Coronavirus Disease 2019 in Rheumatic Patients with Inflammatory Disorders: A Descriptive Study from a High Infection Incidence Region of Northern Spain.

BACKGROUND: Since the first confirmed case of severe acute respiratory syndrome coronavirus 2 in Spain in January 2020, the susceptibility of patients with rheumatic disease has remained unclear. In this report, we will describe the main features of coronavirus disease 2019 (COVID-19) that occurred in rheumatic patients with inflammatory disorders and try to identify features associated with severe disease. METHODS: We included all rheumatic patients with immune-mediated diseases followed at 6 centers belonging to the public healthcare system in the Basque Country (Spain) and diagnosed with COVID-19 from March 1, 2020, to May 31, 2020. RESULTS: In total, 131 patients were included in this study. The most frequent rheumatic disease was rheumatoid arthritis (46.6%), and the main comorbidities were arterial hypertension (45%). Fortyseven percent were taking glucocorticoids (GC) (62 patients), 61.8% were under treatment with conventional synthetic disease-modifying antirheumatic drugs (csDMARD), and 25 patients (19.1%) were receiving targeted therapies (TT). Thirty-eight percent of patients required hospital admission, 2.3% required transfer to intensive care uni, and the rate of mortality was 9.2%. Associated factors in univariate analysis for a bad outcome were older age, use of GC, obesity, previous cardiovascular disease, and lymphopenia. Use of GC and lymphopenia remained within the multivariate model. CONCLUSION: The frequency of COVID-19 seems to be similar in rheumatic patients as in the general population. Advanced age, obesity, heart disease, glucocorticoids, and low levels of lymphocytes were more common among the patients with a bad outcome. Neither exposure to csDMARD nor TT was associated with severe cases.

Cost-Effectiveness of Therapeutic Drug Monitoring-Guided Adalimumab Therapy in Rheumatic Diseases: A Prospective, Pragmatic Trial.

INTRODUCTION: To assess the clinical and cost-effectiveness of therapeutic drug monitoring (TDM) based on serum adalimumab levels compared to standard of care in patients with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. METHODS: This was a non-inferiority, multicentric, non-randomized, pragmatic trial including adult patients diagnosed with moderate-to-severe, clinically stable rheumatic diseases treated with adalimumab. Consecutive patients were assigned 1:2 to the control (CG) or the intervention group (IG), based on the site of inclusion, and followed up for 18 months. Adalimumab serum levels were measured at each study visit and released to the IG only to modify dosing strategy. Data on disease activity, healthcare resource utilization and health-related quality of life (HRQoL) measured through the EQ-5D-5L were collected. Number of persistent and overall flares, time to first flare, days experiencing high disease activity, total direct costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER) were calculated. RESULTS: Of the 169 recruited patients, 150 were included in the analysis (52 and 98 patients in the CG and IG, respectively). The primary endpoint was not met as persistent flares were not significantly lower in the IG, although mean (SD) number of flares was numerically lower in the IG (0.67 [0.70] versus 0.90 [0.82], P = 0.073), respectively. Based on EQ-5D-5L utilities, HRQoL was significantly higher in the IG at 3 (P = 0.001) and 6 months (P = 0.035), which overall translated into 0.075 QALYs gained per patient for the IG at month 18. Overall, direct costs were significantly lower for the IG patients (€15,311.59 [4,870.04] versus €17,378.46 [6,556.51], P = 0.030), resulting in the intervention being dominant, leading to increased QALY at a lower overall cost CONCLUSION: Adalimumab dose tapering based on TDM for rheumatic patients led to an increased quality of life and QALY gain and entailed lower costs, being a more cost-effective alternative than clinically guided management.

Abatacept in interstitial lung disease associated with rheumatoid arthritis: national multicenter study of 263 patients.

