Core items to be included in a definition of moderate psoriatic arthritis: literature review and expert opinion.

Evidence-based treatment recommendations for psoriatic arthritis (PsA) suggest that treatment should be individualised but acknowledge the difficulty of correctly defining levels of activity (mild, moderate and severe). The aim of this study was to define the parameters or disease characteristics that should be included in a future definition of moderate PsA. Mixed. methods: (1) literature review to identify previous assessment tools used to classify patients into mild, moderate and severe forms, and (2) survey of rheumatologists, and experts in PsA, to obtain their opinion on the degree of validation and applicability of published definitions and tools, and on the parameters that should be included in a future definition of moderate PsA. We propose eight domains/items to be included in a definition of moderate PsA: number of active joints and inflamed entheses, physician global assessment (by visual analogue scale), dactylitis, body surface area (BSA) affected by psoriasis, psoriasis in special locations, and absence of hip involvement. The Disease Activity Index for Psoriatic Arthritis (DAPSA) score would be supported as part of this definition, as would the Psoriatic Arthritis Impact of Disease (PsAID) index. This study proposes a set of items/domains to be included in a definition of moderate PsA based on literature and expert opinion, which can be the starting point for further development and validation studies of the proposed items.

Effectiveness of janus kinase inhibitors in relapsing giant cell arteritis in real-world clinical practice and review of the literature.

BACKGROUND: A substantial proportion of patients with giant cell arteritis (GCA) relapse despite standard therapy with glucocorticoids, methotrexate and tocilizumab. The Janus kinase/signal transducer and activator of transcription (JAK/STAT) signalling pathway is involved in the pathogenesis of GCA and JAK inhibitors (JAKi) could be a therapeutic alternative. We evaluated the effectiveness of JAKi in relapsing GCA patients in a real-world setting and reviewed available literature. METHODS: Retrospective analysis of GCA patients treated with JAKi for relapsing disease at thirteen centers in Spain and one center in United States (01/2017-12/2022). Outcomes assessed included clinical remission, complete remission and safety. Clinical remission was defined as the absence of GCA signs and symptoms regardless of the erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) values. Complete remission was defined as the absence of GCA signs and symptoms along with normal ESR and CRP values. A systematic literature search for other JAKi-treated GCA cases was conducted. RESULTS: Thirty-five patients (86% females, mean age 72.3) with relapsing GCA received JAKi therapy (baricitinib, n = 15; tofacitinib, n = 10; upadacitinib, n = 10). Before JAKi therapy, 22 (63%) patients had received conventional synthetic immunosuppressants (e.g., methotrexate), and 30 (86%) biologics (e.g., tocilizumab). After a median (IQR) follow-up of 11 (6-15.5) months, 20 (57%) patients achieved and maintained clinical remission, 16 (46%) patients achieved and maintained complete remission, and 15 (43%) patients discontinued the initial JAKi due to relapse (n = 11 [31%]) or serious adverse events (n = 4 [11%]). A literature search identified another 36 JAKi-treated GCA cases with clinical improvement reported for the majority of them. CONCLUSIONS: This real-world analysis and literature review suggest that JAKi could be effective in GCA, including in patients failing established glucocorticoid-sparing therapies such as tocilizumab and methotrexate. A phase III randomized controlled trial of upadacitinib is currently ongoing (ClinicalTrials.gov ID NCT03725202).

Certolizumab pegol effectiveness, survival and safety in patients with psoriasis: A multicenter retrospective analysis in daily clinical practice by the Spanish Psoriasis Group.

