Rocío Bello-Calvo, Rita González-Resina, Araceli Rubio-Martínez, Itziar Larrodé-Leciñena, María Pilar Delgado-Beltrán, María Reyes Abad-Sazatornil
{"title":"[Translated article] Safety of Bruton kinase inhibitors in chronic lymphocytic leukemia: Real world clinical practice.","authors":"Rocío Bello-Calvo, Rita González-Resina, Araceli Rubio-Martínez, Itziar Larrodé-Leciñena, María Pilar Delgado-Beltrán, María Reyes Abad-Sazatornil","doi":"10.1016/j.farma.2026.03.010","DOIUrl":"https://doi.org/10.1016/j.farma.2026.03.010","url":null,"abstract":"<p><strong>Introduction: </strong>Bruton's tyrosine kinase inhibitors (BTKi) have replaced immunochemotherapy in patients with chronic lymphocytic leukemia (CLL). The safety profile, particularly in monotherapy indications under real-world clinical practice conditions, is key to optimizing outcomes.</p><p><strong>Objective: </strong>To describe the safety and tolerability of continuous/indefinite BTKi therapy in patients with CLL treated in the first line and relapse/refractory (R/R) conditions with BTKi monotherapy, within labeled indications, at a tertiary care hospital.</p><p><strong>Methods: </strong>Observational, retrospective, single-centre study including patients with CLL treated with iBTK (2015-2024). Demographic data, previous lines of treatment, dose adjustments and suspensions, and adverse events (AEs) by system and severity were recorded. Proportions were compared using Fisher's exact test. Treatment continuation was analyzed using Kaplan-Meier curves, log-rank tests, and Cox regression.</p><p><strong>Results: </strong>Eighty-three patients (50.6% male) were included, with a mean age at diagnosis of 67.2 years. Forty-eight (58%) received iBTK as first-line therapy and 35 (42%) in R/R. The most commonly used iBTK was ibrutinib (62.5% in first-line and 88.6% in R/R). Median follow-up was 20.8 months. Overall, 28.9% required dose adjustment, with no differences between the two groups (p = 0.158). Treatment discontinuation was more frequent in patients with R/R patients (74.3% vs. 39.6%; RR 1.81; 95% CI: 1.23-2.66; p = 0.002). AE were the most common reason for treatment discontinuation (15.7%). A total of 161 AEs were recorded, with infectious AE being the most frequent category. Respiratory infections were significantly more common in R/R patients (p = 0.046). Patients with prior exposure to immunochemotherapy had an increased risk of treatment discontinuation (HR = 2.15; 95% CI: 1.18-3.89; p = 0.012).</p><p><strong>Conclusions: </strong>BTKi showed a manageable safety profile, with infections as the most common toxicity and secondary malignancies occurring at rates comparable to those reported in the literature. Treatment discontinuation was less frequent in the frontline setting, underscoring the influence of clinical context and prior therapies. Despite the limitations of a retrospective, single-centre design, this study provides information applicable to daily practice and highlights the importance of close follow-up to optimize both safety and treatment continuity.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Esther Domingo Chiva, Fernando Becerril Moreno, Miguel Ángel Amor García, Laura Doménech Moral, Tatiana Betancor García, Carla Bastida Fernández, Marta Albanell Fernández, Irene Aquerreta González, Sara Cobo Sacristán, Amaia Egüés Lugea, Aurora Fernández Polo, Sara Ortiz Pérez, María Martín Cerezuela
{"title":"Standardized classification of pharmaceutical interventions in intensive care units.","authors":"Esther Domingo Chiva, Fernando Becerril Moreno, Miguel Ángel Amor García, Laura Doménech Moral, Tatiana Betancor García, Carla Bastida Fernández, Marta Albanell Fernández, Irene Aquerreta González, Sara Cobo Sacristán, Amaia Egüés Lugea, Aurora Fernández Polo, Sara Ortiz Pérez, María Martín Cerezuela","doi":"10.1016/j.farma.2026.03.011","DOIUrl":"https://doi.org/10.1016/j.farma.2026.03.011","url":null,"abstract":"<p><p>A standardized classification system was developed to harmonize the documentation of pharmaceutical interventions throughout the pharmacotherapeutic process in intensive care units caring for critically ill adult patients. The Intensive Care and Critical Patient Pharmacists Group (FarMIC) created an initial proposal, which was evaluated in a first phase through one week of intervention recording. After analyzing 168 interventions, modifications were made to improve applicability. In a subsequent phase, volunteer hospital pharmacists used the adapted classification for another week, documenting an additional 562 interventions. The analysis of discrepancies and suggestions allowed the consensus of a final classification comprising 35 types of interventions related to issues in indication, effectiveness, safety, and other aspects such as pharmacist consultations, therapeutic drug monitoring, and nutritional support. This classification provides a homogeneous framework that facilitates the standardization of pharmaceutical interventions in critically ill patients and promotes data comparability across centers.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":" ","pages":""},"PeriodicalIF":1.3,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-04-17DOI: 10.1016/j.farma.2026.02.002
