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ObjectiveThe current analysis assessed the economic and clinical burden of treatment‐Resistant Depression (TRD) imposed on the Kingdom of Saudi Arabia (KSA), Kuwait and United Arab Emirates (UAE) from the societal perspective.MethodsA Microsoft Excel® based Markov model was developed to estimate the overall burden of disease imposed by TRD across KSA, Kuwait and UAE. Data for the models' adaptation were retrieved from literature and validated by country‐specific key opinion leaders. The cycle length and time horizon used in the model were 4 weeks and 1 year, respectively.ResultsThe study results estimated that at the end of 1‐year time horizon, overall burden imposed by TRD was 3994, 982 and 670 million USD in KSA, Kuwait, and UAE, respectively. This can be attributed to the high cost incurred due to non‐responsive health state (ranging from 44% to 47%). The productivity loss was either the greatest or second greatest component of TRD's burden in the countries of interest (ranging from 32% to 43%).ConclusionsTRD represents a large clinical and economic burden on both individual patients and society. Hence, noval and innovative treatments are especially required for the management of TRD patients.

Optimal management of inflammatory bowel disease (IBD) relies on a clear understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This article provides concise guidelines for the management of IBD in adults, based on the most up-to-date information at the time of writing and will be regularly updated. These guidelines were developed by the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacy. After an extensive literature review, 78 evidence-and expert opinion-based recommendations for diagnosing and treating ulcerative colitis and Crohn's disease in adults were proposed and further refined by a voting process. The consensus guidelines include the finally agreed on statements with their level of evidence covering different aspects of IBD diagnosis and treatment.

Background The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, has profoundly impacted global health, leading to over 74 million confirmed cases and 1.67 million deaths by December 2020. In Saudi Arabia, extensive measures were implemented to mitigate the spread of the virus. Kidney transplant recipients, due to their immunosuppressed status, are particularly vulnerable to severe COVID-19 outcomes. This study aims to identify risk factors associated with mortality in COVID-19-infected kidney transplant patients in Saudi Arabia. The primary objective is to identify mortality risk factors among COVID-19-infected kidney transplant patients. The secondary objective is to compare clinical management and outcomes between deceased and recovered patients. Methodology This case-control study matched 82 deceased kidney transplant patients (cases) with 151 survivors (controls). Data were collected from the National Registry for COVID-19 Mortality and King Faisal Specialist Hospital and Research Centre (KFSH&RC) for patients diagnosed between March 2020 and January 2021. Key variables included demographic information, comorbidities, clinical symptoms, and treatment details. Statistical analyses involved chi-square tests and multivariable logistic regression to assess associations with mortality. Results Among cases, 93.9% required ICU admission, and 95.1% were intubated. Males constituted 73.2% of cases, with 53.7% aged over 60. Cardiovascular comorbidities were more prevalent among cases (97% vs. 87.4%, p  = 0.01). and presented more frequently with fever, cough, and respiratory distress. In multivariable analysis, fever, shortness of breath, and desaturation were associated with increased mortality odds. Notably, patients who discontinued immunosuppressive therapy had higher mortality odds (OR = 63.2, p  = 0.083), whereas those who held or adjusted their therapy had significantly lower odds (OR = 0.1, p  = 0.042; OR = 0.0, p  = 0.007). Bacterial infections also increased mortality risk (OR = 56.6, p  = 0.009). Conclusion This study identifies critical risk factors for mortality among kidney transplant patients infected with COVID-19 in Saudi Arabia. The findings underscore the need for tailored clinical management strategies to improve outcomes in this vulnerable population. Further research is warranted to explore long-term implications and effective treatment protocols.

