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Purpose: To examine the adherence to risk minimization measures (RMMs) in newly treated patients with anti‐tumor necrosis factor‐alpha (anti‐TNF‐α) medications at one of the largest tertiary care hospitals in Saudi Arabia. Methods: We included patients who had at least one prescription of infliximab or adalimumab. The index date was the first recorded date of infliximab or adalimumab prescription. New users of anti‐TNF‐α were divided into pre‐ and post‐RMM implementation groups. The outcome of interest was the proportion of patients that received tuberculosis (TB) screening, including a chest X‐ray (CXR) or a QuantiFERON test within 1 month prior to the index date. Results: A pre‐post RMM implementation comparison of TB screening among infliximab users showed a significant increase in the rates of CXR tests (from 7.5% before RMM implementation to 13.8% after RMM implementation, p < 0.001) and the rates of QuantiFERON tests (4.5% before RMM implementation to 24.1% after RMM implementation, p < 0.001). RMMs were introduced to the study site at the same time as adalimumab was approved and the proportion of patients receiving TB screening was 25.2%. Conclusion: TB screening prior to initiation of infliximab or adalimumab was not optimal. However, we noted an improvement in TB screening after the implementation of RMMs for infliximab. Future research may address reasons for low adherence to testing requirements for TB prior to initiation of anti‐TNF‐α medications. [ABSTRACT FROM AUTHOR]

Biopharmaceuticals have emerged as a cornerstone of modern medicine, offering targeted and effective treatments for a diverse array of medical conditions. This review provides an overview of the key applications, challenges, and opportunities in biopharmaceutical development. Key applications include cancer immunotherapy, rare genetic disorders, autoimmune diseases, infectious diseases, and neurological disorders. Challenges such as complex manufacturing processes, regulatory requirements, and high costs are discussed, alongside opportunities arising from advances in biotechnology, personalized medicine, and collaborative partnerships. The importance of prioritizing patient safety, accessibility, and affordability is emphasized. By embracing innovation and collaboration, the biopharmaceutical industry can continue to revolutionize healthcare and improve patient outcomes. [ABSTRACT FROM AUTHOR]

Summary: Tirzepatide is a new glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) that has shown promising results for weight loss. A Bayesian network meta‐analysis was conducted to compare the efficacy and safety of GLP‐1RAs for obesity management. Embase and MEDLINE were searched looking for randomized clinical trials (RCTs) that evaluated the efficacy of GLP‐1RAs for weight loss in patients without diabetes. The main efficacy outcomes evaluated were the mean change in actual and percentage weight loss and the proportion of patients with weight loss of ≥5%–20%. Main safety outcomes evaluated include nausea, vomiting, diarrhea, constipation, loss of appetite, pancreatitis, gallbladder‐related disorders, and withdrawal due to adverse events. Seven RCTs with more than 12,300 patients were analyzed, including patients with body mass index (BMI) ≥ 30 kg/m2, or BMI ≥ 27 kg/m2 with comorbidities. Weekly tirzepatide 10 and 15 mg resulted in more weight loss than weekly semaglutide 2.4 mg, daily semaglutide 0.4 mg, or liraglutide 3 mg. Tirzepatide and weekly semaglutide demonstrated comparable results but with significantly higher odds of achieving ≥5%–20% weight loss compared with liraglutide. GLP‐1RAs triggered more gastrointestinal adverse events than placebo, with no in‐between difference. Although all GLP‐1RAs lead to significant weight reduction, tirzepatide was associated with better efficacy outcomes while having a comparable safety profile. [ABSTRACT FROM AUTHOR]

To assess the cost-efficiency and expanded access of three rituximab biosimilars versus the reference rituximab from the perspective of the Jordanian national health payer. A 1-year cost-efficiency and expanded access model of conversion from reference rituximab (Mabthera) to the approved biosimilars (Truxima, Rixathon, and Tromax) to assess five metrics: total annual cost to treat a hypothetical patient; head-to-head cost comparison; changes in patients' access to rituximab; number-needed-to-convert (NNC) to provide an additional 10 patients access to a rituximab treatment; and relative amount of Jordanian Dinar (JOD) spent on rituximab options. The model included rituximab doses at 100 mg/10 ml and 500 mg/50 ml and considered both cost-saving and cost-wastage scenarios. Costs of treatments were based on the fiscal year 2022 tender prices received by the Joint Procurement Department (JPD). Rixathon was associated with the lowest average annual cost per patient (JOD2,860) across all six indications among all rituximab comparators, followed by Truxima (JOD4,240), Tromax (JOD4,365) and reference Mabthera (JOD11,431). The highest percentage of patient access to rituximab treatment (321%) was achieved when switching patients from Mabthera to Rixathon in the RA and PV indications. At four patients, Rixathon was associated with the lowest NNC to provide an additional 10 patients access to rituximab treatment. For each JOD1 spent on Rixathon, an additional JOD3.21 must be spent on Mabthera, an additional JOD0.55 on Tromax, and an additional JOD0.53 on Truxima. Rituximab biosimilars were associated with cost savings in all approved indications in Jordan compared to reference rituximab. Rixathon was associated with the lowest annual cost, the highest percentage of expanded patient access for all six indications, and the lowest NNC providing 10 additional patients with access. [ABSTRACT FROM AUTHOR]

Purpose: The main objective of this study was to evaluate the effectiveness and safety of apixaban versus warfarin in patients with venous thromboembolism (VTE) in a "real-world" setting. Patients and Methods: A retrospective cohort study was conducted using data from a large tertiary hospital in Saudi Arabia. Patients were included if they were adults (≥ 18 years), diagnosed with VTE, and treated with either apixaban or warfarin between January 2016 and September 2018. Patients who had received anticoagulation therapy within three months of the date of the index event were excluded. The effectiveness outcomes were incidence of VTE recurrence (ie, deep vein thrombosis DVT or pulmonary embolism [PE]), while the safety outcome was incidence of any major bleeding (MB) event within 90 days of follow-up. Results: Among the 492 patients included for study, 212 (43.1%) received apixaban and 280 (56.1%) received warfarin. The mean age of patients was 53.6± 19.1 years and 62% of the cohort was female. Comparable rates of VTE recurrence were observed for apixaban and warfarin treatment groups during follow-up (adjusted odds ratio (AOR) =0.95; 95% CI 0.53– 1.68), including DVT (AOR=1.06; 95% CI 0.52– 2.17) and PE (AOR=0.78; 95% CI 0.31– 1.96). However, apixaban was associated with significantly fewer MB events than warfarin (AOR=0.18; 95% CI 0.04– 0.83). Conclusion: The use of apixaban for the treatment of Saudi patients with acute VTE is associated with a VTE recurrence rate comparable to that of warfarin, with significantly fewer MB events. [ABSTRACT FROM AUTHOR]