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1.
Artículo en Inglés | MEDLINE | ID: mdl-38351719

RESUMEN

It is well known that difficulty in the retrieval of people's names is an early symptom of Alzheimer's Disease Dementia (ADD), but there is a controversy about the nature of this deficit. In this study, we analyzed whether the nature of the difficulty in retrieving proper names in ADD reflects pre-semantic, semantic, or post-semantic difficulties. To do so, 85 older adults, 35 with ADD and 50 cognitively healthy (CH), completed a task with famous faces involving: recognition, naming, semantic questions, and naming with phonological cues. The ADD group scored lower than the CH group in all tasks. Both groups showed a greater capacity for recognition than naming, but this difference was more pronounced in the ADD group. Additionally, the ADD group showed significantly fewer semantic errors than the CH group. Overall results suggest that the difficulties people with ADD have in naming reflect a degradation at semantic level.

2.
Artículo en Inglés | MEDLINE | ID: mdl-38243722

RESUMEN

OBJECTIVE: To report the interim 5-year safety and effectiveness of abatacept in patients with juvenile idiopathic arthritis (JIA) in the PRINTO/PRCSG registry. METHODS: The Abatacept JIA Registry (NCT01357668) is an ongoing observational study of children with JIA receiving abatacept; enrolment started in January 2013. Clinical sites enrolled patients with JIA starting or currently receiving abatacept. Eligible patients were assessed for safety (primary end point) and effectiveness over 10 years. Effectiveness was measured by clinical 10-joint Juvenile Arthritis Disease Activity Score (cJADAS10) in patients with JIA over 5 years. As-observed analysis is presented according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. RESULTS: As of 31 March 2020, 587 patients were enrolled; 569 are included in this analysis (including 134 new users) with 1214.6 patient-years of safety data available. Over 5 years, the incidence rate (IR) per 100 patient-years of follow-up of serious adverse events was 5.52 (95% confidence interval [CI]: 4.27, 7.01) and of events of special interest was 3.62 (95% CI: 2.63, 4.86), with 18 serious infections (IR 1.48 [95% CI: 0.88, 2.34]). As early as month 3, 55.9% of patients achieved cJADAS10 low disease activity and inactive disease (20.3%, 72/354 and 35.6%, 126/354, respectively), sustained over 5 years. Disease activity measures improved over 5 years across JIA categories. CONCLUSION: Abatacept was well tolerated in patients with JIA, with no new safety signals identified and with well-controlled disease activity, including some patients achieving inactive disease or remission. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01357668.

3.
Semin Arthritis Rheum ; 64: 152240, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-37500379

RESUMEN

OBJECTIVE: To evaluate the risk of malignancy (overall, breast, lung, and lymphoma) in patients with rheumatoid arthritis treated with abatacept, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs), and other biologic/targeted synthetic (b/ts)DMARDs in clinical practice. METHODS: Four international observational data sources were included: ARTIS (Sweden), RABBIT (Germany), FORWARD (USA), and BC (Canada). Crude incidence rates (IRs) per 1000 patient-years of exposure with 95% confidence intervals (CIs) for a malignancy event were calculated; rate ratios (RRs) were estimated and adjusted for demographics, comorbidities, and other potential confounders. RRs were then pooled in a random-effects model. RESULTS: Across data sources, mean follow-up for patients treated with abatacept (n = 5182), csDMARDs (n = 73,755), and other b/tsDMARDs (n = 37,195) was 3.0-3.7, 2.9-6.2, and 3.1-4.7 years, respectively. IRs per 1000 patient-years for overall malignancy ranged from 7.6-11.4 (abatacept), 8.6-13.2 (csDMARDs), and 5.0-11.8 (other b/tsDMARDs). IRs ranged from: 0-4.4, 0-3.3, and 0-2.5 (breast cancer); 0.1-2.8, 0-3.7, and 0.2-2.9 (lung cancer); and 0-1.1, 0-0.9, and 0-0.6 (lymphoma), respectively, for the three treatment groups. The numbers of individual cancers (breast, lung, and lymphoma) in some registries were low; RRs were not available. There were a few cases of lymphoma in some of the registries; ARTIS observed an RR of 2.8 (95% CI 1.1-6.8) with abatacept versus csDMARDs. The pooled RRs (95% CIs) for overall malignancy with abatacept were 1.1 (0.8-1.5) versus csDMARDs and 1.0 (0.8-1.3) versus b/tsDMARDs. CONCLUSIONS: This international, post-marketing observational safety study did not find any statistically significant increase in the risk of overall malignancies in pooled data in patients treated with abatacept compared with csDMARDs or with other b/tsDMARDs. Assessment of larger populations is needed to further evaluate the risks for individual cancers, especially lymphoma.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Neoplasias Pulmonares , Linfoma , Humanos , Abatacept/efectos adversos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Artritis Reumatoide/inducido químicamente , Neoplasias Pulmonares/tratamiento farmacológico , Linfoma/inducido químicamente , Linfoma/tratamiento farmacológico , Mercadotecnía , Productos Biológicos/uso terapéutico
4.
Semin Arthritis Rheum ; 64: 152313, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38044241

