Is the patient-perceived impact of psoriatic arthritis a global concept? An international study in 13 Arab countries (TACTIC study).

The Psoriatic Arthritis Impact of Disease (PsAID-12) questionnaire, a recommended measure of patient-reported impact for psoriatic arthritis (PsA), was initially developed in Europe and may lack universal validity. Recognizing the need for a culturally appropriate tool for Arab patients, this study aimed to TranslAte, CulTurally adapt, and validate the PsAID in ArabIC (TACTIC). The PsAID-12 was translated into Arabic using a rigorous process of double translation, back-translation, and cognitive debriefing. The Arabic version was then validated through a study conducted in 13 Arab countries in 2022. Participants were consecutive literate adult patients diagnosed with PsA and fulfilling the CASPAR criteria. Collected data included PsAID-12, disease activity, and legacy patient-reported outcomes. Psychometric properties, such as internal consistency, construct validity, and test-retest reliability, were examined. Factors associated with high PsAID-12 total scores (> 4) were explored using multivariable binary logistic regression. A culturally adapted Arabic PsAID-12 questionnaire was achieved with minor rephrasing. The validation study included 554 patients from 13 countries (mean age 45 years, 59% females), with a mean PsAID score of 3.86 (SD 2.33). The Arabic PsAID-12 demonstrated excellent internal consistency (Cronbach's α = 0.95), and correlations with other measures ranged from 0.63 to 0.78. Test-retest reliability (N = 138 patients) was substantial (intraclass correlation coefficient, ICC 0.90 [0.86-0.93]; Cohen's kappa 0.80). Factors associated with a high PsAID score were disability (odds ratio, OR 3.15 [2.03-4.89]), depression (OR 1.56 [1.35-1.81]), widespread pain (OR 1.31 [1.12-1.53]), and disease activity (OR 1.29 [1.13-1.47]). Pain and fatigue were identified as the most impactful PsAID-12 domains for PsA patients. The Arabic PsAID is a valid and reliable measure that reflects the priorities of patients with PsA. PsAID scores correlated with disease activity and legacy outcome measures, as expected, indicating PsAID is a consistent measure of PsA impact across cultures. These findings highlight the potential of the Arabic PsAID in improving the care provided to Arabic-speaking patients worldwide.

Birthweight predicts glomerular filtration rate in adult-life: population based cross sectional study.

INTRODUCTION: Worldwide, there is a global progressive rise of chronic kidney disease. In parallel, children born after intra-uterine growth retardation are surviving to adult-life and beyond. This study describes the association of birthweight with and estimated glomerular filtration rate (eGFR). METHODS: Australian Diabetes, Obesity and Lifestyle (AusDiab) study participants were asked to complete a birthweight questionnaire. The associations between birthweight and eGFR were determined. RESULTS: A total of 4502 reported information related to their birthweight, with the other responders did not provide a value. The birthweight of the participants ranged from 0.4 to 7.0 kg with a mean-(SD) of 3.37 (0.7) kg. The mean (95%CI) birthweight was lower for females, 3.28 (0.6) kg, when compared to males, 3.5 (0.7) kg. Eight percent had a birthweight less than 2.5 kg. The eGFR was strongly and positively associated with birthweight, with people in the lowest sex-specific birthweight-quintiles having the lowest mean eGFR. This relationship persisted with adjustment for confounding factors. The OR(CI) for eGFR <10th-percentile (<61.4 ml/min for females and <73.4 for males) for people in the lowest vs. the higher birthweight-quintile was 2.19 (95%CI 1.14-4.2) for females and 2.37 (1.1-5.3) for males, after adjustment for other factors. CONCLUSIONS: Birthweight had a positive relationship with eGFR. Possible explanations include an association of birthweight with nephron-endowment. From a global health perspective but more in developing countries and in populations in epidemiologic transition, where substantially lower birthweights coexist with recently improved infant and adult survivals, the overall impact of this phenomenon on the population health profile could be more substantial.

Time to address gender inequalities against female physicians.