BACKGROUND: Certolizumab is an Fc-free PEGylated tumor necrosis factor-alpha (TNFα) inhibitor recently approved for the treatment of moderate-to-severe plaque psoriasis, although there is limited real-world evidence on the effectiveness and safety in patients with plaque psoriasis treated with certolizumab. The objective of this article is to determine the effectiveness, drug survival, and safety, including pregnancy, childbirth, and lactation, of certolizumab in moderate-to-severe plaque psoriasis under real-world conditions. METHODS: This is a retrospective, multicenter, observational study performed in 15 hospitals in Spain. It evaluates the effectiveness and safety of certolizumab in plaque psoriasis in the clinical practice setting. RESULTS: A total of 67 patients (73% female) were evaluated with a mean baseline Psoriasis Area Severity Index (PASI) of 8.9. At Week 12, the mean PASI was 2.3 (n = 67), 1.3 (n = 57) at Week 24 and 1.3 at Week 52 (n = 34). Absolute PASI < 3 was achieved in 69, 86, and 92% of patients at Weeks 12, 24, and 52, respectively, as observed. For its part, using the under-response imputation analysis, PASI < 3 at Weeks 12, 24, and 52 were achieved by 69, 73, and 49% of the patients, respectively. A total of 35 patients (52%) had concomitant psoriatic arthritis, and, in 24 of them, Disease Activity in Psoriatic Arthritis Score (DAPSA) was recorded at baseline, with a mean value of 17.9 which decreased to 8.2 at Week 12 (n = 22) and to 3.6 at Week 24 (n = 18). Certolizumab treatment was discontinued in 14 out of 67 patients (21%), due to lack/loss of cutaneous or articular effectiveness (n = 11) or patient decision (n = 2) or adverse event in only one patient who developed active tuberculosis. A lower baseline PASI [hazard ratio (HR): 1.12 (1.02-1.23); P = 0.023] and a more significant reduction in PASI at Week 12 [HR: 1.16 (1.07-1.27); P < 0.001] and Week 52 [HR: 1.47 (1.11-1.96); P = 0.007] was shown to be significantly related with better survival for the entire follow-up period. Fourteen patients were treated during pregnancy and/or lactation without reporting adverse events in either the patient or the newborn. CONCLUSIONS: Certolizumab consistently showed high effectiveness and drug survival rates in this real-life cohort. The safety demonstrated in clinical trials during pregnancy and lactation seems to be confirmed in clinical practice.

Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice.

INTRODUCTION: Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited. METHODS: Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire). RESULTS: We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (Q1, Q3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12. CONCLUSIONS: In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL. Trial registration number Clinicaltrials.gov: NCT03828045.

Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice / Uso real de apremilast en pacientes con artritis psoriásica sin tratamiento biológico. Datos de la práctica clínica española

Introduction: Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited. Methods: Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire). Results: We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (Q1, Q3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12. Conclusions: In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL.(AU)

Introducción: Apremilast está aprobado para el tratamiento de la psoriasis y la artritis psoriásica (APs). La evidencia sobre la efectividad de apremilast en la práctica clínica es limitada. Métodos: Estudio observacional en el que se incluyó a pacientes adultos, de 21 centros españoles, que habían iniciado apremilast en los 6 (± 1) meses previos y no habían recibido biológicos. Los datos se recogieron en visitas rutinarias de seguimiento a los 6 y 12 meses del inicio de apremilast. El objetivo primario fue la persistencia de apremilast a los 6 y 12 meses. Los objetivos secundarios incluyeron la actividad de la enfermedad para APs (DAPSA), erosiones articulares, entesitis, dactilitis y la calidad de vida informada por el paciente (CdV, medida mediante el cuestionario “PsA Impact of disease [PsAID]”). Resultados: Se incluyó a 59 pacientes. La mayoría presentaba APs oligoarticular, actividad moderada de la enfermedad y alta comorbilidad. Tres cuartas partes continuaban con apremilast a los 6 meses y 2 tercios a los 12 meses; la duración media (DE) del tratamiento con apremilast fue de 9,43 (1,75) meses. Las puntuaciones DAPSA mostraron una mejora de la actividad de la enfermedad: un tercio de los pacientes en remisión o baja actividad al inicio de apremilast frente al 62 y el 78% a los 6 y 12 meses, respectivamente. Once de 46 pacientes con evaluaciones radiográficas presentaban erosiones articulares al inicio de apremilast y ninguno en el mes 12. La mediana (Q1, Q3) del número de articulaciones inflamadas fue de 4,0 (2,0, 6,0) al inicio de apremilast frente a 0,0 (0,0, 2,0) a los 12 meses. La incidencia de dactilitis y la entesitis disminuyeron entre el inicio de apremilast (el 35,6 y el 28,8%, respectivamente) y el mes 12 (el 11,6 y el 2,4%, respectivamente). Más de 2 tercios de los pacientes tenían una puntuación PSAID-9 < 4 (punto de corte del estado sintomático aceptable para el paciente) en el mes 12.(AU)

Prevention and control of COVID-19 outbreak in a hemodialysis center.

