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Biologics in Kidney Transplantation: Why and How Should We Personalize Their Dosage?

The therapeutic arsenal of immunosuppressive drugs in kidney transplantation has recently expanded with the introduction of biologics, approved or used off-label, that specifically target the immune system. Although therapeutic drug monitoring is well established for calcineurin inhibitors, its utility for biological immunosuppressants remains unclear. The objective of this narrative review was to evaluate whether biologics used to prevent or treat renal allograft rejection could be suitable candidates for therapeutic drug monitoring. This review provides (1) a comprehensive and up-to-date syn

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… Syversen SW Jørgensen KK Goll GL Brun MK Sandanger Ø Bjørlykke KH Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases: a randomized clinical trial JAMA 2021 326 23 2375 2384 10.1001/jama … Effect of therapeutic drug monitoring vs standard therapy during maintenance infliximab therapy on disease control in patients with immune-mediated inflammatory diseases: a randomized clinical trial. …

Drug-induced herpes zoster: a pharmacovigilance analysis of FDA adverse event reports from 2004 to 2024.

BACKGROUND: Herpes zoster severely impacts patients' quality of life and therapeutic results. This research utilized data from the FDA Adverse Event Reporting System (FAERS) to examine the prevalence and attributes of drug-induced herpes zoster. METHODS: We analyzed FAERS reports about zoster from Q1 2004 to Q3 2024 and developed a list of possible pathogenic agents. Ranked the 30 medicines with the greatest incidence of reported herpes zoster cases. Statistical disproportionality analysis was employed to identify an elevated reporting frequency of herpes zoster linked to a particular medicat

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… Drug name | n (%s) | Package insert suggests risk for herpes zoster adalimumab | 3577 (11.95) | Yes etanercept | 3380 (11.29) | Yes tofacitinib | 2696 (9.01) | Yes infliximab | 2240 (7.48) | Yes lenalidomide | 1639 (5.47) | Yes natalizumab | 1500 (5.01) | Yes ocrelizumab | 1224 (4.09) | Yes rituximab … For example, SLE and multiple sclerosis treatments such as anifrolumab, ocrelizumab, alemtuzumab, and fingolimod, as well as rheumatoid arthritis treatments like infliximab and tocilizumab, all include warnings about herpes zoster risk in their labels. …

Managing fatigue in patients with primary Sjögren's syndrome: challenges and solutions.

Primary Sjögren's syndrome (pSS) patients identify fatigue as their most important symptom and the one most difficult to cope with, but there are still many challenges and few solutions to manage this debilitating symptom. Promising pharmacological treatments, such as rituximab, have failed in more stringent tests including randomized controlled trials (RCTs) and meta-analysis. While non-pharmacological interventions may be safer, less costly, and address other common comorbidities, to date only aerobic exercise seems to be effective at reducing fatigue in pSS. All interventions, pharmacologic

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… Other treatments such as dehydroepiandrosterone, gamma-linolenic acid, doxycycline, and infliximab are not effective based on available data. Robust studies using non-pharmacological approaches are urgently needed. … Inefficacy of Infliximab in primary Sjögren’s Syndrome: results of the randomized, controlled trial of remicade in primary Sjögren’s Syndrome (TRIPSS) . Arthritis Rheum . 2004 ; 50 ( 4 ): 1270 – 1276 . doi: 10.1002/art.20146 15077311 73. …

Review Article: Immune Effector Cell-Mediated Enterocolitis Following CAR-T Cell Therapy-Clinical Features, Pathophysiology and Management.

BACKGROUND: Chimeric antigen receptor T-cell (CAR-T) therapy has revolutionised the treatment of hematologic malignancies, and its use is expanding rapidly into numerous other disease states including autoimmune diseases. However, CAR-T therapy is associated with a spectrum of immune-related toxicities. In addition to the already well characterized cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, it has become apparent that rarely, CAR-T can cause gastrointestinal mucosal inflammation, termed immune effector cell-mediated enterocolitis (IEC-EC). AIMS: This

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… Infliximab is faster acting and likely has greater efficacy for small bowel disease than vedolizumab. … In one study, a prior responder to infliximab was able to see a response after ruxolitinib and photopheresis, while a second treated with ruxolitinib alone had no response [ 27 ]. …

Evolving Paradigms in Chronic Graft-Versus-Host Disease: From Global Immunosuppression to Precision Targeted and Cell-Based Therapies.

