Potential Adverse Events Research Articles

Delayed Hypersensitivity Reaction to Dermal Fillers Following mRNA COVID-19 Vaccination

Dear Editor, I wish to bring attention to a potential delayed immune reaction associated with dermal fillers in the context of mRNA COVID-19 vaccines. While severe vaccine reactions remain uncommon, the widespread administration of mRNA vaccines and the prevalent use of dermal fillers necessitate a closer examination of their possible interactions. We recently encountered a 59-year-old female patient who developed persistent facial swelling months after receiving the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine. Notably, the patient had a history of dermal filler injections, predominantly hyaluronic acid, administered three to four years prior. Despite various therapeutic interventions, including antihistamines, corticosteroids, and ACE inhibitors, she experienced recurrent episodes of swelling. Ultrasound assessment revealed the absence of residual filler material, leading us to consider an immune-mediated response potentially triggered by the mRNA vaccine. This case highlights the importance of further research into the interaction between mRNA COVID-19 vaccines and dermal fillers. It suggests that individuals with a history of dermal fillers may be susceptible to delayed inflammatory reactions post-vaccination. Clinicians should be aware of this potential adverse event, particularly when evaluating patients with unexplained facial swelling following vaccination.

Analysis of lumateperone data for patients with schizophrenia using related adverse events from the FDA adverse reporting system

ABSTRACT Background Our study utilized the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) to analyze and study the adverse event (AEs) signals of second-generation antipsychotic drug lumateperone, providing a reference for clinical safety monitoring in the treatment of schizophrenia. Methods The International Dictionary of Medical Terminology (version 26.0) was used to standardize the preferred system organ category (SOC) and preferred terminology (PT) for adverse drug events (ADE) data related to lumateperone. ADE signals were classified and described using four algorithms: reporting odds ratios (ROR), proportional reporting ratios (PRR), Bayesian confidence-propagation neural network (BCPNN) and Multinomial gamma-poisson shrinkage (MGPS). Result Among the 2542 case reports collected from the FAERS database, 1762 reports with lumateperone as a ‘principal suspect(PS)’ AEs were identified. Lumateperone-induced AEs occurred in 26 system organ categories (SOC). A total of 118 significant disproportionate preferred terms (PTs) meeting the requirements of 4 algorithms were retained, and unexpected major events, such as burning sensation, tremor, migraine etc. may also occur. The median time to onset of lumateperone-related adverse events was 9 days (interquartile range [IQR] 2–31.25 days), and most AEs occurred within the first 10 days and 1 month after initiation of lumateperone therapy. Conclusion Our research may provide a better understanding of the potential adverse events that may be caused by lumateperone and those not recorded in the drug instructions, providing valuable signals for clinical use.

Endoscopic ultrasound-guided rendezvous techniques for difficult biliary cannulation: Technical review.

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard procedure for the diagnosis and treatment of biliary diseases. However, selective biliary cannulation, the essential first step in ERCP, can sometimes fail due to anatomical variations or technical limitations. In these cases, the endoscopic ultrasound-guided rendezvous technique (EUS-RV) offers a valuable salvage option. Nevertheless, it is crucial to be aware of potential adverse events associated with bile duct puncture. To optimize the success rate and safety of EUS-RV, understanding the basic techniques, technical tips for each procedural step, and troubleshooting strategies for potential difficulties is essential. This review article summarizes the clinical outcomes and technical considerations of EUS-RV, including a comprehensive analysis of the current evidence.

A Framework for Best Practices and Readiness in the Advent of Anti-Amyloid Therapy for Early Alzheimer's Disease in Asia.