BACKGROUND: The prevention and control of SARS-CoV-2 infection in hemodialysis (HD) units is challenging. AIM: To describe the clinical characteristics and outcome of patients with chronic kidney disease (CKD) on HD with COVID-19, between March 2020 and January 28, 2021, attending a single HD unit in Bogotá, Colombia. MATERIAL AND METHODS: In this prospective observational study, incidence, prevalence, and case-fatality rate were estimated, including screening results with RT-PCR and anti-SARS-CoV-2 IgG and IgM antibodies in all patients and health personnel in the HD unit. RESULTS: Among patients and health workers, 55 and 9 cases of COVID-19 were identified, respectively. The median age of patients was 63 years (84% males). Fifty five percent of patients were symptomatic, with fever, cough and/or myalgia. The most common comorbidities were hypertension, type 2 diabetes mellitus, and coronary heart disease. The cumulative incidence of infection was 30.2%, population seroprevalence was 24.9%, and fatality was 9.1%. CONCLUSIONS: The incidence of SARS-CoV-2 infection in this HD unit was high. Strict biosafety protocols are required to prevent outbreaks.

Implementation of the recommendations for the psychological management of patients with spondyloarthritis and inflammatory bowel disease.

OBJECTIVE: To assess and improve the level of implementation of the recommendations for the psychological management of patients with spondyloarthritis (SpA) and associated inflammatory bowel disease (IBD). METHODS: Qualitative study. We performed a narrative literature review to identify the recommendations for the psychological management of SpA and associated IBD and to explore their level of implementation. Based on the findings, we developed a national survey to assess: (1) current level of knowledge and implementation of the recommendations; (2) attitudes towards the recommendations; and (3) barriers and facilitators to their implementation. The results of the review and survey were discussed by a multidisciplinary group of 9 expert rheumatologists and gastroenterologists, who defined implementation strategies to increase the uptake of the recommendations. RESULTS: The review included 4 articles, 2 of them included direct recommendations on the identification and management of psychological problems in patients with SpA and IBD. None assessed the level of implementation of the recommendations in routine clinical practice. Our survey showed a great lack of awareness and implementation of the recommendations, even though psychological issues are very relevant for health professionals. Lack of time, resources, and knowledge are considered the main barriers to adherence to the recommendations. We propose several implementation strategies related to educational activities, clinical practice, and others to increase the uptake of reported recommendations. CONCLUSIONS: Further research and efforts are required to achieve behaviour changes in clinical practice to improve the identification and management of psychological problems and needs in patients with SpA and IBD.

Implementation of the recommendations for the psychological management of patients with spondyloarthritis and inflammatory bowel disease / Implementación de las recomendaciones para el manejo psicológico de pacientes con espondiloartritis y enfermedad inflamatoria intestinal

Objective: To assess and improve the level of implementation of the recommendations for the psychological management of patients with spondyloarthritis (SpA) and associated inflammatory bowel disease (IBD). Methods: Qualitative study. We performed a narrative literature review to identify the recommendations for the psychological management of SpA and associated IBD and to explore their level of implementation. Based on the findings, we developed a national survey to assess: (1) current level of knowledge and implementation of the recommendations; (2) attitudes towards the recommendations; and (3) barriers and facilitators to their implementation. The results of the review and survey were discussed by a multidisciplinary group of 9 expert rheumatologists and gastroenterologists, who defined implementation strategies to increase the uptake of the recommendations. Results: The review included 4 articles, 2 of them included direct recommendations on the identification and management of psychological problems in patients with SpA and IBD. None assessed the level of implementation of the recommendations in routine clinical practice. Our survey showed a great lack of awareness and implementation of the recommendations, even though psychological issues are very relevant for health professionals. Lack of time, resources, and knowledge are considered the main barriers to adherence to the recommendations. We propose several implementation strategies related to educational activities, clinical practice, and others to increase the uptake of reported recommendations. Conclusions: Further research and efforts are required to achieve behaviour changes in clinical practice to improve the identification and management of psychological problems and needs in patients with SpA and IBD. (AU)