Allogeneic haematopoietic stem cell transplantation (allo-HSCT) is a well-established treatment for a range of medical conditions. However, the procedure carries with it a significant risk of chronic graft-versus-host disease (cGVHD), which can have a considerable impact on patients’ quality of life and clinical outcomes. In recent years, there has been a marked shift in treatment strategies for this condition, with greater emphasis being placed on novel targeted therapies and cell therapies that target specific pathways. This shift in approach signifies a more profound comprehension of the pa

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… In another retrospective study, three patients with steroid-refractory cGVHD all achieved clinical remission after receiving infliximab; however, all experienced infections, highlighting the associated infectious risk [ 162 ]. … Furthermore, a prospective trial demonstrated that the addition of infliximab to standard GVHD prophylaxis failed to reduce the incidence of GVHD but significantly increased the risk of bacterial and invasive fungal infections [ 163 ]. …

Precision Medicine in Inflammatory Bowel Disease: A Spotlight on Emerging Molecular Biomarkers.

Inflammatory bowel diseases (IBD) remain challenging in terms of understanding their causes and in terms of diagnosing, treating, and monitoring patients. Modern diagnosis combines biomarkers, imaging, and endoscopic methods. Common biomarkers like CRP and fecal calprotectin, while invaluable tools, have limitations and are not entirely specific to IBD. The limitations of existing markers and the invasiveness of endoscopic procedures highlight the need to discover and implement new markers. With an ideal biomarker, we could predict the risk of disease development, as well as the possibility of

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… Therefore, Cao et al. tested the efficacy of fecal OSM alone and in combination with fecal calprotectin on three levels: diagnosing IBD, testing disease activity, and predicting response on infliximab therapy [ 87 ]. … The study included 340 children diagnosed with IBD who were treated with infliximab or adalimumab. …

Hematologic Malignancy Risk in Inflammatory Arthritis Patients Treated with TNF Inhibitors: The Real-Life Data from the HUR-BIO Registry.

INTRODUCTION: This study aimed to assess the incidence of hematologic malignancy (HM) among inflammatory arthritis (IA) patients receiving tumor necrosis factor inhibitors (TNFi) compared with the general Turkish population. METHODS: HUR-BIO (Hacettepe University Rheumatology Biologic Registry) is a single-center biological disease-modifying anti-rheumatic drug (bDMARD) registry since 2005. Patients with IA, including rheumatoid arthritis, spondyloarthritis, or psoriatic arthritis who had at least one visit after the TNFi were screened from 2005 to November 2021. Standardized incidence rates

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… Currently, there are five anti-TNF antibodies approved as a treatment option: three monoclonal agents (infliximab, adalimumab, and golimumab), PEGylated Fab’ fragment (certolizumab), and TNF receptor fusion protein (etanercept) [ 3 ]. … This was consistent with the result that the risk of lymphoma was higher with mAbs than with soluble receptor anti-TNF therapy in the RATIO registry collected 38 cases of lymphoma (SIR [95% CI], 4.1 [2.3–7.1] for infliximab and 3.6 [2.3–5.6] for adalimumab vs. 0.9 [0.4–1.8] for etanercept) [ 26 ]. …

Pyoderma gangrenosum: pathogenetic mechanisms and their implications for treatment.

