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Critical analysis of the prescription and evaluation of monoclonal antibodies approved in Germany for the outpatient setting from 2010-2021.

Monoclonal antibodies (mAbs) are increasingly being launched on the German market and account for a growing share of total drug costs every year. In 2021 alone, eleven monoclonal antibodies were among the 30 best-selling drugs, accounting for 9.91% of total drug costs. In contrast, a considerable additional benefit of the newly introduced monoclonal antibodies is not predominantly demonstrable. Therefore, our objective was to analyze the drug prescriptions and associated costs in comparison to the benefit assessment of the Federal Joint Committee (GBA). This paper analyzes 62 monoclonal antibo

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… Migraine prophylaxis for at least 4 migraine days per month 19 | Cemiplimab (Libtayo) | 2019 | 92.6/332.45 | 144.9/205.45 | Metastasized or locally advanced cutaneous squamous cell carcinoma 20 | Lanadelumab (Takhzyro) (O) | 2019 | 47.8/1053.71 | 61.4/1052.37 | Prophylaxis of attacks of hereditary angioedema …

Current state and future opportunities in granulocyte colony-stimulating factor (G-CSF).

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… Other side effects are described, for example, by the EMA in the summary of product characteristics of pegfilgrastim (Neulasta): Hypersensitivity reactions, including rash, urticaria, angioedema, dyspnea, erythema, flushing, and hypotension, occurred during initial or subsequent treatment with pegfilgrastim …

Preventing and Repairing Myeloma Bone Disease by Combining Conventional Antiresorptive Treatment With a Bone Anabolic Agent in Murine Models.

Multiple myeloma is a plasma cell malignancy, which develops in the bone marrow and frequently leads to severe bone destruction. Current antiresorptive therapies to treat the bone disease do little to repair damaged bone; therefore, new treatment strategies incorporating bone anabolic therapies are urgently required. We hypothesized that combination therapy using the standard of care antiresorptive zoledronic acid (Zol) with a bone anabolic (anti-TGFβ/1D11) would be more effective at treating myeloma-induced bone disease than Zol therapy alone. JJN3 myeloma-bearing mice (n = 8/group) treated w

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… Acute dystonic reaction leading to lingual hematoma mimicking angioedema. Indian J Pharmacol. 2017;49(4):325–7. 61. Neer RM, Arnaud CD, Zanchetta JR, et al. Effect of parathyroid hormone (1‐34) on fractures and bone mineral density in postmenopausal women with osteoporosis. …

Роль альфа-рецептора, активированного пероксидисом, в нейродегенеративных заболеваниях и других неврологических расстройствах: перспективы клинического применения.

Альфа-рецептор, активированный с помощью пероксисом, является членом сверхсемейства суперрецептора ядерного гормона и функционирует в качестве коэффициента транскрипции, связанного с регулированием клеточного метаболизма. Предыдущие исследования показали, что PPARα играет ключевую роль в возникновении и развитии нейродегенеративных заболеваний. Таким образом, альфа-агонисты, работающие на рецепторах, привлекают все большее внимание в качестве потенциальных средств лечения неврологических расстройств. Цель этого обзора состоит в том, чтобы прояснить прогресс в области исследований, касающихся п

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… Other possible adverse reactions include dizziness, vertigo, myopathy, rhabdomyolysis, angioedema, urticaria, and rash (Ahmed et al., 2021). …

Adverse Events of Oncologic Immunotherapy and Their Management.

Over the past two decades, immunotherapy has emerged as a promising treatment option for patients with cancer. However, newer versions of immunotherapy, such as checkpoint inhibitors, may be associated with unusual adverse effects (AEs) that can range in severity from mild to life-threatening. Unlike common AEs of conventional chemotherapy, which have a predictable nadir or cyclic pattern after administration, AEs of these newer immunotherapies are variable, depending on the type of immunotherapy, route of administration, and mechanism of action. The onset and resolution of these AEs may be pr

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… release.[ 17 , 30 ] Infusion-related AEs can occur within 30 min to 2 h after the infusion or 24 h later and are described as pruritus, chills, fever, asthenia, dyspnea, nausea, rash, or headache.[ 30 , 34 ] Severe and potentially fatal infusion-related AEs may occur in 0.3% of patients and present as angioedema …

Evidence for the use of intravenous immunoglobulins--a review of the literature.

Intravenous immunoglobulins (IVIg) were first introduced in the middle of the twentieth century for the treatment of primary immunodeficiencies. In 1981, Paul Imbach noticed an improvement of immune-mediated thrombocytopenia, in patients receiving IVIg for immunodeficiencies. This opened a new era for the treatment of autoimmune conditions with IVIg. Since then, IVIg has become an important treatment option in a wide spectrum of diseases, including autoimmune and acute inflammatory conditions, most of them off-label (not included in the US Food and Drug Administration recommendation). A panel

Bruton's tyrosine kinase inhibition-An emerging therapeutic strategy in immune-mediated dermatological conditions.