Objetivo: Analizar y mejorar la implementación de las recomendaciones sobre la evaluación y el manejo psicológico de pacientes con espondiloartritis (EspA) y enfermedad inflamatoria intestinal (EII) asociada. Métodos: Estudio cualitativo. Se realizó una revisión narrativa de la literatura para identificar las recomendaciones sobre el manejo psicológico de pacientes con EspA y EII asociada y explorar su grado de implementación. En base a ello se diseñó una encuesta para analizar el nivel de conocimiento de las recomendaciones, las barreras y los facilitadores a su implementación. Todos los resultados fueron discutidos por un grupo multidisciplinar de expertos reumatólogos y gastroenterólogos que definieron estrategias para incrementar el seguimiento de las recomendaciones. Resultados: La revisión incluyó 4 artículos, de los que 2 aportan recomendaciones directas sobre la evaluación y el manejo psicológico de pacientes con EspA y EII. Ninguno ha evaluado el grado de implementación de las recomendaciones en la práctica diaria. La encuesta mostró que el conocimiento de las mismas y la implementación de estas recomendaciones son prácticamente nulos a pesar de ser un tema muy relevante para los profesionales que manejan estos pacientes. La falta de tiempo, la escasez de recursos y la falta de reconocimiento se consideran las principales barreras para la correcta identificación y manejo de los aspectos psicológicos en pacientes con EspA y EII. Se proponen una serie de actividades formativas y relacionadas con la práctica clínica para mejorar esta situación. Conclusiones: Se precisa seguir trabajando en la implementación para conseguir cambios en la práctica diaria para mejorar la evaluación y el manejo psicológico de los pacientes con EspA y EII. (AU)

Audiovestibular Manifestations in Patients with Primary Raynaud's Phenomenon and Raynaud's Phenomenon Secondary to Systemic Sclerosis.

OBJECTIVES: To address the prevalence of audiovestibular disorders in patients with primary Raynaud's Phenomenon (RP). A series of patients with primary RP and secondary RP in the context of systemic sclerosis (SSc) were compared with healthy controls. METHODS: A prospective multicenter observational cross-sectional study was conducted in several Otolaryngology and Rheumatology Divisions of tertiary referral hospitals, recruiting 57 patients with RP and 57 age- and gender-matched controls. Twenty patients were classified as primary RP when unrelated to any other conditions and 37 patients who met the 2013 ACR/EULAR classification criteria for SSc were classified as having secondary RP associated with SSc. Audiometric and vestibular testing (vHIT), clinical sensory integration and balance testing (CTSIB), and Computerized Dynamic Posturography (CDP) were performed. RESULTS: As significant differences were found in the age of the two study groups, primary and secondary RP, no comparisons were made between both groups of RP but only with their control groups. No sensorineural hearing loss (SNHL) was recorded in any of our patients with primary RP and no differences were found in the voice audiometry tests with respect to controls. Four of 37 (10.8%) secondary RP patients presented SNHL. Those with SNHL were 7.03 times more likely to have a secondary RP than controls (p < 0.001). The audiometric curve revealed high-frequency hearing loss in 4 patients with RP secondary to SSc, and statistically significant differences were achieved when RP secondary was compared to controls in vHIT gain, caloric test, CTSIB, and CDP. CONCLUSIONS: Unlike patients with RP secondary to SSc, patients with primary RP do not show audiovestibular abnormalities. Regarding audiovestibular manifestations, primary RP can be considered a different condition than secondary RP.

Prevention and control of COVID-19 outbreak in a hemodialysis center / Prevención y control de un brote de COVID-19 en una unidad de hemodiálisis

BACKGROUND: The prevention and control of SARS-CoV-2 infection in hemodialysis (HD) units is challenging. AIM: To describe the clinical characteristics and outcome of patients with chronic kidney disease (CKD) on HD with COVID-19, between March 2020 and January 28, 2021, attending a single HD unit in Bogotá, Colombia. MATERIAL AND METHODS: In this prospective observational study, incidence, prevalence, and case-fatality rate were estimated, including screening results with RT-PCR and anti-SARS-CoV-2 IgG and IgM antibodies in all patients and health personnel in the HD unit. RESULTS: Among patients and health workers, 55 and 9 cases of COVID-19 were identified, respectively. The median age of patients was 63 years (84% males). Fifty five percent of patients were symptomatic, with fever, cough and/or myalgia. The most common comorbidities were hypertension, type 2 diabetes mellitus, and coronary heart disease. The cumulative incidence of infection was 30.2%, population seroprevalence was 24.9%, and fatality was 9.1%. CONCLUSIONS: The incidence of SARS-CoV-2 infection in this HD unit was high. Strict biosafety protocols are required to prevent outbreaks.