Abstract The management of inflammatory bowel disease (IBD) in pregnant women is challenging and must be addressed on a patient-by-patient basis. Optimal patient management requires a multidisciplinary team and clear evidence-based recommendations that cater to this subset of patients. In this article, we provide concise guidelines and clinical care pathway for the management of IBD in pregnant women. Our recommendations were developed by a multidisciplinary working group that includes experts from the Saudi Ministry of Health in collaboration with the Saudi Gastroenterology Association and the Saudi Society of Clinical Pharmacology. All recommendations are based on up-to-date information following an extensive literature review. A total of 23 evidence-based expert opinion recommendations for the management of IBD in pregnant women are herein provided.

Background Spinal Muscular Dystrophy (SMA) is one of the leading causes of death in infants and young children from heritable diseases. Although no large‐scale popultion‐based studies have been done in Saudi Arabia, it is reported that the incidence of SMA is higher in the Saudi population partly because of the high degree of consanguineous marriages. Methods The final analysis included 4198 normal volunteers aged between 18 and 25 years old, 54.7% males, and 45.3% females. Whole blood was spotted directly from finger pricks onto IsoCode StixTM and genomic DNA was isolated using one triangle from the machine. To discern the SMN1 copy number independently from SMN2, Multiplex PCR with Dral restriction fragment analysis was completed. We used the carrier frequency and population‐level data to estimate the prevalence of SMA in the population using the life‐table method. Results This data analysis showed the presence of one copy of the SMN1 gene in 108 samples and two copies in 4090 samples, which resulted from a carrier frequency of 2.6%. The carrier frequency was twofold in females reaching 3.7% compared to 1.6% in males. 27% of participants were children of first‐cousin marriages. We estimated the birth incidence of SMA to be 32 per 100,000 birth and the total number of people living with SMA in the Kingdom of Saudi Arabia to be 2265 of which 188 are type I, 1213 are type II, and 8,64 are type III. Conclusion The SMA carrier rate of 2.6% in Saudi control subjects is slightly higher than the reported global frequency of 1.25 to 2% with links to the high degree of consanguinity. The birth incidence of SMA was estimated to be 32 per 100,000 birth and the total number of people living with SMA in KSA to be 2265 of which 188 are type I, 1213 are type II, and 864 are type III. The SMA carrier rate of 2.6% in Saudi subjects is slightly higher than the reported global frequency with links to the consanguineous marriages.

Background and Aim Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon‐free regimens with a high sustained virological response (SVR‐12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof‐Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1–3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof‐Dac) compared to the Sof‐Led combination in treating genotype 4 HCV. Methods This study is an open‐label, 2‐period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR‐12. Results The study included 111 patients in the (Sof‐Led) Group 1 and 109 patients (Sof‐Dac) Group 2. For the primary outcome, SVR‐12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 (p = 0.2). In addition, all patients who achieved SVR‐12 also achieved SVR‐24. Conclusion Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof‐Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.

Background/Aims: The ideal end point of treatment for chronic hepatitis B virus (HBV) infection is sustained off-therapy hepatitis B surface antigen (HBsAg) loss with or even without seroconversion to anti-HBs. We investigated the role of adding PEGylated interferon (PEG IFN) to ongoing tenofovir treatment in chronic HBV patients for achieving HBsAg clearance. Patients and Methods: In this randomized controlled trial, chronic HBV patients who have been receiving tenofovir for >6 months with HBV viral load <2000 IU/ml were randomized into two groups. One group (add-on therapy) was given subcutaneous PEG IFN 180 mcg weekly for 12 months in addition to tenofovir. Patients in the other group received only tenofovir 300 mg orally on a daily basis. Patients in both groups were followed up for a total of two years, and patients in both groups were given tenofovir 300 mg daily indefinitely until they developed HBsAg clearance. Results: Twenty-three patients were allocated to the PEG IFN and tenofovir (add-on therapy) group, and another 25 patients were recruited to the tenofovir monotherapy group. Before randomization, patients had received tenofovir for 1135 mean days (range203 to 1542 days). One patient (4.3%) in add-on therapy lost HBsAg and seroconverted. Within two years, mean HBsAg decreased significantly with add-on therapy (from 4753 IU/ml to 2402; P = 0.03); and it decreased from 5957 IU/ml to 4198; P = 0.09 in tenofovir monotherapy group. More patients in the add-on group developed serious side effects, with treatment discontinuation, and dose reductions (P = 0.3). Conclusion: PEG IFN and tenofovir add-on therapy was successful in achieving HBsAg clearance and seroconversion in 4.3% of the patients. Add-on therapy patients had a significant decrease in HBsAg levels in two years; and no significant decrease in HBsAg levels with the tenofovir monotherapy. With no significant HBsAg clearance, the utility of this combination regimen is questionable.

