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Objective: This study aimed to estimate the incidence of giant cell arteritis (GCA) in Spain and to analyse its clinical manifestations, and distribution by age group, sex, geographical area and season., Methods: We included all patients diagnosed with GCA between 1 June 2013 and 29 March 2019 at 26 hospitals of the National Health System. They had to be aged ≥50 years and have at least one positive results in an objective diagnostic test (biopsy or imaging techniques), meet 3/5 of the 1990 American College of Rheumatology classification criteria or have a clinical diagnosis based on the expert opinion of the physician in charge. We calculated incidence rate using Poisson regression and assessed the influence of age, sex, geographical area and season., Results: We identified 1675 cases of GCA with a mean age at diagnosis of 76.9±8.3 years. The annual incidence was estimated at 7.42 (95% CI 6.57 to 8.27) cases of GCA per 100 000 people ≥50 years with a peak for patients aged 80-84 years (23.06 (95% CI 20.89 to 25.4)). The incidence was greater in women (10.06 (95% CI 8.7 to 11.5)) than in men (4.83 (95% CI 3.8 to 5.9)). No significant differences were found between geographical distribution and incidence throughout the year (p=0.125). The phenotypes at diagnosis were cranial in 1091 patients, extracranial in 337 patients and mixed in 170 patients., Conclusions: This is the first study to estimate the incidence of GCA in Spain at a national level. We found a predominance among women and during the ninth decade of life with no clear variability according to geographical area or seasons of the year., Competing Interests: Competing interests: Disclosures that might be interpreted as constituting possible conflict(s) of interest for the study: Ed Research funding/consulting and conferences fees from: Abbvie, Novartis, Roche, Pfizer, Janssen, Lilly, MSD, BMS, UC Pharma, Grünenthal and Sanofi. JL had consultation fees/participation in company-sponsored speaker’s bureau from Roche, Galápagos, Novartis, UCB Pharma, MSD, Celgene, Astra Zeneca and Grünenthal and received support for attending meetings and/or travel from Janssen, Abbvie, Roche, Novartis, MSD, UCB Pharma, Celgene, Lilly, Pfizer, Galápagos. Patricia Moya Alvarado had consultation fees/participation in company-sponsored speaker’s bureau from Roche, Novartis, Abbvie, MSD, Lilly, Pfizer and Celgene and received support for attending meetings and/or travel from Novartis, Lilly and, Pfizer. SC has received research support from MSD and Pfizer and had consultation fees/participation in company-sponsored speaker’s bureau from Amgen, BMS, Eli-Lilly, MSD, Roche, Gedeon-Richter, Grünenthal Pharma and UCB. SC is also assistant professor of the cátedra EPID-Future, funded by UAM-Roche, Universidad Autónoma de Madrid (UAM), Spain. RB received grants/research support from AbbVie, MSD and Roche, and had consultation fees/participation in a company-sponsored speaker’s bureau from AbbVie, Pfizer, Roche, Lilly, UCB, Bristol-Myers, Janssen, and MSD. The following authors did not declare financial disclosure: DF-L, IH-R, JN, MD-Á, MS-D, JMB, CMM, JS, EG-A, VA, LA, NG-P, CL, VAN, JC, IC-S, FO-S and TCSM., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: This study aimed to assess the baseline characteristics and clinical outcomes of coronavirus disease 2019 (COVID-19) in pediatric patients with rheumatic and musculoskeletal diseases (RMD) and identify the risk factors associated with symptomatic or severe disease defined as hospital admission, intensive care admission or death., Methods: An observational longitudinal study was conducted during the first year of the SARS-CoV-2 pandemic (March 2020-March 2021). All pediatric patients attended at the rheumatology outpatient clinics of six tertiary referral hospitals in Madrid, Spain, with a diagnosis of RMD and COVID-19 were included. Main outcomes were symptomatic disease and hospital admission. The covariates were sociodemographic and clinical characteristics and treatment regimens. We ran a multivariable logistic regression model to assess associated factors for outcomes., Results: The study population included 77 pediatric patients. Mean age was 11.88 (4.04) years Of these, 30 patients (38.96%) were asymptomatic, 41 (53.25%) had a mild-moderate COVID-19 and 6 patients (7.79%) required hospital admission. The median length of hospital admission was 5 (2-20) days, one patient required intensive care and there were no deaths. Previous comorbidities increased the risk for symptomatic disease and hospital admission. Compared with outpatients, the factor independently associated with hospital admission was previous use of glucocorticoids (OR 3.51; p = 0.00). No statistically significant risk factors for symptomatic COVID-19 were found in the final model., Conclusion: No differences in COVID-19 outcomes according to childhood-onset rheumatic disease types were found. Results suggest that associated comorbidities and treatment with glucocorticoids increase the risk of hospital admission., (© 2021. The Author(s).)