Bruton's tyrosine kinase (BTK), a member of the Tec kinase family, is critically involved in a range of immunological pathways. The clinical application of BTK inhibitors for B-cell malignancies has proven successful, and there is strong rationale for the potential benefits of BTK inhibitors in some autoimmune and allergic conditions, including immune-mediated dermatological diseases. However, the established risk-to-benefit profile of "first-generation" BTK inhibitors cannot be extrapolated to these emerging, non-oncological, indications. "Next-generation" BTK inhibitors such as remibrutinib

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… Chronic spontaneous urticaria CSU is defined by the presence of wheals and/or angioedema occurring for more than 6 weeks without a specific trigger. 45 It is a common condition, affecting approximately 1% of the population worldwide, 46 and showing an increasing trend over time. 47 The burden experienced …

Cytokine release syndrome in solid tumours: mechanism-based therapeutic strategies for prevention and management.

Cytokine release syndrome (CRS) represents a spectrum of immune hyperactivation initiated by rapid T-cell engagement and amplified through innate immune cells, particularly monocytes and macrophages, with downstream cytokine cascades driving endothelial dysfunction, capillary leak and organ impairment. CRS is a frequent, class-associated toxicity of T-cell-engaging immunotherapies and is being observed with increasing regularity as T-cell-redirecting therapies progress through clinical development in solid tumours. Although CRS is typically less severe in patients with solid tumours relative t

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… | Coagulopathy (hypofibrinogenaemia) | | | Liver function derangement | | | Evidence of haemophagocytosis on bone-marrow examination | | | Elevated sCD25 | | | Decreased or absent NK-activity IRR 48 | Anaphylaxis | Within minutes of infusion or at second administration | Elevated IgE | Angioedema …

Targeted Therapy for Idiopathic Inflammatory Myopathy.

BACKGROUND: Idiopathic inflammatory myopathies (IIM) are a heterogeneous group of autoimmune disorders characterized by chronic muscle inflammation and significant extramuscular involvement. A substantial proportion of patients exhibit refractory or relapsing disease despite conventional immunosuppressive therapies, necessitating the development of novel targeted treatments. Recent immunological advances have identified novel therapeutic targets-including B cells, T cells, cytokines and intracellular signalling pathways-paving the way for personalized treatment. Targeted therapies represent pr

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… Kang , “ Ruxolitinib for Refractory PL‐12 Antisynthetase Syndrome‐Associated Angioedema‐Like Panniculitis With Clonal T‐Cell Receptor Gene Rearrangement ,” JAMA Dermatology 160 , no. 3 ( 2024 ): 363 – 366 . 38117485 10.1001/jamadermatol.2023.4940 85 L. Ladislau , X. Suárez‐Calvet , S. …

MUKnine OPTIMUM protocol: a screening study to identify high-risk patients with multiple myeloma suitable for novel treatment approaches combined with a phase II study evaluating optimised combination of biological therapy in newly diagnosed high-risk multiple myeloma and plasma cell leukaemia.

INTRODUCTION: Multiple myeloma (MM) is a plasma cell tumour with over 5800 new cases each year in the UK. The introduction of biological therapies has improved outcomes for the majority of patients with MM, but in approximately 20% of patients the tumour is characterised by genetic changes which confer a significantly poorer prognosis, generally termed high-risk (HR) MM. It is important to diagnose these genetic changes early and identify more effective first-line treatment options for these patients. METHODS AND ANALYSIS: The Myeloma UK nine OPTIMUM trial (MUKnine) evaluates novel treatment

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… Grade 4 rash discontinue including angioedema, exfoliative or bullous rash or Steven Johnson syndrome or toxic epidermal necrosis. …

Proceedings of the 27th European Paediatric Rheumatology Congress (PReS 2021) : Virtual. 19-21 September 2021

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A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.

The latest pandemic, coronavirus disease-2019 (COVID-19), is associated with high prevalence and easy transmission, which is expanding globally with no conventional treatment or vaccine. The new virus revealed 79% and 50% genomic similarities with severe acute respiratory syndrome coronavirus (SARS-CoV) and Middle East respiratory syndrome coronavirus (MERS-CoV), respectively. Accordingly, since the disease resists testing and adopting new therapeutics, repositioning pre-existing drugs may present a fast and attractive strategy with known safety, characteristics, and dosage used. However, they

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… Bradykinin B2 receptor antagonist Icatibant Icatibant is a bradykinin B2 receptor inhibitor and available in the US and Europe as a therapy for hereditary angioedema. …

Therapeutic Antibodies in Cancer Treatment in the UK.

The growing understanding of the molecular mechanisms of carcinogenesis accelerated the development of monoclonal therapeutic antibodies to specifically target multiple cancer pathways. Recombinant protein therapeutics now constitute a large proportion of yearly approved medicines. Oncology, autoimmune diseases and to a smaller degree the prophylaxis of organ transplant rejection are their main application areas. As of the date of this review, 37 monoclonal antibody products are approved for use in cancer treatments in the United Kingdom. Currently, the antibody therapeutics market is dominate

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… to the body systems, however, they are associated with a long list of side-effects that are related to their effect on the EGFR on healthy tissues, these include very common but less serious reactions such as alopecia, constipation, dry mucous membranes, to uncommon but very serious reaction such as angioedema …

The clinical management of lenalidomide-based therapy in patients with newly diagnosed multiple myeloma.

