Zoster Research Articles

Truncated VZV gE Induces High-Titer Neutralizing Antibodies in Mice.

Backgrounds: A contemporary public health challenge is the increase in the prevalence rates of herpes zoster (HZ) worldwide. Methods: In this work, the gE gene structure was analyzed using bioinformatics techniques, and three plasmids of varying lengths, tgE537, tgE200, and tgE350, were expressed in Chinese hamster ovary (CHO) cells. These proteins were used to immunize BALB/c mice with Al/CpG adjuvant; ELISPOT and FCM were used to evaluate cellular immunity; and ELISA, VZV microneutralization, and FAMA assays were performed to detect antibody titers. Results: Target protein concentrations of 1.8 mg/mL for tgE537, 0.15 mg/mL for tgE200 and 0.65 mg/mL for tgE350 were effectively produced. The ability of the three protein segments to stimulate CD4+ and CD8+ T cells, as well as to cause lymphocytes to secrete IFN-γ and IL-4, did not significantly differ from one another. Both tgE537 and tgE350 were capable of generating VZV-specific antibodies and neutralizing antibodies, while tgE350 had the highest neutralizing antibody titer (4388). There was no equivalent humoral immune response induced by tgE200. Conclusions: The results of this investigation provide the groundwork for the creation of HZ recombinant vaccines using truncated proteins as antigens.

Trigeminal Trophic Syndrome With Herpetic Keratitis.

The aim of this study was to report a rare observation of trigeminal trophic syndrome presenting with concurrent herpetic keratitis. This study was a case report. A 42-year-old male with a remote history of a motor vehicle accident, traumatic brain injury, extensive facial reconstructive surgery, and traumatic optic neuropathy presented with left periorbital swelling. He was found to have extensive periorbital and total hypoesthesia in the cranial nerve V1 distribution and partial hypoesthesia in the V2 distribution. Corneal findings were highly suspicious for herpes simplex keratitis or zoster ophthalmicus. The patient was diagnosed with herpetic epithelial and stromal keratitis with periorbital ulceration secondary to Trigeminal trophic syndrome. The patient was treated broad spectrum intravenous antibiotics, intravenous acyclovir, and topical antibiotics. He was treated with topical steroids upon closure of epithelial defect. Upon discharge, the patient's vision improved from hand-motion to 20/30 at near. The patient was later fit with a custom thermoplastic facial mask to minimize further selfinjurious behavior. To our knowledge, this is the first report of trigeminal trophic syndrome presenting with concurrent herpetic keratitis. Successful treatment requires a multidisciplinary approach to provide the patient insight and create protective equipment.

Chimeric antigen receptor-T-cell therapies going viral: latent and incidental viral infections.

Infections are the leading cause of non-relapse mortality following chimeric antigen receptor (CAR)-T-cell therapy, with viral infections being frequent both in the early and late phases post-infusion. We review the epidemiology of viral infections and discuss critical approaches to prevention and management strategies in this setting. Herpesviruses dominate the early period. herpes simplex virus and varicella zoster virus infections are rare due to widespread antiviral prophylaxis, but cytomegalovirus (CMV) reactivation is increasingly observed, particularly in high-risk groups including B cell maturation antigen (BCMA)-CAR-T-cell therapy recipients and patients receiving corticosteroids. While CMV end-organ disease is rare, CMV is associated with increased mortality, emphasizing the need to evaluate the broader impact of CMV on long-term hematological, infection, and survival outcomes. Human herpesvirus-6 (HHV-6) has also emerged as a concern, with its diagnosis complicated by overlapping symptoms with neurotoxicity, underscoring the importance of considering viral encephalitis in differential diagnoses. Respiratory viruses are the most common late infections with a higher incidence after BCMA CAR-T-cell therapy. Vaccination remains a critical preventive measure against respiratory viruses but may be less immunogenic following CAR-T-cell therapy. The optimal timing, type of vaccine, and dosing schedule require further investigation. A better understanding of viral epidemiology and preventive trials are needed to improve infection prevention practices and outcomes following CAR-T-cell therapies.

Herpes zoster in COPD cases: Does the use of high-dose inhaled corticosteroids associated asymptomatic hyperglycemia during treatment or COPD-related comorbidity predispose reactivation?

Herpes zoster in COPD cases: Does the use of high-dose inhaled corticosteroids associated asymptomatic hyperglycemia during treatment or COPD-related comorbidity predispose reactivation?

