Novartis (Spain)

Controlling low-density lipoprotein cholesterol (LDL-C) levels reduces atherosclerotic risk in patients with atherosclerotic cardiovascular disease. However, not all available therapies provide the same efficacy or safety outcomes, influencing treatment preferences. Our study aimed to identify patients’ and healthcare professionals’ (HCP) preferences for the attributes related to lipid-lowering therapies (LLT). A literature review and 2 focus groups (patients = 4; HCP = 8), were conducted to identify LLT attributes and levels. A total of 5 attributes with 2 or 3 levels each resulted in 36 scenarios. The relative importance given to each attribute was estimated using a conditional logit model. A total of 50 patients and 89 HCP participated. The estimated relative importance was: prevention of cardiovascular problems (HCP: 37.7%; patients: 26.8%); LDL-C reduction (HCP: 31.6%; patients: 26.8%); route and frequency of administration (HCP: 10.9; patients: 10.3%) safety (HCP: 10.2%; patients: 24.0%); and medication collection location (HCP: 9.5%; patients: 12.1%). The preferred route and frequency of administration for HCP was a subcutaneous injection administered by an HCP once every 6 months, while patients equally preferred subcutaneous injection administered by an HCP once every 6 months and oral administration ( r = 0.01; P = .95) over a self-administered injection twice per month ( r = −0.36; P = .01). HCP and patients considered treatment efficacy preventing cardiovascular events and reducing LDL-C levels the most important attributes, followed by route and frequency of administration for HCP and safety for patients. Regarding route and frequency of administration, HCP preferred low frequency subcutaneous injection administered by an HCP and patients, are less prompt to accept a self-administered injection twice per month over the other options. El control de los niveles de colesterol unido a lipoproteínas de baja densidad (cLDL) reduce el riesgo ateroesclerótico en pacientes con enfermedad cardiovascular ateroesclerótica. Sin embargo, no todos los tratamientos disponibles ofrecen la misma eficacia o seguridad, lo que influye en las preferencias de tratamiento. Nuestro estudio tuvo como objetivo identificar las preferencias de pacientes y profesionales sanitarios (PS) respecto a los atributos relacionados con los tratamientos hipolipemiantes (THL). Se realizó una revisión de la literatura y 2 grupos focales (pacientes = 4; PS = 8) para identificar los atributos y niveles de las THL. Un total de 5 atributos con 2 o 3 niveles cada uno dieron lugar a 36 escenarios. La importancia relativa asignada a cada atributo se estimó mediante un modelo logit condicional. Participaron un total de 50 pacientes y 89 PS. La importancia relativa estimada fue: prevención de problemas cardiovasculares (PS: 37,7%; pacientes: 26,8%); reducción de cLDL (PS: 31,6%; pacientes: 26,8%); vía y frecuencia de administración (PS: 10,9%; pacientes: 10,3%); seguridad (PS: 10,2%; pacientes: 24,0%); y lugar de recogida de la medicación (PS: 9,5%; pacientes: 12,1%). La vía y frecuencia de administración preferida por los PS fue la inyección subcutánea administrada por un profesional sanitario una vez cada 6 meses, mientras que los pacientes mostraron igual preferencia por la inyección subcutánea administrada por un profesional sanitario una vez cada 6 meses y la administración oral (r = 0,01; p = 0,95) frente a la inyección autoadministrada 2 veces al mes (r = −0,36; p = 0,01). Los PS y los pacientes consideraron que la eficacia del tratamiento en la prevención de eventos cardiovasculares y la reducción de los niveles de cLDL eran los atributos más importantes, seguidos por la vía y frecuencia de administración en el caso de los PS, y la seguridad en el caso de los pacientes. Con respecto a la vía y frecuencia de administración, los PS prefirieron la inyección subcutánea de baja frecuencia administrada por un profesional sanitario, mientras que los pacientes mostraron menor disposición a aceptar la inyección autoadministrada 2 veces al mes en comparación con las otras opciones.

