Current Issue : October-December Volume : 2025 Issue Number : 4 Articles : 5 Articles
Mycoplasma pneumoniae, a cell wall-deficient pathogen, primarily affects children and adolescents, causing Mycoplasma pneumoniae pneumonia (MPP). Following the relaxation of non-pharmaceutical interventions (NPIs) post COVID-19, there has been a global increase in MPP cases and macrolide-resistant strains. Vaccination against M. pneumoniae is being explored as a promising approach to reduce infections, limit antibiotic misuse, and prevent the emergence of drug-resistant variants. We developed an mRNA vaccine, mRNA-SP+P1, incorporating a eukaryotic signal peptide (tissue-type plasminogen activator signal peptide) fused to the C-terminal region of the P1 protein. Targeting amino acids 1288 to 1518 of the P1 protein, the vaccine was administered intramuscularly to BALB/c mice in a three-dose regimen. To evaluate immunogenicity, we quantified anti-P1 IgG antibody titers using enzyme-linked immunosorbent assays (ELISAs) and assessed cellular immune responses by analyzing effector memory T cell populations using flow cytometry. We also tested the functional activity of vaccine-induced sera for their ability to inhibit adhesion of the ATCC M129 strain to KMB17 cells. The vaccine’s protective efficacy was assessed against the ATCC M129 strain and its cross-protection against the ST3-resistant strain. Transcriptomic analysis was conducted to investigate gene expression changes in peripheral blood, aiming to uncover mechanisms of immune modulation. The mRNA-SP+P1 vaccine induces P1 protein-specific IgG antibodies and an effector memory T-cell response in BALB/c mice. Adhesion inhibition assays demonstrated that serum from vaccinated mice attenuatesthe adhesion ability of ATCC M129 to KMB17 cells. Furthermore, three doses of the vaccine confer significant and long-lasting, though partial, protection against the ATCC M129 strain and partial cross-protection against the ST3 drug-resistant strain. Transcriptome analysis revealed significant gene expression changes in peripheral blood, confirming the vaccine’s capacity to elicit an immune response from the molecular level. Our results indicate that the mRNA-SP+P1 vaccine appears to be an effective vaccine candidate against the prevalence of Mycoplasma pneumoniae....
Background: Dose tapering in patients with psoriatic arthritis (PsA) who achieve sustained treatment targets is a common but underexplored strategy, particularly in those receiving TNFα inhibitor biosimilars (TNFibs). This study aimed to assess the prevalence of dose optimization and identify factors associated with its implementation in clinical practice. Methods: We systematically selected 130 PsA patients with sustained treatment response from a database of individuals treated with advanced therapies. We evaluated the prevalence of dose optimization (defined as sustained dose reduction) and explored associated factors using multivariate logistic regression models. Results: Of the 130 patients, 95 were receiving TNF inhibitors and 35 other advanced therapies. Among those on TNFis, 88 (93%) were treated with TNFibs. A total of 32 patients (24.6%) were undergoing dose optimization, including 30 from the TNFi group (p = 0.002). We found that 7 of the 88 patients on TNFibs (8%) experienced loss of therapeutic response during follow-up. One in three patients on TNFis underwent dose tapering. Factors independently associated with dose reduction included no history of tobacco exposure [OR 3.98, 95%CI: 1.3–14.2; p = 0.021], male sex [OR 3.26, 95%CI: 1.26–9.04; p = 0.018] and use of TNFis as first-line advanced therapy [OR 4.8, 95%CI: 1.7–16.7; p = 0.003]. Conclusions: Approximately one in four PsA patients who achieve sustained treatment targets undergo dose optimization, most commonly with TNFibs. This strategy appears to be more feasible in male patients, non-smokers and those treated with TNFis as a first-line option....