The simultaneous spread of COVID-19 and seasonal influenza is an evolving healthcare challenge. This study examines the clinical characteristics of influenza and COVID-19 patients in Saudi Arabia and evaluates the impact of COVID-19 vaccination on hospital and ICU admission risks. We conducted a cross-sectional study of 235 patients (113 with influenza and 122 with COVID-19) admitted between October 2023 and March 2024 to Saudi public hospitals. Data on demographic factors, comorbidities, vaccination status, and ICU admission were collected from medical records. Logistic regression models were used to investigate associations between COVID-19 vaccination and clinical outcomes, adjusting for potential confounders. Among the patients, 48.1 % were male, and 51.1 % were aged over 60 years. Among them, 80.0 % had received at least one COVID-19 vaccine dose; 6.8 % had one dose, 25.5 % had two doses, 46.4 % had three doses, and 1.3 % had four doses. COVID-19 patients had higher rates of comorbidities but lower rates of ICU admissions than influenza patients (18.0 % versus 5.3 %) and (7.4 % versus 13.3 %), respectively. COVID-19 vaccination was associated with a higher likelihood of receiving the seasonal influenza shot (OR [95 % CI] = 4.43 [1.29, 15.26]) and a lower likelihood of COVID-19 hospital admission (OR [95 % CI] = 0.39 [0.19, 0.81]) and ICU admission (OR [95 % CI] = 0.31 [0.12, 0.80]). COVID-19 vaccination was significantly associated with a reduced risk of COVID-19 hospital admission and ICU admission in the post-pandemic period. These findings emphasize the importance of vaccination in mitigating severe outcomes from COVID-19 and influenza infections.

Promising clinical and humanistic outcomes are associated with the use of new oral agents in the treatment of relapsing-remitting multiple sclerosis (RRMS). This is the first cost-effectiveness study comparing these medications in Saudi Arabia. We aimed to compare the cost-effectiveness of fingolimod, teriflunomide, dimethyl fumarate, and interferon (IFN)-b1a products (Avonex and Rebif) as first-line therapies in the treatment of patients with RRMS from a Saudi payer perspective. Cohort Simulation Model (Markov Model). Tertiary care hospital. A hypothetical cohort of 1000 RRMS Saudi patients was assumed to enter a Markov model model with a time horizon of 20 years and an annual cycle length. The model was developed based on an expanded disability status scale (EDSS) to evaluate the cost-effectiveness of the five disease-modifying drugs (DMDs) from a healthcare system perspective. Data on EDSS progression and relapse rates were obtained from the literature; cost data were obtained from King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. Results were expressed as incremental cost-effectiveness ratios (ICERs) and net monetary benefits (NMB) in Saudi Riyals and converted to equivalent $US. The base-case willingness-to-pay (WTP) threshold was assumed to be $100000 (SAR375000). One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to test the robustness of the model. ICERs and NMB. The base-case analysis results showed Rebif as the optimal therapy at a WTP threshold of $100000. Avonex had the lowest ICER value of $337282/QALY when compared to Rebif. One-way sensitivity analysis demonstrated that the results were sensitive to utility weights of health state three and four and the cost of Rebif. None of the DMDs were found to be cost-effective in the treatment of RRMS at a WTP threshold of $100000 in this analysis. The DMDs would only be cost-effective at a WTP above $300000. The current analysis did not reflect the Saudi population preference in valuation of health states and did not consider the societal perspective in terms of cost.