Pyoderma gangrenosum (PG) is a rare inflammatory skin disease belonging to the group of neutrophilic dermatoses. The pathogenesis of PG involves a predisposing genetic background that facilitates a dysregulated innate and adaptive immune response, with an imbalance between pro-inflammatory and anti-inflammatory mediators, leading to neutrophil-driven inflammatory damage. Several immunosuppressants and immunomodulatory drugs are currently available for the treatment of PG, in combination with topical therapies, wound management and pain control strategies. Systemic corticosteroids and cyclospor

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… Tumor necrosis factor alpha inhibitors The overexpression of TNF-α and its related cytokines in PG lesional skin has led to frequent administration of TNF-α antagonists including adalimumab, certolizumab pegol, etanercept, infliximab and golimumab for the treatment of PG. … Complete remission was observed in 87% of PG patients with disease duration of less than 12 weeks, compared with 69% of those with disease duration of more than 12 weeks [ 62 ].However, higher response rates favour adalimumab and infliximab [ 64 , 65 ]. …

Dermatological manifestations of hematologic neoplasms. Part II: nonspecific skin lesions/paraneoplastic diseases.

Cutaneous manifestations occur in the course of hematologic malignancies and precede, accompany or occur late in relation to the diagnosis. They result from paraneoplastic phenomena, tumor infiltrations, immunosuppression resulting from the hematologic disease itself or its treatment. The dermatologist must be aware of these conditions that may be helpful both in the diagnosis of the underlying disease and in reducing patient morbidity. This review (part II) addresses the paraneoplastic dermatological changes associated with systemic hematologic malignancies.

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… In a randomized clinical trial, 69% of the patients treated with infliximab showed improvement and 21% experienced remission six weeks after infusion of the first dose. 25 In addition to infliximab, adalimumab, etanercept, and ustekinumab are also used. 18 In disease refractory to other alternatives, … Infliximab for the treatment of pyoderma gangrenosum: a randomised, double blind, placebo controlled trial. Gut. 2006;55:505–509. doi: 10.1136/gut.2005.074815. 26. Cheng S., Edmonds E., Ben-Gashir M., Yu R.C. Subcorneal pustular dermatosis: 50 years on. …

Current Therapeutic Options for the Main Monogenic Autoinflammatory Diseases and PFAPA Syndrome: Evidence-Based Approach and Proposal of a Practical Guide.

Monogenic autoinflammatory diseases are rare conditions caused by genetic abnormalities affecting the innate immunity. Previous therapeutic strategies had been mainly based on results from retrospective studies and physicians' experience. However, during the last years, the significant improvement in their genetic and pathogenic knowledge has been accompanied by a remarkable progress in their management. The relatively recent identification of the inflammasome as the crucial pathogenic mechanism causing an aberrant production of interleukin 1β (IL-1β) in the most frequent monogenic autoinflamm

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… The use of infliximab and adalimumab has been associated with severe paradoxical reactions, and therefore, they are currently not recommended in TRAPS. While etanercept is a receptor fusion protein, infliximab, and adalimumab are TNF monoclonal antibodies. … One of the proposed mechanisms by which infliximab is involved in a hyperinflammatory response is related to the failure in shedding infliximab-bound receptor from the cell surface, with the subsequent activation of antiapoptotic mechanisms and a widespread inflammatory response ( 171 ). …

Identified Medications Causing Medication-Related Osteonecrosis of the Jaw: A Literature Review.

Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse event that occurs in patients treated with certain medications, leading to a major side effect that can result in substantial morbidity. MRONJ is known to be associated with antiresorptive (AR) and antiangiogenic (AA) medicines, but recent evidence suggests that other medications may also be involved. Recognizing a broad range of drug-induced risk factors is important, notably in light of the increasing number of drugs associated with MRONJ. The primary objective of this review is to update and synthesize findings from th

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… Anti-TNF-α drugs for the treatment of inflammatory diseases include infliximab, adalimumab, etanercept, golimumab, and certolizumab pegol. Romosozumab This medication is a new mAb for osteoporosis. … According to a case report by Oryniak et al. (2024), a 78-year-old man who had received infliximab treatment for ten years suffered from severe bone necrosis in his mandible after having dental extractions. …

Drug-Induced Pulmonary Toxicity in the Era of Immunotherapy and Biologics: A Narrative Review of Mechanism, Diagnosis, and Management.