David Berlana , Pilar Gomis Muñoz , Natividad Lago , Amelia María Chica Marchal , Marta Ubeira Iglesias , Amparo Vázquez Polo , Consuelo Pellicer Franco , en nombre del Grupo de Trabajo de Farmacia de la Sociedad Española de Nutrición Clínica y Metabolismo (SENPE) y el Grupo de Trabajo de Nutrición Clínica de la Sociedad Española de Farmacia Hospitalaria (SEFH)
{"title":"Consenso español sobre preparación de mezclas de nutrientes parenterales: aspectos generales","authors":"David Berlana , Pilar Gomis Muñoz , Natividad Lago , Amelia María Chica Marchal , Marta Ubeira Iglesias , Amparo Vázquez Polo , Consuelo Pellicer Franco , en nombre del Grupo de Trabajo de Farmacia de la Sociedad Española de Nutrición Clínica y Metabolismo (SENPE) y el Grupo de Trabajo de Nutrición Clínica de la Sociedad Española de Farmacia Hospitalaria (SEFH)","doi":"10.1016/j.farma.2026.02.002","DOIUrl":"10.1016/j.farma.2026.02.002","url":null,"abstract":"<div><div>Parenteral nutrition is a complex therapeutic intervention, particularly in pediatric and critically ill patients, requiring strict standards of safety, stability, and compatibility during its preparation. To update and harmonize clinical practice, the Pharmacy Working Group of the Spanish Society of Clinical Nutrition and Metabolism and the Spanish Society of Hospital Pharmacy have developed a new multidisciplinary consensus. This document addresses key practical questions and provides recommendations grounded in scientific evidence and clinical experience.</div><div>The consensus focuses on six key areas related to parenteral nutrition preparation: lipid emulsion stability and lipid peroxidation; calcium-phosphate precipitation risk; stability of amino acids, vitamins, and trace elements; quality control and labeling; automated compounding systems and multi-chamber bags; and drug-parenteral nutritioncompatibility. It outlines strategies to minimize physicochemical instability, including guidelines on analytical techniques, the recommended sequence of component addition, and preventive measures to avoid destabilization phenomena.</div><div>This document serves as a practical guide for healthcare professionals involved in the compounding and administration of parenteral nutrition across various clinical settings. Recommendations were developed using a structured consensus methodology (adapted Delphi technique) and were unanimously endorsed by all participating experts. The result is a reference tool that supports safety, quality, and efficiency in parenteral nutrition preparation throughout Spain.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages 174-180"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147718204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-02-18DOI: 10.1016/j.farma.2026.01.003
Eduardo Tejedor-Tejada , Cristina González-Pérez , María del Puy Goyache Goñi , María Pilar Suñé-Martín , María Serrano-Alonso , Rafael Sánchez-del Hoyo
{"title":"[Translated article] Profile of clinical trials with drugs for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in Spain","authors":"Eduardo Tejedor-Tejada , Cristina González-Pérez , María del Puy Goyache Goñi , María Pilar Suñé-Martín , María Serrano-Alonso , Rafael Sánchez-del Hoyo","doi":"10.1016/j.farma.2026.01.003","DOIUrl":"10.1016/j.farma.2026.01.003","url":null,"abstract":"<div><h3>Background</h3><div>On 11 March 2020, World Health Organisation declared COVID-19 a pandemic. During the early stages, treatments lacking scientific evidence, such as hydroxychloroquine and later remdesivir, were used; meanwhile, clinical trials were being conducted in Spain to evaluate new therapies with greater scientific rigor. This article analyses the study profile, publication rate and completion of studies during the COVID-19 pandemic in Spain.