RESUMEN

OBJECTIVE: To evaluate risk of infections requiring hospitalization and opportunistic infections, including tuberculosis, in patients with rheumatoid arthritis (RA) treated with abatacept versus conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biologic/targeted synthetic (b/ts) DMARDs. METHODS: Five international observational data sources were used: two biologic registries (Sweden, Germany), a disease registry (USA) and two healthcare claims databases (Canada, USA). Crude incidence rates (IRs) per 1000 patient-years, with 95 % CIs, were used to estimate rate ratios (RRs) comparing abatacept versus csDMARDs or other b/tsDMARDs. RRs were adjusted for demographic factors, comorbidities, and other potential confounders and then pooled across data sources using a random effects model (REM). RESULTS: The data sources included 6450 abatacept users, 136,636 csDMARD users and 54,378 other b/tsDMARD users, with a mean follow-up range of 2.2-6.2 years. Across data sources, the IRs for infections requiring hospitalization ranged from 16 to 56 for abatacept, 19-46 for csDMARDs, and 18-40 for other b/tsDMARDs. IRs for opportunistic infections were 0.4-7.8, 0.3-4.3, and 0.5-3.8; IRs for tuberculosis were 0.0-8.4, 0.0-6.0, and 0.0-6.3, respectively. The pooled adjusted RR (95 % CI), only reported for infections requiring hospitalization, was 1.2 (0.6-2.2) for abatacept versus csDMARDs and 0.9 (0.6-1.3) versus other b/tsDMARDs. CONCLUSIONS: Data from this international, observational study showed similar hospitalized infection risk for abatacept versus csDMARDs or other b/tsDMARDs. IRs for opportunistic infections, including tuberculosis, were low. These data are consistent with the known safety profile of abatacept.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Infecciones Oportunistas , Tuberculosis , Humanos , Abatacept/efectos adversos , Antirreumáticos/efectos adversos , Artritis Reumatoide/epidemiología , Infecciones Oportunistas/inducido químicamente , Infecciones Oportunistas/epidemiología , Productos Biológicos/efectos adversos , Tuberculosis/inducido químicamente , Tuberculosis/epidemiología , Mercadotecnía
5.
Ann Rheum Dis ; 83(2): 177-183, 2024 Jan 11.
Artículo en Inglés | MEDLINE | ID: mdl-37932010

RESUMEN

OBJECTIVES: This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA). METHODS: This evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs). RESULTS: ~49 000 patients receiving abatacept were analysed from clinical trials (~7000) and observational studies (~42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs. CONCLUSIONS: Consistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Neoplasias Cutáneas , Humanos , Abatacept/efectos adversos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Artritis Reumatoide/complicaciones , Productos Biológicos/uso terapéutico , Incidencia , Ensayos Clínicos Controlados Aleatorios como Asunto , Neoplasias Cutáneas/inducido químicamente , Neoplasias Cutáneas/epidemiología
6.
Semin Arthritis Rheum ; 62: 152249, 2023 10.
Artículo en Inglés | MEDLINE | ID: mdl-37573754