Background: To assess mortality rate (MR) and standardized mortality rate (SMR) of rheumatoid arthritis-related interstitial lung disease (RA-ILD) patients and to evaluate the role of radiographic patterns in mortality., Methods: A longitudinal multicentric study was conducted in RA-ILD patients from 2005 to 2015 and followed-up until October 2018 in Madrid. Patients were included in the Neumologia-Reumatología y Enfermedades Autoinmunes Registry, from diagnosis of ILD. The main outcome was all-cause mortality. The radiographic pattern at baseline [usual interstitial pneumonia (UIP), nonspecific interstitial pneumonia (NSIP), or others] was the independent variable. Covariables included sociodemographic and clinical data. Survival techniques were used to estimate MR, expressed per 1000 persons-year with their 95% confidence intervals [CI]. Cox multiple regression model was run to examine the influence of radiographic patterns on survival. SMR [CI] was calculated comparing MR obtained with MR expected in the general population of Madrid by indirect age-gender standardization., Results: 47 patients were included with a follow-up 242 patients-year. There were 16 (34%) deaths, and most frequent causes were acute ILD exacerbation and pneumonia. MR was 64.3 [39.4-104.9], and 50% of the patients died at 8.3 years from ILD diagnosis. After adjusting for confounders, (UIP compared to NSIP was associated with higher mortality risk. The overall SMR was 2.57 [1.4-4.17]. Women of 60-75 years of age were the group with the highest SMR., Conclusions: RA-ILD is associated with an excess of mortality compared to general population. Our results support that UIP increases the risk of mortality in RA-ILD, regardless other factors.

Objectives: To describe patients with autoimmune inflammatory rheumatic diseases (AIRD) who had COVID-19 disease; to compare patients who required hospital admission with those who did not and assess risk factors for hospital admission related to COVID-19., Methods: An observational longitudinal study was conducted during the pandemic peak of severe acute respiratory syndrome coronavirus 2 (1 March 2020 to 24 April). All patients attended at the rheumatology outpatient clinic of a tertiary hospital in Madrid, Spain with a medical diagnosis of AIRD and with symptomatic COVID-19 were included. The main outcome was hospital admission related to COVID-19. The covariates were sociodemographic, clinical and treatments. We ran a multivariable logistic regression model to assess risk factors for the hospital admission., Results: The study population included 123 patients with AIRD and COVID-19. Of these, 54 patients required hospital admission related to COVID-19. The mean age on admission was 69.7 (15.7) years, and the median time from onset of symptoms to hospital admission was 5 (3-10) days. The median length of stay was 9 (6-14) days. A total of 12 patients died (22%) during admission. Compared with outpatients, the factors independently associated with hospital admission were older age (OR: 1.08; p=0.00) and autoimmune systemic condition (vs chronic inflammatory arthritis) (OR: 3.55; p=0.01). No statistically significant findings for exposure to disease-modifying antirheumatic drugs were found in the final model., Conclusion: Our results suggest that age and having a systemic autoimmune condition increased the risk of hospital admission, whereas disease-modifying antirheumatic drugs were not associated with hospital admission., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The susceptibility of patients with rheumatic diseases and the risks or benefits of immunosuppressive therapies for COVID-19 are unknown., Methods: We performed a retrospective study with patients under follow-up in rheumatology departments from seven hospitals in Spain. We matched updated databases of rheumatology patients with severe acute respiratory syndrome coronavirus 2-positive PCR tests performed in the hospital to the same reference populations. Rates of PCR+ confirmed COVID-19 were compared among groups., Results: Patients with chronic inflammatory diseases had 1.32-fold higher prevalence of hospital PCR+ COVID-19 than the reference population (0.76% vs 0.58%). Patients with systemic autoimmune or immune-mediated disease (AI/IMID) showed a significant increase, whereas patients with inflammatory arthritis (IA) or systemic lupus erythematosus did not. COVID-19 cases in some but not all diagnostic groups had older ages than cases in the reference population. Patients with IA on targeted-synthetic or biological disease-modifying antirheumatic drugs (DMARDs), but not those on conventional-synthetic DMARDs, had a greater prevalence despite a similar age distribution., Conclusion: Patients with AI/IMID show a variable risk of hospital-diagnosed COVID-19. Interplay of ageing, therapies and disease-specific factors seem to contribute. These data provide a basis to improve preventive recommendations to rheumatic patients and to analyse the specific factors involved in COVID-19 susceptibility., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The aim of this study was to assess the reliability and validity of the Spanish version of the Rosser classification system for disease states in patients with musculoskeletal disorders., Methods: Our study was based on a questionnaire validation design. Patients were attended at an outpatient rheumatology clinic at Hospital Clínico San Carlos, Madrid, Spain. The Rosser classification system was completed by the physician from the research team (PMQ) and by the patient (HMQ). Criterion standards: The EuroQol-5D for the HMQ and the physician global estimate (DOCGL) for the PMQ. Internal consistency reliability was assessed using Cronbach α. Test-retest reliability and interobserver reliability were analyzed using the intraclass correlation coefficient. The criterion validity between HMQ and EuroQol-5D and between PMQ and DOCGL was assessed using the Spearman correlation coefficient., Results: The full analysis was based on 4 samples of patients (104 to 266 patients), most of whom were middle-aged women. For HMQ, Cronbach α was 0.70. Test-retest reproducibility was 0.7. With respect to criterion validity, significant correlations in the expected direction were observed. For PMQ, Cronbach α was 0.70, indicating excellent intraobserver and interobserver reliability. With respect to criterion validity, strong correlations were observed between the PMQ and the DOCGL., Conclusions: The Rosser classification system showed satisfactory reliability and suitable criterion validity for patients with musculoskeletal disorders. The instrument seems to be suitable for clinical decision making and research.

We developed and independently validated a rheumatoid arthritis (RA) mortality prediction model using the machine learning method Random Survival Forests (RSF). Two independent cohorts from Madrid (Spain) were used: the Hospital Clínico San Carlos RA Cohort (HCSC-RAC; training; 1,461 patients), and the Hospital Universitario de La Princesa Early Arthritis Register Longitudinal study (PEARL; validation; 280 patients). Demographic and clinical-related variables collected during the first two years after disease diagnosis were used. 148 and 21 patients from HCSC-RAC and PEARL died during a median follow-up time of 4.3 and 5.0 years, respectively. Age at diagnosis, median erythrocyte sedimentation rate, and number of hospital admissions showed the higher predictive capacity. Prediction errors in the training and validation cohorts were 0.187 and 0.233, respectively. A survival tree identified five mortality risk groups using the predicted ensemble mortality. After 1 and 7 years of follow-up, time-dependent specificity and sensitivity in the validation cohort were 0.79-0.80 and 0.43-0.48, respectively, using the cut-off value dividing the two lower risk categories. Calibration curves showed overestimation of the mortality risk in the validation cohort. In conclusion, we were able to develop a clinical prediction model for RA mortality using RSF, providing evidence for further work on external validation.