Explore genetic susceptibility association between viral infections and Guillain-Barré syndrome risk using two-sample Mendelian randomization

BackgroundNumerous observational studies have indicated that patients with Guillain-Barré syndrome (GBS) frequently had infections with various pathogens before the onset of the disease, particularly several viral infections. Some of these infections are linked to specific clinical and immunological subgroups of GBS, suggesting a potential correlation between viral infections and the development of GBS. However, observational studies have several limitations, including the presence of confounding factors.MethodWe explored the potential correlation between HIV, SARS-CoV-2, varicella-zoster virus, herpes simplex virus, Epstein-Barr virus, hepatitis B virus, and influenza virus with GBS using a two-sample Mendelian randomization approach. The data was derived from published summary statistics from genome-wide association studies (GWAS). After removing linkage disequilibrium, selecting strong instrumental variables and addressing confounding factors, we would conduct a two-sample Mendelian randomization analysis along with sensitivity testing and the MR-Steiger directional test.ResultHIV may have a causal association with GBS (IVW: p = 0.010, OR [95% CI] 1.240 [1.052–1.463]), while no such relationship exists with COVID-19 (IVW: p = 0.275, OR [95% CI] 0.831[0.596–1.159]), varicella (IVW: p = 0.543, OR [95% CI] 0.919 [0.701–1.206]), herpes zoster (IVW: p = 0.563, OR [95% CI] 0.941 [0.766–1.156]), HSV (IVW: p = 0.280, OR [95% CI] 1.244 [0.837–1.851]), EBV (IVW: p = 0.218, OR [95% CI] 0.883 [0.724–1.076]), HBV (IVW: p = 0.179, OR [95% CI] 1.072 [0.969–1.187]), or influenza virus (IVW: p = 0.917, OR [95% CI] 0.971 [0.553–1.703]). We did not find any abnormal SNPs, pleiotropy, or heterogeneity, nor is there any reverse causation.ConclusionOur study results indicate a causal relationship between HIV and GBS, providing new research directions for the etiology of GBS.

B-199 Rapid Molecular Detection of Meningitis Agents in Diverse Brazilian Regions (2019-2023): A Multicenter Study

Abstract Background Meningitis, caused by viral and bacterial agents, is a significant public health issue globally, with a substantial economic impact. In Brazil, the incidence of meningitis varies by region, making the identification of the causative agent crucial for effective treatment. This study aims to evaluate the epidemiology of meningitis agents diagnosed using a rapid molecular detection panel in samples from various hospital units of a nationwide diagnostic and healthcare company. Methods Samples from several hospitals across different regions of Brazil were analyzed using the FilmArray® rapid molecular panel for meningitis and encephalitis, capable of identifying up to 14 agents, including bacteria, viruses, and fungi/yeasts. Gender, age group, regional distribution, and agent prevalence from January 2019 to April 2023, were retrieved from the database ensuring compliance with the Brazilian Data Privacy and Protection (LGPD) and local Research Ethics Committee guidelines. Results The study included 485 patients from 41 cities across 11 Brazilian states. The age range was 0 to 96 years, with an average age of 45 years, and a majority of female participants (59%). The highest number of test requests occurred in 2022 (17.5%), followed by 2021 (10%), with 2019, 2020, and 2023 accounting for less than 5% of requests each. The overall positivity rate was 10.5% (51/485), with 92.8% (13/14) of the possible agents identified. Viral agents were detected in 60.7% of positive cases, bacterial agents in 39.2%, and one mixed infection (human herpesvirus 6 and Escherichia coli K1) in a 2-year-old child. No fungal/yeast infections were detected. The most common agents were varicella-zoster virus (18.2%), Haemophilus influenzae (12.7%), herpes simplex viruses type 1 and 2 (12.7% each), and enterovirus (12.7%). Conclusions The study highlights the importance of rapid molecular diagnostic methods in Brazilian clinical-laboratory practice, offering fast, safe, and sensitive detection of meningitis-causing agents, which can contribute to improved patient outcomes.