INTRODUCCIÓN: La prevención y el control de la infección por SARS-CoV-2 en las unidades de hemodiálisis (HD) es un desafío. OBJETIVO: Describir las características clínicas y la evolución de los pacientes con enfermedad renal crónica (ERC) en HD con COVID-19, entre marzo de 2020 y el 28 de enero de 2021, que acudieron a una unidad de HD en Bogotá, Colombia. MATERIAL Y MÉTODOS: Estudio observacional prospectivo con estimación de incidencia, prevalencia y letalidad, incluyendo los resultados del cribado con RT-PCR y anticuerpos IgG e IgM anti-SARS-CoV-2 en todos los pacientes y personal sanitario de la unidad de HD. RESULTADOS: Se identificaron 55 casos de pacientes en HD y 9 casos de trabajadores de salud con COVID-19. La mediana de edad de los pacientes fue de 63 años y 84% eran hombres. Cincuenta y cinco por ciento de los pacientes eran sintomáticos, con fiebre, tos y/o mialgia. Las comorbilidades más frecuentes fueron hipertensión arterial, diabetes mellitus tipo 2 y enfermedad coronaria. La incidencia acumulada de infección fue del 30,2%, la seroprevalencia poblacional del 24,9% y la letalidad del 9,1%. CONCLUSIONES: La incidencia de infección por SARS-CoV-2 en esta unidad de HD fue alta. Se requieren de protocolos estrictos de bioseguridad para evitar brotes.

Effectiveness and safety of tocilizumab in monotherapy in biologic-naïve and non-naïve patients with rheumatoid arthritis in a real-world setting.

OBJECTIVE: To evaluate the effectiveness and safety of tocilizumab (TCZ) monotherapy in biologic-naïve patients with rheumatoid arthritis (RA) versus patients with previous biologic exposure in a real-world setting. MATERIALS AND METHODS: Non-controlled clinical-trial, 32-week prospective multicenter study including RA patients with moderate-severe disease activity starting TCZ in monotherapy who had a prior inadequate response or were intolerant to methotrexate (MTX). Effectiveness according to EULAR response evaluated at 24-week and safety at 32-weekwere assessed. RESULTS: Of the 93 were enrolled of whom 84 (90%) were eligible for the effectiveness analysis. Biologic-naïve patients (n=46, 54.8%) were younger (51.5 versus 57.9) with shorter disease duration (6.4 versus 13.3) but presented similar comorbidities in comparison with non-naïve patients. DAS28 remission was achieved in a higher percentage in the group of patients with prior biological treatment. 89 adverse events (AE) were recorded in 50 patients, most of them non-serious AE (non-SAE) (86.3%). CONCLUSIONS: In a real world setting, TCZ exhibit similar effectiveness and safety in monotherapy in patients with RA regardless previous exposure to other biologic therapies. This study provides additional and valuable real-world findings on the use of TCZ in patients with RA.

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group.

Guselkumab is a monoclonal antibody that selectively blocks the p19 subunit of interleukin 23 and has been approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis in adult patients due to its efficacy in different clinical trials. Therefore, itis important to know the performance of guselkumab in this setting of patients in clinical practice given that a high percentage of them are not represented in these clinical trials. Our objective was to evaluate the effectiveness and tolerability of guselkumab in clinical practice in the first patients with psoriasis and psoriatic arthritis treated since the date of its approval for psoriasis in Spain, in joint dermatology-rheumatology clinics. A multicenter retrospective data collection was carried out, in which 14 hospitals participated, including a total of 90 patients with psoriatic arthritis confirmed by a rheumatologist. Data collection was recorded at baseline and at weeks 12, 24, and 52 for both the articular and cutaneous domains. Ninety PsA patients started treatment with guselkumab and therefore were included in this study. The vast majority had already failed to at least to one biologic therapyprior guselkumab prescription. The median age was 55 years, 61% were female and 46% had a BMI ≥ 30 kg/m2 . Sixty-nine percent suffered from peripheral arthritis, and in 34% an axial involvement was also detected; dactylitis or enthesitis was present in 24% and 29% of patients, respectively. Guselkumab was effective in controlling both articular and skin manifestations of PsA patients. Absolute PASI significantly decreased from 10.5 to 4.8, 1.9 and 1.3 at weeks 12, 24, and 52, respectively. In 29 out of 61 (48%) of cases, DAPSA was moderate or high, and patients showed a significant reduction in DAPSA at 12, 24, and 52 weeks of treatment (mean DAPSA values at baseline and follow up were 29, 20, 16, and 14, respectively). Patients with DAPSA in low activity or in remission at the time of initiation of guselkumab maintained response at the end of the study period. No new safety concerns were detected. Seventy-eight out of 90 patients (84.4%) persisted on treatment after 2 years follow-up. Our experience suggests that guselkumab isan effective drug for PsA and PsO patients in clinical practice with good tolerability and no additional safety signals, making it a new therapeutic alternative for the treatment of PsA and PsO patients.