Although the health care system depends heavily on female physicians, it discriminates against women and tends to concentrate female physicians' work in lower status occupations. Gender discrimination has structural, social, and cultural dimensions. Such discrimination is perceived differently by various stakeholders and the public. In addition, there is reluctance to publicly acknowledge gender discrimination, especially in the culturally conservative Middle East region. Gender discrimination leads to underrepresentation of female physicians in leadership roles and certain specialties and hence leads to less attention and understanding of the working conditions of female physicians and their roles in the health care system. The lack of accessible data in the region regarding gender discrimination among physicians leads to stakeholders failing to recognize the existence and magnitude of this type of discrimination. This article takes up the relatively neglected issue of gender discrimination in the health care workforce among the stakeholders of the Ministry of Health and Prevention of the United Arab Emirates. Future research should explore the extent of gender discrimination among physicians and the gender remuneration gap, together with other sorts of discrimination, perception of equal opportunity, and dominant stereotypes of men and women working in health care in relation to job obligation, promotion, retention, remuneration, and education.

Health workforce in the United Arab Emirates: analytic point of view.

A strong health system is impossible without health workers who are the ultimate resource. Money and medical supplies are needed, but these inputs require an efficient workforce. Challenges with respect to human resources vary greatly between and within countries, and are associated with the political, economical, cultural and societal context of a country. Moreover, the gaps in the workforce do not generally relate to doctors but to nurses and other classes of health worker who make up the bulk of health workforce. The difficulties caused by low staff numbers are compounded by morale problems, skill imbalances and geographical maldistribution. This paper will discuss how it is difficult for the United Arab Emirates (UAE, a Middle East federation country) to wrestle effectively with the demands of a good health system, exploring how they lack the basis of health systems-motivated, trained and supported people. Additionally, we looked at how the UAE health system further challenged by negative work environment, and weak knowledge-base, out-migration and inadequate investment. At the end of our discussion, we are providing some suggestions to manage human resource problems in the UAE. Highlighting how a national workforce strategic plan is important to guide investments in human resources as the core component of strengthening the UAE national health system.

Simultaneous Pancreatic and Kidney Transplant in Adult with Autosomal Dominant Polycystic Kidney Disease and Type I Diabetes Mellitus: Post Surgical Events and Genetic Review.

Autosomal dominant polycystic kidney disease (ADPKD) is a common inherited condition characterized by the growth of multiple bilateral cysts in the kidneys. We describe the case of a 35-year-old male with combined ADPKD and type 1 diabetes mellitus with a strong family history of both. At the age of 32, he developed end-stage kidney disease for which he underwent preemptive simultaneous pancreatic and kidney transplant, which in turn led to multiple perioperative complications. Evaluation of familial clustering of genetic disease is critical in genetic epidemiology and precision medicine as it enables estimation of lifetime disease risk and early assessment as well as detection of the disease among one's siblings.

The economic burden of systemic lupus erythematosus in United Arab Emirates.

AIMS: Our study aims to provide an enhanced comprehension of systemic lupus erythematosus (SLE) burden in United Arab Emirates (UAE), over a five-year period from payer and societal perspective. MATERIALS AND METHODS: A Markov model was established to simulate the economic consequences of SLE among UAE population. It included four health states: i) the three phenotypes of SLE, representing mild, moderate, and severe states, and ii) death. Clinical parameters were retrieved from previous literature and validated using the Delphi panel-the most common clinical practice within the Emirati healthcare system. We calculated the disease management, transient events, and indirect costs by macro costing. One-way sensitivity analysis was conducted. RESULTS: The estimated number of SLE patients in our study was 13,359. The number of SLE patients with mild, moderate, and severe phenotypes was 3,914, 8,109, and 1,336, respectively. Disease management costs, including treatment of each phenotype and disease follow-up, were AED 2 billion ($0.89 billion), whereas the costs of transient events (infections, flares, and consequences of SLE-related organ damage) were AED 1 billion ($0.44 billion). The productivity loss costs among adult-employed patients with SLE in the UAE were estimated at AED 7 billion ($3.1 billion). The total SLE cost over five years from payer and societal perspectives is estimated at AED 3 ($1.3 billion) and 10 billion ($4.4 billion), respectively. Additionally, the costs per patient per year from the payer and societal perspectives were AED 45,960 ($20,610) and AED 148,468 ($66,578), respectively. CONCLUSION: Our findings demonstrate that the burden of SLE in the UAE is enormous, mainly because of the costly complications and productivity loss. More awareness should be created to limit the progression of SLE and reduce the occurrence of flares, necessitating further economic evaluations of novel treatments that could help reduce the economic consequences of SLE in the UAE.

Consensus-Based Overarching Principles and Recommendations on the Use of Biosimilars in the Treatment of Inflammatory Arthritis in the Gulf Region.

