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 ABA was withdrawn in 62 (23.6%) patients due to adverse events (n = 30), articular inefficacy (n = 27), ILD worsening (n = 3) and other causes (n = 2).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 retention rate of a biological drug (percentage of patients remaining on treatment over time) provides an index of a drug's overall effectiveness. The golimumab retention rate as first-line biological therapy was high in clinical trial extensions lasting 5 years. Real-world studies also indicate good retention rates but have been of shorter duration. The probability of retention with golimumab treatment was assessed, as any line of anti-tumor necrosis factor-alpha therapy, for up to 5 years in patients with rheumatoid arthritis (RA), axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), associated factors were analyzed. A retrospective database analysis of the Spanish registry of patients with rheumatic disorders receiving biological drugs (BIOBADASER) was performed. Among 353 patients, 29.8% had RA, 41.6% SpA and 28.6% PsA. Golimumab was the first biological drug in 40.1% of patients, second in 30.1% and third/later in 29.8%. The overall probability of retention of golimumab at years 1, 2, 3, 4 and 5 was 85.9% (95% confidence interval 81.4-89.5%), 73.7% (67.1-79.1%), 68.5% (60.5-75.1%), 60.6% (50.2-69.5%) and 57.1% (44.9-67.5%), respectively. Retention was similar across indications (p = 0.070) but was greater when golimumab was used as the first biological agent compared with later therapy lines (p < 0.001). Factors associated with higher retention of golimumab treatment (Cox regression) were use as a first-line biological and concomitant methotrexate treatment; corticosteroid need was associated with lower retention. The long-term probability of golimumab retention was high in this real-world study of patients with rheumatic diseases, especially when used as the first biological drug.
The better understanding of the safety of biologic DMARDs (bDMARDs), as well as the emergence of new bDMARDs against different therapeutic targets and biosimilars have likely influenced the use patterns of these compounds over time. The aim of this study is to assess changes in demographic characteristics, disease activity and treatment patterns in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) who started a first- or second-line biologic between 2007 and mid-2020. Patients diagnosed with RA, PsA or AS included in the BIOBADASER registry from January 2007 to July 2020 were included. According to the start date of a first- or second-line biologic therapy, patients were stratified into four time periods: 2007–2009; 2010–2013; 2014–2017; 2018–2020 and analyzed cross-sectionally in each period. Demographic and clinical variables, as well as the type of biologic used, were assessed. Generalized linear models were applied to study the evolution of the variables of interest over time periods, the diagnosis, and the interactions between them. A total of 4543 patients initiated a first biologic during the entire time frame of the study. Over the four time periods, disease evolution at the time of biologic initiation (p < 0.001), disease activity (p < 0.001), retention rate (p < 0.001) and the use of tumor necrosis factor inhibitors as a first-line treatment (p < 0.001) showed a significant tendency to decrease. Conversely, comorbidities, as assessed by the Charlson index (p < 0.001), and the percentage of patients using bDMARDs in monotherapy (p < 0.001), and corticosteroids (p < 0.001) tended to increase over time. Over the entire period of the study's analysis, 3289 patients started a second biologic. The following trends were observed: decreased DAS28 at switching (p < 0.001), lower retention rates (p = 0.004), and incremental changes to the therapeutic target between the first and second biologic (p < 0.001). From 2007 until now rheumatic patients who started a biologic were older, exhibited less clinical activity, presented more comorbidities, and switched to a different biologic more frequently and earlier.
The aim of this study was to analyze the longitudinal practice patterns of prophylaxis of glucocorticoid-induced osteoporosis in patients with polymyalgia rheumatica (PMR). Patients diagnosed with PMR were collected retrospectively in two rheumatology departments. In addition to demographic and diagnostic criteria, the chart review included the following information at baseline and at follow-up: doses of prednisone, prescription of calcium, vitamin D and bisphosphonates, bone mass measurement (BMD) and fragility fractures. We analyzed the percentage of patients undergoing BMD and were prescribed a bisphosphonate over the years. We evaluated 158 patients: 117 of them were women, mean age was 73 years, and they had an average follow-up of 4.8 years. 104 patients (66 %) received osteoporosis medication during the first visit, 44 of them were given bisphosphonate. During follow-up, another 30 treatments with bisphosphonate were added (46 % overall) while 37 cases (23 %) received no treatment with calcium or bisphosphonate. BMD was performed in 111 patients (69 %; 53 % of males and 76 % of females). Factors associated with the use of bisphosphonates were female sex (OR 4.4, 95 % CI 4.02-4.86), BMD (OR 2.4, 95 % CI 2.05-2.78) and commencement of treatment after the year 2005 (54 vs 37 %, OR 1.93, 95 % CI 1.60-2.26). No significant differences were found with age, initial doses of prednisone or the hospital. According to recent prevention guidelines, treatment with biphosphonate should have been administered in more than 90 % of patients. Although prophylaxis of glucocorticoid-induced osteoporosis in patients with PMR has increased in the recent years, many patients do not receive prophylaxis with bisphosphonate during the first visit.