OBJECTIVE: To assess the efficacy of abatacept (ABA) in RA patients with interstitial lung disease (ILD) (RA-ILD). METHODS: This was an observational, multicentre study of RA-ILD patients treated with at least one dose of ABA. ILD was diagnosed by high-resolution CT (HRCT). We analysed the following variables at baseline (ABA initiation), 12 months and at the end of the follow-up: Modified Medical Research Council (MMRC) scale (1-point change), forced vital capacity (FVC) or diffusion lung capacity for carbon monoxide (DLCO) (improvement or worsening ≥10%), HRCT, DAS on 28 joints evaluated using the ESR (DAS28ESR) and CS-sparing effect. RESULTS: We studied 263 RA-ILD patients [150 women/113 men; mean (s.d.) age 64.6 (10) years]. At baseline, they had a median duration of ILD of 1 (interquartile range 0.25-3.44) years, moderate or severe degree of dyspnoea (MMRC grade 2, 3 or 4) (40.3%), FVC (% of the predicted) mean (s.d.) 85.9 (21.8)%, DLCO (% of the predicted) 65.7 (18.3) and DAS28ESR 4.5 (1.5). The ILD patterns were: usual interstitial pneumonia (UIP) (40.3%), non-specific interstitial pneumonia (NSIP) (31.9%) and others (27.8%). ABA was prescribed at standard dose, i.v. (25.5%) or s.c. (74.5%). After a median follow-up of 12 (6-36) months the following variables did not show worsening: dyspnoea (MMRC) (91.9%); FVC (87.7%); DLCO (90.6%); and chest HRCT (76.6%). A significant improvement of DAS28ESR from 4.5 (1.5) to 3.1 (1.3) at the end of follow-up (P < 0.001) and a CS-sparing effect from a median 7.5 (5-10) to 5 (2.5-7.5) mg/day at the end of follow-up (P < 0.001) was also observed. ABA was withdrawn in 62 (23.6%) patients due to adverse events (n = 30), articular inefficacy (n = 27), ILD worsening (n = 3) and other causes (n = 2). CONCLUSION: ABA may be an effective and safe treatment for patients with RA-ILD.

Eficacia y seguridad de los glucocorticoides en la artritis reumatoide: revisión sistemática de la literatura / Efficacy and safety of glucocorticoids in rheumatoid arthritis: systematic literature review

OBJETIVOS: 1) Revisar sistemática y críticamente la evidencia sobre las características de uso, eficacia y seguridad de los glucocorticoides (GC) en la artritis reumatoide (AR); 2) emitir recomendaciones prácticas sobre su utilización. MÉTODOS: Se realizó una revisión sistemática de la literatura con una estrategia de búsqueda bibliográfica sensible en Medline, Embase y Cochrane Library. Se seleccionaron ensayos clínicos aleatorizados que analizasen la eficacia y/o la seguridad de los GC en pacientes con AR. Dos revisores realizaron la primera selección por título y abstract y 10, la selección tras lectura en detalle y la recogida de datos. La calidad se evaluó con la escala de Jadad. En una reunión de grupo nominal con base en sus resultados se consensuaron una serie de recomendaciones. RESULTADOS: Se incluyeron 47 artículos. Los GC, en combinación con los fármacos antirreumáticos modificadores de la enfermedad, ayudan a controlar la actividad de la enfermedad y a inhibir la progresión radiográfica, especialmente en el corto-medio plazo y en las AR de inicio. Los GC pueden mejorar la función y el dolor. Distintos tipos y vías de administración son eficaces, sin que exista un esquema de tratamiento estandarizado (dosis de inicio, desescalada y duración del tratamiento con los GC) superior a otro. Los acontecimientos adversos de los GC son muy frecuentes, dependientes de la dosis, de gravedad variable, muchos de ellos leves. Se generaron 7 recomendaciones sobre el uso y la gestión del riesgo de los GC. CONCLUSIONES: Estas recomendaciones pretenden resolver algunos interrogantes clínicos habituales y facilitar la toma de decisiones con respecto al uso de GC en la AR

OBJECTIVES: 1) To systematically and critically review the evidence on the characteristics, efficacy and safety of glucocorticoids (CS) in rheumatoid arthritis (RA); 2) to generate practical recommendations. METHODS: A systematic literature review was performed through a sensitive bibliographic search strategy in Medline, Embase and the Cochrane Library. We selected randomized clinical trials that analyzed the efficacy and/or safety of CS in patients with RA. Two reviewers performed the first selection by title and abstract. Then 10 reviewers selected the studies after a detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. In a nominal group meeting, based on the results of the systematic literature review, related recommendations were reached by consensus. RESULTS: A total of 47 articles were finally included. CS in combination with disease-modifying antirheumatic drugs help control disease activity and inhibit radiographic progression, especially in the short-to-medium term and in early RA. CS can also improve function and relieve pain. Different types and routes of administration are effective, but there is no standardized scheme (initial dose, tapering and duration of treatment) that is superior to others. Adverse events when using CS are very frequent and are dose-dependent and variable severity, although most are mild. Seven recommendations were generated on the use and risk management of CS. CONCLUSIONS: These recommendations aim to resolve some common clinical questions and aid in decision-making for CS use in RA

Association of apolipoprotein B/apolipoprotein A1 ratio and cardiovascular events in rheumatoid arthritis: results of the CARMA study.

