Objective:The aims of this study were to describe the long-term retention rate of golimumab (GLM) treatment in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and spondyloarthritis (SpA) in real life, and to analyze determinants of discontinuation. Methods:We conducted a single-center, medical records review study of all patients with RA, PsA, and SpA on GLM treatment attending a large rheumatology department from 2010 to 2017. Times from start to end of GLM treatment were collected, as well as sociodemographic, clinical, and safety variables. Golimumab retention rate was estimated by the Kaplan-Meier method, and comparison across diseases was analyzed with the Mantel-Haenszel statistic (log-rank test). Cox proportional hazards regression models were used to identify factors associated with GLM discontinuation.Results: In the study period, a total of 212 patients (61 RA, 48 PsA, 103 SpA) were prescribed GLM. Retention rates were 72% in the first year, 61% in the second, 56% in the third, and 38% at 5 years. Differences were statistically significant across diseases (median times to GLM discontinuation were 50.2, 46.0, and 38.7 months for RA, SpA, and PsA, respectively) and according to the number of previous biologic therapies (55.2 months in biologic-naive patients vs 14.0 months in patients with ≥2 previous biologics; p < 0.001). The use of concomitant conventional synthetic disease-modifying antirheumatic drugs was associated with a lower probability of discontinuation (hazards ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.97). Female sex (HR, 1.84; 95% CI, 1.07-3.17) and having used 2 biologics before GLM (HR, 2.99; 95% CI, 1.76-5.06) were associated with increased discontinuation rates. Twenty-three patients (10.9%) had at least 1 serious adverse event.Conclusions: In a real-life setting, GLM shows appropriate long-term safety-effectiveness ratio.
Background:Patients with immunity mediated inflammatory diseases (IMID) often have clinical manifestations and comorbidity in the field of various medical specialties. A center has been created in our hospital for the comprehensive care of patients with IMID. It is an innovative healthcare model, that incorporate patients into its governance. Physicians, pharmacists and advanced practice nurses (APN), collaborates in consultation or in the day hospital (DH).Objectives:To analyze the activity of the rheumatology APN consult integrated in the multidisciplinary team, and the impact on health care and quality of life on IMID patients.Methods:Descriptive study of the rheumatology APN activity since the opening of the center for a year. The APN consultations were face-to-face (scheduled or demanded) or by telephone. Variables measured: demography, diagnosis, treatments, clinic activity and patient reported outcomes (PRO). In the face-to-face consultation, was included: integral valuation (clinic, functional and psychosocial), education for Health (information about disease and treatments, adverse effects, healthy living habits), drug administration, emotional support. In the telephone consultation, the rheumatology APN is the reference professional for monitoring, question solving and advice in case of flare or adverse event.Results:721 patients were evaluated, mean age 54.6 years, (range, SD) (20-90, 13.9), 61.3% women, with a total of 1737 consults. Diagnosis: 324 (44.9%) RA, 221 (30.6%) SpA, 100 (13.9%) PsA and 76 (10.5%) other diseases. Treatment modality: IV 293 (40.4) SC 399 (55.3%) and oral 29 (4.0%). Rheumatology APN activities are described in Table 1. 1415 face-to-face consultation were made, 82.7% scheduled and 17.2% demanded either by the patient, the rheumatologist or another member of the multidisciplinary work-team. Among the face-to-face consultations, 62 (4.4%) patients were attended the same day in the medic consult due to disease flare or other disease problems, 38 (2.7%) patients were sent to another specialist of the work-team due to co-morbidity. The activity executed in the rheumatology APN consultation is shown in Table 2Table 1.Educative interventions by the APN.•Information about the disease•Information about the treatment•Medicine administration•Adverse effects of the medicine•Healthy life style habits•Vaccines•Evaluation of cardiovascular risk•Signs and symptoms of alerts due to the pathology•Ongoing following of the evolution of the disease.