Risk Factors for the Development of Ocular Complications in Herpes Zoster Ophthalmicus and Zoster Vaccine Utilization in a Large, Urban Health System

To characterize the epidemiology of herpes zoster (HZ) and herpes zoster ophthalmicus (HZO) in an urban hospital system and determine risk factors associated with developing ocular complications in HZO. To report the frequency of shingles vaccination and HZ reactivation following shingles vaccination in this population. A retrospective cohort study was conducted on patients seen at the University of Illinois Hospital system from January 1, 2010 to December 1, 2021 with HZ and HZO identified by diagnosis code. Charts of HZO patients seen within 1 year of diagnosis were abstracted. Multivariable logistic regression analysis identified factors associated with the development of ocular complications in HZO. During the study period, 3283 patients had HZ; mean age of onset was 52.3 years, 61.6% were female, and 37% were Black. HZO with ocular involvement was seen in 110 (3.4%) patients. Ocular complications developed in 40 (36.4%) patients; the most common complication was corneal scarring (70%). Age (odds ratio [OR] 1.04, 95%CI 1.0-1.1), female gender (OR 2.86, 95%CI 1.0-8.1), steroids at initial visit (4.46, 95%CI 1.4-14.6), and stromal keratitis (OR 3.45, 95% CI 1.2, 9.8) were associated with developing ocular complications. Of eligible populations, 5333 (1.5%) received shingles vaccination; 43 patients developed reactivation of HZ following vaccination. In HZO, age, female gender, steroids at initial visit, and stromal keratitis are strongly associated with developing ocular complications. Shingles vaccination rates were low in this study population. Understanding potential for complications in HZ/HZO and vaccination uptake can help identify at risk populations to prevent disease.

Assessment of ultrasound-guided intercostal nerve block for acute herpes zoster and its' possible prophylaxis for postherpetic neuralgia: a retrospective and case-controlled trial.

This study aimed to compare the intercostal nerve block (ICNB) and thoracic paravertebral block (TPVB) for acute herpes zoster-associated pain (ZAP) and possible prophylaxis for post-herpetic neuralgia (PHN). This study enrolled 128 patients with ZAP. Their records were stratified into standard antiviral treatment (AVT) plus US-guided TPVB (the TPVB group), AVT plus US-guided ICNB (the ICNB group) or AVT alone (the control group). Herpes zoster (HZ)-related burden of illness (HZ-BOI) within the post-procedural 30 days was defined as the primary endpoint, determined by a composite of pain severity and follow-up duration. Procedure time, rescue analgesic requirement, PHN incidence, health-related quality of life and side effects were also recorded. Significantly lower HZ-BOI-AUC30 was reported in the TPVB and ICNB groups as compared to the control group, with a mean difference of 57.5 (P < 0.001) and 40.3 (P = 0.003), respectively. However, there was no difference between the TPVB and ICNB groups (P = 0.978). Both TPVB and ICNB reported significantly greater improvements in PHN incidence, EQ-5D-3L scores and rescue analgesic requirements during follow-up, as opposed to the control AVT. Shorter procedure time was observed in ICNB as compared to TPVB (16.47 ± 3.39 vs. 11.69 ± 2.58, P < 0.001). Both US-guided TPVBs and ICNBs were effective for ZAP, and accounted for possible prophylaxis for PHN, as compared to AVT alone. The ICNB approach could be recommended as an alternative to conventional TPVB with a better consumed procedure time and side effect profile.a.

A Real-World Study on Adverse Reactions of Belimumab Based on the FDA Adverse Event Reporting System Database.

This investigation leverages data derived from the United States Food and Drug Administration Adverse Event Reporting (FAERS) to real-world adverse reactions associated with Belimumab, with the intention of providing guidance for safe clinical pharmacotherapy. Data encompassing adverse drug event (ADE) reports relating to Belimumab from Q1 2011 to Q4 2023 within the FAERS were extracted and analyzed using methodologies such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). The study identified a total of 19 825 ADE reports where Belimumab was the primary suspect medication, with the United States constituting the majority of reporting countries (16 312 cases, or 82.28%). Patients aged 18 to 64.9 years accounted for the largest demographic (36.29%), while the proportion of female patients (77.91%) significantly surpassed that of male patients (5.03%). The analysis uncovered 184 unique Preferred Terms (PTs) across 21 System Organ Classes (SOCs). Following selection through ROR, the SOC signal strength was prioritized as follows: Systemic disorders and administration site conditions, infections and infestations, a variety of musculoskeletal and connective tissue disorders, and conditions related to pregnancy, puerperium, and the perinatal period. The top five PTs for ADE reports not included in the product's labeling were hypersensitivity reactions, immunosuppression, non-vascular diseases, herpes virus infections, and Sjögren's syndrome. The top five PTs for ADE signal strength not included in the labeling were disseminated cutaneous herpes zoster, herpes zoster meningitis, onycholysis, cyclothymic disorder, and mixed connective tissue disease. Based on pharmacovigilance research utilizing the FAERS database, it is recommended that clinical monitoring of Bevacizumab should be intensified to support effective pharmaceutical care and ensure rational clinical medication use.