To evaluate the efficacy of a program for subacute physical disability due to musculoskeletal disorders (MSD) in the elderly. We carried out a randomized controlled evaluator-blinded intervention study in a health district (October 2005 to April 2008). Subjects older than 64, starting a subacute MSD episode of physical disability-defined as moderate disability or higher in the Rosser classification-and identified by general practitioners, were randomized into standard care or an early specific program. The program was carried out by rheumatologists following detailed proceedings. Efficacy was defined as the difference between groups in the duration of episodes-time from onset until an improvement larger than a point in the Rosser classification). Hazard ratios (HR) to recovery of the program over standard care were obtained from Cox regression analyses. One hundred and twenty-three patients were included, generating 244 episodes of subacute MSD. Mean duration of episodes was 5 months; 14.5 % of them were chronically disabled throughout follow-up. The program was associated with shorter duration of episodes compared with CG analyzing just the ended ones (p = 0.004). The HR to recovery between groups did not achieve statistical differences. Nevertheless, recovery rate at 12 months and HR from those with moderate physical disability at the inclusion period (Rosser disability level 4, n = 84) were superior in the IG (HR 1.9, p = 0.03; HR 1.93; p = 0.03 respectively). An early intervention program for subacute MSD-related disability in elderly has partial efficacy; the program benefited patients with moderate physical disability and after a year of follow-up.

To evaluate a rheumatology outpatient consultation access system for new patients. New patients seen from April 2005 to April 2006 at our rheumatology clinic (n = 4,460) were included and classified according to their appointment type: ordinary appointments (OA) to be seen within 30 days, urgent appointments (UA) and work disability appointments (WDA) to be seen within 3 days. Age, sex, diagnosis, and health-related quality of life (HRQoL) as determined by the Rosser Index were recorded. Logistic regression models were run to identify factors that contribute to each type of appointment. OA was the method of access for 1,938 new patients, while 1,194 and 1,328 patients were seen through WDA and UA appointments, respectively. Younger male patients, and those with microcrystalline arthritis, sciatica, shoulder, back, or neck pain, were more likely to use the faster access systems (UA or WDA), whereas patients with a degenerative disease were mainly seen through OA (<0.001). Subjects with poor (3.96; 95 % CI, 2.8-5.5) or very poor HRQoL (70.8; 95 % CI, 14.9-334) were strongly associated to visiting a rheumatologist through the WDA or UA access systems, respectively, compared to OA. Age, gender, diagnosis, and mainly health-related quality of life are associated with the referral pattern of access to rheumatologic outpatient care. Among new patients subjects with the worst HRQoL were more likely to access with faster methods (UA or WDA) than those with better HRQoL.

To study the combined effect of both genetic and environmental factors in the age of rheumatoid arthritis onset. Patients (n = 507). Shared epitope characterization was performed using Lifecodes HLA-SSO. Genotyping of protein tyrosine phosphatase non-receptor 22 (PTPN22) rs2476601 and signal transducers and activators of transcription 4 (STAT4) rs7574865 polymorphism was performed using fast real-time PCR System. Shared epitope, antibodies directed against cyclic citrulinated peptide (anti-CCP) antibodies and a higher level of education were associated with a younger age at disease onset (P = 0.033, P = 0.004 and P < 0.0001, respectively). Neither carriers of the minor allele of PTPN22 rs2476601 nor STAT4 rs7574 polymorphisms showed a significant association with a younger age at disease onset (P = 0.355, P = 0.065, respectively). We found an additive effect of the three genetic markers in the age at onset: subjects with three markers were associated with a disease onset 9.56, 8.61, and 6.41 years before than those with none, one, or two genetic markers (P = 0.004, P = 0.006 and P = 0.043, respectively). We also described the additive effect of shared epitope, anti-CCP antibodies, educational level, PTPN22, and STAT4 polymorphisms in age at onset. Patients with two, three, four, or five variables were associated with a significant younger age of disease onset (4.72 [0.05-9.38] years (P = 0.048), 9.56 [4.72-14.40] years (P < 0.0001), 12.74 [6.84-18.64] years (P < 0.0001), and 20.87 [10.40-37.17] years (P < 0.0001)). Risk factors for the development of rheumatoid arthritis are also associated, with an additive effect, with a younger age at disease onset.