Abstract Background: Ribociclib (RIB), a CDK4/6 inhibitor, in combination with endocrine therapy (ET), has demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer (ABC), as evidenced by the MONALEESA phase III trials. Despite these robust clinical trial outcomes, to our knowledge, real-world data on safety and tolerability of RIB + ET, in the Spanish healthcare setting, remain scarce. This study aims to address this gap by evaluating the safety profile of RIB in combination with a non-steroidal aromatase inhibitor (NSAI) as first-line (1L) therapy in both younger and older patients with HR+/HER2− ABC, based on routine clinical practice in Spain. In this report, we show a preliminary result from the first 147 patients. The final analysis will include at least 500 patients. Methods: This is a non-interventional, retrospective cohort study involving patients diagnosed with HR+/HER2− ABC who initiated 1L treatment with RIB + NSAI between January 2021 and August 2023. Data was collected exclusively from medical records across participating centers. Following the final patient inclusion date, a subsequent 12-month follow-up period (until August 2024) is established to ensure adequate exposure to RIB across all participants and to monitor the potential emergence of adverse events (AEs). If discontinuation occurs for any reason, the duration of exposure to RIB was measured. Results: The median follow-up was 23.8 months (range: 3.1 - 43.4), and the median time on treatment was 18.39 months (range: 0.5 - 43.4). Stratified by age, the PFS rate at 24 months was 63.3% (95% CI: 52.6 - 72.3) in patients aged ≤ 65 years and 65.5% (95% CI: 47.0 - 78.9) in those aged > 65 years. In general, the safety profile was consistent with previously reported data, with no new safety signals. From 141 patients reporting at least one AEs, 16 discontinued RIB due to AEs (10.9% of the whole population). The two most common AEs for both, safety and tolerability are summarized in Table 1. Conclusions: Preliminary real-world data suggest that RIB + NSAI is well tolerated in both younger and older patients with HR+/HER2− ABC in the Spanish healthcare setting. PFS outcomes appear consistent across age groups. Final results from the full set of at least 500 patients will provide more definitive insights into the safety profile and treatment outcomes. Citation Format: T. Díaz-Redondo, R. Sánchez-Bayona, P. Zamora Auñon, I. Garcia-Fructuoso, A. Bujosa, J. Sánchez, J. Ponce Lorenzo, A. Jiménez Ortega, E. Marin Olivo, A. Corbera, A. López. Ribo-age: age-stratified descriptive analysis of adverse drug reactions in patients with advanced breast cancer treated with ribociclib plus nonsteroidal aromatase inhibitors: preliminary results [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS1-12-06.

Background and Objectives: Patients with atherosclerotic cardiovascular disease (ASCVD) remain at high risk of recurrent events. REALITY aims to analyse the actual levels of low-density lipoprotein cholesterol (LDL-C), the modalities of lipid-lowering therapies (LLT) used, and ASCVD patient outcomes in a real-world setting in Spain. Methods: REALITY is a retrospective observational study conducted using a healthcare database of 1.8 million patients representative of the Spanish population. The study included 26,976 patients with new or recurrent ASCVD events recruited from 2017 to 2019 and followed up for two years. Results: Management of ASCVD involved the utilisation of high-intensity (53%) or very high-intensity (36%) LLT. After two years, a decrease in total cholesterol (from 228.7 to 176.7 mg/dL), LDL-C (from 126.4 to 99.0 mg/dL), and triglycerides (from 216.7 to 163.7 mg/dL), accompanied by a moderate increase in HDL-C levels was observed. However, LDL-C goals of ESC/EAS guidelines were only reached by a minority of patients. Less than 15% of ASCVD patients achieved their LDL-C goals of <70, as stated in contemporary guidelines (3% if the present <55 mg/dL threshold in the ESC/EAS guidelines is considered). During the follow-up period, 9% of ASCVD patients died and 25% experienced a new ASCVD event. Conclusions: In the REALITY study, most patients did not achieve their target LDL-C goals despite receiving high- or very high-intensity LLT. Increasing the utilisation of extreme LLT is crucial to reducing recurrent ASCVD events and mitigating these patients' high morbidity and mortality risk.

Spondyloarthritis is a group of immune-mediated rheumatic disorders that significantly impact patients’ physical function and quality of life. Patients with spondyloarthritis experience a greater prevalence of cardiometabolic disorders, such as obesity, hypertension, dyslipidemia and diabetes mellitus, and these comorbidities are associated with increased spondyloarthritis disease activity and risk of cardiovascular events. This narrative review summarizes the evidence for a physiological link between inflammatory status and cardiometabolic comorbidities in spondyloarthritis, as well as the impact of interleukin (IL)-17 blockade versus other molecular mechanisms in patients with cardiometabolic conditions. The IL-23/IL-17 axis plays a pivotal role in the pathophysiology of spondyloarthritis by promoting inflammation and tissue remodeling at the affected joints and entheses. The importance of the IL-23/IL-17 signaling cascade in underlying sub-clinical inflammation in common cardiometabolic disorders suggests the existence of shared pathways between these processes and spondyloarthritis pathophysiology. Thus, a bidirectional relationship exists between the effects of biologic drugs and patients’ cardiometabolic profile, which must be considered during treatment decision making. Biologic therapy may induce changes in patients’ cardiometabolic status and cardiometabolic conditions may conversely impact the clinical response to biologic therapy. Available evidence regarding the impact of IL-17 blockade with secukinumab on cardiometabolic parameters suggests this drug does not interfere with traditional cardiovascular risk markers and could be associated with a decreased risk of cardiovascular events. Additionally, the efficacy and retention rates of secukinumab do not appear to be negatively affected by obesity, with some studies reporting a positive impact on clinical outcomes, contrary to that described with other approaches, such as tumor necrosis factor blockade. In this article, we also review evidence for this bidirectional association with other treatments for spondyloarthritis. Current evidence suggests that IL-17–targeted therapy with secukinumab is highly effective in spondyloarthritis patients with cardiometabolic comorbidities and may provide additional cardiometabolic benefits.