Advances in biomarker-based diagnostic modalities, recent approval of anti-amyloid monoclonal antibodies for early Alzheimer's disease (AD; mild cognitive impairment or mild dementia due to AD) and late-stage clinical development of other disease-modifying therapies for AD necessitate a significant paradigm shift in the early detection, diagnosis and management of AD. Anti-amyloid monoclonal antibodies target the underlying pathophysiological mechanisms of AD and have demonstrated a significant reduction in the rate of clinical decline in cognitive and functional outcome measures in patients with early AD. With growing recognition of the benefit of early interventions in AD, an increasing number of people may seek diagnosis for their subjective cognitive problems in an already busy medical system. Various factors such as limited examination time, lack of expertise for cognitive assessment and limited access to specialized tests can impact diagnostic accuracy and timely detection of AD. To overcome these challenges, a new model of care will be required. In this paper, we provide practical guidance for institutional readiness for anti-amyloid therapies for early AD in Asia, in terms of best practices for identifying eligible patients and diagnosing them appropriately, safe administration of anti-amyloid monoclonal antibodies and monitoring of treatment, managing potential adverse events such as infusion reactions and amyloid-related imaging abnormalities, and cross-disciplinary collaboration. Education and training will be the cornerstone for the establishment of new pathways of care for the identification of patients with early AD and delivery of anti-amyloid therapies in a safe and efficient manner to eligible patients.

First-trimester medication abortion via telemedicine: A retrospective cohort study

BackgroundFollowing the decriminalization of abortion in Colombia and amidst a global health crisis due to COVID-19, Profamilia implemented a telemedicine-assisted first-trimester Medication Abortion (MAB) program. This is an opportunity to reduce inequalities in access and to promote empowerment and sexual and reproductive rights. This study aims to describe socio-demographic and clinical characteristics of users and to assess its effectiveness and safety. Study designA retrospective cohort study. MethodsThe study analyzed data from users who received Profamilia's telemedicine abortion services between August 2021 and August 2022 (n = 3073). A descriptive analysis of their sociodemographic and clinical characteristics was performed, grouping, and comparing them according to follow-up status and abortion outcome. Effectiveness was assessed by the percentage of complete abortions without surgical intervention, and safety by the incidence of complications, potential adverse events, and potentially dangerous signs. ResultsMost of the users were less than 8 weeks gestation at the start of treatment (88.3 %), from low socioeconomic strata (84.8 %), affiliated to the subsidized healthcare system (87.6 %), with educational levels up to secondary school (81.6 %), between 18 and 35 years (87.4 %), from urban areas (97.8 %) and singles (90,8 %). 94.9 % of users had a complete abortion using medication, and 0.3 % of cases reported complications. ConclusionsFirst-trimester MAB through telemedicine in the Latin American context is an effective and safe choice. Telehealth is an important strategy to expand access to safe abortion care, especially for those with limited financial means or educational backgrounds. Rural and marginalized populations need more attention to improve access.

Intraoperative Complications in Medial Opening Wedge High Tibial Osteotomy.

Medial opening wedge high tibial osteotomy has been established for treatment of medial symptomatic knee arthrosis with varus malalignment in young and elderly but active patients. To obtain satisfactory results, it is essential for surgeons performing osteotomy to identify, prevent, and treat potential intraoperative adverse events. Lateral hinge fracture (LHF) is the most common intraoperative complication while popliteus artery injury is rare but limb-threatening. Computed tomography is the benchmark to detect LHF, the risk of which increased markedly with the opening gap larger than 11 mm. Setting the lateral hinge in a safe zone is the most important preventive measure. Medial long locking plate fixation may allow patients even with unstable hinge fractures to start early full weight bearing. Additional fixation of LHF is optional, and bone void filling is not routinely used. For protection of popliteus artery injury, flexing the knee joint is unreliable. It is paramount to place a protective retractor just behind the posterior tibial cortex toward the proximal tibiofibular joint before osteotomy, particularly in case of aberrant artery. A repertoire of surgical pearls is described in detail in this review to identify, prevent, and manage those intraoperative complications.

Botulinum toxin treatment for hemifacial spasm: harmonising neurological and aesthetic outcomes.