Drug-induced interstitial lung disease (DI-ILD) has emerged as a clinically significant complication associated with a broadening spectrum of therapeutic agents. DI-ILD can result in significant morbidity and mortality if not promptly diagnosed and treated. In this review, we synthesize current evidence concerning the epidemiology, risk factors, pathophysiological mechanisms, clinical manifestations, diagnostic approaches, and management strategies of DI-ILD, with focused emphasis on three major therapeutic groups: immune checkpoint inhibitors (ICIs), chimeric antigen receptor T-cell (CAR-T) t

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… Kashima S Moriichi K Ando K Ueno N Tanabe H Yuzawa S Development of pulmonary sarcoidosis in Crohn’s disease patient under infliximab biosimilar treatment after long-term original infliximab treatment: a case report and literature review BMC Gastroenterol 2021 21 1 373 10.1186/s12876-021-01948-6 34641810 … Development of pulmonary sarcoidosis in Crohn’s disease patient under infliximab biosimilar treatment after long-term original infliximab treatment: a case report and literature review. …

Systemic complications of rheumatoid arthritis: Focus on pathogenesis and treatment.

As a systemic autoimmune disease, rheumatoid arthritis (RA) usually causes damage not only to joints, but also to other tissues and organs including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system. Excessive complications are closely related to the prognosis of RA patients and even lead to increased mortality. This article summarizes the serious complications of RA, focusing on its incidence, pathogenesis, clinical features, and treatment methods, aiming to provide a reference for clinicians to better manage the complications of RA.

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… Infliximab has beneficial effects on bone metabolism in RA patients, studies on the effect of TNFi on bone loss have demonstrated that the use of infliximab can improve bone loss in RA patients ( 145 ). … Infliximab improves sleep quality and relieves vigilance disorders in RA patients, possibly a result of central effects by suppressing TNF-α circulation ( 168 ). …

Urgent considerations on renal immune-related adverse events in oncology practice.

In recent years, immune checkpoint inhibitors (ICIs) have emerged as a critical component of hematological malignancies and solid malignant tumors therapy. However, clinical practice has revealed that these agents may induce immune-related adverse events (irAEs). Notably, renal irAEs stands out as a significant clinical concern, frequently necessitating treatment discontinuation and thereby enabling tumor progression. Renal irAEs constitutes a critical consideration for patients with cancer complicated by chronic kidney disease (CKD). This review systematically examines the immunologic pathoge

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… | 10 (8 cases of biopsy-proven or 2 cases of clinically suspected ICI-AIN) | Infliximab-containing regimens were used to treat 10 patients with ICI-AIN. … Recent case series indicate that infliximab may be an effective therapeutic option for patients with relapsing or refractory ICIs-AIN ( 90 ). …

Преодоление разрыва в знаниях о беременности: реальный всемирный анализ потребления лекарств и риска взаимодействия наркотиков в болезни Крона и множественном склерозе.

Исключение беременных людей из клинических испытаний привело к значительному разрыву в уровне медицинских знаний для этого населения. Использование реальных данных (РВД) является важнейшим звеном в распространении и использовании лекарственных средств во время беременности. С помощью базы данных планов медицинского страхования " IQVIA Pharmetrics(R) Plus " мы провели оценку использования методов лечения заболеваний и сопутствующих лекарств у беременных. Мы сосредоточились на two примеры: болезнь Крона (CD) и множественный склероз (MS)-анализирующие пациенты с историей использования D

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… The usage of other mAbs or mAb‐derived medicines, including vedolizumab, infliximab, and certolizumab pegol, did not display a notable difference between pregnancy stages. Lastly, consistent prescription of mesalamine throughout all pregnancy stages was also observed. … Routes include: subcutaneous (adalimumab (or biosimilar), ustekinumab, certolizumab pegol), oral (prednisone, mesalamine, sulfasalazine), intravenous (infliximab (or biosimilar), vedolizumab), and rectal (mesalamine). …

A retrospective review of the management of patients following a malignancy diagnosis on biologic therapies for the treatment of dermatological disorders.