BACKGROUND: Though biologic agents have significantly improved the treatment of inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis), high costs, stringent regulations, strict reimbursement criteria, and existing patents have limited patient access to treatments. While being highly similar in quality, safety, and efficacy to biologic reference products, biosimilars can reduce the financial burden and prevent underutilization of medication. OBJECTIVE: The objective of this initiative was to develop an evidence-based consensus of overarching principles and recommendations aimed at standardizing the use of biosimilars in treating inflammatory arthritis in the Gulf region. METHODS: A task force of practicing rheumatologists, a clinical pharmacist, a health economist, patients, regulators, and payors from across the Gulf region developed recommendations and overarching principles based on the outputs of a systematic literature review conducted to address Patient-Intervention-Comparison-Outcome (PICO) questions specific to key challenges regarding the use of biosimilars for the treatment of inflammatory arthritis in the region. As the data before 2017 have been previously reviewed in another publication, the current review focused on data published between January 2017 and August 2022 (PROSPERO ID CRD42022364002). Consensus on each statement required a level of agreement of 70% or greater. RESULTS: Consensus was reached for five overarching principles and nine recommendations by the task force. The principles emphasize the importance of improving the awareness, understanding, and perception of biosimilars, as well as the need for regulated regional real-world data generation and protocols to make biosimilars a viable and affordable treatment option for all patients. The consensus recommendations advocate the need for shared treatment decisions between rheumatologists and patients when considering biosimilars. They further recommend that confirmation of a biosimilar's efficacy and safety in a single indication is sufficient for extrapolation to other diseases for which the reference product has been approved. Finally, there is a need for pharmacovigilance and national health policies governing the adoption and prescription of biosimilars in clinical practice across the region. CONCLUSIONS: These are the first consensus recommendations for the Gulf region based on a systematic literature review and Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) guidelines, integrating clinical evidence with clinical expertise to optimize decision making for the use of biosimilars in patients with inflammatory arthritis. They were formulated based on predominantly international data because of the limited regional data and therefore can be generalized to serve as recommendations for healthcare professionals in other parts of the world.

Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: ABO1020 is a monovalent COVID-19 mRNA vaccine. Results from a phase 1 trial showed ABO1020 was safe and well tolerated, and phase 3 trials to evaluate the efficacy, immunogenicity, and safety of ABO1020 in healthy adults are urgently needed. METHODS: We conducted a multinational, randomized, placebo-controlled, double-blind, phase 3 trial among healthy adults (ClinicalTrials.gov: NCT05636319). Participants were randomly assigned (1:1) to receive either 2 doses of ABO1020 (15 µg per dose) or placebo, administered 28 days apart. The primary endpoint was the vaccine efficacy in preventing symptomatic COVID-19 cases that occurred at least 14 days post-full vaccination. The second endpoint included the neutralizing antibody titers against Omicron BA.5 and XBB and safety assessments. FINDINGS: A total of 14,138 participants were randomly assigned to receive either vaccine or placebo (7,069 participants in each group). A total of 366 symptomatic COVID-19 cases were confirmed 14 days after the second dose among 93 participants in the ABO1020 group and 273 participants in the placebo group, yielding a vaccine efficacy of 66.18% (95% confidence interval: 57.21-73.27, p < 0.0001). A single dose or two doses of ABO1020 elicited potent neutralizing antibodies against both BA.5 and XBB.1.5. The safety profile of ABO1020 was characterized by transient, mild-to-moderate fever, pain at the injection site, and headache. CONCLUSION: ABO1020 was well tolerated and conferred 66.18% protection against symptomatic COVID-19 in adults. FUNDING: National Key Research and Development Project of China, Innovation Fund for Medical Sciences from the CAMS, National Natural Science Foundation of China.

Immunogenicity and safety of boosting with a recombinant two-component SARS-CoV-2 vaccine: two randomized, parallel-controlled, phase 2 studies.