</div></div><div><h3>Methods</h3><div>Meta-epidemiological, analytical, and retrospective study analyzing the characteristics and rate of completion of clinical trials with SARS-CoV-2-related drugs authorized in Spain between March 2020 and March 2021, focusing on treatment and prophylaxis. 179 clinical trials were reviewed using sources such as Registro Español de Estudios Clínicos, <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, PubMed, Embase and TESEO. Statistical analysis was performed with SPSS v.26.</div></div><div><h3>Results</h3><div>67.0% of the trials were national and 71.0% multicentre, with non-commercial sponsors (64.8%) and phase II (44.7%) and phase III (48.0%) studies being the most common. The majority employed a comparative design (93.9%), preferentially focused on treatment (91.1%) versus prophylaxis of SARS-CoV-2 disease, with a predominance of therapeutic repositioning (72.1%). Notably, studies initiated during the first wave of the pandemic (March–June 2020) were mostly non-international, non-commercial, non-placebo-controlled and aimed at drug repositioning. Some 21.2% of the clinical trials closed prematurely, mainly due to recruitment problems, involuntary discontinuation or failure to achieve expected efficacy. By the end of the study, 41.1% of the clinical trials had a final report and 31.3% published their results, most of them (71.9%) in first quartile journals. Statistically significant associations were found between the publication of results and variables such as multicentre, not having closed prematurely, having a final report, and phase III trials.</div><div>The fact that a large number of clinical trials were not published (68.7%) represents a missed opportunity in terms of knowledge.</div></div><div><h3>Conclusion</h3><div>We conclude that there is a need to improve transparency, record all results– including negative ones– and review key aspects of design and funding, as recommendations for future research, including in health emergencies.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T144-T150"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146229180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-04-23DOI: 10.1016/j.farma.2025.11.005
Isabel Romero Crespo , Maria Luisa Gaspar Carreño , Maria Cristina Muñoz Contreras
{"title":"[Translated article] Surface disinfectants used in healthcare environments","authors":"Isabel Romero Crespo , Maria Luisa Gaspar Carreño , Maria Cristina Muñoz Contreras","doi":"10.1016/j.farma.2025.11.005","DOIUrl":"10.1016/j.farma.2025.11.005","url":null,"abstract":"<div><h3>Objective</h3><div>To review the most relevant aspects to consider when selecting the optimal surface disinfectant for use in healthcare settings.</div></div><div><h3>Method</h3><div>The review was conducted over a three-month period (January to March 2024) based on the list of healthcare surface disinfectants authorized by the Spanish Agency of Medicines and Medical Devices and those in a transitional period, with marketing allowed until their registration in the Official Biocide Register. Biocidal agents belonging to the categories of skin antiseptics and insect repellents were excluded. A total of 100 biocidal agents were selected and evenly distributed among four researchers. The review strategy involved consulting the marketing representatives of these products via email or by reviewing their technical data sheets on their respective websites. The reviewed aspects of each disinfectant included marketed presentations, declared efficacy, composition, indication, dosage and usage instructions.</div></div><div><h3>Results</h3><div>The total number of biocidal agents included in the study was 85. A total of 29 suppliers were consulted, covering 141 marketed presentations, 25 (29.41%) of which were sterile. Regarding the efficacy reported by suppliers, 100% (85 products) showed bactericidal, 81.18% (69) fungicidal, 78.82% (67) virucidal, 50.59% (43) yeasticidal, 20% (17) mycobactericidal/tuberculocidal, and 17.65% (15) sporicidal activity. In terms of usage instructions, 40 of the 85 biocides (47.06%) were presented in a ready-to-use dosage format, and 34 (40%) allowed for cleaning and disinfection in a single step. A total of 14 biocides (16.47%) included airborne disinfection options.</div></div><div><h3>Conclusions</h3><div>Selecting the most appropriate surface disinfectant is not straightforward given the wide range of marketed products, the number of factors to consider, and the fact that not all products meet every criterion. For this reason, the selection process must be accompanied by the implementation of optimized programs aimed at reducing the transmission of pathogens from surfaces to patients and healthcare personnel.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T181-T203"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147783612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-04-22DOI: 10.1016/j.farma.2026.02.003
