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Item does not contain fulltext OBJECTIVE: Real-world studies are needed to identify factors associated with response to biologic therapies in patients with axial spondyloarthritis (SpA). The objective was to assess sex differences in response to tumor necrosis factor inhibitors (TNFi) and to explore possible risk factors associated with TNFi efficacy. METHODS: A total of 969 patients with axial SpA (315 females, 654 males) enrolled in the BIOBADASER registry (2000-2019) who initiated a TNFi (first, second, or further lines) were studied. Statistical and artificial intelligence (AI)-based data analyses were used to explore the association of sex differences and other factors to TNFi response, using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), to calculate the BASDAI50, with an improvement of at least 50% of the BASDAI score, and using the Ankylosing Spondylitis Disease Activity Score, calculated using the C-reactive protein level (ASDAS-CRP). RESULTS: Females had a lower probability of reaching a BASDAI50 response with a first line TNFi treatment at the second year of follow-up (P = 0.018) and a lesser reduction of the ASDAS-CRP at this time point. The logistic regression model showed lower BASDAI50 responses to TNFi in females (P = 0.05). Other factors, such as older age (P = 0.004), were associated with unfavorable responses. The AI data analyses reinforced the idea that age at the beginning of the treatment was the main factor associated with an unfavorable response. The combination of age with other clinical characteristics (female sex or cardiovascular risk factors and events) potentially contributed to an unfavorable response to TNFi. CONCLUSION: In this national multicenter registry, female sex was associated with less response to a first-line TNFi by the second year of follow-up. A higher age at the start of the TNFi was the main factor associated with an unfavorable response to TNFi. 01 januari 2023

Background: Among COVID-19–associated deaths reported in the United States (U.S.), minority communities were disproportionately represented. The objective was to assess differences in mortality by race and ethnicity among patients with coronavirus disease 2019 (COVID-19) in the U.S. Methods: This is a retrospective case series study with information extracted from the U.S. Centers for Disease Control and Prevention between January 20 and December 29, 2020. Clinical and sociodemographic data were analyzed by race and ethnicity from non-hospitalized and hospitalized patients with COVID-19. Binary logistic models were fitted to evaluate factors associated with COVID-19-related mortality. Results: A total of 434,076 patients with COVID-19 were characterized; 284,574 cases were Non-Hispanic White, 10,468 cases were Non-Hispanic Asian, and 949,022 cases were Non-Hispanic Black, and 89,407 cases were Hispanic/Latino. For non-hospitalized patients, Hispanic/Latino with pneumonia (OR 3.34, 95%CI: 1.70-6.58) and Non-Hispanic Asian with comorbidities (OR 3.88, 95%CI: 0.99-15.2) had the highest odds for mortality. For hospitalized patients, Non-Hispanic Black with comorbidities (OR 3.02, 95%CI: 2.24-4.08) and Non-Hispanic Asian and Non-Hispanic Black with pneumonia (OR 2.98, 95%CI: 2.09-4.26; and OR 2.97, 95%CI: 2.60-3.38, respectively) had the highest odds for mortality. Conclusion: Racial/ethnic disparities in mortality persist among patients with COVID-19 in the U.S. These findings support the assertion that racial and ethnic minorities are disproportionately affected by COVID-19 in the U.S.

To investigate the distribution of patient-reported outcomes (PROs) in axial spondyloarthritis (axSpA) patients initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the New York criteria for ankylosing spondylitis (AS) versus non-radiographic axSpA (nr-axSpA) patients.Fifteen European registries contributed PRO scores for pain, fatigue, patient global, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI) and Health Assessment Questionnaire (HAQ) from 19,498 axSpA patients. Changes in PROs and PRO "remission" rates (definitions: ≤20 mm for pain, fatigue, patient global, BASDAI and BASFI; ≤0.5 for HAQ) were calculated at 6, 12 and 24 months of treatment.Heterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, six months after start of a 1st TNFi, pain score was reduced by approximately 60% (median at baseline/6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25), patient global (66/29/21/20), BASDAI (58/26/21/19), BASFI (46/20/16/16) and HAQ (0.8/0.4/0.2/0.2). Patients with AS, n=3281 had a slightly better response than nr-axSpA patients, n=993. LUNDEX-adjusted "remission" rates at 6 months for pain/fatigue/patient global/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the non-radiographic axSpA cohort. Better PRO responses were seen with a 1st TNFi compared to 2nd and 3rd TNFi.AxSpA patients starting a TNFi achieved high PRO "remission" rates, most pronounced in those fulfilling the modified New York criteria and for the first TNFi.