BACKGROUND: Recombinant protein vaccines are vital for broad protection against SARS-CoV-2 variants. This study assessed ReCOV as a booster in two Phase 2 trials. RESEARCH DESIGN AND METHODS: Study-1 involved subjects were randomized (1:1:1) to receive 20 µg ReCOV, 40 µg ReCOV, or an inactivated vaccine (COVILO®) in the United Arab Emirates. Study-2 participating individuals were randomized (1:1:1) to receive 20 µg ReCOV (pilot batch, ReCOV HA), 20 µg ReCOV (commercial batch, ReCOV TC), or 30 µg BNT162b2 (COMIRNATY®) in the Philippines. The primary immunogenicity objectives was to compare the geometric mean titer (GMT) and seroconversion rate (SCR) of neutralizing antibodies induced by one ReCOV booster dose with those of inactivated vaccine and BNT162b2, respectively, at 14 days post-booster. RESULTS: Heterologous ReCOV booster doses were safe and induced comparable immune responses to inactivated vaccines and BNT162b2 against Omicron variants and the prototype. They showed significant advantages in cross-neutralization against multiple SARS-CoV-2 variants, surpassing inactivated vaccines and BNT162b2, with good immune persistence. CONCLUSIONS: Heterologous ReCOV boosting was safe and effective, showing promise in combating COVID-19. The study highlights ReCOV's potential for enhanced protection, supported by strong cross-neutralization and immune persistence. CLINICAL TRIAL REGISTRATION: Study-1, www.clinicaltrials.gov, identifier is NCT05323435; Study-2, www.clinicaltrials.gov, identifier is NCT05084989.

COVID-19 Associated Acute Viral Myocarditis and Thyroid Gland Follicular Neoplasm in a Hemodialysis Patient.

Since the first cases were reported in Wuhan, China, COVID-19 has spread swiftly worldwide and is caused by SARS-CoV-2. The development of myocardial injury is associated with significantly worse clinical course and increased mortality. However, currently, it is unclear whether cardiac injury occurred in COVID-19 patients. Histological results obtained directly from the viral infection of the myocardium (i.e., SARS-CoV-2 viral myocarditis) or indirectly from the complications of COVID-19, showed that only a portion of patients infected with the virus developed viral myocarditis. Therefore, it is possible that with more autopsy evidence of SARS-CoV-2 and more correlation with the severity of the viral infection, viral myocarditis will emerge. Although COVID-19 manifests primarily as respiratory disease, few cases of cardiac injury without respiratory involvement or febrile illness have been reported. The pathogenesis of cancer and viral infections is due to the inability of the immune system to distinguish between self and non-self. Several oncogenic (hepatitis B virus, hepatitis C virus, human papilloma virus, Epstein-Barr virus, and HIV) and oncolytic viruses (coxsackievirus, reovirus, vaccinia virus, and adenovirus) are known to cause and regress various cancer types. We report a case of atypical manifestation of COVID-19-induced acute myocarditis and thyroid gland follicular neoplasm in a hemodialysis patient with no respiratory symptoms. This case illustrates that COVID-19 can present atypically and affect non-respiratory organ systems.

Mycophenolate Induced Colitis: One-year Post-kidney Transplantation.

The incidence of end-stage kidney disease (ESKD) has been increasing over the past few years as a direct result of the growing percentages of individuals with metabolic syndrome. From 2001 to 2015 there were 2805 individuals diagnosed with ESKD in Oman with a growing number of patients undergoing renal transplant as the gold standard management of renal replacement therapy. Mycophenolate mofetil (MMF) is one of the most frequently used medications as a part of immunosuppressive medications in renal transplant specifically and solid organ transplant generally. We are reporting a case of MMF-induced colitis in a young female patient that underwent a living-related kidney transplant. She presented with a three-month history of watery non-bloody and afebrile diarrhea. Investigations confirmed the diagnosis of MMF-induced colitis. Histopathological examination of colonic biopsies obtained during the colonoscopy procedure showed mildly increased crypt apoptosis, mild architectural disarray, and focal crypt attenuation; features consistent with MMF-induced colitis. The patient was treated by stopping the causative agent and replacing it with another immunosuppressive medication, which led to complete resolution of the symptoms on follow-up appointments. In this case report, we highlighted the underlying mechanism, pathogenesis, and clinical features of MMF-induced colitis.

Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial.