Background: Influenza remains a persistent public health challenge due to antigenic drift and shift, necessitating vaccines capable of eliciting broad and durable immunity. Hemagglutinin (HA) antigen serves as the critical target for eliciting protective immune responses against influenza. DNA vaccines offer distinct advantages over conventional platforms, including accelerated development and induction of both humoral and cellular immune responses. Methods: To optimize HA antigen presentation, we designed and systematically compared the immunogenicity and protective efficacy of HA antigen display strategies—bacteriophage T4 fibritin (HA-Foldon) and ferritin-based virus-like particles (HA-Ferritin)—versus monomeric HA DNA vaccines against seasonal influenza viruses. Results: HA-Ferritin showed superior structural stability. All vaccines induced similar HA-specific antibody levels, but HA-Ferritin elicited higher neutralizing antibodies and stronger T cell responses. Upon challenge, HA-Ferritin and HA-Foldon protected mice from weight loss and reduced lung virus loads by 3.27 and 0.76 times, respectively. Monomeric HA provided limited protection, with only 40% survival and minimal viral or pathological reduction. Conclusions: The HA-Ferritin DNA vaccine demonstrated enhanced immunogenicity and protection, supporting structured antigen display as a promising strategy for influenza DNA vaccine development....
Background/Objectives: Infliximab biosimilars entered the United States (US) market in November 2016. Uptake of infliximab biosimilars has been slow in adult studies. We aimed to assess variation in the initiation of infliximab biosimilars in a large pediatric cohort. Methods: We performed a retrospective cohort study using data from 2016 to 2023 prospectively collected by the ImproveCareNow (ICN) Network, a multicenter pediatric inflammatory bowel disease (IBD) quality improvement collaborative. Pediatric patients with IBD who started any infliximab therapy were included. Descriptive statistics were used to summarize patient characteristics and changes in the use of infliximab agents. Chi-square or Fisher’s exact tests were used to evaluate differences in infliximab biosimilar initiation over time by race, age, ethnicity, and region. Results: In total, 4602 patients from 73 ICN centers started an infliximab agent. Infliximab biosimilar initiation rose steadily from 1% in 2018 to nearly 42% in 2023, with 88% of centers using biosimilars in 2023. Overall, from 2016 to 2023, the total percentage of patients who were started on an infliximab biosimilar was 17.3%. There were no differences in infliximab biosimilar initiation by age, race, or ethnicity, except in 2020 for age and race. The Midwest, West, and Southwest regions had higher initiation rates of infliximab biosimilars than the rest of the US. Conclusions: The percentage of patients with IBD initiating an infliximab biosimilar rose slowly to nearly 42% by 2023, and eight (12%) centers never recorded prescribing an infliximab biosimilar in the ICN Network. There were no differences in biosimilar initiation based on race or ethnicity....
Background: Biosimilar versions of rituximab have similar safety and efficacy as the reference product across all indications based on the extrapolation principle. Our organization replaced intravenous (IV) rituximab (Mabthera) with IV rituximab (Truxima- Biosimilar) in 2021. Hence, our practice changed to providing first cycles of IV rituximab (Truxima-Biosimilar) instead of rituximab (Mabthera), and if the first cycle was completed without severe infusion-related reactions (IRRs), then subsequent cycles were given with subcutaneous (SC) rituximab as per institutional guidelines. However, the safety of this approach has not been evaluated. Methods: A retrospective study was conducted at the Princess Nourah Oncology Center in Saudi Arabia. The primary objective was to assess IRRs after using IV rituximab (Truxima-Biosimilar) in the first cycle followed by SC rituximab in subsequent cycles. Results: Of the 71 patients reviewed, 35 patients met the eligibility criteria. Only one (3%) patient developed an IRR. However, it was a Grade 1 IRR, as per CTCAE.V5, and the patient was able to complete the remaining IV infusion successfully. Hence, all patients transitioned from IV rituximab biosimilar to SC rituximab Mabthera. Conclusions: This real-world study demonstrates that transitioning from IV rituximab biosimilar to SC Mabthera is a well-tolerated and safe practice, confirming the extrapolation principle of biosimilars....
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