Preliminary investigation and analysis of nucleotide site variability of nine glycoproteins on varicella-zoster virus envelope, Jilin Province, China, 2010-March 2024

Varicella is endemic worldwide. In China, varicella has not yet been included in the list of legal infectious diseases, nor has a unified national surveillance program been established. And the live attenuated varicella vaccine has not been included in routine immunization. In this study, we analyzed for the first time the varicella epidemiology in Jilin Province in the past 20 years, and the nucleotide site, amino acid site and N-glycosylation site variation of glycoprotein in varicella-zoster virus (VZV) surface 9 in the past 15 years. The results showed that the reported incidence of varicella in Jilin Province in the last 20 years was fluctuating above and below 20/100,000, especially after the epidemic of the COVID-19, and fatal cases appeared in individual years. The genotypic branching of VZV was monitored as Clade 2 in the last 15 years. 9 glycogen nucleotide sites of VZV had different degrees of variability, and the variability had specificity. Therefore, it gives us the idea that in order to reduce the incidence of varicella and herpes zoster, a provincial or even national surveillance program should be introduced as early as possible, and the dynamic monitoring of the variability of the nucleotide sites of VZV should be strengthened at the same time as the vaccine immunization strategy is introduced.

Methotrexate, Tofacitinib, and Biologic Disease-Modifying Antirheumatic Drug Safety and Effectiveness Among Patients with Rheumatoid Arthritis in Japan: CorEvitas Registry Observational Study.

The evolution of disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA) has improved patient prognosis. However, more real-world safety/effectiveness data comparing methotrexate (MTX), tofacitinib, tumor necrosis factor inhibitors (TNFi), and non-TNFi biologic DMARDs (bDMARDs)are warranted. The CorEvitas RA Japan registry was used to identify patients with rheumatologist-diagnosed RA who initiated MTX/tofacitinib/TNFi/non-TNFi bDMARDs. Safety outcomes included incidence of major adverse cardiovascular events (MACE), total cardiovascular disease, total serious infections, total herpes zoster, and total malignancies (excluding non-melanoma skin cancer). Effectiveness outcomes included change from baseline (Δ) in Clinical Disease Activity Index (CDAI) and proportion of patients achieving a minimum clinically important difference (MCID) in CDAI at month6. Adjusted regression models were fit; marginal means were estimated. Overall, 1972 patients were included in the safety cohort: MTX (N = 298); tofacitinib (N = 253); TNFi (N = 663); non-TNFi (N = 758). Mean follow-up time was 3.8, 2.9, 3.0, and 2.9years for MTX, tofacitinib, TNFi, and non-TNFi, respectively. Adjusted incidence rates (IRs, patients with events/100 patient-years [95% confidence intervals]) for MACE and total cardiovascular disease, respectively, were numerically lower for MTX (0.34 [0, 0.83]; 0.42 [0, 0.92]) and TNFi (0.09 [0, 0.27]; 0.61 [0.15, 1.07]) versus tofacitinib (0.48 [0, 1.20]; 2.30 [0.38, 4.22]) and non-TNFi (0.77 [0.35, 1.19]; 1.28 [0.73, 1.82]). Serious infections were numerically higher for non-TNFi (4.47 [3.38, 5.56]); herpes zoster was higher for tofacitinib (7.41 [4.52, 10.29]), versus other groups. IRs for malignancies were comparable between groups. Mean ΔCDAI and rates of achieving MCID in CDAI at month6 were generally greater with tofacitinib versus other groups. Some variations in incidence of safety outcomes were observed between treatments, while certain effectiveness outcomes favored tofacitinib. Sample size variation between groups and low number of safety events limited the analysis. Further studies are warranted to investigate observed differences. GOV: NCT05572567.

Current vaccination and immunization strategies in dermatology

Vaccinations are an important pillar of public health. They have high benefits for individuals and society as awhole by specifically preventing or mitigating infectious diseases. In many cases, they offer benefits that go beyond protection against the disease in question, e.g., protective cardiovascular effects. Vaccination recommendations in Germany are drawn up by the Standing Committee on Vaccination (STIKO), while the European Medicines Agency (EMA) is responsible for the approval of vaccines in the EU. Vaccinations may be carried out by physicians regardless of their specialty. In dermatology, vaccinations against varicella (chickenpox), herpes zoster, and human papillomavirus are established. The development of vaccines against other dermatologically relevant diseases and cancer vaccines is the subject of intensive research. Particularly in the case of immunosuppression, the physician must also take into consideration which vaccinations are possible and useful or contraindicated. TypeI or typeIV allergies to components of vaccinations are very rare, but reactions at the injection site often occur as adermatological side effect. Urticarial reactions are also possible, as does the worsening of underlying dermatological conditions such as psoriasis vulgaris.

