Результаты поиска

High-yield production and preclinical protection assessment of a Chinese Hamster Ovary-K1 (CHO-K1) derived PRV gB and gD subunit vaccine against variant pseudorabies virus in pigs.

Pseudorabies virus (PRV) re-emergence in swine highlights the need for safe, scalable vaccines compatible with DIVA surveillance. We developed a CHO - K1 subunit platform expressing PRV gB-N + IV and gD that achieved high and consistent antigen yields (1.12 and 2.0 g/L, respectively) with downstream purity >95 %, supporting a practical manufacturing path for veterinary biologics. Formulated with Montanide ISA 201 VG or aluminum hydroxide, the vaccine was evaluated in piglets challenged with a virulent JK strain and compared with two commercial inactivated vaccines. Under a discriminatory intra

Обзор описательной части по вопросу о безопасности глатирамерного ацетатата при множественном склерозе: сосредоточение внимания на Европе.

Глатирамер ацетат (GA) является ключевой терапией для повторного склероза (MS) из-за его благоприятного профиля безопасности. Долгосрочные данные, рассчитанные на десятилетия, свидетельствуют о том, что они продолжают использоваться в различных популяциях пациентов. Неблагоприятные явления включают реакцию на локальные инъекции, липоатрофию или некроз, а также редкие случаи повреждения печени. ГУ оказывает минимальное воздействие на иммунную функцию и не повышает риск оппортунистических инфекций, что делает их пригодными для пациентов, подверженных риску заражения или реактивации скрытых инфек

Совпадение в аннотации оригинала
Glatiramer acetate (GA) has been a pivotal therapy for relapsing multiple sclerosis (MS) due to its favorable safety profile. Long-term data spanning decades demonstrate its continued use in diverse patient populations. Adverse events include manageable localized injection site reactions, lipoatrophy or necrosis, and rare cases of liver injury. GA has minima…

Anakinra in the management of adult-onset still's disease: a single-center experience.

Adult-onset Still's disease (AOSD) is a rare systemic autoinflammatory disorder of unknown etiology characterized by systemic inflammation, … 19 ± 13.5 mg vs. 4.6 ± 5.8 mg, p < 0.001]. Mild adverse events occurred in 11 patients (32.3%) with injection site reactions being the most common. One patient (2.9%) was diagnosed with tuberculosis within the treatment period. Anakinra is an effective and generally safe option for biological treatment initiation in the management of AOSD.

Evaluation of Safety and Efficacy of Emicizumab Prophylaxis in Egyptian Pediatric Patients with Hemophilia A.

OBJECTIVE: Hemophilia A (HA) is a hereditary X-linked bleeding disorder secondary to deficiency of the clotting factor VIII (FVIII). Emicizumab is a monoclonal antibody that replaces the function of the activated FVIII and prevents bleeding in HA patients. Emicizumab is expected to ameliorate bleeding risk in those patients together with subsequent complications. However, there is a scarcity of data about its safety and efficacy in patients with HA. We aimed to evaluate the safety and efficacy of emicizumab prophylaxis in Egyptian pediatric patients with HA. MATERIALS AND METHODS: A prospecti

Safety and Adverse Effects Related to COVID-19 Viral Vector Vaccines: A Systematic Review.

BACKGROUND: There have been safety concerns regarding the COVID-19 vaccines because of their unprecedented speed of development. Therefore, systematic reviews are necessary to address these concerns and reduce public hesitancy regarding COVID-19 vaccines. This study aims to systematically review the reported adverse events related to viral vector COVID-19 vaccines. MATERIALS AND METHODS: We performed a systematic search in the databases of PubMed, Scopus, Web of Science, and Cochrane on September 15th, 2021. This study adheres to the Preferred Reporting Items for Systematic Reviews and Meta-A

SLN124, a GalNAc conjugated 19-mer siRNA targeting tmprss6, reduces plasma iron and increases hepcidin levels of healthy volunteers.

SLN124, an N-acetylgalactosamine conjugated 19-mer short interfering RNA, is being developed to treat iron-loading anemias (including beta-t … e to adverse events, and most treatment-emergent adverse events were mild, including transient mild injection site reactions, resolving without intervention. SLN124 was rapidly absorbed, with a median tmax of 4-5 h across all treatment groups, and largely eliminated from plasma by 48 h. Plasma concentrations increased in a greater than dose proportional fashion between t …

Psoriasis patient preferences for the use of biologics during the coronavirus era.