Hemifacial spasm (HFS) represents a challenging cranial movement disorder primarily affecting the facial nerve innervated muscles, with significant prevalence among Asians. Botulinum toxin type A (BoNT/A) injections, established as a primary therapeutic intervention since FDA approval, offer considerable effectiveness in alleviating spasms, albeit accompanied by challenges such as temporary effects and potential adverse events including facial asymmetry. This comprehensive review underscores the crucial need for harmonising neurological benefits and aesthetic outcomes in HFS management. The discussion delves into the interplay between facial aesthetics and neurological objectives in BoNT/A injections, emphasising precise techniques, dosages, and site considerations. Distinct aspects in neurological and aesthetic domains are also examined, including detailing the targeted muscles and injection methodologies for optimal therapeutic and aesthetic results. Importantly, evidence regarding various BoNT/A formulations, recommendations, and reconstitution guidelines in both neurology and aesthetics contexts are provided, along with a schematic approach outlining the stepwise process for BoNT/A injection in HFS treatment, addressing critical areas such as orbicularis oculi muscle sites, eyebrow correction strategies, mid- and lower-face considerations, contralateral injection sites, and post-injection follow-up and complication management. By highlighting the culmination of neurological efficacy and facial esthetics in BoNT/A treatment for HFS patients, this review proposes a holistic paradigm to achieve balanced symptomatic relief and natural aesthetic expression, ultimately enhancing quality of life for individuals grappling with HFS.

Effectiveness and Safety of the Allurion Swallowable Intragastric Balloon for Short-term Weight Loss: A Systematic Review and Meta-analysis.

Obesity poses a severe health problem worldwide, with an estimated impact on 17.5% of the adult population by 2035. Among the endoscopic applications for treating this comorbidity, intragastric balloons are the most widely used. The new liquid-filled swallowable balloon meets the requirements of major guidelines and allows significant weight loss with few adverse events. This systematic review and meta-analysis aims to demonstrate the efficacy and safety profile of this new device for weight loss. We conducted a search from 2016 to 2024 to assess the efficacy of the swallowable intragastric balloon for weight loss, including improvements in metabolic profiles and anthropometric measurements. Additionally, we evaluated potential adverse events related to the device to demonstrate its safety. Eleven observational studies totalling 2107 patients were included, showing a reduction of 4.75 in BMI (95% CI: -5.02; -4.47), a mean total weight loss of 12.47% (95% CI: -13.77; -11.17), a mean excess weight loss of 48.04% (95% CI: -50.61; -45.48), and a rate of serious adverse events of 0.90%. An improvement in the metabolic profile was observed for three parameters: HDL, triglycerides, and glycaemia. The swallowable liquid-filled intragastric balloon is safe and effective for managing weight loss within a four-month follow-up period.

Erythema Multiforme and Epidermal Necrolysis Following COVID-19 Vaccines: A Systematic Review.

The outbreak of COVID-19 pandemic has raised urgent vaccine development to prevent viral transmission. Cutaneous adverse events such as erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been observed following COVID-19 vaccination. In this systematic review, we aimed to investigate the clinical features and outcomes of EM/SJS/TEN following COVID-19 vaccination. A comprehensive literature search was conducted in PubMed, Embase, Web of Science, and Cochrane databases up to July 3, 2022. We included studies reporting patients who developed EM, SJS, or TEN following COVID-19 vaccination. A total of 47 studies involving 90 patients with EM and 16 patients with SJS/TEN were reviewed and outlined. EM predominantly occurred after the messenger ribonucleic acid vaccines (70.4%), mostly after the first (47.5%) and second doses (42.4%), with delayed onsets ranging from 1 day to 30 days. SJS/TEN were observed following either the first (55.6%)- or second-dose (33.3%) vaccination, with onset times ranging from 6 hours to 14 weeks. Three EM cases and 1 SJS case showed recurrence upon reexposure to the same vaccines. No mortality was reported. Most patients exhibited improvement or resolution after treatment, with resolution times ranging from 6 days to 8 weeks. In conclusion, EM and epidermal necrolysis, including SJS and TEN, have emerged as potential cutaneous adverse events following COVID-19 vaccine administration. Further research is warranted to elucidate the pathogenesis and casual relationship between COVID-19 vaccines and EM/SJS/TEN.

Mechanochemical chemically assisted ablation of varicose veins for venous insufficiency: American vein and lymphatic society position statement.

