Search

Background: The leading cause of blindness due to non-infectious uveitis is cystoid macular edema (CME). Behçet's disease (BD) is one of the most commonly conditions related to CME. Objectives: To compare the effectiveness and safety of adalimumab (ADA), infliximab (IFX) and certolizumab (CZP) in refractory CME due to BD. Methods : Multicenter study of BD-CME patients with no response to glucocorticoids (GCs) and at least one conventional immunosuppressive drug. At baseline, all patients presented CME, defined by OCT > 300 µ. The effectiveness of ADA, IFX and CZP was assessed over a 2-year period from baseline using the following ocular parameters: macular thickness (µm), visual acuity (BCVA), anterior chamber (AC) cells and vitritis. Mixed-effects regression models were applied. Results: a total of 50 patients (75 eyes) were studied (ADA = 25; IFX = 15 and CZP = 10). No significant differences in demographic parameters were found among the three groups. However, individuals in the CZP group had a significantly extended time from diagnosis to treatment onset (72 (36-120) months, p = 0.03) and had received a higher number of biological therapies (1.7 ± 1.1) compared to the ADA and IFX groups. Within the CZP group, ADA and IFX were previously administrated in seven patients. After 2 years of follow-up, a rapid and sustained reduction in macular thickness was noted in all three groups with no significant differences between them. Additionally, enhancements in BCVA, AC cells and vitritis were also observed. No serious adverse events were reported in the CZP group, although one isolated case of bacteremia was documented in the ADA group. ADA, IFX and CZP appear to be effective and safe treatments for refractory CME in BD. CZP seems to remain effective even in patients with an insufficient response to ADA and/or IFX. Conclusions: ADA, IFX and CZP appear to be effective and safe treatments for refractory CME in BD. CZP seems to remain effective even in patients with an insufficient response to ADA and/or IFX. more...

Objective: To compare the efficacy of TNF inhibitors (adalimumab (ADA) and infliximab (IFX)) vs tocilizumab (TCZ) in patients with refractory cystoid macular edema (CME) due to Behçet's disease (BD)., Methods: Multicenter study of patients with BD-associated CME refractory to conventional and/or biological immunosuppressive drugs. From a cohort of 177 patients treated with anti-TNF and 14 patients treated with TCZ, we selected those with CME at baseline. We analyzed the evolution of macular thickness (main outcome), best-corrected visual acuity (BCVA) and intraocular inflammation (Tyndall and vitritis) from baseline up to 4 years in the 3 groups mentioned., Results: 49 patients and 72 eyes with CME were included. ADA was used in 25 patients (40 eyes), IFX in 15 (21 eyes) and TCZ in 9 (11 eyes). No statistically significant baseline differences were observed between the 3 groups except for a lower basal BCVA in TCZ group and a higher basal degree of intraocular inflammation in ADA group. Most patients from all groups had received several conventional immunosuppressive drugs. In addition, most patients in the group of TCZ had also received anti-TNF agents. Biological therapy was used in monotherapy (n=8) or combined with conventional immunosuppressive drugs (n=41). Macular thickness progressively decreased in the 3 groups, with no signs of CME after 1 year of treatment. Similarly, BCVA improvement and inflammatory intraocular remission was achieved in all groups., Conclusion: Refractory CME associated with BD uveitis can be effectively treated either with ADA, IFX or TCZ. Furthermore, TCZ is effective in patients resistant to anti-TNF therapy., Competing Interests: Declaration of Competing Interest Disclosures that might be interpreted as constituting of possible conflict(s) of interest for the study: B. Atienza-Mateo received grants/research supports from Abbvie and Roche and had consultation fees/participation in company-sponsored speaker´s bureau from Pfizer, Celgene, Novartis, Sanofi, Janssen, UCB and Lilly. I. Ferraz-Amaro has received grants/research supports from Abbott, MSD, Jansen and Roche and had consultation fees/participation in company-sponsored speaker´s bureau from Abbott, Pfizer, Roche, Sanofi, Sobi, Amgen, Celgene and MSD. D. Prieto-Peña is supported by a research contract from the Carlos III Health Institute of Spain (Río Hortega program, ref. CM20/00006) and has received research support from UCB Pharma, Roche, Sanofi, Pfizer, Jansen, Amgen, AbbVie, Novartis and Lilly. A. Adán received grants/research supports from Abbvie and UCB. M. Cordero-Coma had consultation fees/participation in company-sponsored speaker´s bureau from Abbvie, Merck Sharp & Dohme, Allergan and UCB. He also participated in Advisory Boards from Abbvie and Allergan. He also had travel grants from Abbvie, UCB and Allergan. J.M. Nolla received grants/research supports from BMS, Galápagos, Kern, Lilly and UCB. V. Calvo-Río had consultation fees/participation in company-sponsored speaker's bureau from AbbVie, Lilly, MSD, UCB Pharma, Grünenthal Pharma and Celgene. S. Castañeda has received grants/research support from Amgen, MSD and Pfizer, and has received consultation fees in company sponsored speaker's bureau from Amgen, Bristol-Myers-Squibb, Grünenthal Pharma, Janssen, Lilly, MSD, Novartis, Sanofi, Sobi, Stata and UCB. S. Castañeda is also associated professor of the UAM-Roche chair, EPID-Future, Department of Medicine, Universidad Autónoma de Madrid, Madrid, Spain. Miguel A. González-Gay received grants/research supports from Abbvie, MSD, and Roche, and had consultation fees/participation in company-sponsored speaker´s bureau from Pfizer, Celgene, Novartis, Roche, Sanofi, and Lilly. R. Blanco received grants/research supports from Abbvie, MSD, and Roche, and had consultation fees/participation in company-sponsored speaker´s bureau from Abbvie, Pfizer, Roche, BMS, Janssen, Lilly and MSD. No financial disclosure declared: N. Barroso-García, E. Beltrán, M. Hernández-Garfella, L. Martínez-Costa, M. Díaz-Llopis, J.M. Herreras, O. Maíz-Alonso, I. Torre-Salaberri, A. De Vicente-Delmás, D. Díaz-Valle, A. Atanes-Sandoval, F. Francisco, S. Insua, J. Sánchez, R. Almodóvar-González, A. Jiménez-Sosa, O. Ruiz-Moreno, M. Gandía Martínez., (Copyright © 2022. Published by Elsevier Inc.) more...