Comparison of technical parameters and women's experience between self-compression and standard compression modes in mammography screening: a single-blind randomized clinical trial.

OBJECTIVES: We compared the compression force, breast thickness, and glandular dose, as well as the severity of discomfort and women's experience between the patient-assisted compression (PAC) and standard compression (SC) modes. MATERIALS AND METHODS: We conducted a prospective randomized controlled study at Hospital del Mar in Barcelona, Spain. We included 448 asymptomatic women aged 50 to 69 years old, attending their screening round from December 2017 to December 2019. Mammograms included the two bilateral views. In each woman, one breast was studied with SC and the other with PAC. The mode used in each breast was selected following a randomized list. Compression force, breast thickness, and average glandular dose were obtained for each of the 1792 images. We also recorded the degree of discomfort and women's experience, after mammogram acquisitions, using a predefined survey. RESULTS: Higher compression forces were obtained with PAC than with SC (99.27 N vs 83.25 N, p < 0.001). Breast thickness mode (56.11 mm vs 57.52 mm, p = 0.015) and glandular dose (1.34 mGy vs 1.37 mGy, p = 0.018) were lower in PAC. The discomfort score was slightly higher with PAC (mean 3.94 vs 3.69, p = 0.042), but in the satisfaction survey, more women reported that PAC caused less discomfort. Additionally, 63.2% of women (289/448) preferred PAC. CONCLUSION: PAC achieved higher compression forces without impairing the other technical imaging parameters and enhanced women's experience of screening mammography. We believe there were no clinically significant differences in the severity of discomfort between the two modes. KEY POINTS: • Self-compression allows higher compression forces than the standard compression mode. • Self-compression does not affect technical imaging parameters. • Self-compression improved women's experience of screening mammography when standard compression was used on one breast and self-compression on the other.

Does the patient-assisted compression mode affect the mammography quality? A within-woman randomized controlled trial.

OBJECTIVES: Evaluate the image quality of a mammography screening device using the patient-assisted compression (PAC) compared with the standard compression (SC) mode. METHODS: This prospective within-woman, randomized controlled trial was conducted between September 2017 and December 2019. Participants were asymptomatic women aged 50 to 69 years attending their second or subsequent screening mammography round. By random assignment, one breast underwent the SC and the other breast, the PAC. Image quality was evaluated as perfect, good, moderate, or inadequate (PGMI) on 10 criteria for the craniocaudal (CC) view and 8 criteria for the mediolateral oblique (MLO) view. Pearson's chi-square test, with Yates' correction if pertinent, was performed to compare image quality between compression modes. RESULTS: A total of 444 participants were included (mean [± standard deviation] age, 60 [± 4.9] years). There were no differences in the percentages of PGMI between the PAC and SC modes for the CC view (perfect, 37% [162/444] vs 37% [163/444]; good, 1% [5/444] vs 2% [9/444]; moderate, 62% [277/444] vs 61% [271/444]; inadequate, 0% vs 0.2% [1/444]; p = .88) or for the MLO view (perfect, 53% [237/444] vs 56% [247/444]; good, 22% [99/444] vs 22% [97/444]; moderate, 23% [102/444] vs 22% [98/444]; inadequate, 1% [6/444] vs 0.5% [2/444]; p = .72). No differences were found when we stratified by laterality or when analyzed by PGMI criteria. CONCLUSION: PAC does not seem to impair mammographic image quality. Future research should focus in a daily practice setting. KEY POINTS: No differences were found in the distribution of the PGMI classification, a tool for quality assessment, between patient-assisted compression and standard compression. Similar results were found on stratification of image quality by mammographic view and breast laterality for both types of compression. None of the PGMI criteria had significantly more errors in patient-assisted compression than in standard compression.

Prevalence of Metabolic Syndrome in Psoriatic Arthritis: Systematic Literature Review and Results From the CARMA Cohort.

