackgroundAlthough the 13-valent pneumococcal conjugate vaccine (PCV13) showed good efficacy against pneumococcal disease in the the CAPiTA trial, the 23-valent pneumococcal polysaccharide vaccination (PPSV23) program has been ongoing for older adults aged ≥ 65 years in Korea since May of 2013. This study aimed to evaluate the cost-effectiveness of the current vaccination strategy (a single-dose PPSV23 vaccination) compared to a single-dose PCV13 vaccination and sequential PCV13-PPSV23 vaccinations in the elderly population aged ≥ 65 years.MethodsUsing a Markov model, the incremental cost-effe

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… transplantation, (5) chronic renal disease such as nephrotic syndrome or chronic renal failure, (6) HIV infection, (7) high-dose corticosteroid use (≥ 20 mg/day of prednisone or an equivalent) lasting two or more weeks, or (8) treatment with a recombinant human immunomodulator, such as rituximab, adalimumab, or infliximab …

8(th) Annual European Antibody Congress 2012: November 27-28, 2012, Geneva, Switzerland.

The 8th European Antibody Congress (EAC), organized by Terrapin Ltd., was again held in Geneva, Switzerland, following on the tradition established with the 4th EAC. The new agenda format for 2012 included three parallel tracks on: (1) naked antibodies; (2) antibody drug conjugates (ADCs); and (3) bispecific antibodies and alternative scaffolds. The meeting started and closed with three plenary lectures to give common background and to share the final panel discussion and conclusions. The two day event included case studies and networking for nearly 250 delegates who learned of the latest adva

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… Anti-idiotype antibodies to several different marketed antibody products are commercially available, including ones recognizing adalimumab, alemtuzumab, bevacizumab, infliximab, rituximab, trastuzumab and ustekinumab. … She discussed the results of 5 approved anti-TNF products (3 full-length mAbs – infliximab, adalimumab, golimumab; PEGylated Fab – certolizumab pegol; TNF receptor–Fc fusion – etanercept) where etanercept did not show efficacy in Crohn disease, but is approved for other indications. …

Passive Monoclonal and Polyclonal Antibody Therapies

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… This medication is also FDA approved for UC. 270 , 271 Infliximab (Remicade, Inflectra, Remsira) is a chimeric Mab (IgG1κ) with specificity to TNF-α and is FDA approved for IBD and multiple inflammatory arthritic diseases. … response, three studies terminated by company business Intravenous Guanylate cyclase C (GUCY2C) Inebilizumab MEDI-551 Humanized monoclonal antibody IgG2κ ADCC Antineoplastic Refractory DLBCL phase II 2016 Disease modifying systemic sclerosis, multiple sclerosis Neuromyelitis optica Intravenous CD19 Infliximab …

Oncolytic virus therapy in the elderly: immune frailty, challenges, and perspectives.

With global aging accelerating, cancer incidence among older adults is rapidly increasing. Individuals aged ≥65 years now represent 64% of new cancer cases and 71.3% of cancer-related deaths worldwide. This population exhibits a distinct immune imbalance-driven by tumor-induced immunosuppression, immunosenescence, and inflammaging-which contributes to poor tolerance of standard therapies and suboptimal outcomes with PD-1/PD-L1 inhibitors. As an emerging immunotherapeutic strategy, oncolytic viruses (OVs) selectively infect tumor cells, induce immunogenic cell death (ICD), and activate the cGAS

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… .) | Broad immune overactivation leading to organ-specific immune-related adverse events (irAEs) | Graded management: treatment interruption/dose reduction; corticosteroids as the mainstay; organ-specific second-line agents (e.g., infliximab for colitis, mycophenolate for hepatitis, IVIG/rituximab for … First-line glucocorticoids will serve as foundational therapy, with second-line, organ-specific agents such as infliximab for colitis, mycophenolate mofetil for hepatitis, and IVIG/rituximab for dermatologic and hematologic toxicity ( 8 , 9 ). …