Introduction and Objectives: Despite the evidence, there are doubts about the positioning of apremilast in the psoriatic arthritis (PsA) treatment algorithm. The objective of this project was to collect the scientific evidence and the experience of a group of rheumatologists who are experts in the management of PsA with apremilast in clinical practice in Spain., Material and Methods: A scientific committee made up of 6 experts proposed 5 clinical scenarios where the evidence on the use of apremilast in PsA was controversial: (i) Efficacy in peripheral PsA; (ii) Efficacy in enthesitis and dactylitis; (iii) Efficacy in PsA with skin involvement; (iv) Comorbidities; and (v) Apremilast safety. After this, a panel of 17 rheumatologists with expertise in PsA management discussed these scenarios and generated a questionnaire with 50 questions and 156 items following the Delphi methodology. This questionnaire was anonymously answered by the panel., Results: After 2 voting rounds, the panel of experts reached consensus in 93 of the 156 items raised (59.6%) (67 in agreement and 26 in disagreement). The degree of consensus was 53.3% in the area of "Efficacy in peripheral PsA"; 60.0% in "Efficacy in enthesitis and dactylitis"; 50.0% in "Efficacy in PsA with skin involvement"; 57.1% in "Management of comorbidities in patients with PsA"; and 67.3% in "Implications of safety in the use of apremilast"., Conclusions: The structured opinion of the experts complements the available evidence and contributes to the establishment of consensual guidelines for the use of apremilast in PsA., (Copyright © 2022 The Authors. Published by Elsevier España, S.L.U. All rights reserved.) more...

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., (© The Author(s) 2020. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.) more...

The aim of this study was to generate practical recommendations to assist rheumatologists and dermatologists in the management of cardiovascular (CV) comorbidities in patients with moderate-to-severe psoriasis (MS-PSO) and psoriatic arthritis (PsA). A two-round Delphi study was conducted. A panel of experts rated their agreement with a set of statements (n = 52) on a nine-point Likert scale (1 = totally disagree; 9 = totally agree). Statements were classified as inappropriate (median 1-3), irrelevant (median 4-6) or appropriate (median 7-9). Consensus was established when at least two-thirds of the panel responded with a score within any one range. A total of 25 experts, 60% rheumatologists and 40% dermatologists, participated in two consultation rounds. There was overall unanimity on the appropriateness of an initial assessment for CV risk factors in all patients with MS-PSO and PsA. Most panelists (88.0%) also supported the evaluation of patients' psychological and physical status. Additionally, most panelists (72.2%) agreed on a novel sequential approach for the management of CV comorbidities. This sequence starts with the assessment of hypertension, diabetes and dyslipidemia along with the identification of depression and anxiety disorders. Once these factors are under control, smoking cessation programs might be initiated. Finally, if patients have not met weight loss goals with lifestyle modifications, they should receive specialized treatment for obesity. This study has drawn up a set of practical recommendations that will facilitate the management of CV comorbidities in patients with MS-PSO and PsA. more...