RESUMEN

OBJECTIVE: To assess real-world comparative effectiveness studies of biologic (b) and targeted synthetic (ts) disease-modifying antirheumatic drugs (DMARDs) in adults with rheumatoid arthritis (RA) through a systematic review. METHODS: We searched Medline for journal articles (2001-2021) and Embase® for abstracts presented at the European Alliance of Associations for Rheumatology and American College of Rheumatology (ACR) 2020 and 2021 annual meetings on non-randomized studies comparing the effectiveness of b/tsDMARDs using ACR-recommended disease activity measures, measures of functional status, and patient-reported outcomes (HAQ, PROMIS PF, patient pain, Patient and Physician Global Assessment of disease activity). Methodological heterogeneity between studies precluded meta-analyses. Risk of bias was assessed using the Cochrane Risk Of Bias In Non-randomized Studies of Interventions-I tool. RESULTS: Of 1283 records screened, 68 were selected for data extraction, of which 1 was excluded due to critical risk of bias. Most studies were multicenter observational cohort/registry studies (n = 60) and were published between 2011 and 2021 (n = 60). Mean or median reported RA duration was between 6 and 15 years. Disease Activity Score in 28 joints (46 studies), Clinical Disease Activity Index (37 studies), and Health Assessment Questionnaire-Disability Index (32 studies) were the most common outcomes used in clinical practice, with regional differences identified. The most common comparison was between tumor necrosis factor inhibitors (TNFis) and non-TNFi bDMARDs (35 studies). There were no evident differences between b/tsDMARDs in clinical effectiveness. CONCLUSION: This systematic review summarizing real-world evidence from a very large number of global studies found there are many effective options for the treatment of RA, but relatively less evidence to support the use of any one b/tsDMARD or drug class over another. Treatment for patients with RA should be tailored to suit individual clinical profiles. Further research is needed to identify whether specific patient subgroups may benefit from specific drug classes.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Productos Biológicos , Humanos , Artritis Reumatoide/terapia , Antirreumáticos/uso terapéutico , Resultado del Tratamiento , Productos Biológicos/uso terapéutico , Estudios Multicéntricos como Asunto
7.
Arthritis Res Ther ; 25(1): 101, 2023 06 12.
Artículo en Inglés | MEDLINE | ID: mdl-37308978

RESUMEN

BACKGROUND: Patients with rheumatoid arthritis (RA) have an increased risk of infection and malignancy compared with the general population. Infection risk is increased further with the use of disease-modifying antirheumatic drugs (DMARDs), whereas evidence on whether the use of biologic DMARDs increases cancer risk remains equivocal. This single-arm, post-marketing study estimated the incidence of prespecified infection and malignancy outcomes in patients with RA treated with intravenous or subcutaneous abatacept. METHODS: Data were included from seven European RA quality registries: ATTRA (Anti-TNF Therapy in Rheumatoid Arthritis [Czech Republic]), DANBIO (Danish Rheumatologic Database), ROB-FIN (National Registry of Antirheumatic and Biological Treatment in Finland), ORA (Orencia and Rheumatoid Arthritis [France]), GISEA (Italian Group for the Study of Early Arthritis), BIOBADASER (Spanish Register of Adverse Events of Biological Therapies in Rheumatic Diseases), and the SCQM (Swiss Clinical Quality Management) system. Each registry is unique with respect to design, data collection, definition of the study cohort, reporting, and validation of outcomes. In general, registries defined the index date as the first day of abatacept treatment and reported data for infections requiring hospitalization and overall malignancies; data for other infection and malignancy outcomes were not available for every cohort. Abatacept exposure was measured in patient-years (p-y). Incidence rates (IRs) were calculated as the number of events per 1000 p-y of follow-up with 95% confidence intervals. RESULTS: Over 5000 patients with RA treated with abatacept were included. Most patients (78-85%) were female, and the mean age range was 52-58 years. Baseline characteristics were largely consistent across registries. Among patients treated with abatacept, IRs for infections requiring hospitalization across the registries ranged from 4 to 100 events per 1000 p-y, while IRs for overall malignancy ranged from 3 to 19 per 1000 p-y. CONCLUSIONS: Despite heterogeneity between registries in terms of design, data collection, and ascertainment of safety outcomes, as well as the possibility of under-reporting of adverse events in observational studies, the safety profile of abatacept reported here was largely consistent with previous findings in patients with RA treated with abatacept, with no new or increased risks of infection or malignancy.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Humanos , Femenino , Persona de Mediana Edad , Masculino , Abatacept , Inhibidores del Factor de Necrosis Tumoral , Sistema de Registros
8.
Drug Healthc Patient Saf ; 15: 25-38, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36742440

RESUMEN

Purpose: The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS) database. Methods: A case-series design was used. Results: A total of 183 cases listed D8-THC as a suspect drug in FAERS as of June 30, 2021. The most common events included dyspnea, respiratory disorder, and seizure. The reporting odds ratios were consistently and significantly greater than 2, a 2-fold increase from 2019 to 2021, indicating a potential safety signal. Conclusion: The first report of D8-THC, in the FAERS database, as a suspect drug appears to be in 2011. Overall, there are 183 total cases listing D8-THC as a suspect drug in the FAERS database as of June 30, 2021. Of the 183 cases, most were respiratory in nature.