Background: Mechanical occlusion chemically assisted ablation (MOCA) of incompetent saphenous veins has been utilized since its FDA approval in 2008. However, only recently have longer-term three and 5year clinical follow up data become available. This updated information necessitates a societal update to guide treatment and ensure optimal patient outcomes. Method: The American Vein and Lymphatic Society convened an expert panel to write a Position Statement with explanations and recommendations for the appropriate use of MOCA for patients with venous insufficiency. Result: This Position Statement was produced by the expert panel with recommendations for appropriate use, treatment technique, outcomes review, and potential adverse events. These recommendations were reviewed, edited, and approved by the Guidelines Committee of the Society. Conclusions: MOCA is effective in alleviating symptoms and a safe treatment option for venous insufficiency. It obviates the need for tumescent anesthesia, has less procedural discomfort and lower risk of thermal nerve or skin injury. It may be used in both the below knee distal GSV as well as the SSV. However, it is associated with significantly lower rates of vessel closure and higher recanalization rates compared to both RFA and EVLA and is less cost effective than thermal techniques. It is an available option for those in whom thermal ablation is not suitable.

Recent progress and current status of pancreatobiliary interventional endoscopic ultrasound in children.

In recent years, the usefulness of endoscopic ultrasound (EUS) has been recognized in children. A dedicated pediatric EUS scope has not been developed; in our experience, however, an adult EUS scope can be used. The American Society for Gastrointestinal Endoscopy Technical Committee status assessment report on pediatric endoscopy equipment provides some guidance on the feasibility of EUS according to body size. Careful monitoring is required, keeping in mind potential adverse events such as cervical esophageal perforation and unstable breathing due to tracheal compression. Most devices designed for interventional pancreatobiliary endoscopy are also available for children. Sedation or intubated general anesthesia (GA) is mandatory when performing interventional EUS (I-EUS). I-EUS for children is generally performed using GA in the operating room, but sedation in the endoscopy room is also possible under appropriate monitoring by pediatricians. I-EUS in the operating room is sometimes difficult for endoscopists to perform because of the unsuitable fluoroscopic imaging and the lack of familiar equipment and staff. Compared to GA, sedation in the endoscopy room facilitates easier and quicker repetition of procedures when necessary. Adult pancreatobiliary endoscopists perform most I-EUS procedures in the pediatric population because most pediatric endoscopists have few opportunities to perform EUS-related procedures and thus have difficulty maintaining their skills. To popularize I-EUS techniques for children, it will be necessary to establish a training program for developing pediatric endoscopists.

Evaluating potential unexpected adverse events and mortality after oral analgesics administration in fracture care-A cohort study.

Analgesic selection per individual's tolerance is essential to avoid risks. The study evaluated current oral analgesic prescription practice, analgesic adverse effects-related factors, unexpected events, and mortality post-fracture surgery. Present prospective cohort study from June 2022 to July 2023 enrolled a total of 198 proximal femoral, ankle, and hindfoot trauma fracture patients. Stratification was done for oral analgesics prescribed at hospital discharge and 1 week with their accompanying toxicity assessed for 2 weeks. Analyzed Kaplan-Meier curve and the absolute risk for possible analgesics-related deaths. Following oral analgesics administration, 122 (62%) patients experienced adverse events. In seven expiries, five were possibly due to acetaminophen added tramadol combined with any of pregabalin, diclofenac, etoricoxib, or gabapentin (absolute risk 2.5%, 97.5% proportion 2 weeks survival). Three (2% of 122) patients taking acetaminophen added tramadol or diclofenac experienced unexpected serious adverse events. Elderly diabetic and hypertensive hip fracture patients expired or experienced unexpected events. Data suggest that oral acetaminophen added tramadol combined with any of pregabalin, diclofenac, etoricoxib, or gabapentin might increase the death risk or unexpected serious adverse events in elderly diabetic and hypertensives suffering from intertrochanteric/femoral neck fracture. Safe analgesic selection is necessitated for at-risk patients.