The present study was undertaken to assess mortality, causes of death, and associated prognostic factors in a large cohort of patients diagnosed with idiopathic inflammatory myositis (IIM) from Spain. A retrospective longitudinal study was carried out in 467 consecutive patients with IIM, identified from 12 medical centers. Patients were classified as primary polymyositis, primary dermatomyositis (DM), overlap myositis, cancer-associated myositis (CAM), and juvenile idiopathic inflammatory myopathies. A total of 113 deaths occurred (24%) after a median follow-up time of 9.7 years. In the overall cohort, the 2-, 5-, and 10-year survival probabilities were 91.9, 86.7, and 77%, respectively. Main causes of death were infections and cancer (24% each). Multivariate model revealed that CAM (HR = 24.06), OM (HR = 12.00), DM (HR = 7.26), higher age at diagnosis (HR = 1.02), severe infections (HR = 3.66), interstitial lung disease (HR = 1.61), and baseline elevation of acute phase reactants (HR = 3.03) were associated with a worse prognosis, while edema of the hands (HR = 0.39), female gender (HR = 0.39), and longer disease duration (HR = 0.73) were associated with a better prognosis. The standardized mortality ratio was 1.56 (95% CI 1.28-1.87) compared to the Spanish general population. Our findings indicate that IIM has a high long-term mortality, with an excess of mortality compared to the Spanish population. A more aggressive therapy may be required in IIM patients presenting with poor predictive factors. more...

Objectives: To explore barriers to exercise of patients with spondyloarthritis (SpA) and to propose facilitators., Methods: Analysis of the speech of focus groups. It included the identification the elements that shape the studied reality, description of the relationship between them and synthesis through: 1) Thematic segmentation, 2) Categorization according to situations, relationships, opinions, feelings or others, 3) Coding of the various categories and 4) Interpretation of results., Results: Two focus groups of one hour each with 11 patients recruited from associations and social networks in Madrid and surrounding provinces took place (64% men, 72% between 40 and 60 years, 57% with disease duration longer than 10 years, 80% performed some type of exercise or physical activity). The following were identified: 1) barriers to exercise, among which the following pointed out: disinformation, fear, pain, distrust, and prior negative experiences with exercise; 2) facilitators to exercise: the complementary to barriers plus regularity and social and professional support; 3) items that could influence in either way, negative or positively; and 4) four phases of coping with exercise or physical activity in SpA., Conclusion: Apart from recognizing the existence of some modifiable personal factors, patients generally demand: more knowledge and education on exercise, including the pros and cons in the context of their disease, and coherence of messages received, together with better monitors that accompany them in their coping with disease and exercise., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.) more...

Background: Nursing clinics in rheumatology (NCR) are organizational models in the field of nursing care. There are various NCR models, but there is no consensus on its operational definition. Our objective is to develop quality standards to define and characterize a NCR., Method: Two-round Delphi method. The panel consisted of 67 experts: Rheumatologists and nurses of the nursing working group of the Spanish Society of Rheumatology (SSR). The Delphi questionnaire was developed after a literature and experience review from previous SSR projects. The questionnaire consists of 7 sections: general considerations, standards of structure, process, treatment and monitoring, health education, training and research and quality of care. Each item was scored from 1 (least important) to 9 (most important) or by assigning a number (e.g., waiting days). The degree of agreement among the experts was categorized according to the coefficient of variation (CoV) between very high (CoV≤25%) and very low (CoV>100%)., Results: The second round questionnaire (182 items) was answered by 46 panelists (34 rheumatologists and 12 nurses). A very important agreement was reached on the general standards of structure, process, treatment and monitoring, health education and quality of care. Less agreement was observed on standards related to training time, number of recommended nurses' research projects and publications., Conclusion: The standards developed in this study would be useful for establishing desirable quality standards of structure and process, and criteria for clinical work, research and teaching that can be used to develop and evaluate the NCRs., (Copyright © 2012 Elsevier España, S.L. All rights reserved.) more...

Objective: To evaluate the degree of agreement between primary care physicians and rheumatologists when evaluating the referral criteria in patients with suspected early spondyloarthropathy (Spa)., Material and Methods: Patients with suspected early Spa (according to predefined clinical referral criteria) were sent by primary care physicians to early Spa units (where a rheumatologist evaluated the same criteria and confirmed the diagnosis) through an on-line platform. We assessed the agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria among patients with definitive Spa using the kappa index (k)., Results: Eight hundred and two patients were analysed, 8.31% of whom were incorrectly referred to the rheumatologist. The degree of agreement regarding the predefined clinical referral criteria was poor for inflammatory back pain (k=0,16; 95% confidence interval [95% CI] 0,09-0,23), radiographic sacroiliitis (k=0,31; 95% CI 0,211-0,428), back or joint pain (k=0,21; 95% CI 0,14-0,29); mild for asymmetric arthritis (k=0,51; 95% CI 0,43-0,59), positive HLA B27 (k=0,59; 95% CI 0,52-0,67) and family history (k=0,50; 95% CI 0,415-0,604); and it was good or very good for anterior uveitis (k=0,81; 95% CI 0,68-0,93), inflammatory bowel disease (k=0,87; 95% CI 0,79-0,96) and psoriasis (k=0,73; 95% CI 0,65-0,81),., Conclusions: The degree of agreement between primary care physicians and rheumatologists regarding the predefined clinical referral criteria was variable. Agreement was very poor for variables like inflammatory back pain, which are crucial for the diagnosis of Spa. Training programs for primary care physicians are important in order for them to correctly identify early Spa patients., (Copyright © 2012 Elsevier España, S.L. All rights reserved.) more...