Objective: To describe the risk of cancer in patients exposed to tumor necrosis factor (TNF) antagonists., Methods: The following 2 clinical cohorts were studied: (1) BIOBADASER 2.0: a registry of patients suffering from rheumatic diseases exposed to TNF antagonists (2531 rheumatoid arthritis (RA), 1488 spondyloarthropathies, and 675 other rheumatic conditions); and (2) EMECAR: a cohort of 789 RA patients not exposed to TNF antagonists. Cancer incidence rates (IR) per 1000 patient-years and incidence rate ratios (IRR) were calculated for BIOBADASER 2.0 and EMECAR patients. The IR over time in BIOBADASER 2.0 patients was analyzed by joinpoint regression. The IRR was estimated to compare cancer rates in exposed versus nonexposed RA patients. Standardized incidence and mortality ratios (SIR, SMR) were also estimated. Risk factors for cancer in patients exposed to TNF antagonists were investigated by generalized linear models., Results: The SMR for cancer in BIODASER 2.0 was 0.67 (95% CI: 0.51-0.86), and the SIR was 0.1 (95% CI 0.03-0.23). The IR in RA patients exposed to TNF antagonists was 5.8 (95% CI: 4.4-7.6), and the adjusted IRR was 0.48 (95% CI: 0.09-2.45). The IR in patients with previous cancer was 26.4 (95% CI: 4.1-171.5). Age, chronic obstructive pulmonary disease, and steroids were associated with a higher risk of developing cancer. The IR decreased after the first 4 months of exposure, without statistical significance., Conclusion: Overall cancer and mortality rates in patients with rheumatic diseases exposed to TNF antagonists are no higher than in the background Spanish population. However special attention should be paid to elderly patients, those with previous cancers, and patients treated with steroids., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: To estimate the direct and indirect osteoarthritis (OA)-attributable costs and predictors of costs of knee and hip OA in Spain., Methods: This study included consecutive patients age > or = 50 years with symptomatic and radiologic knee and/or hip OA who were seen at primary care centers in all provinces of Spain. Information on demographics, health status (Short Form 12 Health Survey), comorbidities (Charlson Index), clinical (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and radiologic OA severity (Kellgren/Lawrence [K/L] scale), data related to OA health resources utilization (medical and nonmedical), and subjects' and caregivers' expenses and time lost in the previous 6 months were collected in 2 separate, structured, and detailed interviews. Costs in euros were assigned using market prices and official sources if available, and were annualized (to 2007). The predictors of costs were assessed in multivariate regression models. Costs were log-transformed before being modeled., Results: A total of 1,071 subjects were analyzed (74% women, mean +/- SD age 71 +/- 9 years). Average total annual costs were euro1,502 per patient. Direct costs accounted for 86% of the total cost. We estimated a national cost of euro4,738 million, representing 0.5% of the gross national product. Higher total costs were associated with comorbidity (Charlson Index odds ratio [OR] 1.27, 95% confidence interval [95% CI] 1.03-1.58), poorer health status (P < 0.050), worse WOMAC scores (OR 1.05, 95% CI 1.03-1.08), and grade 4 K/L scores (OR 1.76, 95% CI 1.15-2.69)., Conclusion: The economic burden of knee and hip OA is substantial. Costs increased with comorbidity, poorer health status, and clinical and radiologic OA severity.

Objective: To analyze the annual cost of rheumatoid arthritis (RA) and its predictive factors., Methods: Data were obtained from a 12-month retrospective cohort of 201 RA patients, randomly selected from a rheumatology registry, through a structured interview and records of the Central Information System of the hospital. Results were divided into direct, indirect, and total costs in 2001 US dollars. A sensitivity analysis was performed. Multiple linear regression models for the different types of costs were carried out., Results: The total cost was US dollars 2.2 million per year, with a cost attributable to RA of US dollars 2.07 million per year. The average cost per patient was US dollars 10419 per year (ranging from US dollars 7914 per patient per year in the best scenario to US dollars 12922 per patient per year in the worst case). Direct costs represent nearly 70% of total costs. We found an average increment in total costs of US dollars 11184 per year per unit of Health Assessment Questionnaire (HAQ) score (P < 0.0001) and an average annual increment of US dollars 621 per year of disease (P < 0.0001). After adjustment, the HAQ score, inability to perform housework tasks, and being permanently disabled for work were the only predictors of high costs., Conclusion: Our data show a remarkable economic impact of RA over society and link the costs of the disease to its consequences in terms of functional disability, work disability, and housework disability.