OBJECTIVE: To analyze the prevalence of metabolic syndrome (MetS) in patients with psoriatic arthritis (PsA) in a systematic literature review (SLR) and in the Spanish CArdiovascular in RheuMAtology (CARMA) cohort. METHODS: A SLR and a subanalysis of the CARMA cohort were performed. In the SLR, PubMed, EMBASE, the Cochrane Library, and ClinicalTrials.gov up to March 2019 were searched. Systematic literature reviews, clinical trials, and observational studies that analyzed the prevalence or frequency of MetS in PsA were analyzed. Two reviewers selected the articles, assessed the quality of the studies, and collected data, independently. In addition, data on sociodemographic characteristics and MetS in patients with PsA from the CARMA cohort were collected and analyzed. Comparative descriptive analysis was performed. RESULTS: The SLR included 18 articles, of moderate to high quality, with PsA patients of both sexes, with mean ages between 42 and 59 years. The rate of MetS varied from 23.5% to 62.9%. The most commonly used classification method was that of the National Cholesterol Education Program. Additionally, 724 PsA patients from the CARMA cohort were analyzed; 327 (45.4%) were women, 157 (21.8%) smokers, with a mean age of 51 years and a mean PsA disease duration of 9 years. Hypertension was the most common abnormal finding (66.8%), followed by hyperglycemia (42.6%) and hypertriglyceridemia (30.6%). Notably, 222 patients (30.6%) had MetS. CONCLUSIONS: The prevalence of MetS in PsA varies, depending on the definition. Whereas 23.5% to 62.9% of PsA patients have MetS, in the CARMA cohort almost a third of patients with PsA have MetS.

Biologic therapy in refractory neurobehçet's disease: a multicentre study of 41 patients and literature review.

OBJECTIVES: To assess efficacy and safety of biologic therapy (BT) in neurobehçet's disease (NBD) refractory to glucocorticoids and at least one conventional immunosuppressive drug. METHODS: Open-label, national, multicentre study. NBD diagnosis was based on the International Consensus Recommendation criteria. Outcome variables were efficacy and safety. Main efficacy outcome was clinical remission. Other outcome variables analysed were glucocorticoid-sparing effect and improvement in laboratory parameters. RESULTS: We studied 41 patients [21 women; age 40.6 (10.8) years]. Neurological damage was parenchymal (n = 33, 80.5%) and non-parenchymal (n = 17, 41.5%). First BTs used were infliximab (n = 19), adalimumab (n = 14), golimumab (n = 3), tocilizumab (n = 3) and etanercept (n = 2). After 6 months of BT, neurological remission was complete (n = 23, 56.1%), partial (n = 15, 37.6%) and no response (n = 3, 7.3%). In addition, median (IQR) dose of oral prednisone decreased from 60 (30-60) mg/day at the initial visit to 5 (3.8-10) mg/day after 6 months (P < 0.001). It was also the case for mean erythrocyte sedimentation rate [31.5 (25.6)-15.3 (11.9) mm/1st h, P = 0.011] and median (IQR) C-reactive protein [1.4 (0.2-12.8) to 0.3 (0.1-3) mg/dl, P = 0.001]. After a mean follow-up of 57.5 months, partial or complete neurological remission persisted in 37 patients (90.2%). BT was switched in 22 cases (53.6%) due to inefficacy (n = 16) or adverse events (AEs) (n = 6) and discontinued due to complete prolonged remission (n = 3) or severe AE (n = 1). Serious AEs were observed in two patients under infliximab treatment. CONCLUSIONS: BT appears to be effective and relatively safe in refractory NBD.

Local adaptation of recommendation-based materials for shared decision-making and management of comorbidity in rheumatoid arthritis.

OBJECTIVES: To describe local adaptations of materials derived from evidence-based recommendations in a training programme in rheumatoid arthritis (RA). METHODS: The eRA (evolving the management of rheumatoid arthritis) programme generated shared decision-making practises and a checklist for managing comorbidity in RA, among others, at the international level. Unmet needs in RA management were first identified and prioritised. Then educational materials were designed and developed to address these gaps. These materials were evaluated in detailed and discussed in small regional groups by practicing rheumatologists. Voting, open discussions and recommendations were extracted from the meetings. RESULTS: Thirty-five Spanish rheumatologists discussed a comorbidity checklist and a shared decision-making tool. The results of the local meetings were synthesised as (1) a judicious commitment to check agreed comorbidities, and (2) a list of barriers and facilitators for the implementation of shared decision making in the local settings. With regards to ways to implement the agreed list and periodicity, two issues stand-out: (1) patient education and (2) the need of easy access to information and the use of local organisational systems in place. With respect to shared decision-making, issues raised included messages for self-awareness, challenges, and practical facilitators. CONCLUSIONS: Discussion, adaptation, and planning are needed before implementing any evidence-based recommendation and materials if we want to achieve a successful implementation. Further studies should demonstrate whether this initiative was successful in achieving the goals of improved patient care. Our experience could be used as a guidance or example for implementation elsewhere.

