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Background: The Saudi Food and Drug Authority (SFDA) has approved the subcutaneous (SC) administration of infliximab, presenting a more convenient alternative with reduced outpatient visits and diminished expenses compared to the intravenous (IV) administration. However, the financial implications of this formulation have not been examined from the perspective of Saudi payers., Methods and Materials: A prevalence-based budget impact model was developed to evaluate the financial effects of introducing "environment without" versus "with infliximab SC." The model's time horizon spanned over 2 years (2021-2023), aligning with the biennial national pharmaceutical procurement cycle. The comparison focused on infliximab SC versus all available formulations of infliximab IV in the Saudi market for two inflammatory bowel diseases (IBD): Ulcerative Colitis (UC) and Crohn's Disease (CD). Treatment comparators' comparability and dose escalations were substantiated by published studies, utilizing dosing information from the summary of product characteristics. Drug acquisition costs were derived from SFDA registered prices, with IV formulation administration costs included. Scenario analysis assessed the budget impact of infliximab SC introduction at uptake rates ranging from 0% to 100%., Results: Introducing infliximab SC demonstrated cost-saving potential in the treatment of IBD. At 100% uptake with UC patients for 2 years, infliximab SC resulted in savings of -SAR-31.9 million (-SAR29,145 per patient). Similarly, for CD, introducing infliximab SC at 100% uptake over 2 years yielded savings of -SAR106.2 million (-SAR36,585 per patient)., Conclusion: This study reveals that infliximab SC is associated with cost-saving potential when compared to infliximab IV formulations available in Saudi Arabia. Future research should address uncertainties related to real-world comparative effectiveness, the convenience of administration, patient tolerability, and physician acceptance of the SC formulation of infliximab, alongside comparisons with other TNF-alpha inhibitors., Competing Interests: N Alkhatib holds equity in Pi Pharma Intelligence, LLC, which provides health technology solutions, scientific and consulting services to biopharmaceutical, diagnostics, and medical device companies on a nonexclusivity basis. By the company internal policy, owners, employees, and associates are prohibited from holding equity in client and sponsor organizations or contracting independently with client and sponsor organizations or receiving compensation independently from such organizations. This does not alter our adherence to PLOS ONE policies on sharing data and materials., (Copyright: © 2024 Alkhatib et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Reduced bone mineral density (BMD) has broadly been found to be associated with inflammatory bowel disease across a number of geographical locations and cultures. We aimed to estimate the prevalence of reduced BMD and identify clinical predictors in a cohort of Crohn's disease patients (CD) in Saudi Arabia. We conducted a retrospective study involving children and adolescents with CD between 2013 and 2018. BMD was evaluated using dual-energy X-ray absorptiometry scans of the spine and body. A multivariate analysis was performed for the detection of predictors of low BMD. Sixty-four patients were enrolled. The median age was 16 years (range, 8-19 years) and 55% of patients were males. Total body BMD scanning identified 25 patients (39%) with osteoporosis. Twenty patients (31.3%) were found to have z scores consistent with osteopenia. A multivariate regression analysis identified a low weight-for-age z score (B coefficient = 0.347, 95% confidence interval [CI] = 0.211-0.482, p < 0.001 for Spine BMD and B coefficient = 0.321, 95% CI = 0.170-0.472, p < 0.001 for total body BMD), a low height-for-age z score (B coefficient = 0.187, 95% CI = 0.035-0.338, p = 0.017 for spine BMD and B coefficient = 0.0.258, 95% CI = 0.089-0.427, p = 0.004 for total body BMD), a low 25-hyroxyvitamin D level (B coefficient = 0.026, 95% CI = 0.013-0.038, p < 0.001 for spine BMD and B coefficient = 0.016, 95% CI = 0.002-0.031, p = 0.026 for total body BMD), and a higher number of corticosteroid induction courses (B coefficient = -0.567, 95% CI = -0.923 to -0.212, p = 0.003 for spine BMD and B coefficient = -0.566, 95% CI = 0.963-0.169, p = 0.007 for total body BMD) as predictors of low BMD. In the spine BMD analysis, older age at the time of presentation was identified as a significant predictor for low bone density (B coefficient = 0.254, 95% CI = 0.141-0.368, p < 0.001). In conclusion, Saudi Arabian children and adolescents with CD have a high prevalence rate of low bone density compared to Western populations. Several clinical characteristics are identified as significant predictors for low BMD., (Copyright © 2020 The International Society for Clinical Densitometry. Published by Elsevier Inc. All rights reserved.)

