ABSTRACT
INTRODUCTION: Non-infectious uveitis include a heterogeneous group of sight-threatening and incapacitating conditions. Their correct management sometimes requires the use of immunosuppressive drugs (ISDs), prescribed in monotherapy or in combination. Several observational studies showed that the use of ISDs in combination could be more effective than and as safe as their use in monotherapy. However, a direct comparison between these two treatment strategies has not been carried out yet. METHODS AND ANALYSIS: The Combination THerapy with mEthotrexate and adalImumAb for uveitis (CoTHEIA) study is a phase III, multicentre, prospective, randomised, single-blinded with masked outcome assessment, parallel three arms with 1:1:1 allocation, active-controlled, superiority study design, comparing the efficacy, safety and cost-effectiveness of methotrexate, adalimumab or their combination in non-infectious non-anterior uveitis. We aim to recruit 192 subjects. The duration of the treatment and follow-up will last up to 52 weeks, plus 70 days follow-up with no treatment. The complete and maintained resolution of the ocular inflammation will be assessed by masked evaluators (primary outcome). In addition to other secondary measurements of efficacy (quality of life, visual acuity and costs) and safety, we will identify subjects' subgroups with different treatment responses by developing prediction models based on machine learning techniques using genetic and proteomic biomarkers. ETHICS AND DISSEMINATION: The protocol, annexes and informed consent forms were approved by the Reference Clinical Research Ethic Committee at the Hospital Clínico San Carlos (Madrid, Spain) and the Spanish Agency for Medicines and Health Products. We will elaborate a dissemination plan including production of materials adapted to several formats to communicate the clinical trial progress and findings to a broad group of stakeholders. The promoter will be the only access to the participant-level data, although it can be shared within the legal situation. TRIAL REGISTRATION NUMBER: 2020-000130-18; NCT04798755.
Subject(s)
Uveitis, Anterior , Uveitis , Adalimumab/therapeutic use , Clinical Trials, Phase III as Topic , Cost-Benefit Analysis , Humans , Methotrexate/therapeutic use , Multicenter Studies as Topic , Outcome Assessment, Health Care , Prospective Studies , Proteomics , Quality of Life , Randomized Controlled Trials as Topic , Research Design , Treatment Outcome , Uveitis/drug therapy , Uveitis, Anterior/drug therapyABSTRACT
La ecografía es una técnica de amplia implantación en reumatología que implica una gran interacción entre paciente y profesional. La pandemia COVID-19 hace necesario un cambio en nuestra práctica clínica, mediante estrategias que permitan la asistencia integral de nuestros pacientes, garantizando la seguridad tanto de los pacientes como de los profesionales sanitarios. OBJETIVO: Desarrollar unas recomendaciones prácticas, consensuadas entre un panel de expertos, sobre el uso y seguridad de la ecografía reumatológica durante la pandemia COVID-19. MÉTODOS: Analizando la literatura disponible se realizaron unas recomendaciones preliminares, posteriormente consensuadas con un panel de expertos mediante el método Delphi con una escala Likert 1-5. RESULTADOS: Se elaboraron y consensuaron por el panel 5 principios fundamentales y 28 recomendaciones. El consenso del grupo se logró en el 100% de ítems (acuerdo para cada recomendación ≥4 en escala de Likert del 75% de componentes del panel). CONCLUSIONES: El documento proporciona información de utilidad acerca de medidas preventivas en la práctica de ecografía en reumatología en tiempos de pandemia COVID-19 de acuerdo a la experiencia y literatura disponible hasta el momento
Ultrasound is a widely implemented imaging modality in rheumatology practice that implies a great interaction between patient and professional. The COVID-19 pandemic requires a change in our clinical practice, through the adoption of new strategies that allow comprehensive care for our patients, guaranteeing the safety of both patients and healthcare professionals. OBJECTIVE: Our objective was to develop practical recommendations, agreed among a panel of experts, on the use and safety of rheumatological ultrasound during the COVID-19 pandemic. METHODS: We performed a narrative review of the available literature. Based on the literature review, we produced preliminary recommendations that were subsequently agreed among a panel of experts using the Delphi methodology with a 1-5 Likert scale. Agreement for each recommendation was considered if 75% of the panel members scored the item ≥4 on the Likert scale. RESULTS: 5 overarching principles and 28 recommendations were issued and agreed among the panel. Group consensus was achieved in 100% of items. CONCLUSIONS: The document provides useful information about preventive measures in the practice of ultrasound in rheumatology in times of a COVID-19 pandemic based on the experience and literature available to date