•Support for the achievement of the treatment and possible difficulties.Table 2.Activity done in the consult. N° 1.737Face-to-face activityN° consults 1.415Non face-to-face activityN° consults 322Complete valuation due to necessities721 (51%)Valuation58 (18.0%)Educative Interventions1.305 (92.2%)Questions96 (29.8%)Valuation and following1.372 (97.0%)Test result26 (8.1%)PRO execution1.156 (81.7%)Articular counting’s733 (51.8%)Valuation of the diseases activity•DAS28 PCR•ASDAS-PCR737 (52.1%)419 (26.6%)Process of appointment•Requested by the doctor•Requested by the patient.105 (32.6150 (47.0%)55(53.0%)Cardiovascular risk valuation.721 (51.0%)Derivative to different medical consults37 (11.5%)Blood extraction724 (51.2%)Solved by APN285(88.5%)Analytics monetarization1.171 (82.8%)Medicine monetarization1.372 (97.0%)Day Hospital ManagementConclusion:The rheumatology APN takes a vital part in the multidisciplinary team, offering a holistic approach, as well as efficient and high-quality care, offering quick response, reducing waiting time and becoming an important part of this patient-centered model.Disclosure of Interests:None declared
BackgroundIn patients with rheumatic diseases, suicidal ideation (Si) and suicide attempt (Sa) have been observed more frequently than in the general population.Objectives1. To determine the prevalence of Si and Sa in patients with biological therapies. 2. To evaluate possible factors associated with the Si.MethodsObservational cross-sectional study in patients with intravenous BT from Day Hospital of a tertiary hospital in Madrid. Sociodemographic, disease features [weight, height, work disability (WD), diagnosis, treatment] and PRO (FiRST, FACIT-F, HAD, and GHQ-28) were collected. We defined the Si according to the answer at the 6th and 7th questions of section D of the GHQ-28. The Sa was registered according the patient`s clinical history. The categorical variables were analyzed with the Chi square test. A logistic regression analysis was performed to evaluate the possible factors associated with suicidal behavior (SB). To evaluate the variance of discrete quantitative variables between groups the Kruskal-Wallis test was used, with a post-hoc analysis with U-Mann Whitney, to determinate the difference between pairs.ResultsWe included 321 patients, 65% women, with a mean age (range, SD) of 56 years (89-15, 14.1), and a mean disease duration (range, SD) of 16 years, DS (53-1, 9.7). The sociodemographic and clinical characteristics are described in Table 1 and 2. Of all patients, 4% had had 1 or more Sa and 11% had Si. 23% of patients had associated fibromyalgia (FiRST), 47% fatigue (FACIT-F), 27.4% anxiety (A-HAD), 16.2% depression (D-HAD) and a 48.6% a probable psychic disorder (GHQ-28). The final logistic regression model includes FACIT-F, IL, D-HAD, and first biological with Cox R2 and Snell 20.1% and Nagelkerke 35.5%. The area under the curve was 0.849 with significance p <0.0001 [95% CI (0.786 - 0.912)]. Regarding the GHQ-28 score, a significant difference was observed among the diagnostic groups (p <0.001); in post-Hoc, a lower score was observed among patients with ankylosing spondylitis p <0.001. We also observed a significant difference among the treatment groups (p <0.001) for the GHQ-28 score. In the post-hoc analysis, the Abatacept group had a significantly higher mean p = 0.042 of GHQ-28 score, however, in the multivariate analysis no significant difference was observed p = 0.416.ConclusionThere is a high prevalence of Si and Sa in patients with BT. Depression, fatigue, sleep disorders, fibromyalgia and work disability were associated with a higher prevalence of SB.Table 1 Demographic characteristics No ideation/No attempt (273) Ideation (36) Attempt (12)Table 2 Clinical characteristicsNo ideation/No attempt (273)Ideation (36)Attempt (12)Diagnostic (%)Rheumatoid arthritis125 (45,78)20 (55,55)5 (41,66)Ankylosing spondylitis94 (34,43)6 (16.6)3 (25)Psoriatic arthritis20 (7,3)4 (11,11)0 (0)Others34 (12,4)6 (16,6)4 (33,33)Treatment (%)Infliximab159 (58,24)16 (44,44)3 (25)Tocilizumab46 (16,84)8 (22,2)2 (16,67)Abatacept12 (4,3)6 (16,67)2 (16,67)Rituximab49 (17,94)5 (13,88)5 (41,67)Others7 (2,5)1 (2,7)0 (0)P...