Objective: Metabolic bone disease concerns a broad spectrum of conditions related to reduced bone density. Metabolic bone disease has been linked to chronic inflammatory diseases, such as ulcerative colitis. This study examines the prevalence of metabolic bone disease in ulcerative colitis patients and explores possible clinical predictors., Method: The authors performed a retrospective study involving children and adolescents with confirmed ulcerative colitis between January 2013 and December 2018. Bone density was evaluated through a dual-energy X-ray absorptiometry scan of the spine and total body. Osteoporosis was defined as a bone mineral density Z-score of <-2 and osteopenia as a Z-score of between -1.0 and -2., Results: A total of 37 patients were included in this analysis, with a mean age of 13.4±3.9 years and a mean duration of illness of 2.1±2.4 years. Using lumbar spine Z-scores and total body Z-scores, osteoporosis and osteopenia were identified by dual-energy X-ray absorptiometry scan measurements in 11 patients (29.7%) and 15 patients (40.5%), and in ten patients (27%) and 13 patients (35%), respectively. Lumbar spine Z-scores were significantly positively associated with male gender (B=2.02; p=0.0001), and negatively associated with the presence of extraintestinal manifestations (B=-1.51, p=0.009) and the use of biologics (B=-1.33, p=0.004). However, total body Z-scores were positively associated with body mass index Z-scores (B=0.26, p=0.004) and duration of illness in years (B=0.35, p=0.003)., Conclusions: Metabolic bone disease is very common in this cohort of Saudi Arabian children and adolescents with ulcerative colitis and its occurrence appears to increase in female patients who suffer from extraintestinal manifestations., (Copyright © 2020 Sociedade Brasileira de Pediatria. Published by Elsevier Editora Ltda. All rights reserved.)

Objective: Inflammatory bowel disease (IBD) has been associated with restless leg syndrome (RLS). This study aims to explore the prevalence, clinical predictors, and severity of RLS in IBD patients compared to controls., Methods: We conducted a case-control study between January and December of 2019 comparing IBD patients with controls. Assessment of RLS was performed using the previously validated diagnostic restless leg syndrome questionnaire (RLSQ). Logistic regression analyses were applied to investigate associations between patient demographics and clinical features and RLS diagnosis., Results: A total of 218 IBD patients and 211 healthy controls were incorporated after excluding 6 patients with positional discomfort and 4 patients with habitual foot tapping. The mean age was 30.2+/-11.7 and 64% were females. The prevalence of RLS was 16/218 (7.34%) and 17/211 (8.06%) among cases and controls, respectively. Based on the RLSQ severity score, 6/16 (37.5%), 4/16 (25%) and 1/16 (6.3%) of the IBD patients with RLS had mild, moderate and severe RLS; respectively. The odds of IBD were lower among patients with confirmed RLS (OR=0.90, 95% CI=0.44-1.84, p=0.78). In the logistic regression analysis, only vitamin B12 deficiency (OR=10.20, 95% CI=1.40-74.10, p=0.022) was associated with RLS diagnosis among IBD patients., Conclusion: No difference was found in the prevalence of RLS between IBD patients and non-IBD controls. Vitamin B12 deficiency was associated with RLS diagnosis among patients with IBD.

Objective: The aim of this study is to evaluate the impact of adopting a pharmaceutical care model on clinical outcomes, patient satisfaction, and cost at a health payer level., Methods: All patients with hepatitis C virus (HCV) who were insured by Bupa Arabia, with a direct-acting antivirals prior authorization drug request between April 2015 and October 2018 were included in this retrospective quasi-experimental study. The clinical outcome was the achievement of a sustained virologic response at least 12 weeks from end of treatment. Economic and patients' satisfaction outcomes were included in this study. The differences in cost of treatment was analyzed by using the paired t test. Stata statistical software package (StataCorp, College Station, TX) was used for data analysis., Results: A total of 371 patients were enrolled in this program of which 74% (n = 273) required clinical intervention. Among those, HCV treatment was modified for 64%. The overall cure rate was 97% among 267 patients for which sustained virologic responses were available. The results of the paired t test show that there was a 38% reduction in the mean direct cost of medications before and after intervention (95% confidence interval, 33%-43%; P<.001) and the calculated patients' satisfaction was 98%., Conclusions: A structured pharmaceutical care program for HCV patients can guide the use of specialty medications to achieve optimal clinical outcomes, with lower expenditures and high patients' satisfaction. We can conclude that healthcare insurance can play a key role in managing specialty pharmaceuticals like HCV medications. Because this is a preliminary study, further studies are needed in an experimental design to strengthen the evidence behind the effectiveness of such a program., (Copyright © 2020 ISPOR--The professional society for health economics and outcomes research. Published by Elsevier Inc. All rights reserved.)