Predicting Beef Carcass Fatness Using an Image Analysis System.

The amount and distribution of subcutaneous fat is an important factor affecting beef carcass quality. The degree of fatness is determined by visual assessments scored on a scale of five fatness levels (the SEUROP system). New technologies such as the image analysis method have been developed and applied in an effort to enhance the accuracy and objectivity of this classification system. In this study, 50 young bulls were slaughtered (570 ± 52.5 kg) and after slaughter the carcasses were weighed (360 ± 33.1 kg) and a SEUROP system fatness score assigned. A digital picture of the outer surface of the left side of the carcass was taken and the area of fat cover (fat area) was measured using an image analysis system. Commercial cutting of the carcasses was performed 24 h post-mortem. The fat trimmed away on cutting (cutting fat) was weighed. A regression analysis was carried out for the carcass cutting fat (y-axis) on the carcass fat area (x-axis) to establish the accuracy of the image analysis system. A greater accuracy was obtained by the image analysis (R2 = 0.72; p < 0.001) than from the visual fatness scores (R2 = 0.66; p < 0.001). These results show the image analysis to be more accurate than the visual assessment system for predicting beef carcass fatness.

Reliability and validity of a Spanish-language measure assessing clinical capacity to sustain Paediatric Early Warning Systems (PEWS) in resource-limited hospitals.

BACKGROUND: Paediatric Early Warning Systems (PEWSs) improve identification of deterioration, however, their sustainability has not been studied. Sustainability is critical to maximise impact of interventions like PEWS, particularly in low-resource settings. This study establishes the reliability and validity of a Spanish-language Clinical Sustainability Assessment Tool (CSAT) to assess clinical capacity to sustain interventions in resource-limited hospitals. METHODS: Participants included PEWS implementation leadership teams of 29 paediatric cancer centres in Latin America involved in a collaborative to implement PEWS. The CSAT, a sustainability assessment tool validated in high-resource settings, was translated into Spanish and distributed to participants as an anonymous electronic survey. Psychometric, confirmatory factor analysis (CFA), and multivariate analyses were preformed to assess reliability, structure and initial validity. Focus groups were conducted after participants reviewed CSAT reports to assess their interpretation and utility. RESULTS: The CSAT survey achieved an 80% response rate (n=169) with a mean score of 4.4 (of 5; 3.8-4.8 among centres). The CSAT had good reliability with an average internal consistency of 0.77 (95% CI 0.71 to 0.81); and CFAs supported the seven-domain structure. CSAT results were associated with respondents' perceptions of the evidence for PEWS, its implementation and use in their centre, and their assessment of the hospital culture and implementation climate. The mean CSAT score was higher among respondents at centres with longer time using PEWS (p<0.001). Focus group participants noted the CSAT report helped assess their centre's clinical capacity to sustain PEWS and provided constructive feedback for improvement. CONCLUSIONS: We present information supporting the reliability and validity of the CSAT tool, the first Spanish-language instrument to assess clinical capacity to sustain evidence-based interventions in hospitals of variable resource levels. This assessment demonstrates a high capacity to sustain PEWS in these resource-limited centres with improvement over time from PEWS implementation.

Volatile Compounds, Odour and Flavour Attributes of Lamb Meat from the Navarra Breed as Affected by Ageing.

This study aimed to assess the influence of ageing on the volatile compounds, as well as odour and flavour attributes of lamb meat from the Navarra breed. Twenty-one male lambs were fed a commercial concentrate diet after weaning and were harvested at 101 ± 6.5 days of age. From the Longissimus thoracis, 26 volatile compounds were identified, with hexanal, 2-propanone, and nonanal the most abundant (57.17% relative percentage abundance, RPA). The effect of ageing (1 vs. 4 d) was observed (p < 0.05) in six compounds: 1,4-dimethylbenzene decreased with ageing, while tridecane, 3-methylbutanal, 2-heptanone, 3-octanone, and 1-octen-3-ol increased. In general, ageing was linked to a decrease in livery and bloody flavour, bloody odour and ethanal, and an increase in pentane, hexanal, and heptanal, which are usually associated with fresh green grass and fat descriptors. Consequently, ageing lamb from the Navarra breed for four days might have a positive effect on meat sensory odour and flavour quality.