Non-linear association of triglyceride-glucose index with cardiovascular and all-cause mortality in T2DM patients with diabetic kidney disease: NHANES 2001–2018 retrospective cohort study

BackgroundThe triglyceride glucose (TyG) index is a cutting-edge and highly effective marker of insulin resistance, a crucial factor in the development and exacerbation of diabetic kidney disease (DKD). To date, there has been limited research on how the triglyceride-glucose (TyG) index affects the outlook for patients suffering from DKD.MethodsIn this multicenter retrospective cohort study, the analysis recruited 2,203 DKD patients from the National Health and Nutrition Examination Survey (NHANES) dataset, which covers the US from 2001 to 2018. The research applied a Cox proportional hazards model with multiple variables to investigate the association of the TyG index with mortality outcomes. Restricted cubic splines (RCS) and methods for analyzing threshold effects were employed to identify possible non-linear relationships.ResultsOver nearly 19 years of follow-up, this study captured data on 753 all-cause and 231 cardiovascular disease-specific fatalities. Sophisticated statistical methods, including RCS and smoothing curve adjustments via penalized splines, helped identify distinctive patterns: The baseline TyG index was observed to have a U-shaped pattern related to overall mortality and an L-shape with cardiovascular diseases(CVD) mortality among individuals with DKD. Notably, TyG index below 9.15 for overall mortality and 9.27 for CVD mortality were linked to reduced death rates (HR = 0.65, 95% CI = 0.52–0.82 for all-cause; HR = 0.58, 95% CI = 0.43–0.83 for CVD). On the other hand, TyG index exceeding these benchmarks (greater than 9.15 for all-cause and 9.27 for CVD) correlated with increased all-cause mortality risks (HR = 1.21, 95% CI = 1.02–1.43) and showed a non-significant change in CVD mortality risks (HR = 1.07, 95% CI = 0.83–1.38).ConclusionsThis study emphasizes the non-linear linkage involving the TyG index and death rates due to CVD and other factors in patients with DKD, demonstrating its effectiveness in estimating potential adverse events within this demographic.

Understanding Cardiopulmonary Resuscitation Knowledge in Physiotherapy Undergraduates - A Cross-Sectional Study

Background: CPR is a lifesaving technique. It aims to keep blood and oxygen flowing through the body when a person’s heart and breathing have stopped. When the heart stops breathing, Cardiopulmonary resuscitation (CPR) is used to save the patient’s life. After a cardiac arrest, immediate CPR can double or triple the possibilities of survival. C-A-B [ chest compression, airway and breathing], should be commenced when a victim/patient is unresponsive and not breathing normally. Early compressions can improve outcomes by keeping the brain and heart perfused with the oxygenated blood in the circulatory system prior to collapse. When patients receive timely cardiopulmonary resuscitation from qualified medical personnel, cardiac arrests and the deaths that accompany them are decreased. When using exercise as a therapeutic approach, physiotherapists must be proficient in CPR not only to handle potential adverse cardiac events during exercise, but also because early defibrillation and widespread application of CPR can drastically lower the death rate from a heart attack. In this study, we evaluated physiotherapy students' understanding of cardiopulmonary resuscitation in Surat. Aims: The study aimed to assess the knowledge regarding the Cardiopulmonary resuscitation in Physiotherapy undergraduates in Surat, Gujarat. Objectives: The objective of this study is to assess knowledge of CPR by using online google form questionnaire. Method: A cross-sectional study of physiotherapy students in Surat was conducted. An online survey was conducted with a self-administered questionnaire. The data was collected from 103 physiotherapy students in Surat aged 18-27 years. A CPR knowledge questionnaire was completed by the students and the result was analyzed with Microsoft Excel 2019. Result: Results suggest that the students were a good understanding of the importance of CPR in clinical practice and stand average in knowing its indications and effectiveness. Whereas, 62% of them were completely aware of the universal compression ventilation ratio, and 45% were aware of the current order of CPR being compression, airway, and breathing. Conclusion: In this study, it concludes that awareness of CPR is good among physiotherapy students in Surat. Keywords: Cardiopulmonary resuscitation knowledge, Physiotherapy students, Awareness of CPR.

Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.

Adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult rheumatoid arthritis (RA), and subsequently approved for pediatric treatment of various autoimmune diseases in children of different ages. Due to genetic differences between children and adults in terms of physiology and immunity, there is a need to explore the safety of adalimumab in children in the real world. The aim of this study is to identify potential adverse event (AE) signals associated with the use of adalimumab in pediatric patients (<18 years old) using data from the FDA Adverse Event Reporting System (FAERS). AEs associated with adalimumab in pediatric patients reported in the FAERS database from the first quarter (Q1) of 2017 to the third quarter (Q3) of 2022 were systematically gathered. Reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), and the empirical Bayes geometric mean (EBGM) were used to assess the relationship between adalimumab and AEs in children. Out of 8,363,304 reports collected from the FAERS database during the study period, 3819 reports on children on adalimumab were identified. Adalimumab-related AEs reports were concentrated on 10 toxicity areas and a total of 202 positive signals were detected, of which injection site papule (ROR = 261.97) and intestinal fistula (ROR = 122.09) had the strongest signals. Unexpected significant AEs, including intestinal obstruction, immunodeficiency, abdominal abscess, and Takayasu's arteritis might also occur. In comparison with patients of all ages in the same time window, the median onset time of children was shorter (99 vs. 149 days). Most of the AE cases occurred in children within the first 1 (1.71%), 2 (8.12%), and 3 months (8.39%) and had early failure types after adalimumab initiation. Methotrexate, folic acid, prednisone, azathioprine, and mesalamine were the top five drugs used concomitantly for adalimumab-associated AEs. When adalimumab is used in children, especially in the first 3 months of treatment, in addition to the AEs recorded in the drug package insert, close attention should be paid to the new potential AEs off-label to ensure the safety of adalimumab in children.

Redefining Statin Dosage Post-Gastric Bypass: Insights from a Population Pharmacokinetics-Pharmacodynamics Link Approach.

Roux-en-Y gastric bypass (RYGB) involves creating a small stomach pouch, bypassing part of the small intestine, and rerouting the digestive tract. These alterations can potentially change the drug exposure and response. Our primary aim was to assess the impact of RYGB on the pharmacokinetics of simvastatin lactone (SV) and its active metabolite, simvastatin hydroxy acid (SVA). Ultimately, we aimed to optimize dosing for this understudied population by employing a population pharmacokinetic-pharmacodynamic link approach. The study comprised patients who had undergone RYGB surgery and individuals without a previous history of RYGB. All participants received a single oral dose of simvastatin. Plasma concentration data were analyzed with a nonlinear mixed-effect modeling approach. A parent-metabolite model with first-order absorption, 2-compartments for SV and 1-compartment for SVA, linear elimination, and enterohepatic circulation best described the data. The model was linked to the turnover pharmacodynamic model to describe the SVA inhibition on LDL-cholesterol production. Our simulations indicated that following RYGB surgery, the exposure to SV and SVA decreased by 40%. Consequently, for low-intensity statin patients, we recommend increasing the dose from 10 to 20 mg in post-RYGB patients to maintain a comparable response to that of non-operated subjects. Moderate-intensity statin patients should require increasing doses to 40 or 60 mg or the addition of a non-statin medication to achieve similar therapeutic outcomes. In conclusion, individuals post-RYGB exhibit diminished exposure to SV and may benefit from increasing the dose or adjunctive therapy with non-statin drugs to attain equivalent responses and mitigate potential adverse events.

Mendelian randomization study of sodium-glucose cotransporter 2 inhibitors in cardiac and renal diseases.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) target the reabsorption of sodium and glucose in the kidney proximal tubules to reduce blood sugar levels. However, clinical randomized controlled trials on SGLT2i have yielded inconsistent results, necessitating further research into their efficacy and safety for specific cardiac and renal diseases. "Sodium in urine" was selected as a downstream biomarker of SGLT2i. Single nucleotide polymorphisms were extracted from genome-wide association study data as instrumental variables. Mendelian randomization analysis was then conducted for cardiac and renal diseases and potential adverse events. The causal effects of SGLT2i on these diseases were determined based on inverse variance weighted results, followed by sensitivity and pleiotropy tests. SGLT2i had a significant protective effect against nephrotic syndrome (odds ratio [OR] 0.0011, 95% confidence interval [CI] 0.000-0.237), chronic glomerulonephritis (OR 0.0002, 95% CI 0.000-0.21), and hypertensive nephropathy (OR 0.0003, 95% CI 0.000-0.785). No causal effects were observed between SGLT2i and cardiac diseases or potential adverse events. SGLT2i can act as protective factors against nephrotic syndrome, chronic glomerulonephritis, and hypertensive nephropathy.

Baricitinib in the treatment of systemic lupus erythematosus: a systematic review of randomized controlled trials.