Understanding patient preferences concerning the use of biologics for psoriasis treatment can support proper treatment selection to satisfy … experiment: efficacy at 1 year, risk of serious infections requiring hospitalization, incidence of injection site reactions, administration route and visits, co-payment, indications, and efficacy on skin symptoms and other manifestations (the last two have not been evaluated in previous studies). Data were collected from October 4 to October 8, 2021. An analysis of data …

Safety, Tolerability and Pharmacokinetics of Half-Life Extended Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Monoclonal Antibodies AZD7442 (Tixagevimab-Cilgavimab) in Healthy Adults.

BACKGROUND: AZD7442 is a combination of extended half-life, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-specific neutralizing monoclonal antibodies (tixagevimab and cilgavimab). METHODS: This phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study evaluated AZD7442 administered intramuscularly (300 mg) or intravenously (300, 1000, or 3000 mg) in healthy adults (aged 18-55 years). The primary end point was safety and tolerability. Secondary end points included pharmacokinetics and antidrug antibodies. RESULTS: Between 18 August and 16 Octo

Comparative efficacy and safety of combination therapy with infliximab for Crohn's disease: a systematic review and network meta-analysis.

PURPOSE: There is not enough information to position medications for the treatment of Crohn's disease (CD). Therefore, using a network meta-analysis and systematic review, we evaluated the efficacy and safety of combination therapy and infliximab (IFX) monotherapy in CD patients. METHODS: We identified randomized controlled trials (RCTs) in CD patients who were given IFX-containing combination therapy versus IFX monotherapy. Induction and maintenance of clinical remission were the efficacy outcomes, while adverse events were the safety outcomes. The surface under cumulative ranking (SUCRA) pr

IgE and anaphylaxis specific to the carbohydrate alpha-gal depend on IL-4.

BACKGROUND: Alpha-gal (Galα1-3Galβ1-4GlcNAc) is a carbohydrate with the potential to elicit fatal allergic reactions to mammalian meat and drugs of mammalian origin. This type of allergy is induced by tick bites, and therapeutic options for this skin-driven food allergy are limited to the avoidance of the allergen and treatment of symptoms. Thus, a better understanding of the immune mechanisms resulting in sensitization through the skin is crucial, especially in the case of a carbohydrate allergen for which underlying immune responses are poorly understood. OBJECTIVE: We aimed to establish a

Decoupling Fe0 Application and Bioaugmentation in Space and Time Enables Microbial Reductive Dechlorination of Trichloroethene to Ethene: Evidence from Soil Columns.

Fe0 is a powerful chemical reductant with applications for remediation of chlorinated solvents, including tetrachloroethene and trichloroethene. Its utilization efficiency at contaminated sites is limited because most of the electrons from Fe0 are channeled to the reduction of water to H2 rather than to the reduction of the contaminants. Coupling Fe0 with H2-utilizing organohalide-respiring bacteria (i.e., Dehalococcoides mccartyi) could enhance trichloroethene conversion to ethene while maximizing Fe0 utilization efficiency. Columns packed with aquifer materials have been used to assess the e

The JNK signaling pathway against titanium-particle-induced osteoclastogenesis and bone resorption in vivo.

OBJECTIVE: The c-Jun N-terminal kinases (JNK) signaling pathway may be involved in the regulation of osteoclast development. The purpose of this investigation was to investigate whether SB600125, a JNK inhibitor, could attenuate titanium-particle-induced inflammatory osteolysis in vivo. MATERIALS AND METHODS: A total of 45 mice were randomly divided into a Sham group, a Titanium group, and a Titanium + JNK inhibitor group, 15 mice per group. After establishing an air pouch bone graft model, we injected phosphate-buffered saline (PBS), titanium particles, or titanium particles + JNK inhibitor

Adalimumab-Adbm: The First Interchangeable Biosimilar for the Treatment of Inflammatory Diseases.

OBJECTIVE: The objective of the study was to review the pharmacologic and clinical profile of adalimumab-adbm (BI 695501), the first interch … ety between adalimumab-adbm and reference adalimumab. Common adverse events included infections and injection site reactions. Similar to reference adalimumab, adalimumab-adbm contains black box warnings related to serious infections and malignancy. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Adalimumab-adbm is the first interchangeable biosimilar to be approved for …

Ixekizumab four-week dosing is comparable to two-week dosing in psoriasis patients and reduces treatment costs: experience in a real-world setting over a 12-week period.