9.
Children (Basel) ; 9(11)2022 Nov 04.
Artículo en Inglés | MEDLINE | ID: mdl-36360422

RESUMEN

Developmental language disorder (DLD) is considered a neurodevelopmental disorder that compromises language comprehension and/or expression and constitutes a risk factor for learning to read. The aim of the present study was to analyse the reading strategies used by students with DLD to read sentences. There is evidence in the literature that, when linguistic resources are insufficient, the keyword strategy (identifying some of the words in the sentence with their own semantic content, with barely no processing of the function words) is used to read sentences. A total of 31 primary and secondary school students diagnosed with DLD were evaluated using the PEALE battery. The results reveal that students with DLD present heterogeneous profiles that are below the established reading level for their age. In addition, children with DLD and better reading skills use the keyword strategy to read sentences. In conclusion, clinical and educational implications for reading intervention in individuals with DLD are discussed.

10.
Arthritis Care Res (Hoboken) ; 74(12): 2091-2099, 2022 12.
Artículo en Inglés | MEDLINE | ID: mdl-34269524

RESUMEN

OBJECTIVE: Despite advances in treatments and outcomes among patients with rheumatic diseases, there is an unmet need in pain management. Cannabis has emerged as a potential opioid-sparing alternative, with arthritic pain as a commonly cited reason for medicinal cannabis use. However, little is known, and we set out to understand patterns of cannabis use in a US-wide rheumatic disease population. METHODS: The study included participants in FORWARD, The National Databank for Rheumatic Diseases. Participants were asked in 2014 and 2019 about their past and current cannabis use. Demographic characteristics, patient-reported outcomes, medications, comorbidities, and diagnoses were compared between cannabis users and non-users with t-tests, chi-square tests, logistic regression, and geographic assessment. RESULTS: Among 11,006 respondents, cannabis use increased from 6.3% in 2014 to 18.4% in 2019, with the greatest prevalence of use in states where cannabis use was legalized. Most users (74% and 62% in 2014 and 2019, respectively) reported that cannabis was effective in the relief of arthritis symptoms. Cannabis users were more likely to be taking weak opioids (odds ratio 1.2 [95% confidence interval 1.0, 1.5], P = 0.03), to have a history of smoking tobacco (odds ratio 1.7 [95% confidence interval 1.5, 2.1], P < 0.001), and had worse measures on all assessed patient-reported outcomes. CONCLUSION: Reported cannabis use in this cohort increased significantly between 2014 and 2019. Characteristics of users suggest that those who try cannabis are feeling worse symptomatically, and their pain management needs may not be adequately addressed by other therapies. The association between cannabis, opioids, and patient-reported outcomes highlight areas for future work.


Asunto(s)
Cannabis , Marihuana Medicinal , Enfermedades Reumáticas , Humanos , Adulto , Estados Unidos/epidemiología , Marihuana Medicinal/uso terapéutico , Analgésicos Opioides/uso terapéutico , Manejo del Dolor/métodos , Enfermedades Reumáticas/diagnóstico , Enfermedades Reumáticas/tratamiento farmacológico , Enfermedades Reumáticas/epidemiología
11.
RMD Open ; 7(2)2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-34193517

RESUMEN

OBJECTIVE: Venous thromboembolism (VTE) is an increasing concern in rheumatoid arthritis (RA) with little known about risk factors. We aimed to compare risk factors for unprovoked VTE and atherosclerotic cardiovascular disease (ASCVD) in patients with RA and to assess subsequent ASCVD risk after an unprovoked VTE. METHODS: People with RA participating in a US-wide longitudinal observational registry from 1998 to 2018 were assessed for incident unprovoked VTE (deep venous thrombosis and pulmonary emboli not associated with cancer, recent surgery, hospitalisation, fracture and pregnancy) and ASCVD (myocardial infarction and stroke) validated from hospital/death records. Risk factors for VTE and ASCVD and the risk of ASCVD after an unprovoked VTE were determined using Cox proportional hazards models. RESULTS: During median (IQR) 4 (1.5-7) years of follow-up in 31 366 patients with RA, 539 unprovoked VTE and 1648 ASCVD events were identified. The adjusted models showed increased VTE and ASCVD risk with older age, male sex, comorbidities, prior fracture, worse disability, higher disease activity and glucocorticoids. Traditional cardiovascular disease risk factors were common in both ASCVD and VTE but only increased ASCVD risk with obesity as the exception (VTE HR (95% CI), 1.46 (1.13-1.87)) and ASCVD, 0.58 (0.50-0.68)). ASCVD risk doubled after an unprovoked VTE (HR (95% CI), 2.05 (1.43-2.95)). CONCLUSION: Our findings suggest that unprovoked VTE is mediated by inflammation of RA and may be considered a spectrum of pan-cardiovascular syndrome.