BACKGROUND: Booster vaccination is an efficient way to address the waning protection of vaccines and immune escape of SARS-CoV-2 variants. We aimed to assess the safety and immunogenicity of SCTV01C, a novel bivalent protein vaccine as a booster for people who previously received two doses of mRNA vaccine. METHODS: In this randomized, phase 1/2 trial, adults fully vaccinated with mRNA vaccines 3-24 month earlier were enrolled. Participants received SCTV01C at 20 µg, 40 µg or placebo. The primary endpoints were adverse reactions within 7 days and immunogenicity on Day 28 after vaccination. This trial was registered with ClinicalTrials.gov (NCT05043311). FINDINGS: Between January 27 and April 28, 2022, 234 adults were randomly assigned to receive SCTV01C or placebo. The most common solicited adverse events (AEs) were Grade 1 injection-site pain (10.7%) and pyrexia (6.3%). There were no reports of Grade 3 or above solicited AE, serious AEs or AEs of special interests. On Day 28 post the booster, the geometric mean concentrations (GMCs) of the specific binding IgG antibodies to spike protein for placebo, 20 µg and 40 µg SCTV01C were 1649, 4153 and 5354 BAU/mL, with fold of increase from baseline of 1.0, 2.8 and 3.4-fold, respectively. GMTs of neutralizing antibodies against live Delta variant were 1280, 3542, and 4112, with fold of increase of 1.1, 3.9 and 4.1-fold, respectively; GMTs of neutralizing antibodies against live Omicron variant were 218, 640, and 1083, with fold of increase of 1.1, 4.4 and 5.1-fold, respectively. Participants with low neutralizing antibody titers at baseline (below the lower limit of quantitation) had 64.0 and 49.4-fold of increase in GMTs for Delta and Omicron, respectively. INTERPRETATION: The heterologous booster of SCTV01C was safe, and induced uniformly high cross-neutralization antibody responses against Delta and Omicron variants. FUNDING: Beijing Science and Technology Plan Project (Z221100007922012) and the National Key Research and Development Program of China (2022YFC0870600) supported this study.

Physicians' attitudes, knowledge, and practices regarding antibiotic prescriptions.

OBJECTIVES: Inappropriate and overuse of antimicrobials, incorrect dosing, and extended duration are some of the leading causes of antibiotic-resistance that have led to the development of antimicrobial resistance (AMR). We aimed to evaluate knowledge, attitudes, and practices regarding rational antibiotic prescribing among physicians in a teaching hospital in Oman, with the goal of identifying knowledge gaps and interventions that could lead to judicious use of antimicrobials and reduce the emergence of resistant organisms METHODS: A cross-sectional study assessing physicians' knowledge of and attitudes towards prescribing antibiotics was conducted at the Royal Hospital from 15 January to 31 March 2020. Likert scales were used to evaluate physicians' awareness and perception of personal performance regarding the care of patients with infections and rational use of antibiotics. RESULTS: Inadequate hand washing was regarded as the most important factor contributing to AMR (51.6%), followed by widespread use of antibiotics (49%), prescribing broad-spectrum antibiotics (47.3%), lack of effective narrow-spectrum antibiotics (47.3%), inappropriate duration of antibiotic therapy (46.2%), inappropriate empirical choice of antibiotics (45.1%), poor access to information on local antibiotic resistance patterns (40.8%), and inadequate restrictions on antibiotic prescribing (34.4%). Other factors contributing to AMR such as lack of local hospital guidelines on antibiotic usage, random mutations in microbes, patient demands and expectations for antibiotics, and the role of pharmaceutical companies in advertising and promoting use of antibiotics were deemed important by 33.3%, 26.8%, 22.5% and 20.4%, respectively. CONCLUSIONS: AMR is a global health threat with significant effect on the health system and the economy. Misuse and overuse of antimicrobials remain the main drivers for the development of drug-resistant pathogens. Identifying knowledge gaps and planning interventions that could lead to judicious use of antimicrobials including establishing an Antimicrobial Stewardship Program are of paramount importance in reducing AMR in the twenty-first century and beyond.

Safety and immunogenicity of a tetravalent and bivalent SARS-CoV-2 protein booster vaccine in men.

The safety and immunogenicity of a protein-based tetravalent vaccine SCTV01E that contains spike protein ectodomain (S-ECD) of Alpha, Beta, Delta and Omicron BA.1 are assessed and compared with bivalent protein vaccine SCTV01C (Alpha and Beta variants) and monovalent mRNA vaccine (NCT05323461). The primary endpoints are the geometric mean titers (GMT) of live virus neutralizing antibodies (nAb) to Delta (B.1.617.2) and Omicron BA.1 at day 28 post-injection. The secondary endpoints include the safety, day 180 GMTs against Delta and Omicron BA.1, day 28 GMTs to BA.5, and seroresponse rates of neutralizing antibodies and T cell responses at day 28 post-injection. 450 participants, comprising of 449 males and 1 female, with a median age (range) of 27 (18-62) years, are assigned to receive one booster dose of BNT162b2, 20 µg SCTV01C or 30 µg SCTV01E and completed 4-week follow-up. All SCTV01E related adverse events (AEs) are mild or moderate and no Grade ≥3 AE, serious AE or new safety concerns are identified. Day 28 GMT of live virus neutralizing antibodies and seroresponse against Omicron BA.1 and BA.5 with SCTV01E are significantly higher than those with SCTV01C and BNT162b2. These data indicate an overall neutralization superiority with tetravalent booster immunization in men.

Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial.

Background: COVID-19 vaccines that offer broad-spectrum protection are needed. We aimed to evaluate the safety and immunogenicity of multivalent vaccines, SCTV01E and SCTV01C, and compare them with an inactivated vaccine. Methods: In the phase 3 trial (ClinicalTrials.gov: NCT05323461), adult participants previously vaccinated with Sinopharm's inactivated SARS-CoV-2 vaccine (BBBIP-CorV) were assigned to receive one booster dose of BBBIP-CorV, 20 µg SCTV01C, or 30 µg SCTV01E. The primary endpoint was to evaluate the geometric mean titers (GMT) of neutralizing antibody (nAb) against the Delta and Omicron BA.1 variants on day 28 after injection. Additional endpoints included GMTs of nAb against Delta (B.1.617.2) and Omicron BA.1 variants on day 180, GMTs against BA.5 on day 28, as well as solicited adverse events (AEs) within seven days, unsolicited AEs within 28 days, and serious AEs, AEs of special interest within 180 days after vaccination. Findings: Between May 30, 2022 and October 28, 2022, a total of 1351 participants were randomized to BBBIP-CorV, SCTV01C, or SCTV01E in a 1:1:1 ratio, with immunogenicity assessments performed on the first 300 participants. For BBBIP-CorV, SCTV01C, and SCTV01E groups, the day 28 GMTs of neutralizing antibody against Omicron BA.1 were a 2.38-, 19.37-, and 28.06-fold increase from baseline; the GMTs against Omicron BA.5 were 2.07-, 15.89- and 21.11-fold increases; the GMTs against Delta variants were 1.97-, 12.76-, and 15.88-fold increases, respectively. The day 28 geometric mean ratio (GMR) of SCTV01C/BBIBP-CorV for Omicron BA.1 was 6.49 (95% CI: 4.75, 8.88), while the GMR of SCTV01E/BBIBP-CorV was 9.56 (95% CI: 6.85, 13.33). For the Delta variant, the day 28 GMR of SCTV01C/BBIBP-CorV was 6.26 (95% CI: 4.78, 8.19), and the day 28 GMR of SCTV01E/BBIBP-CorV was 7.26 (95% CI: 5.51, 9.56). On Day 180, the GMTs against Omicron BA.1 were 2.80-, 9.51-, and 15.56-fold increase from baseline, while those against Delta were 1.58-, 5.49-, and 6.63-fold for BBBIP-CorV, SCTV01C, and SCTV01E groups, respectively. Subgroup analyses showed that SCTV01C and SCTV01E induced uniformly high GMTs against both BA.1 and BA.5, demonstrating its superiority over BBIBP-CorV, regardless of baseline GMT levels. Safety and reactogenicity were similar among the three vaccines. Most AEs were Grade 1 or 2. There were 15 ≥Grade 3 AEs: 6 in the BBIBP-CorV group, 4 in the SCTV01C group and 5 in the SCTV01E group. No SAE was reported and one grade 1 AESI (Bell's palsy) was observed in SCTV01C group. Interpretation: A booster dose of the tetravalent vaccine SCTV01E consistently induced high neutralizing antibody responses against Omicron BA.1, BA.5, and Delta variants, demonstrating superiority over inactivated vaccine. There is evidence to suggest that SCTV01E may have GMT superiority over bivalent vaccine SCTV01C against Delta, BA.1 and BA.5 variants. Funding: This study was sponsored by Sinocelltech Ltd., and funded by the Beijing Science and Technology Planning Project [Z221100007922012] and the National Key Research and Development Program of China [2022YFC0870600].

Epidemiology, Management, and Outcome of Atypical Hemolytic Uremic Syndrome in an Omani Cohort.