OBJECTIVES: To assess the plasma apolipoprotein B/apolipoprotein A1 ratio and its potential association with cardiovascular events (CVE) in patients with rheumatoid arthritis (RA). METHODS: A baseline analysis was made of the CARdiovascular in rheuMAtology Project (CARMA), a 10-year prospective study evaluating the presence of at least one CVE in 775 Spanish patients with RA. Of them, 29 had already experienced CVE prior to the inclusion in the study. We assessed the association between the elevation of the apoB/apoA1 ratio with the presence of CVE according to a logistic regression model for possible confounding factors. We also analysed the main parameters of activity of RA and parameters related to lipid metabolism. RA patients were classified according to treatment: patients treated with disease-modifying anti-rheumatic drugs without biologics and those undergoing biologic therapy (anti-TNF-α, anti-IL-6 receptor, and other biologic agents). RESULTS: The apoB/apoA1 ratio of patients who had experienced CVE was higher than that of patients without previous CVE (0.65 vs. 0.60). However, the difference between both subgroups did not reach statistical significance (p=0.197). It was also the case after the multivariate analysis [OR: 1.48 (95% CI: 0.15-14.4); p=0.735]. RA patients from the group with CVE were more commonly receiving lipid-lowering treatment with statins than those without CVE history (41.4% vs. 20%, p=0.005). High HAQ and high atherogenic index were significantly associated with the presence of CVE. There was no statistical association between the type of biologic therapy used in RA and the presence of CVE. CONCLUSIONS: No association between ApoB/apoA1 ratio and CVE was found at the baseline visit of patients with RA from the CARMA study.

Efficacy and safety of glucocorticoids in rheumatoid arthritis: Systematic literature review. / Eficacia y seguridad de los glucocorticoides en la artritis reumatoide: revisión sistemática de la literatura.

OBJECTIVES: 1) To systematically and critically review the evidence on the characteristics, efficacy and safety of glucocorticoids (CS) in rheumatoid arthritis (RA); 2) to generate practical recommendations. METHODS: A systematic literature review was performed through a sensitive bibliographic search strategy in Medline, Embase and the Cochrane Library. We selected randomized clinical trials that analyzed the efficacy and/or safety of CS in patients with RA. Two reviewers performed the first selection by title and abstract. Then 10 reviewers selected the studies after a detailed review of the articles and data collection. The quality of the studies was evaluated with the Jadad scale. In a nominal group meeting, based on the results of the systematic literature review, related recommendations were reached by consensus. RESULTS: A total of 47 articles were finally included. CS in combination with disease-modifying antirheumatic drugs help control disease activity and inhibit radiographic progression, especially in the short-to-medium term and in early RA. CS can also improve function and relieve pain. Different types and routes of administration are effective, but there is no standardized scheme (initial dose, tapering and duration of treatment) that is superior to others. Adverse events when using CS are very frequent and are dose-dependent and variable severity, although most are mild. Seven recommendations were generated on the use and risk management of CS. CONCLUSIONS: These recommendations aim to resolve some common clinical questions and aid in decision-making for CS use in RA.

Aortitis no infecciosa: experiencia con tocilizumab en un hospital comarcal / Noninfectious aortitis: experience with tocilizumab in a regional hospital

OBJETIVOS: Describir pacientes con aortitis no infecciosa y su respuesta al tratamiento de un hospital comarcal. MÉTODOS: Revisión de pacientes con aortitis no infecciosa, técnica diagnóstica utilizada y tratamiento inmunosupresor recibido. RESULTADOS: Se encontraron 8 pacientes (7 mujeres y un hombre) diagnosticados de aortitis mediante tomografía por emisión de positrones (PET). La mediana de edad fue de 69 años (IQR62-72,2). Tocilizumab (TCZ) mejoró los síntomas, la VSG y la PCR a los 3meses del tratamiento (p < 0,001 y p < 0,012, respectivamente) en los 6 pacientes en que se utilizó. CONCLUSIÓN: TCZ fue eficaz y seguro en los pacientes que fueron refractarios a esteroides y a otros tratamientos inmunosupresores

OBJECTIVES: Describe patients with noninfectious aortitis and their response to treatment in a regional hospital. METHODS: Review of patients with noninfectious aortitis, diagnostic technique used and immunosuppressive therapy received. RESULTS: We report 8 patients (7 women and one man) diagnosed with aortitis by positron emission tomography (PET). The mean age was 69 years (interquartile range [IQR] 62-72.2). Three months of treatment with tocilizumab improved symptoms, erythrocyte sedimentation rate and C-reactive protein level (P<.001 and P<.012, respectively) in the 6 patients in whom it was used. CONCLUSIONS: Tocilizumab was an effective and safe treatment in those patients diagnosed with aortitis refractory to steroids and conventional immunosuppressive therapy

Noninfectious aortitis: Experience with tocilizumab in a regional hospital. / Aortitis no infecciosa: experiencia con tocilizumab en un hospital comarcal.