ObjectivesThe expanded therapeutic arsenal in rheumatoid arthritis (RA) raises new clinical questions. The objective of this study is to compare the effectiveness of cycling Janus kinase inhibitors (JAKi) with switching to biologic disease-modifying antirheumatic drug (bDMARD) in patients with RA after failure to the first JAKi.MethodsThis is a nested cohort study within data pooled from an international collaboration of 17 national registries (JAK-pot collaboration). Data from patients with RA with JAKi treatment failure and who were subsequently treated with either a second JAKi or with a bDMARD were prospectively collected. Differences in drug retention rates after second treatment initiation were assessed by log-rank test and Cox regression analysis adjusting for potential confounders. Change in Clinical Disease Activity Index (CDAI) over time was estimated using a linear regression model, adjusting for confounders.Results365 cycling and 1635 switching patients were studied. Cyclers were older and received a higher number of previous bDMARDs. Both strategies showed similar observed retention rates after 2 years of follow-up. However, adjusted analysis revealed that cycling was associated with higher retention (p=0.04). Among cyclers, when the first JAKi was discontinued due to an adverse event (AE), it was more likely that the second JAKi would also be stopped due to an AE. Improvement in CDAI over time was similar in both strategies.ConclusionsAfter failing the first JAKi, cycling JAKi and switching to a bDMARD appear to have similar effectiveness. Caution is advised if an AE was the reason to stop the first JAKi.

Objectives Many axial spondylarthritis (axSpA) patients receive a conventional synthetic DMARD (csDMARD) in combination with a TNF inhibitor (TNFi). However, the value of this co-therapy remains unclear. The objectives were to describe the characteristics of axSpA patients initiating a first TNFi as monotherapy compared with co-therapy with csDMARD, to compare one-year TNFi retention and remission rates, and to explore the impact of peripheral arthritis. Methods Data was collected from 13 European registries. One-year outcomes included TNFi retention and hazard ratios (HR) for discontinuation with 95% CIs. Logistic regression was performed with adjusted odds ratios (OR) of achieving remission (Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP Results Amongst 24 171 axSpA patients, 32% received csDMARD co-therapy (range across countries: 13.5% to 71.2%). The co-therapy group had more baseline peripheral arthritis and higher CRP than the monotherapy group. One-year TNFi-retention rates (95% CI): 79% (78, 79%) for TNFi monotherapy vs 82% (81, 83%) with co-therapy (P Conclusion This large European study of axial SpA patients showed similar one-year treatment outcomes for TNFi monotherapy and csDMARD co-therapy, although considerable heterogeneity across countries limited the identification of certain subgroups (e.g. peripheral arthritis) that may benefit from co-therapy.

ObjectiveTo investigate the distribution of patient-reported outcomes (PROs) in patients with axial spondyloarthritis (axSpA) initiating a tumor necrosis factor inhibitor (TNFi), to assess the proportion reaching PRO "remission" across registries and treatment series, and to compare patients registered to fulfill the modified New York (mNY) criteria for ankylosing spondylitis (AS) vs patients with nonradiographic axSpA (nr-axSpA).MethodsFifteen European registries contributed PRO scores for pain, fatigue, patient global assessment (PtGA), Bath Ankylosing Spondylitis (AS) Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), and Health Assessment Questionnaire (HAQ) from 19,498 patients with axSpA. Changes in PROs and PRO remission rates (definitions: ≤ 20 mm for pain, fatigue, PtGA, BASDAI, and BASFI; ≤ 0.5 for HAQ) were calculated at 6, 12, and 24 months of treatment.ResultsHeterogeneity in baseline characteristics and outcomes between registries were observed. In pooled data, 6 months after the start of a first TNFi, pain score was reduced by approximately 60% (median at baseline/ 6/12/24 months: 65/25/20/20 mm) in patients on treatment. Similar patterns were observed for fatigue (68/32/30/25 mm), PtGA (66/29/21/20 mm), BASDAI (58/26/21/19 mm), BASFI (46/20/16/16 mm), and HAQ (0.8/0.4/0.2/0.2). Patients with AS (n = 3281) had a slightly better response than patients with nr-axSpA (n = 993). The Lund Efficacy Index (LUNDEX)-adjusted remission rates at 6 months for pain/fatigue/PtGA/BASDAI/BASFI/HAQ were 39%/30%/38%/34%/35%/48% for the AS cohort and 30%/21%/26%/24%/33%/47% for the nr-axSpA cohort. Better PRO responses were seen with a first TNFi compared to a second and third TNFi.ConclusionPatients with axSpA starting a TNFi achieved high PRO remission rates, most pronounced in those fulfilling the mNY criteria and for the first TNFi.