Validity of Plasma Neuropeptide Y in Combination with Clinical Factors in Predicting Neuralgia Following Herpes Zoster

Validity of Plasma Neuropeptide Y in Combination with Clinical Factors in Predicting Neuralgia Following Herpes Zoster

Acute Retinal Necrosis: A Review of Diagnosis and Management

Acute retinal necrosis (ARN) is a profound infection of the retina, marked by acute panuveitis, retinal periarteritis, and widespread necrotizing retinitis. The etiology of ARN involves human herpesviruses, such as herpes simplex virus (HSV) and varicella-zoster virus (VZV), which can lead to severe visual impairment or even blindness. A diagnosis of ARN is based on clinical characteristics and disease progression according to the standard diagnostic criteria established by the American Uveitis Society (AUS) in 1994. The polymerase chain reaction(PCR) of aqueous specimens can enable identification of the type of virus. Early initiation of antiviral medication is essential for treatment efficacy to stop lesion progression, accelerate the healing process, and prevent contralateral eye involvement. Ocular complications of ARN include atrophic retina, multiple retinal breaks, rhegmatogenous retinal detachment (RRD), tractional retinal detachment (TRD), optic atrophy, macular edema, epiretinal membrane (ERM), and retinal and optic disc neovascularization. This review summarizes the clinical features, diagnostic criteria, and recently recommended ARN management.

Viral Infections in Pediatric Kidney Transplant Recipients: Effects on Graft Function, Risk Factors, and Patient Outcomes.

Viral infections are the leading cause of posttransplant morbidity and mortality. We aimed to determine the effect on graft function, the risk factors, the frequency, and types of viral infections and to evaluate the effect of viral infections on kidney and patient outcomes in pediatric kidney transplant patients. Records of children undergoing kidney transplant in our center during the period February 1, 2010, to December 31, 2023, were retrospectively evaluated. Demographic and laboratory data, kidney failure etiologies, donor types, immunosuppression treatments, acute rejection episodes, accompanying viral infections, glomerular filtration rate, and graft loss rate were analyzed. Seventy-nine pediatric kidney transplant recipients were included in the study. The number of patients who experienced viral infections was 18 (23%). In total, 25 infection episodes were identified, with 6 (24%) attributed to cytomegalovirus infection, 8 (32%) to BK virus infection, 6 (24%) to varicella zoster virus infection (4 cases of shingles, 2 cases of chickenpox), 4 (16%) to parvovirus B19 infection, and 2 (8%) to COVID-19. Of 25 infection episodes, rejection episodes were observed in 11 cases (44%), and infections manifested after rejection in 8 cases (32%). Viral infections occurred an average of 15 months after rejection episodes. For 15 (60%) of the 25 infection episodes, the glomerular filtration rate was observed to be <60 mL/min/1.73 m2 during viral infection. Two patients succumbed to viral infections; 1 was due to COVID-19, and 1 was due to coinfection with parvovirus B19 and cytomegalovirus. Our data emphasized the significant effect of viral infections on pediatric kidney transplant recipients. Early diagnosis and treatment in kidney transplant recipients are important, and clinicians should be alert.

Effect of the Antibody-mediated Immune Responses on COPD, Asthma, and Lung Function: A Mendelian Randomization Study

IntroductionThe precise cause of antibody-mediated immune responses on chronic obstructive pulmonary disease (COPD), asthma, and lung function remains unclear. We characterized the relationship between antibody-mediated immune responses to COPD, asthma, and lung function, ultimately achieve the prevention or treatment. MethodsWe obtained summary data from published genome-wide association studies, including antibody-mediated immune responses, COPD, asthma, forced expiratory volume in the first second (FEV1), forced expiratory volume (FVC), and FEV1/FVC. Bidirectional two-sample mendelian randomization (MR) analysis was used to assess causal relationships of antibody-mediated immune responses, COPD, asthma, FEV1, FVC, and FEV1/FVC. ResultsA total of 20 antibody-mediated immune responses were identified have a significant causal effect on COPD, asthma, FEV1, and FVC, with six exhibiting reverse causality. Importantly, the results of the five MR analyses were almost identical with respect to the causal effect of anti-polyomavirus 2 IgG seropositivity and varicella zoster virus glycoprotein E and I antibody levels on the risk of COPD, asthma, FEV1, and FVC. ConclusionsThis study contributes to existing knowledge by investigating the causal relationship between antibody-mediated immune responses and respiratory conditions, including COPD, asthma, and lung function, using a two-sample MR design. The key findings can aid in identifying individuals at risk of these conditions and facilitate early prevention and diagnosis.