Asunto(s)
Artritis Reumatoide , Enfermedades Cardiovasculares , Tromboembolia Venosa , Anciano , Artritis Reumatoide/complicaciones , Artritis Reumatoide/epidemiología , Enfermedades Cardiovasculares/epidemiología , Femenino , Humanos , Incidencia , Masculino , Embarazo , Factores de Riesgo , Tromboembolia Venosa/epidemiología , Tromboembolia Venosa/etiología
12.
RMD Open ; 7(1)2021 03.
Artículo en Inglés | MEDLINE | ID: mdl-33731444

RESUMEN

OBJECTIVE: Many autoimmune diseases share common pathogenic mechanisms; however, there are limited studies quantifying the coexistence of autoimmune diseases and associated conditions in patients with juvenile idiopathic arthritis (JIA). This large US-based study estimated and compared the prevalence of multiple coexisting autoimmune diseases in patients with JIA with a general paediatric (GP) patient population. METHODS: This retrospective cohort study was conducted using registry data from the Cincinnati Children's Hospital Medical Center (January 2010-October 2018). The prevalence of multiple autoimmune diseases was estimated in patients (age <21 years) with JIA and a control group from the GP patient population. Crude prevalences of 26 prespecified autoimmune diseases and associated conditions were compared using Bayesian Poisson regression modelling for each year up to the end of the study period. RESULTS: Overall, 2026 patients were included in the JIA cohort and 41 572 in the GP cohort. Of 26 autoimmune diseases and associated conditions evaluated, 14 (53.8%) had a significantly higher prevalence in the JIA cohort compared with the GP cohort. In total, seven (26.9%) autoimmune diseases or associated conditions had a >20-fold increased prevalence in the JIA cohort compared with the GP cohort. CONCLUSION: In this study, patients with JIA had a greater prevalence of a large number of coexisting autoimmune diseases and associated conditions compared with the GP population. Physicians should consider coexisting autoimmune diseases in the treatment and management of patients with JIA.


Asunto(s)
Artritis Juvenil , Adulto , Artritis Juvenil/epidemiología , Teorema de Bayes , Niño , Estudios de Cohortes , Humanos , Prevalencia , Estudios Retrospectivos , Adulto Joven
13.
Arthritis Res Ther ; 23(1): 17, 2021 01 11.
Artículo en Inglés | MEDLINE | ID: mdl-33430948

RESUMEN

BACKGROUND: To evaluate incidence of opportunistic infections (OIs) in patients with rheumatoid arthritis (RA) treated with abatacept in clinical trials. METHODS: This pooled analysis of 16 randomized, double-blind/open-label trials, with ≥ 1 abatacept (intravenous or subcutaneous) arm, and with/without placebo control covered cumulative (controlled short-term and open-label long-term) abatacept exposure periods. OIs were analyzed separately in controlled (abatacept and placebo individually) and cumulative periods. OIs were identified using a prespecified list; events were independently adjudicated. Unadjusted incidence rates (IRs; per 100 patient-years) with 95% confidence intervals (CIs) were calculated. RESULTS: In cumulative periods, 7044 patients received abatacept, with a mean (standard deviation) duration of exposure of 36.9 (26.2) months (21,274 patient-years of exposure). IRs (95% CIs) of OIs were 0.17 (0.05-0.43) for abatacept and 0.56 (0.22-1.15) for placebo during the controlled periods and 0.21 (0.15-0.28) for abatacept during the cumulative periods. There was 1 case of tuberculosis in both the abatacept (IR [95% CI] 0.04 [0.00-0.24]) and placebo (IR [95% CI] 0.08 [0.00-0.44]) groups during the controlled periods; 13 verified tuberculosis cases (IR [95% CI] 0.06 [0.03-0.10]) were reported in the cumulative period. Herpes zoster was reported numerically more often with abatacept (IR 1.9 [1.4-2.5]), versus placebo (1.7 [1.1-2.6]) in the controlled periods; within the cumulative period, herpes zoster IR (95% CI) was 1.53 (1.36-1.71) for abatacept-treated patients. CONCLUSION: In controlled periods of the clinical trials, abatacept-treated patients had similarly low rates of OIs compared with placebo-treated patients. Overall, OI rates were similar among abatacept-treated patients in the controlled and cumulative periods and consistent with the ranges reported in the literature.