The objective of the study was to assess the ESSDAI index characteristics in the SJOGRENSER cohort (Spanish Rheumatology Association’s registry of patients with Primary Sjogren Syndrome [PSS]). SJOGRENSER is a prospective multicentric study on a cohort of Spanish patients with PSS who meet the 2002 American–European consensus from rheumatology units. 298 variables were studied in patients for the inclusion of the study from an anonymous list from each department. The ESSDAI (EULAR Sjogren’s syndrome disease activity index) includes 12 domains and measures systematic activity in PSS patients. Each domain is divided into 3–4 levels, (0: no activity; 1: low activity; 2: moderate activity; 3: high activity) and is attributed a weight. Each domain score is obtained by multiplying the activity level by the weight assigned. According to ESSDAI: low activity

Heart failure (HF) is a serious health-care problem. The aim of this study is to evaluate the effect of the first acute episode of decompensated HF that requires a hospitalization on the survival of newly diagnosed cases of HF with follow-up for 5 years in primary care (PC).This was a longitudinal observational study of a retrospective cohort of patients with information extracted from electronic medical records of PC. Incident cases of HF from 2006 to 2010 or until death were studied through a survival analysis with Kaplan-Meier and Cox proportional hazards multivariate regression, after applying the propensity score matching technique (PSM).A total of 3061 new cases of HF were identified. The PSM analysis was performed with 529 couples, with a total of 1058 patients. 5-year survival was 65% in no hospitalized and 53% in hospitalized patients. Factors with an increased risk of mortality were having prescribed nitrates (heart rate [HR] = 1.56; 1.08-2.24). Factors with protective effect were having received the annual influenza vaccine (HR = 0.04; 0.01-0.15) and having been indicated X-rays by PC physician (HR = 0.76; 0.67-0.88).The findings indicate that hospitalizations are associated with a significant increase in mortality in patients recently diagnosed with HF. It is important to reinforce the need for the prevention of acute decompensated HF and for strategies to improve post-discharge outcomes.La insuficiencia cardiaca (IC) es un serio problema de asistencia médica. El objetivo de este estudio es evaluar el efecto del primer episodio de IC aguda descompensada que requiere una hospitalización en la supervivencia de los casos de IC recientemente diagnosticados con un seguimiento de 5 años en Atención Primaria (AP).Estudio observacional longitudinal de una cohorte retrospectiva de pacientes con información extraída de la historia clínica electrónica de AP. Se estudiaron los casos incidentes de IC desde 2006 a 2010 o hasta su fallecimiento con un análisis de supervivencia de Kaplan-Meier y un modelo de regresión de Cox, después de aplicar la técnica del Propensity Score Matching (PSM).Se identificaron 3.061 casos nuevos de IC. El análisis PSM se realizó con 529 pareja, con un total de 1.058 pacientes. La supervivencia a los cinco años fue del 65% en pacientes no hospitalizados y del 53% en pacientes hospitalizados. Los factores con mayor riesgo de mortalidad fueron tener prescritos nitratos (HR = 1,56; 1,08-2,24). Los factores con efecto protector fueron haber recibido la vacuna anual de la gripe (HR = 0,04; 0,01-0,15) y haber sido indicadas radiografías por el médico de AP (HR = 0,76; 0,67-0,88).Los hallazgos indican que las hospitalizaciones se asocian con un aumento significativo de la mortalidad en pacientes diagnosticados recientemente con IC. Es importante reforzar la necesidad de prevenir la IC descompensada aguda y las estrategias para mejorar los resultados posteriores al alta.

Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III).Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015.During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations.BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores.

To compare the prevalence of the main comorbidities in 2 large cohorts of patients with primary Sjögren's syndrome (SS) and systemic lupus erythematosus (SLE), with a focus on cardiovascular (CV) diseases.This was a cross-sectional multicenter study where the prevalence of more relevant comorbidities in 2 cohorts was compared. Patients under followup from SJOGRENSER (Spanish Rheumatology Society Registry of Primary SS) and RELESSER (Spanish Rheumatology Society Registry of SLE), and who fulfilled the 2002 American-European Consensus Group and 1997 American College of Rheumatology classification criteria, respectively, were included. A binomial logistic regression analysis was carried out to explore potential differences, making general adjustments for age, sex, and disease duration and specific adjustments for each variable, including CV risk factors and treatments, when appropriate.A total of 437 primary SS patients (95% female) and 2,926 SLE patients (89% female) were included. The mean age was 58.6 years (interquartile range [IQR] 50.0-69.9 years) for primary SS patients and 45.1 years (IQR 36.4-56.3 years) for SLE patients (P 0.001), and disease duration was 10.4 years (IQR 6.0-16.7 years) and 13.0 years (IQR 7.45-19.76 years), respectively (P 0.001). Smoking, dyslipidemia, and arterial hypertension were associated less frequently with primary SS (odds ratio [OR] 0.36 [95% confidence interval (95% CI) 0.28-0.48], 0.74 [95% CI 0.58-0.94], and 0.50 [95% CI 0.38-0.66], respectively) as were life-threatening CV events (i.e., stroke or myocardial infarction; OR 0.57 [95% CI 0.35-0.92]). Conversely, lymphoma was associated more frequently with primary SS (OR 4.41 [95% CI 1.35-14.43]). The prevalence of severe infection was lower in primary SS than in SLE (10.1% versus 16.9%; OR 0.54 [95% CI 0.39-0.76]; P 0.001).Primary SS patients have a consistently less serious CV comorbidity burden and a lower prevalence of severe infection than those with SLE. In contrast, their risk of lymphoma is greater.