Background: Interstitial lung disease (ILD) associated with Rheumatoid Arthritis (RA) has a poor prognosis. Treatments such as anti-TNF, have been implicated in the exacerbation of an ILD. Objectives: Our objective is to evaluate and compare the evolution of ILD in patients with RA treated with Abatacept (ABA), Rituximab (RTX) and Tocilizumab (TCZ) after 1 year of treatment. Methods: Retrospective multicentre study of patients with ILD and AR treated with ABA, RTX and TCZ at standard doses. The ILD was diagnosed by CT. Conclusions: There seems to be a trend towards a better radiological response in patients treated with RTX and ABA. It would be necessary prospective studies. Background: Approximately a third of Rheumatoid Arthritis (RA) patients treated with tumour necrosis factor (TNF)-a inhibitors such as Infliximab (IFX) fail to respond. This has prompted a widespread interest in the finding of measures for predictors of response to TNFa inhibitors. Objectives: To search for serum autoantibodies that aid to identify RA patients most likely to benefit from IFX. Methods: We analysed serum of 170 biologic-naïve RA patients at baseline assigned to receive IFX plus methotrexate. The serum samples were distributed in 3 independent samples sets that were provided by 3 different sources: 1 discovery sample set (n=24) collected from Hospital Clínico Universitario of Santiago de Compostela (Spain) and 2 validation sample sets collected from Hospital Universitario de A Coruña (Spain), (n=61); and the Swedish Farmacotherapy (SWEFOT) trial (Sweden), (n=85). The European League Against Rheumatism (EULAR) criteria were used to assess the clinical response at six months of follow-up: good response (GR, n=60), moderate (MR, n=60) and non-response (NR, n=50). A suspension bead array platform built on protein fragments within Human Protein Atlas and selected from an initial screening using an array containing 42 000 antigens was employed to identify the IgG and IgA autoantibodies in the discovery sample set and validate the results within the 2 validation sets. Thresholds for autoantibodies were calculated by Receiver Operating Characteristics (ROC) curve analysis performed with SPSS 24. Results: Our data revealed a more prevalent IgG reactivity and higher IgG autoantibody levels against the antigen Centromere Protein F (CENPF) in GR when compared with NR, showing an overall reactivity of 31% vs 0%, 45% vs. 26% and 17% vs 4% in the three sample sets analysed respectively. The area under the ROC curve was 0,649 [p-value=0.049; IC 95% (0.510-0.789)]. CENP-F is a proliferation-associated and cell cycle-dependent centromere autoantigen that might be involved in the increased or abnormal cell proliferation that occurs during RA process. Interestingly, our results also showed that IgA autoantibodies levels toward the antigen Solute Carrier family 39 member 2 (SLC39A2), a zinc transporter protein, were decreased in GR when compared with MR in the discovery sample set and this trend was significantly validated (p=0.018) in the SWEFOT c...
BackgroundPrimary Sjögren’s syndrome (pSS) is a systemic autoimmune disease characterized by the involvement of the exocrine glands, mainly salivary and lacrimal glands. Approximately half of patients will experience extraglandular complications throughout their evolution.ObjectivesTo characterize the involvement of the nervous system (NS) in patients with pSS.MethodsMulticenter cross-sectional study of a cohort of patients with pSS, constructed by random selection of pSS patients fulfilling the 2002 American-European Consensus Criteria for pSS1 from 33 rheumatology units. Through review of clinical records and interview with patients, demographic, clinical, analytical, therapeutic data and disease activity indexes were collected. Univariate analysis was done by Chi square test, Mann-Whitney U test and Student’s t test. Multivariate analysis was done by linear logistic regression. A p <0.05 was considered significant. Patients signed an informed consent. The study was authorized by the ethics committees.Results437 patients were included (95% women, median age of 58 years). 65 patients developed NS involvement: 26 patients central NS, 31 peripheral NS and 8 both. Multivariate analysis showed association between NS involvement and atherosclerotic stroke (OR 10.4, 95% CI 2.8-38.5), ear disease (OR 2.1, 95% CI 1.1-4.2) and myopathy (OR 6.5, 95% CI 1.3-31,6). Patients with NS involvement had higher probability of being treated with glucocorticoids (OR 3.3, 95%CI 1.5-7.2) and cyclophosphamide (OR 6.8, 95% CI 1.5-31).Conclusion15% of patients with pSS develope NS involvement that is associated with atherosclerotic stroke, ear disease and myopathy.Reference[1] Vitali C. et al. Ann Rheum Dis 2002; 61:554Disclosure of InterestsJose Luis Andreu: None declared, Carlos Sánchez-Piedra: None declared, Monica Fernandez Castro: None declared, Victor Martinez Taboada: None declared, Alejandro Olive: None declared, Jose Rosas Consultant for: Abbvie, Amgen, Bristol, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, UCB Pharma, Speakers bureau: Abbvie, Amgen, Bristol, Janssen, Lilly, Merck Sharp & Dohme, Pfizer, UCB Pharma, Raúl Menor-Almagro: None declared, Beatriz Rodriguez Lozano: None declared, Ángel García-Aparicio: None declared, Francisco J López-Longo: None declared, Sara Manrique Arija Speakers bureau: ABBvie, MSD, Janssen, Lillly, Roche, Pfyzer, Novartis., Jesús ALberto García Vadillo: None declared, Susana Gil: None declared, Ruth López González: None declared, J. Narváez Consultant for: Bristol-Myers Squibb, Carles Galisteo: None declared, Jorge Juan Gonzalez Martin: None declared, M E Ruiz: None declared, Iñigo Rúa-Figueroa: None declared, Oscar Illera: None declared, Lurdes Romani: None declared, Sheila Melchor: None declared, Begoña Moreira: None declared, Enrique Raya: None declared, Jose M Pego-Reigosa: None declared, Natalia Cid Boza: None declared, Enrique Judez: None declared, Clara Moriano: None declared, Vicente Torrente: None declared, Héctor Corominas: None declared, Blanca Garcia-Magallon: None declared, Carlos Gui...
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