David Berlana , Pilar Gomis Muñoz , Natividad Lago , Amelia María Chica Marchal , Marta Ubeira Iglesias , Amparo Vázquez Polo , Consuelo Pellicer Franco , en nombre del Grupo de Trabajo de Farmacia de la Sociedad Española de Nutrición Clínica y Metabolismo (SENPE) y el Grupo de Trabajo de Nutrición Clínica de la Sociedad Española de Farmacia Hospitalaria (SEFH)
{"title":"[Translated article] Spanish consensus on the preparation of parenteral nutrient mixtures – General aspects","authors":"David Berlana , Pilar Gomis Muñoz , Natividad Lago , Amelia María Chica Marchal , Marta Ubeira Iglesias , Amparo Vázquez Polo , Consuelo Pellicer Franco , en nombre del Grupo de Trabajo de Farmacia de la Sociedad Española de Nutrición Clínica y Metabolismo (SENPE) y el Grupo de Trabajo de Nutrición Clínica de la Sociedad Española de Farmacia Hospitalaria (SEFH)","doi":"10.1016/j.farma.2026.02.003","DOIUrl":"10.1016/j.farma.2026.02.003","url":null,"abstract":"<div><div>Parenteral nutrition is a complex therapeutic intervention, particularly in pediatric and critically ill patients, requiring strict standards of safety, stability, and compatibility during its preparation. To update and harmonize clinical practice, the Pharmacy Working Group of the Spanish Society of Clinical Nutrition and Metabolism and the Spanish Society of Hospital Pharmacy have developed a new multidisciplinary consensus. This document addresses key practical questions and provides recommendations grounded in scientific evidence and clinical experience.</div><div>The consensus focuses on six key areas related to parenteral nutrition preparation: lipid emulsion stability and lipid peroxidation; calcium-phosphate precipitation risk; stability of amino acids, vitamins, and trace elements; quality control and labeling; automated compounding systems and multi-chamber bags; and drug-parenteral nutritioncompatibility. It outlines strategies to minimize physicochemical instability, including guidelines on analytical techniques, the recommended sequence of component addition, and preventive measures to avoid destabilization phenomena.</div><div>This document serves as a practical guide for healthcare professionals involved in the compounding and administration of parenteral nutrition across various clinical settings. Recommendations were developed using a structured consensus methodology (adapted Delphi technique) and were unanimously endorsed by all participating experts. The result is a reference tool that supports safety, quality, and efficiency in parenteral nutrition preparation throughout Spain.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T174-T180"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147783649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2025-10-28DOI: 10.1016/j.farma.2025.06.014
María Martín Cerezuela , Esther Domingo Chiva , Tatiana Betancor García , Miguel Ángel Amor García , Irene Aquerreta González , Marta Albanell-Fernández , Laura Doménech Moral , Carla Bastida Fernández , Sara Ortiz Pérez , Sara Cobo Sacristán , Aurora Fernández Polo , Amaia Egüés Lugea , Fernando Becerril Moreno
{"title":"Manejo de sedoanalgesia y delirio en el paciente crítico","authors":"María Martín Cerezuela , Esther Domingo Chiva , Tatiana Betancor García , Miguel Ángel Amor García , Irene Aquerreta González , Marta Albanell-Fernández , Laura Doménech Moral , Carla Bastida Fernández , Sara Ortiz Pérez , Sara Cobo Sacristán , Aurora Fernández Polo , Amaia Egüés Lugea , Fernando Becerril Moreno","doi":"10.1016/j.farma.2025.06.014","DOIUrl":"10.1016/j.farma.2025.06.014","url":null,"abstract":"<div><div>The management of pain, agitation/sedation and delirium is a fundamental part of the treatment received by patients admitted to Intensive Care Units (ICU). The use of different strategies for the prevention and treatment of pain, agitation and delirium is one of the bases in the management of these patients. Knowledge of the different techniques for monitoring pain and delirium, pharmacokinetic behavior and the dosage used in this population, as well as the adverse effects and their management, is essential in order to provide optimal pharmacotherapeutic validation by the ICU clinical pharmacist.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages 167-173"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145402352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-01-28DOI: 10.1016/j.farma.2025.11.010