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… and Registry (a US-based registry of 12,090 patients). 23 , 24 Table I Available articles studying the association between biologic drugs in patients with psoriasis and a history of cancer Study Biologic agent(s) Number of patients diagnosed with cancer Cancer(s) diagnosed Balato et al 4 Etanercept Infliximab … Study | Biologic agent(s) | Number of patients diagnosed with cancer | Cancer(s) diagnosed Balato et al 4 | Etanercept Infliximab | 1 | Chronic lymphocytic leukemia Bellinato et al 5 | Secukinumab Ixekizumab | 10 | Melanoma (3) Prostate carcinoma (2) Rectal adenocarcinoma (1) Breast adenocarcinoma (2 …

Review of COVID-19 Therapeutics by Mechanism: From Discovery to Approval.

The global research and pharmaceutical community rapidly mobilized to develop treatments for coronavirus disease 2019 (COVID-19). Existing treatments have been repurposed and new drugs have emerged. Here we summarize mechanisms and clinical trials of COVID-19 therapeutics approved or in development. Two reviewers, working independently, reviewed published data for approved COVID-19 vaccines and drugs, as well as developmental pipelines, using databases from the following organizations: United States Food and Drug Administration (US-FDA), European Medicines Agency (EMA), Japanese Pharmaceutical

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… Remicade (infliximab) Infliximab blocks tumor necrosis factor (TNF) [formerly named TNF-α) that was developed by Janssen Biotech (Horsham, PA, USA). 83 Infliximab received FDA approval for treating Crohn disease, colitis, and RA in 1998. 84 Infliximab is now being repurposed to treat COVID-19 patients … The study consisted of three arms (infliximab, abatacept, and cenicriviroc). Participants in each arm received either drug or placebo, together with standard of care. Participants in the infliximab arm received a single 5 mg/kg dose of infliximab on day 1. …

Antibody and aptamer-based therapies for osteoarthritis: Application of antibodies and promise of aptamers.

Osteoarthritis (OA) is a common degenerative inflammatory joint disease with progressive loss of articular cartilage that undermines patients' quality of life. There are no regulatory-approved, disease-modifying OA medications, despite a great deal of studies done to elucidate OA pathogenesis. Until now, OA pharmacological treatment focused mainly on generalized inhibition of inflammation and pain. Currently, monoclonal antibodies and nucleic-acid aptamers emerge as targeted therapies offering potential alternatives by addressing the complex challenges posed by OA, such as specifically reducin

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… efficacy of infliximab were further evaluated in a phase 4, unbalanced, randomized, double-blind pilot study ( NCT01144143 ) for the treatment of knee OA. … Nanocomposites-based targeted oral drug delivery systems with infliximab in a murine colitis model J. Nanobiotechnol. 18 2020 133 10.1186/s12951-020-00693-4 PMC7493402 32933548 77 Zhang Q. Lv H.h. Chen A. Liu F. Wu X. Efficacy of infliximab in a rabbit model of osteoarthritis Connect. …

Неделя ГЭЭ 2017 Презентации на плакате

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Molecular therapeutic strategies targeting pancreatic cancer induced cachexia.

Pancreatic cancer (PC) induced cachexia is a complex metabolic syndrome associated with significantly increased morbidity and mortality and reduced quality of life. The pathophysiology of cachexia is complex and poorly understood. Many molecular signaling pathways are involved in PC and cachexia. Though our understanding of cancer cachexia is growing, therapeutic options remain limited. Thus, further discovery and investigation of the molecular signaling pathways involved in the pathophysiology of cachexia can be applied to development of targeted therapies. This review focuses on three main p

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… In phase II clinical trials, adjunct infliximab to standard gemcitabine therapy showed no significant change in lean body mass, performance status, or survival[ 58 , 59 ]. … A multicenter, phase II study of infliximab plus gemcitabine in pancreatic cancer cachexia. J Support Oncol. 2008;6:18–25. 59. Centocor, Inc. …