Background/aims: Success of colorectal cancer (CRC) screening is dependent in part on the proportion of uptake by the targeted population. We aimed in this study to identify factors that were associated with willingness to undergo CRC screening based on the health belief model (HBM)., Patients and Methods: This was a cross-sectional study among citizens of Riyadh, Saudi Arabia. Demographic data collected included gender, age, education, marital status, employment status, a history of CRC in the family or knowing a friend with CRC, as well as income. A questionnaire was developed in Arabic based on the HBM and included enquiries on knowledge about CRC symptoms and risk factors, types of CRC screening tests, perceived risk of CRC, previously undergoing CRC screening, intent to undergo CRC screening, perceived barriers to CRC screening, perceived severity of CRC, as well as attitudes toward CRC and its screening., Results: Five hundred participants were included. The mean age was 41.0 years (SD 10.7). Males were 50% and only 6.7% of those between 50 and 55 years of age had undergone CRC screening. Of those surveyed, 70.7% were willing to undergo CRC screening. Also, 70.5% thought that CRC is curable, 73.3% believed it was preventable, whereas 56.7% thought it was a fatal disease. Neither gender, level of education, occupation, income, marital status, nor general knowledge about CRC was found to be associated with the willingness to undergo CRC screening. Recognizing that colonoscopy was a screening test (OR 1.55, 95% CI; 1.04-2.29) was associated with a strong desire to undergo CRC screening while choosing a stool-based test was associated with not willing to undergo CRC screening (OR 0.59, 95%CI; 0.38-0.91)., Conclusion: We found that the majority of those interviewed were willing to undergo CRC screening and identified a number of barriers as well as potential areas that could be targeted in the promotion of CRC screening uptake if such a national program were to be implemented.

Background and Objectives: Colorectal cancer (CRC) is a major health problem in the Kingdom of Saudi Arabia (KSA). Our aim was to characterize the epidemiology of CRC in the Saudi population., Design and Setting: Retrospective analysis of all cases of CRC recorded in the Saudi Cancer Registry (SCR) between January 2001 and December 2006 amongst Saudi citizens in KSA., Patients and Methods: Data were retrieved from the database of the SCR. Descriptive statistics was performed using SPSS., Results: A total of 4,201 cases of CRC were registered in the SCR. The incidence of CRC increased between 2001 and 2006. The mean age of patients at the time of diagnosis was 58 years; most patients were above 45 years of age (n=3322; 79.1%). At the time of diagnosis, 977 patients (23.0%) presented with localized disease and 1,018 (24.0%) had distant metastasis. The most frequent pathological variant was adenocarcinoma (73%), with grade 2 (moderately differentiated) being the most common grade among all variants (61%). For all cancer grades, the frequency of CRC was significantly higher among patients >45 years (P=0.004), who presented with more advanced disease (stages III and IV) (P=0.012). Based on logistic regression, age >45 years was associated with advanced regional presentation (P=0.001). Tumor grade was associated with advanced regional presentation and metastasis., Conclusion: There was an increase in the incidence of CRC between 2001 and 2006. The age at the time of diagnosis was low when compared with reports from developed countries. A nationwide approach is needed to encourage and illustrate the importance of screening programs.

Background: The aim of this study was to outline the trend in the incidence of colorectal cancer (CRC) in the city of Jeddah, Kingdom of Saudi Arabia (KSA), for comparison with previously published national CRC data., Materials and Methods: A retrospective data analysis was performed on all cases of CRC diagnosed between January 2000 and December 2006 amongst Saudi patients in Jeddah using data retrieved from the Saudi Cancer Registry (SCR). Descriptive analysis was performed and results were compared to national CRC data from the SCR., Results: In Jeddah, 644 cases of CRC were diagnosed during the time period, accounting for 15% of all CRC cases in KSA. Males were more commonly affected than females (58% versus 42%). The male preponderance of CRC was similar to that observed at a national level. In Jeddah, the incidence was higher among those >45 years (77.0%), and the mean age at diagnosis was 57 years. At diagnosis, 10% of patients presented with localized disease; 25% presented with distant metastasis and the remaining patients had various stages of regional extension. Adenocarcinomas accounted for 72% of cases. Statistical analysis did not reveal any clinically significant differences between cases diagnosed in Jeddah and those diagnosed throughout KSA., Conclusions: The increased trend in the incidence of CRC in Jeddah between 2000 and 2006 mirrors the recent trend in KSA. This highlights the magnitude of this healthcare hazard, not only in Jeddah, but also across the country and supports the need for preventive measures and early detection of the disease.