Effectiveness Of Tocilizumab In Aortitis And Aneurysms Associated With Giant Cell Arteritis.

OBJECTIVE: Aortitis in Giant Cell Arteritis (GCA-aortitis) is a frequent complication that may lead to aneurysms. Tocilizumab (TCZ) was approved in GCA, but the efficacy in GCA-aortitis and aneurysms has not been analyzed to date. Our aim was to assess the effectiveness and safety of TCZ in a wide series of GCA-aortitis and aneurysms. METHODS: Multicentre observational study with GCA-aortitis treated with TCZ. GCA was diagnosed by: a) ACR criteria, b) temporal artery biopsy, and/or c) imaging techniques. Aortitis was diagnosed mainly by PET/CT. Main outcomes were EULAR and imaging remission. Others were clinical remission, analytical normalization, corticosteroid-sparing effect, and the prevention and improvement of aneurysms. RESULTS: 196 patients with GCA-aortitis treated with TCZ. After 6 months, 72.2% reached EULAR remission but only 12% an imaging remission; increasing up-to 81.4% and 31.8%, respectively, at 24 months. A rapid clinical remission, ESR and CRP normalization was observed in 47.4%, 84.3% and 55.6%, at 1 month, increasing to 89.6%, 85.3% and 80.3% at 24 months, respectively. Aneurysms were present in 10 (5%) patients. Five of them required early surgery, while 3 others enlarged. No patient on TCZ therapy developed aneurysms during follow-up. CONCLUSION: In patients with GCA-aortitis treated with TCZ, a rapid and maintained clinical and analytical improvement was observed. However, there was an uncoupling between clinical and EULAR remission with imaging remission.

Pilot Study Assessing the Safety and Acceptance of a Novel Virtual Reality System to Improve Visual Function.

PURPOSE: To assess the feasibility of the clinical use of a novel Virtual Reality (VR) training software designed to be used for active vision therapy in amblyopic patients by determining its preliminary safety and acceptance on the visual function of healthy adults. METHODS: Pilot study enrolling 10 individuals (3 men, 7 women, mean age: 31.8 ± 6.5 years) with a best-corrected visual acuity (BCVA) of ≥ .90 (decimal) in both eyes were evaluated before and after 20 minutes of exposure to the NEIVATECH VR system using the HTC Vive Pro Eye head mounted display. Visual function assessment included near (40 cm) and distance (6 m) cover test (CT), stereopsis, binocular accommodative facility (BAF), near point of convergence (NPC), near point of accommodation (NPA), accommodative-convergence over accommodation (AC/A) ratio and positive and negative fusional vergences. Safety was assessed using the VR Sickness Questionnaire (VRSQ) and acceptance using the Technology Acceptance Model ;(TAM). Changes in all these variables after VR exposure were analyzed. RESULTS: Short-term exposure to the NEIVATECH VR system only induced statistically significant changes in distance phoria (p = .016), but these changes were not clinically relevant. No significant changes were observed in VRSQ oculo-motricity and disorientation scores after exposure (p = .197 and .317, respectively). TAM scores showed a good acceptance of the system in terms of perceived enjoyment and perceived ease of use, although some concerns were raised in relation to the intention-to-use domain. CONCLUSION: Exposure to the NEIVATECH VR system does not seem to adversely affect the visual function in healthy adults and its safety and acceptance profile seems to be adequate for supporting its potential use in other populations, such as amblyopic patients.

Randomized Controlled Trial Evaluating the Benefit of a Novel Clinical Decision Support System for the Management of COVID-19 Patients in Home Quarantine: A Study Protocol.

(1) Background: We present the protocol of a randomized controlled trial designed to evaluate the benefit of a novel clinical decision support system for the management of patients with COVID-19. (2) Methods: The study will recruit up to 500 participants (250 cases and 250 controls). Both groups will receive the conventional telephone follow-up protocol by primary care and will also be provided with access to a mobile application, in which they will be able to report their symptoms three times a day. In addition, patients in the active group will receive a wearable smartwatch and a pulse oximeter at home for real-time monitoring. The measured data will be visualized by primary care and emergency health service professionals, allowing them to detect in real time the progression and complications of the disease in order to promote early therapeutic interventions based on their clinical judgement. (3) Results: Ethical approval for this study was obtained from the Drug Research Ethics Committee of the Valladolid East Health Area (CASVE-NM-21-516). The results obtained from this study will form part of the thesis of two PhD students and will be disseminated through publication in a peer-reviewed journal. (4) Conclusions: The implementation of this telemonitoring system can be extrapolated to patients with other similar diseases, such as chronic diseases, with a high prevalence and need for close monitoring.