Objectives: Atypical hemolytic uremic syndrome (aHUS) is a rare, life-threatening disease of chronic uncontrolled complement pathway activation that leads to thrombotic-microangiopathy, along with severe organ damage, including end-stage kidney disease. This study aimed to evaluate the epidemiology, management, and outcome of aHUS in an Omani population. Methods: This retrospective descriptive cohort study assessed all cases of aHUS diagnosed and followed up at two tertiary care centers in Oman from January 2008 to December 2019, based on clinical features, complement pathway assays, histopathological, and genetic testing. Results: The study accrued 19 patients who fulfilled the inclusion criteria, of whom 11 (57.9%) were male. The participants' median age was 25.0 years (range = 0.1-69.0). Most (15; 78.9%) patients presented in the acute phase of the disease. The triad of hemolytic anemia, acute kidney injury, and thrombocytopenia was present in all patients. A trigger factor (e.g., infection) was identified in 68.4% of cases. Of the 14 (73.7%) patients who underwent kidney biopsy, 10 (71.4%) were found to have aHUS in native kidneys and three in grafted kidneys. Of the 11 (57.9%) patients who underwent genetic analysis, five (45.5%) were found to have a known pathogenic variant in their aHUS susceptibility genes. Plasma exchange followed by eculizumab was the treatment method in 11 (57.9%) cases. Complete renal recovery was achieved in seven (36.8%) patients, while four (21.1%) passed away during the study period. Conclusions: The wide spectrum and multiple expressions of aHUS make it a challenge to diagnose and consequently may delay the commencement of the targeted treatment. Eculizumab is considered the first-line therapy and should be commenced as early as possible.

Comprehensive description of the prevalence, serological and clinical characteristics, and visceral involvement of systemic sclerosis (scleroderma) in a large cohort from the United Arab Emirates Systemic Sclerosis Registry.

Systemic sclerosis is an autoimmune condition characterized by a wide range of clinical presentations. Registries may serve to expand understanding about systemic sclerosis and aid in patient care and follow-up. The objective of this study was to analyze the prevalence of systemic sclerosis in a large cohort from the United Arab Emirates Systemic Sclerosis Registry and find the significant similarities and differences between the different subsets. All scleroderma patients in the United Arab Emirates were included in this multicenter national retrospective analysis. Data on demographics, comorbidities, serological characteristics, clinical aspects, and treatment were collected and analyzed, highlighting the most common traits identified. A total of 167 systemic scleroderma patients from diverse ethnic backgrounds were enrolled. Overall, 54.5% (91/167) of the patients were diagnosed with diffuse cutaneous systemic sclerosis, and 45.5% (76/167) with limited cutaneous systemic sclerosis. The prevalence of systemic sclerosis was 1.66 per 100,000 for the total registry and 7.78 per 100,000 for United Arab Emirates patients. Almost all patients in the diffuse cutaneous systemic sclerosis and limited cutaneous systemic sclerosis groups tested positive for the immunofluorescence antinuclear antibody. Antibodies against Scl-70 were significantly more associated with diffuse cutaneous systemic sclerosis, whereas anticentromere antibodies were significantly more associated with the limited cutaneous systemic sclerosis group (p < 0.001). Sclerodactyly, shortness of breath, and digital ulcers were more common in diffuse cutaneous systemic sclerosis patients compared with the limited cutaneous systemic sclerosis subtype in terms of clinical symptoms and organ involvement. Telangiectasia was much more common in the limited cutaneous systemic sclerosis group. Furthermore, diffuse cutaneous systemic sclerosis patients had more lung fibrosis (interstitial lung disease) than limited cutaneous systemic sclerosis patients (70.5% vs 45.7%), and pulmonary arterial hypertension was twice as common in limited cutaneous systemic sclerosis patients as it was in diffuse cutaneous systemic sclerosis patients. Local registries are paramount to understanding the clinical/serological characteristics of scleroderma. This study emphasizes the importance of raising disease awareness and distinguishing between the various systemic sclerosis subsets to implement patient-tailored strategies for early detection, better management, and higher quality of care.

Epidemiology of Cancer Among Chronic Kidney Disease Patients Compared to The General Population.