Lenalidomide is an integral, yet evolving, part of current treatment pathways for both transplant-eligible and transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). It is approved in combination with dexamethasone as first-line therapy for transplant-ineligible patients with NDMM, and as maintenance treatment following autologous stem cell transplantation (ASCT). Although strong clinical trial evidence has supported the integration of lenalidomide into current treatment paradigms for NDMM, applying those paradigms to individual patients and determining which patients are

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… Treatment interruption or discontinuation should be considered for grade 2 or 3 skin rash, and lenalidomide must be discontinued for angioedema, grade 4 rash, exfoliative or bullous rash, or if serious reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or Drug Reaction with Eosinophilia …

Passive Monoclonal and Polyclonal Antibody Therapies

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… active hepatitis B infection. 105 Adverse reactions The local adverse reactions that may occur at the site of injection after intramuscular (IM) administration are pain, tenderness, swelling, and erythema. 100 , 101 , 109 The systemic effects that may occur after IM administration are urticaria, angioedema …

Heart failure with preserved ejection fraction in cancer patients and survivors. A scientific statement of the Heart Failure Association of the ESC and the ESC Council of Cardio-Oncology.

Heart failure with preserved ejection fraction (HFpEF) is increasingly recognized in cancer patients and survivors, yet it remains underdiagnosed and its epidemiology largely unknown. This statement underscores the imperative need to include HFpEF in the cardiotoxicities identified during or after anticancer treatments. It also highlights the prognostic value of pre-existing HFpEF for periprocedural and cardiotoxicity risk and it discusses the challenges in the diagnosis and treatment of HFpEF in cancer patients. It also explores the aetiologic role of anticancer therapies (chemotherapy, targe

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… states, vasculitis; ***Non‐Cardiovascular: renal causes (nephrotic syndrome, acute kidney injury, chronic kidney disease, glomerulonephritis), hepatic causes (acute liver failure, acute hepatic cirrhosis, endocrine and metabolic causes (hyper‐ and hypo‐thyroidism, Cushing's syndrome, malnutrition), angioedema …

Monoclonal Gammopathies of Clinical Significance: A Critical Appraisal.

Monoclonal gammopathies of clinical significance (MGCSs) represent a group of diseases featuring the association of a nonmalignant B cells or plasma cells clone, the production of an M-protein, and singularly, the existence of organ damage. They present a current framework that is difficult to approach from a practical clinical perspective. Several points should be addressed in order to move further toward a better understanding. Overall, these entities are only partially included in the international classifications of diseases. Its definition and classification remain ambiguous. Remarkably,

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… Subtype | Mechanism | Main Organ Involved AUTOANTIBODY Type II Cryoglobulinemia | Rheumatoid | S, K, PN, SYS C1 inhibitor deficiency | C1 inhibitor | Angioedema vWD | vWF | Bleeding Bullous diseases | Collagen VII | S Xanthomatosis | Lipoproteins | S, tendons, other Cold agglutinin disease | RBC | S, …

Abstracts from the 37th Annual Meeting of the Society of General Internal Medicine, 2014, San Diego, CA, USA.

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Skin-Directed Therapies in Mycosis Fungoides: An Update.

Mycosis fungoides (MF) is the most common subtype of cutaneous T cell lymphoma (CTCL), characterized by monoclonal proliferation of malignant T cells primarily involving the skin. The management of MF, especially in the early stages, involves skin-directed therapies (SDTs) to achieve disease control, alleviate symptoms, and enhance the quality of life (QoL). This review provides an updated overview of SDTs in MF treatment, including topical agents such as corticosteroids, retinoids, mechlorethamine, carmustine, imiquimod, as well as photodynamic therapy (PDT); phototherapy modalities including

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… CAILS | 16.4% of participants were responders compared to 4% in the placebo group at 8 weeks, 40% compared to 4% in the placebo group at 16 weeks; 48.7% of patients achieved a treatment response at 24 weeks compared to week 16 in SGX301 treatment group | Serious AEs reported during the study included angioedema …

Infarcts and ischemia in the abdomen: an imaging perspective with an emphasis on cross-sectional imaging findings.

Infarcts and ischemia of abdominal organs may present with acute abdominal pain, and early diagnosis is crucial to prevent morbidity and mortality. Unfortunately, some of these patients present in poor clinical conditions to the emergency department, and imaging specialists are crucial for optimal outcomes. Although the radiological diagnosis of abdominal infarcts is often straightforward, it is vital to use the appropriate imaging modalities and correct imaging techniques for their detection. Additionally, some non-infarct-related abdominal pathologies may mimic infarcts, cause diagnostic con

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… segmental veno-occlusive mesenteric ischemia, and the patient was treated accordingly Other clinical entities presenting with segmental and symmetrical bowel wall thickening, such as inflammatory bowel disease, infections, radiation enteritis, spontaneous intramural bowel hematoma, portal enteropathy, and angioedema …