Baricitinib, a Janus Kinase (JAK) inhibitor, has emerged as a potential therapeutic option for systemic lupus erythematosus (SLE). This systematic review aims to synthesize evidence from randomized controlled trials (RCTs) evaluating the potential of baricitinib in treating SLE. A systematic search was conducted across electronic databases to identify relevant RCTs assessing baricitinib in patients with SLE. Studies reporting outcomes such as the Systemic Lupus Erythematosus Responder Index-4 (SRI-4), adverse events, and safety profiles were included. Data extraction and quality assessment were performed following PRISMA guidelines. A total of four studies were evaluated for efficacy and safety of baricitinib therapy. Three studies reported SRI-4, British Isles Lupus Assessment Group (BILAG), and Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), except for Dorner and colleagues Only Dorner and colleagues and Wallace and colleagues discuss the anti-dsDNA titres following treatment with baricitinib. The findings consistently demonstrated improved efficacy of baricitinib compared to placebo, particularly in terms of SRI-4 scores. Higher dosages of baricitinib showed significant improvement in disease activity and severity indices. Adverse events, including infections and gastrointestinal disturbances, were reported. Baricitinib holds promise for treating SLE, but caution is needed due to potential adverse events. Careful patient selection and monitoring are crucial. Future research should prioritize long-term safety and comparative effectiveness studies to better understand baricitinib's role in managing SLE.

Expert Consensus on the Management of Adverse Events of Lorlatinib in the Treatment of ALK+ Advanced Non-small Cell Lung Cancer.

The use of anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), such as lorlatinib, for the treatment of patients with ALK gene rearrangement (or ALK-positive) non-small cell lung cancer (NSCLC) has been shown to improve the overall survival and quality of life of these patients. However, lorlatinib is not exempt from potential adverse events. Adequate monitoring and management of these adverse events are critical for increasing patient adherence to lorlatinib, thereby maximizing the benefits of treatment and minimizing the risks associated with treatment discontinuation. Considering that the adverse events of lorlatinib can affect different organs and systems, the participation of a multidisciplinary team, including cardiologists, neurologists, internal medicine specialists, and oncology pharmacists, is needed. This article presents specific and pragmatic strategies for identifying and treating the most relevant adverse events associated with lorlatinib in patients with advanced ALK-positive NSCLC based on the clinical experience of a multidisciplinary panel of experts.

A Five-Year Retrospective Study from a Single Center on the Location, Presentation, Diagnosis, and Management of 110 Patients with Aneurysms of the Femoral and Popliteal Arteries of the Lower Limb.

Background: Peripheral aneurysms, although known about for centuries, are challenging to monitor due to their asymptomatic nature. Advanced imaging has improved detection, which is crucial for preventing emergent complications. This five-year retrospective study from a single center aimed to evaluate the location, presentation, diagnosis, and management of 110 patients with aneurysms of the femoral and popliteal arteries of the lower limb. Materials and methods: The study included 71 true aneurysms and 39 pseudoaneurysms patients treated between 2018-2023. Treatment methods were based on aneurysm size, atherosclerosis severity, and operation risk. The study assessed patient demographics, surgical details, postoperative complications, and aneurysm characteristics. Results: Acute limb ischemia was more prevalent in true aneurysms (25.4% vs. 7.7%; p = 0.02). Aneurysmectomy was performed more frequently in pseudoaneurysms (87.2% vs. 54.9%; p < 0.001), while endovascular treatment and surgical bypass were more common in true aneurysms (Endovascular: 22.5% vs. 2.6%; p = 0.01; bypass: 21.1% vs. 0%; p < 0.001). Early postoperative complications occurred in 22.7% of patients. The 12-month freedom from reoperations (73.7% vs. 87%; p = 0.07), amputations (97.7% vs. 93.8%; p = 0.2), and graft stenosis (78.7% vs. 86.87%; p = 0.06) showed no significant differences between groups. Conclusions: Lower limb aneurysms often present with non-specific symptoms, leading to late diagnosis and life-threatening complications. Both open and endovascular treatments are feasible, though more research is needed for pseudoaneurysms. Vigilant follow-up is crucial due to potential adverse events, though overall mortality and morbidity remain low.