BACKGROUND: Kidney disease has a major effect on global health, both as direct cause of morbidity and mortality and as an important factor for other comorbid diseases including malignancy. Different studies report a higher risk of cancer development in patients with chronic kidney disease (CKD), but the impact of less sever CKD on risk of cancer is uncertain. However, data concerning the cancer risk in Oman CKD including dialysis patients is scarce. More importantly, there is lack of information about the cancer-specific mortality in CKD and dialysis patients. METHODS: During January 2006 to December 2019, all patients with CKD and those on regular dialysis who are admitted or follow up in Royal Hospital were included for evaluation of malignancy. RESULTS: During the study, a total of 2500 patients with CKD were included, of which 25 patients were found to have different types of cancers, of which 13 were male (52%) and 12 were female (48%).Most of patients 13 (52%) were senior adult (>65 years), then 11 (44%) were adult (19:64- ys) and only one case (4%) was child (<18years.). Cancer was detected in the ovaries (16%), stomach, multiple myeloma and renal (12%) each, while breast and colorectal (1 male/1 female) (8%), parathyroid, thyroid, uterus, cervix, prostate, skin, liver, lymphoma, pituitary gland, and myelofibrosis were present in 4% each. In general population, the breast cancer is the most common cancer among females, followed by thyroid cancer, and colorectal cancer while the most common cancer types among males are colorectal cancer followed by the prostate and then the Non-Hodgkin lymphoma disease. CONCLUSION: These epidemiologic findings should prompt clinicians and health authorities to assess strategies for cancer screening in high-risk population of CKD patients. Additional studies are needed to explain the reasons for this association and represent the potential use of cancer screening in patients with CKD in Oman. KEY WORDS: cancer, chronic kidney disease, epidemiology, hemodialysis.

Consensus statements for evaluation and nonpharmacological Management of Psoriatic Arthritis in UAE.

OBJECTIVE: Psoriatic arthritis (PsA), a chronic inflammatory arthropathy, is often underdiagnosed in Middle Eastern countries, substantially impacting the treatment of affected individuals. This article aims to highlight current unmet clinical needs and provide consensus recommendations for region-specific evaluation methods and nonpharmacological therapies in the United Arab Emirates (UAE). METHOD: An extensive literature review was conducted, focusing especially on global and regional guidelines for the evaluation and treatment of PsA. These form the basis of the consensus statements formulated. Additionally, an expert panel of key opinion leaders from the UAE reviewed these guidelines and available literature at an advisory board meeting to identify unmet needs, bridge clinical gaps in the UAE, and develop consensus statements for the evaluation and treatment of PsA. RESULT: The consensus statements were developed based on overarching principles for the management of PsA, evaluation of patients with PsA, and nonpharmacological approaches for the management of PsA. The overarching principles included adopting a targeted, multidisciplinary approach, along with collaboration between rheumatologists and dermatologists in cases of clinically significant skin involvement. The panel also highlighted the value of composite disease severity measures for characterizing clinical manifestations of PsA. In terms of nonpharmacological management approaches, lifestyle modification (comprising dietary change, exercise, and cessation of smoking) and psychotherapy were recommended. CONCLUSION: The consensus statements will aid healthcare professionals in clinical decision-making in the context of PsA.

Thyroid Dysfunction and Kidney Dysfunction.

Objectives: The incidence and prevalence of chronic kidney disease (CKD) are rising worldwide. It is becoming more common in the developing world with the increasing impact of non-communicable diseases in these countries. Also, autoimmune disorders, including thyroid dysfunction are more common and may worsen the clinical status of patients with CKD. We sought to determine the thyroid status in patients with CKD and explore the clinical, biochemical, immunological, and hematological parameters that can be affected by thyroid dysfunction among CKD patients. Methods: We conducted a cross-sectional observational study at the Royal Hospital, Muscat. The data was progressively collected for all newly diagnosed CKD patients with no known history of thyroid disease from January 2018 to December 2019. Assessment of thyroid status was performed at their initial diagnosis. Results: During the study period, 121 females (40.3%) and 179 males (59.7%) were diagnosed with CKD with no prior thyroid diseases. The mean age for females and males were 53.6±16.5 and 49.5±16.5 years, respectively. There were 35 patients with thyroid dysfunction with a prevalence of 11.7%. Of these, 22 patients (62.9%) had subclinical hypothyroidism, and 13 (37.1%) had subclinical hyperthyroidism. Total cholesterol and low-density lipoprotein were higher in hypothyroid patients. Urea was higher in hyperthyroid patients with CKD, and hemoglobin level was significantly lower. Conclusions: Thyroid dysfunction was not uncommon among CKD patients, with subclinical hypothyroidism more common than subclinical hyperthyroidism. Thyroid dysfunctions coexisted with kidney dysfunction. These hormonal axis dysfunctions may not be apparent at first presentation; and therefore, may require close clinical and laboratory evaluations.