BACKGROUND: Little is known about different Ixekizumab (IXE) dosing regimens during routine clinical practice. OBJECTIVES: To evaluate the … t these differences were not significant. Adverse events were reported in 25 patients (37.9%), with injection site reactions being most common, followed by infections. CONCLUSION: IXE is effective and safe in a real-world setting for the treatment of plaque psoriasis. Moreover, patients can reduce their medical expenses by choosing a four-week dosing regimen while still …

Real-world experience of switching from intravenous to subcutaneous vedolizumab maintenance treatment for inflammatory bowel diseases.

BACKGROUND: Subcutaneous (SC) vedolizumab is effective in inflammatory bowel diseases (IBD) when administered after induction with two infus … witched back to IV vedolizumab due to adverse events, and three due to needle fear. Common AEs were injection site reactions (n = 15) and headache (n = 6). Median clinical and biochemical disease activity remained stable after the switch. Median serum vedolizumab concentrations increased from 19 μg/ml at the time of the switch to 31 μg/ml 12 weeks after the switch (p < 0 …

Volanesorsen, an antisense oligonucleotide to apolipoprotein C-III, increases lipoprotein lipase activity and lowers triglycerides in partial lipodystrophy.

BACKGROUND: Partial lipodystrophy (PL) syndromes involve deficiency of adipose tissue, causing severe insulin resistance and hypertriglyceri … r decreased. After 32-52 weeks of volanesorsen, liver fat decreased. Common adverse events included injection site reactions and decreased platelets. CONCLUSIONS: In PL, volanesorsen decreased apoC-III and triglycerides, in part through an LPL dependent mechanism, and may improve insulin resistance and hepatic steatosis.

Oral erythema multiforme after Pfizer-BioNTech COVID-19 vaccination: a report of four cases.

BACKGROUND: The 2019 Coronavirus disease (Covid-19) has affected thousands of people worldwide. To date, vaccines appear to be the only method to prevent and reduce mortality. Four vaccinations have been outwardly approved by European Medicine Agency (EMA) in Europe: BNT162b2 (Comirnaty-BioNTech/Pfizer), mRNA-1273 (Spikevax-Moderna), ChAdOx1 (VaxzevriaAstrazeneca), and Ad26.COV2-S (Janssen-Johnson&Johnson). After vaccination, local and systemic adverse effects can occur. Cutaneous reactions like urticaria, local injection site pain, morbilliform rash have been documented after vaccination. CA

Vaccine-associated complications: a comparative multicenter evaluation among dental practitioners and dental students-which candidate vaccine is more safe in SARS COV II, Gam-COVID-Vac (Sputnik V), ChAdOx1 nCoV-19 (AstraZeneca), BBV152 (Covaxin), or BBIBP-CorV(Sinopharm)?

BACKGROUND: The rapidly developed vaccines against the severe acute respiratory syndrome coronavirus 2 carry a risk of provoking side effects. This study aimed to evaluate current vaccination non-serious/serious side effects. METHODS: A multicenter electronic questionnaire via an online platform was conducted over a 1-week period among vaccinated dental staff and dental students inquiring whether they experienced vaccine-related side-effects after vaccine administration. RESULTS: A total of 1205 respondents with a mean age of 39 (SD: 12) were retained for the analyses. The following vaccines

Correlation of adverse effects and antibody responses following homologous and heterologous COVID19 prime-boost vaccinations.

BACKGROUND: Studies correlating reactogenicity and immunogenicity of COVID-19 vaccines are limited to BNT162b2, with inconsistent results. We investigated whether adverse reactions after other COVID-19 vaccines reliably predict humoral responses. METHODS: Adult volunteers were recruited for homologous or heterologous prime-boost vaccinations with adenoviral (ChAdOx1, AstraZeneca) and/or mRNA (mRNA-1273, Moderna) vaccines administered either 4 or 8 weeks apart. Adverse effects were routinely solicited and recorded by subjects in a standard diary card for up to 84 days post booster vaccination.

Establishing an Animal Model of Cytomegalovirus Keratouveitis in Rats: Broad Infection of Anterior Segment Tissue by Cytomegalovirus.

PURPOSE: Considering the difficulty of obtaining adequate biological tissue in clinical practice, we established an animal model of cytomegalovirus (CMV) keratouveitis in rats and investigated the viral infection sites and corresponding imaging and histopathological features. METHODS: Subconjunctival injection and topical use of dexamethasone were used to induce ocular immunosuppression in rats followed by intracameral inoculation of murine cytomegalovirus (MCMV). The clinical manifestations, intraocular pressure (IOP) and imaging changes were observed. Infected eyes were further examined by