Alicia Aguado-Paredes, Laura Moñino-Dominguez, Maria del Carmen Damas-Fuentes
{"title":"[Translated article] Acute esophageal necrosis in a patient with lung cancer under treatment with osimertinib: Case report","authors":"Alicia Aguado-Paredes, Laura Moñino-Dominguez, Maria del Carmen Damas-Fuentes","doi":"10.1016/j.farma.2025.11.010","DOIUrl":"10.1016/j.farma.2025.11.010","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T208-T210"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146087526","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-02-10DOI: 10.1016/j.farma.2025.12.007
Gabriel Martínez-Orea , Carlos Devesa-García , Laura Puente-Romero , Marta Vela-Martínez , Mariella R. Lindo-Gutarra , Pedro L. Fernández-García
{"title":"[Translated article] Desensitization protocol to pomalidomide in a patient with cutaneous hypersensitivity: A case report","authors":"Gabriel Martínez-Orea , Carlos Devesa-García , Laura Puente-Romero , Marta Vela-Martínez , Mariella R. Lindo-Gutarra , Pedro L. Fernández-García","doi":"10.1016/j.farma.2025.12.007","DOIUrl":"10.1016/j.farma.2025.12.007","url":null,"abstract":"","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T211-T213"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
FARMACIA HOSPITALARIAPub Date : 2026-05-01Epub Date: 2026-02-12DOI: 10.1016/j.farma.2026.01.002
Betel del Rosario García , Laura Ramos , Ruth Ramos Díaz , Ana Salas Pérez , Marta Carrillo Palau , Cristina Reygosa Castro , Inmaculada Alonso Abreu , Sergio Medina Chico , Fernando Gutiérrez Nicolás
{"title":"[Translated article] Relationship between plasma concentrations of ustekinumab at week 8 and its effectiveness in patients with Crohn's disease","authors":"Betel del Rosario García , Laura Ramos , Ruth Ramos Díaz , Ana Salas Pérez , Marta Carrillo Palau , Cristina Reygosa Castro , Inmaculada Alonso Abreu , Sergio Medina Chico , Fernando Gutiérrez Nicolás","doi":"10.1016/j.farma.2026.01.002","DOIUrl":"10.1016/j.farma.2026.01.002","url":null,"abstract":"<div><h3>Objective</h3><div>The individualization of treatments through pharmacokinetic monitoring is a therapeutic strategy aimed at improving both the effectiveness and safety of drug therapy. For tumor necrosis factor inhibitors used in Crohn's disease, a robust correlation has been demonstrated between drug exposure and clinical response. However, evidence regarding ustekinumab concentrations and their relationship with treatment effectiveness remains limited.</div><div>The objective of this study was to analyze ustekinumab concentrations at week 8 of treatment for Crohn's disease and to evaluate their association with biochemical remission at week 24 and treatment persistence.</div></div><div><h3>Methods</h3><div>This prospective study included patients with Crohn's disease who initiated ustekinumab between 2020 and 2023. Ustekinumab trough plasma concentrations were measured at week 8. Quartile analysis and binary logistic regression were performed to assess the relationship between ustekinumab concentrations and biochemical remission rates at week 24. Treatment persistence across concentration quartiles was evaluated using Kaplan–Meier analysis.</div></div><div><h3>Results</h3><div>A total of 36 patients were included. Individuals achieving biochemical remission at week 24 had higher ustekinumab concentrations at week 8 compared with non-responders (10.64 vs. 5.83 μg/mL; <em>p</em> = 0.016). Patients within the quartile-4 (><!--> <!-->13.29 μg/mL) at week 8 showed significantly higher biochemical remission rates at week 24 compared with the remaining quartiles (100% vs. 57.1%; <em>p =</em> 0.023); Odds Ratio = 1.20; 95%-Confidence Interval [1.02–1.42]; <em>p =</em> 0.027. The 2-year treatment persistence rate was significantly greater among patients in quartiles 3–4 (100%) compared with those in quartile-1 (55.6%) and quartile 2 (50%) (<em>p =</em> 0.014).</div></div><div><h3>Conclusion</h3><div>This study confirms the association between ustekinumab concentrations at week 8 and treatment effectiveness in Crohn's disease. A concentration ><!--> <!-->13.29 μg/mL at week 8 was identified as a predictive marker of biochemical remission at week 24, which could serve as a basis for future therapeutic decision-making algorithms.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"50 3","pages":"Pages T151-T157"},"PeriodicalIF":1.3,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146195795","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}