S1322 Increased Herpes Zoster Rates, but Not Other Infections, in IBD Patients Treated With JAK Inhibitors: A Multi-Center 5-Year Study

S1322 Increased Herpes Zoster Rates, but Not Other Infections, in IBD Patients Treated With JAK Inhibitors: A Multi-Center 5-Year Study

S1210 Lower Rates of Recurrent Herpes Zoster Complications in Patients With Inflammatory Bowel Disease Who Received Recombinant Zoster Vaccination: A Propensity Score Matched Analysis

S1210 Lower Rates of Recurrent Herpes Zoster Complications in Patients With Inflammatory Bowel Disease Who Received Recombinant Zoster Vaccination: A Propensity Score Matched Analysis

Identifying and Evaluating Biological Markers of Postherpetic Neuralgia: A Comprehensive Review.

Postherpetic neuralgia (PHN) manifests as persistent chronic pain that emerges after a herpes zoster outbreak and greatly diminishes quality of life. Unfortunately, its treatment efficacy has remained elusive, with many therapeutic efforts yielding less than satisfactory results. The research to discern risk factors predicting the onset, trajectory, and prognosis of PHN has been extensive. However, these risk factors often present as nonspecific and diverse, indicating the need for more reliable, measurable, and objective detection methods. The exploration of potential biological markers, including hematological indices, pathological insights, and supportive tests, is increasing. This review highlights potential biomarkers that are instrumental for the diagnosis, management, and prognosis of PHN while also delving deeper into its genesis. Drawing from prior research, aspects such as immune responsiveness, neuronal injury, genetic makeup, cellular metabolism, and pain signal modulation have emerged as prospective biomarkers. The immune spectrum spans various cell subtypes, with an emphasis on T cells, interferons, interleukins, and other related cytokines. Studies on nerve injury are directed toward pain-related proteins and the density and health of epidermal nerve fibers. On the genetic and metabolic fronts, the focus lies in the detection of predisposition genes, atypical protein manifestations, and energy-processing dynamics, with a keen interest in vitamin metabolism. Tools such as functional magnetic resonance imaging, electromyography, and infrared imaging have come to the forefront in the pain signaling domain. This review compiles the evidence, potential clinical implications, and challenges associated with these promising biomarkers, paving the way for innovative strategies for predicting, diagnosing, and addressing PHN.

Comparison of the safety profile of tofacitinib and etanercept in rheumatoid arthritis patients aged 60 years and over: The real-life data from the HUR-BIO registry

Objective: To investigate the safety profile of tofacitinib in rheumatoid arthritis (RA) patients aged 60 and over and to compare these findings with etanercept. Materials and methods: HUR-BIO (Hacettepe University Rheumatology Biologic Registry) is a single-center registry for biological and targeted synthetic DMARDs since 2005. We included RA patients aged ≥ 60 years who were prescribed tofacitinib or etanercept as their first bDMARD or tsDMARD and had at least one control visit. MACE (major adverse cardiovascular event), VTE (venous thromboembolism), malignancy, herpes zoster, and infections requiring hospitalization were recorded for the safety profile. Incidence rate (IR) and incidence rate ratios (IRR) per 1000 patient years were calculated for all safety data. Results: This study consisted of 123 RA patients (tofacitinib n=70, etanercept n=53). In the overall population, the mean age was 67.9 ± 6.2 years and the median follow-up period was 2.1 years. Among the traditional cardiovascular risk factors, smoking history and hyperlipidemia were more common in the tofacitinib group. The IRR per 1000 patients years for MACE, herpes zoster, and infections requiring hospitalization was similar between the groups. All three patients who diagnosed with DVT or PE were in the tofacitinib group, and the significance level of the increase in IR was close to the statistical threshold (p=0.057). There was only one patient who developed non-melanoma skin cancer, and that patient was in the tofacitinib group. Conclusion: The incidence of MACE, herpes zoster, and infections requiring hospitalization was comparable between tofacitinib and etanercept. However, the occurrence of VTE exclusively in the tofacitinib group suggests that this issue needs careful evaluation for these patients.