OBJECTIVES: Describe patients with noninfectious aortitis and their response to treatment in a regional hospital. METHODS: Review of patients with noninfectious aortitis, diagnostic technique used and immunosuppressive therapy received. RESULTS: We report 8 patients (7 women and one man) diagnosed with aortitis by positron emission tomography (PET). The mean age was 69years (interquartile range [IQR] 62-72.2). Three months of treatment with tocilizumab improved symptoms, erythrocyte sedimentation rate and C-reactive protein level (P<.001 and P<.012, respectively) in the 6 patients in whom it was used. CONCLUSIONS: Tocilizumab was an effective and safe treatment in those patients diagnosed with aortitis refractory to steroids and conventional immunosuppressive therapy.

Abatacept in patients with rheumatoid arthritis and interstitial lung disease: A national multicenter study of 63 patients.

OBJECTIVE: Interstitial lung disease (ILD) is one of the most serious complications of rheumatoid arthritis (RA). In the present study, we aimed to assess the efficacy of abatacept (ABA) in patients with ILD associated to RA. METHODS: National multicenter, non-controlled, open-label registry study of RA patients with ILD treated with ABA. RESULTS: 63 patients (36 women) with RA-associated ILD undergoing ABA therapy were studied. The mean ± standard deviation age at the time of the study was 63.2 ± 9.8 years. The median duration of RA and ILD from diagnosis were 6.8 and 1 year, respectively. RA was seropositive in 55 patients (87.3%). In 15 (23.8%) of 63 patients the development of ILD was closely related to the administration of synthetic or biologic disease modifying anti-rheumatic drugs. After a follow-up of 9.4 ± 3.2 months, two-thirds of patients remained stable whereas one-quarter experienced improvement in the Modified Medical Research Council scale. At that time forced vital capacity remained stable in almost two-thirds of patents and improved in one out of five patients assessed. Also, diffusing capacity of the lung for carbon monoxide remained stable in almost two-thirds and showed improvement in a quarter of the patients assessed. At 12 months, 50% of the 22 patients in whom chest HRCT scan was performed due persistence of respiratory symptoms showed stabilization, 8 (36.4%) improvement and 3 worsening of the HRCT scan pattern. Eleven of 63 patients had to discontinue ABA, mainly due to adverse events. CONCLUSION: ABA appears to be an effective in RA-associated ILD.

Resultado del tratamiento hipouricemiante de la gota en ancianos / Results of hypouricemic treatment of gout in the elderly

Algunos autores recomiendan un abordaje conservador del tratamiento de la gota en ancianos. Sin embargo, en la bibliografía no se dispone de series publicadas al respecto.Se han revisado los datos procedentes de una cohorte de pacientes con gota. Se seleccionó a 52 de 242 pacientes (21 por ciento) con edad igual o superior a los 70 años. Evaluamos las reducciones de urato sérico, número de ataques y tofos, el porcentaje de pacientes con urato inferior a 6 mg/dl y la variación de la función renal. Se recogieron datos sobre comorbilidad y efectos adversos previos por tratamiento con antiinflamatorios no esteroides y durante el tratamiento hipouricemiante. Asimismo, se les remitió una encuesta anónima sencilla de cumplimentar.De los 49 pacientes vivos, contestaron al cuestionario 35 (71,4 por ciento), cuyos datos fueron analizados. El 87 por ciento presentaba comorbilidad. La uricemia se redujo de 8,84 ñ 1,41 a 4,70 ñ 0,91 mg/dl (p < 0,001), un 97 por ciento con cifras de urato inferiores a 6 mg/dl, y el número de ataques por paciente y año, de 3,14 ñ 1,35 a 0,17 ñ 0,3 (p < 0,001). Once de 13 (85 por ciento) de los pacientes con tofos no los tenían al final del seguimiento. El aclaramiento de creatinina pasó de 63 ñ 27 a 70 ñ 26 ml (p = 0,037). Diez pacientes habían presentado efectos adversos graves previos al tratamiento, mientras que sólo cuatro presentaron efectos adversos leves durante el tratamiento. El 66 por ciento refería encontrarse mucho mejor, el 31 por ciento mejor y sólo el 3 por ciento igual o peor. El 97 por ciento creía que su problema había sido mejor controlado desde la consulta especializada.Concluimos que la gota en ancianos, más compleja por la presencia de comorbilidad, debe ser abordada por especialistas, y los resultados, desde los puntos de vista objetivo y de los pacientes, fueron muy satisfactorios (AU)