Introduction: The aim was to study the association between 25-hydroxyvitamin D (25(OH) D) levels and the clinical characteristics of patients with chronic inflammatory rheumatic diseases (CIRD). Methods: We studied a cross-section from the baseline visit of the CARMA project (CARdiovascular in rheuMAtology), a 10-year prospective study evaluating the risk of cardiovascular events in rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients, and non-CIRD patients who attended rheumatology outpatient clinics from 67 hospitals in Spain. Non-CIRD group was frequency matched by age with the joint distribution of the three CIRD groups included in the study. 25(OH) D deficiency was defined if 25(OH) D vitamin levels were < 20 ng/ml. Results: 2.234 patients (775 RA, 738 AS and 721 PsA) and 677 non-CIRD subjects were assessed. The median (p25-p75) 25(OH) D levels were: 20.4 (14.4-29.2) ng/ml in RA, 20.9 (13.1-29.0) in AS, 20.0 (14.0-28.8) in PsA, and 24.8 (18.4-32.6) ng/ml in non-CIRD patients. We detected 25(OH) D deficiency in 40.5 % RA, 39.7 % AS, 40.9 % PsA and 26.7 % non-CIRD controls (p < 0.001). A statistically significant positive association between RA and 25(OH) D deficiency was found (adjusted (adj.) OR = 1.46; 95 % CI = 1.09-1.96); p = 0.012. This positive association did not reach statistical significance for AS (adj. OR 1.23; 95 % CI = 0.85-1.80) and PsA (adj. OR 1.32; 95 % CI = 0.94-1.84). When the parameters of disease activity, severity or functional impairment were assessed, a marginally significant association between 25(OH) D deficiency and ACPA positivity in RA patients (adj. OR = 1.45; 95 % CI = 0.99-2.12; p = 0.056), and between 25(OH) D deficiency and BASFI in AS patients (adj. OR = 1.08; 95 % CI = 0.99-1.17); p = 0.07) was also found. Conclusions: Patients with RA show an increased risk of having 25(OH) D deficiency compared to non-CIRD controls., This publication was aided by members of the Research Unit of the SER. Dedicated to Dr Jose L Fernandez Sueiro who took part in the initial design of this project and passed away in 2012. The authors thank all of the health professionals and patients who generously participated in this study. Furthermore, the authors thank the approval of the study from all participating centers: Complejo Hospitalario A Coruna, A Coruna; Instituto Dexeus, Barcelona; Hospital Universitari Vall d'Hebron, Barcelona; Hospital Infanta Sofia, Madrid; Hospital S. Pedro de Alcantara, Caceres; Hospital Son Llatzer, Palma de Mallorca; Hospital Univ. de Guadalajara; Hospital Clinic i Provincial, Barcelona; Hospital Clinico Univ. San Carlos, Madrid; Hospital de Barbastro, Huesca; Hospital Univ. de Bellvitge, Barcelona; Hospital Univ. de La Princesa, Madrid; Hospital de Merida, Badajoz; Hospital General Carlos Haya, Malaga; Hospital General Virgen de la Concha, Zamora; Hospital Virgen de la Salud, Toledo; Hospital del Sureste, Madrid; Hospital Ramon y Cajal, Madrid; Hospital Univ. Miguel Servet, Zaragoza; Hospital Dr. Negrin, Las Palmas de Gran Canaria; Hospital de Cabuenes, Gijon; Hospital Gregorio Maranon, Madrid; Hospital Univ. de Salamanca; Hospital Univ. Marques de Valdecilla, Santander; Hospital de la Marina Baixa, Alicante; Hospital de San Rafael, Barcelona; Hospital General. Universitario, Valencia; Instituto Poal, Barcelona; Hospital Universitario Puerta de Hierro, Madrid; Hospital Clinico Univ. San Cecilio, Granada; Hospital Santiago Apostol, Vitoria-Gasteiz; Consorci Sanitari de Terrassa, Terrassa; Hospital de Viladecans, Barcelona; Hospital General de Albacete; Hospital Mutua Terrassa, Terrassa; Hospital Ntra. Sra. de Candelaria, Santa Cruz de Tenerife; Hospital Univ. de Canarias, La Laguna, Tenerife; Hospital Univ. de Valme, Sevilla; Instituto Provincial de Rehabilitacion, Madrid; Hospital de Cantoblanco, Madrid; Hospital de Jerez de la Frontera, Cadiz; Hospital Obispo Polanco, Teruel; Hospital Infanta Leonor, Madrid; Hospital General de Elda, Alicante; Hospital Los Arcos, Murcia; Hospital Severo Ochoa, Madrid; Hospital Principe de Asturias, Madrid; Hospital Univ. 12 de Octubre, Madrid; Hospital Univ. Reina Sofia, Cordoba; Hospital Univ. La Paz, Madrid; Hospital Gutierrez Ortega, Valdepenas, Ciudad Real; Hospital Virgen de la Arrixaca, Murcia; Hospital de El Escorial, Madrid; Hospital de Basurto, Bilbao; Hospital Dos de Maig, Barcelona; Hospital del Mar, Barcelona; Hospital Universitario Son Espases, Palma de Mallorca; Hospital de Donostia, Donostia; Hospital de la Santa Creu i Sant Pau, Barcelona; Hospital de Palamos, Gerona; Hospital Comarcal de L'Alt Penedes, Vilafranca del Penedes, Barcelona; Hospital Sierrallana, Torrelavega; Complejo Asistencial de Leon; Hospital General de Ciudad Real; Hospital General de Mostoles, Madrid; Hospital General Universitario de Elche, Alicante; Hospital Xeral Calde, Lugo. This project has been supported by an unrestricted grant from Abbvie, Spain. The design, analysis, interpretation of results and preparation of the manuscript has been done independently of Abbvie. Dr Gonzalez-Gay's studies have been supported by grants from Fondo de Investigaciones Sanitarias, PI06/0024, PS09/00748 and PI12/00060, and RD12/0009/0013 (RIER) from Instituto de Salud Carlos III (ISCIII) (Spain).