Background:Recommendations to collect the most relevant information on disease course, treatment and outcomes in giant cell arteritis (GCA) has been proposed by EULAR to facilitate clinical research and to improve clinical care.Objectives:To assess the quality of data collection in routine clinical practice according to EULAR recommendations and to describe baseline and follow-up characteristics of a retrospective cohort of patients with GCA.Methods:We reviewed medical records of patients diagnosed with GCA in a tertiary academic center between 2004-2018. We included patients with available data at diagnosis and one year of follow-up. Data extraction included: demographics, diagnosis, GCA-related signs and symptoms, laboratory, imaging modalities, comorbidities and treatment. Data in the chart was then compared with the core set of parameters proposed for GCA registries and databases by EULAR. Major relapse, according to the EULAR 2018 definition, was independently assessed by two rheumatologists.Results:58 patients were identified, 39 met predefined inclusion criteria with 151 visits during first-year follow-up. Headache (100%; 80.4%), ocular symptoms (89.7%; 81.2%), constitutional symptoms (89.7%; 80.4%), polymyalgia rheumatica (89.7%; 82%) and jaw claudication (87%; 81.2%) were the most frequently collected items at baseline and follow-up. Weight and height (2.6%; 2.6%), peripheral pulses (8%; 4.5%), smoking status (41%; 21%), and blood pressure (61.5%; 4.5%) were the less frequently collected. Most patients lacked differential pressure measurement. Myocardial infarction, malignancy, serious infections, arterial hypertension, diabetes and osteoporosis were collected in every patient (39, 100%). Only 2 mayor relapses were identified (5%). Two (2) patients died during the one-year follow-up period. Table 1 provides information on GCA-related signs and symptoms, laboratory and therapeutic data.Table 1.GCA-related signs and symptoms, laboratory and therapeutic data.ItemPerformed BaselineBaselinen=39Performed Follow-upFollow-upn=112Ocular symptoms35/39 (89.7%)15/35 (42.9%)91/112 (81.2%)29/91 (31.9%)Permanent ocular symptoms34/39 (87%)9/34 (26.5%)92/112 (82%)28/92 (30.4%)Headache39 (100%)30/39 (77%)90/112 (80.4%)13/90 (14.4%)Scalp tenderness31/39 (79.5%)9/31 (29.8%)88/112 (78.6%)4/88 (4.5%)Jaw claudication34/39 (87%)19/34 (55.85)91/112 (81.2%)6/91 (6.6%)Cranial artery abnormality27/39 (69.2%)17/27 (63%)69/112 (61.6%)3/69 (4.3%)Constitutional symptoms35/39 (89.7%)19/35 (54.3%)90/112 (80.4%)11/90 (12.2%)PMR35/39 (89.7%)18/35 (51.4%)92/112 (82%)9/92 (9.8%)ESR mean (SD)33/39 (84.6%)58.7 (32.1)83/112 (74%)14.6 (18.8)CRP mean (SD)31/39 (79.5%)8.4 (7.9)70/112 (62.5%)1.3 (3.3)Haemoglobin mean (SD)38/39 (97.4%)12.0 (1.7)90/112 (80.4%)12.9 (1.5)Peripheral pulses9/39 (8%)3/9 (33.3%)5/112 (4.5%)2/5 (40%)Large vessel involvement8/39 (20.5%)5/8 (62.5%)7/112 (6.25%)3/7 (42.8%)Glucocorticoids median (IQR)39 (100%)102.5 (50-250)112 (100%)10.0 (5-15)Synthetic DMARD39 (100%)8/39 (20.5%)111/112 (99%)17/39 (43.6%)Biological DMARD39 (100%)0/39 (0%)111/112 (99%)3/39 (7.7%)Antiplatelet agents39 (100%)6/39 (15.4%)110/112 (98%)25/110 (22.7%)PMR: polymyalgia rheumatica, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, SD: standard deviation, IQR: interquartile range, DMARD: disease modifying antirheumatic drugsConclusion:Although data collection in routine care is usually comprehensive enough according to EULAR proposed data set, key components in physical exam mostly those aiming to detect large vessel involvement, should be addressed more carefully.References:[1]Ehlers L, et al. Ann Rheum Dis. 2019;78(9):1160–6.[2]Hellmich B, et al. Ann Rheum Dis. 2019;1–12.Disclosure of Interests:Julia Martínez-Barrio Consultant of: UCB Pharma, Belén Serrano Benavente: None declared, Tamara Del Río Blasco: None declared, Alfonso Ariza: None declared, Juan Ovalles: None declared, Juan Molina Collada: None declared, Teresa González: None declared, Carlos Gonzalez Consultant of: Gilead, Janssen, Novartis,, Speakers bureau: Abbvie, Celgene, Gilead, Janssen, Novartis, Pfizer, Roche, Isabel Castrejon: None declared, Jose Maria Alvaro Gracia: None declared
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