Asunto(s)
Antirreumáticos , Artritis Reumatoide , Inmunoconjugados , Infecciones Oportunistas , Abatacept/efectos adversos , Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Método Doble Ciego , Humanos , Inmunoconjugados/efectos adversos , Resultado del Tratamiento
14.
Arthritis Care Res (Hoboken) ; 73(4): 510-519, 2021 04.
Artículo en Inglés | MEDLINE | ID: mdl-32004411

RESUMEN

OBJECTIVE: To consider the acceptability and content validity of patient-reported outcome measures commonly used in rheumatoid arthritis by describing patients' perceptions of patient-reported outcome measures and comparing patients' responses on patient-reported outcome measures with their verbal accounts of disease impacts. METHODS: We used a sequential mixed methods approach, combining analysis of interviews and data from patient-reported outcome measures (from the Health Assessment Questionnaire, the Functional Assessment of Chronic Illness Therapy-Fatigue subscale, the EuroQol 5-domain instrument, the Short Form 36 health survey, and a visual analog scale [VAS] for pain, fatigue, sleep, and patient global assessment of disease activity). Qualitative analysis of patients' perceptions of patient-reported outcome measures informed a subsequent comparison between data from patient-reported outcome measures and verbal accounts of pain, fatigue, sleep, and functional limitations to assess the effectiveness of patient-reported outcome measures in communicating disease impact. RESULTS: The study included 18 patients. Although a few patients offered positive comments about patient-reported outcome measures, most doubted that patient-reported outcome measures could accurately convey their experience of symptoms and functional limitations. Patients discussed the ease of responding to questions, capturing and conveying symptoms, and concerns about the underreporting of symptoms and interpretation of responses. Compared with verbal accounts, patient-reported outcome measures often did not convey the personal significance of limitations; however, patient-reported outcome measures captured limitations that patients omitted or described with insufficient detail during interviews. Although verbal accounts of pain could be categorized into 3 levels of severity (pain without interference in activities, pain is not the worst ever experienced but interferes with activities, and pain is omnipresent), the pain VAS was more effective at conveying finer gradations in pain severity. CONCLUSION: Although patients may feel that patient-reported outcome measures have certain shortcomings, patient-reported outcome measures also have advantages relative to verbal discussion for communicating symptoms and disease impact.


Asunto(s)
Artritis Reumatoide/diagnóstico , Medición de Resultados Informados por el Paciente , Satisfacción del Paciente , Adulto , Anciano , Anciano de 80 o más Años , Artritis Reumatoide/complicaciones , Artritis Reumatoide/fisiopatología , Artritis Reumatoide/psicología , Costo de Enfermedad , Femenino , Estado Funcional , Humanos , Entrevistas como Asunto , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Valor Predictivo de las Pruebas , Investigación Cualitativa , Sistema de Registros , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad
15.
Patient Prefer Adherence ; 14: 2001-2007, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33132698

RESUMEN

Assessing a patient's perspective on their treatment is part of an increasingly integrated approach to pharmacovigilance and treatment optimization. New tools and methods developed in partnership with patients can capture and quantify cognitive and behavioral aspects of the treatment experience. These treatment insights have the potential to shape the drug development process, as well as supplement patient-reported outcome data in a way that is meaningful to the patient. We highlight examples of tools developed to assess the impact of treatment on the aspects of disease that are of utmost concern to the patient in their daily life.

16.
Pediatr Rheumatol Online J ; 18(1): 43, 2020 Jun 05.
Artículo en Inglés | MEDLINE | ID: mdl-32503658

RESUMEN

BACKGROUND: Many autoimmune diseases share common pathogenic mechanisms, cytokine pathways and systemic inflammatory cascades; however, large studies quantifying the co-existence of autoimmune diseases in patients with juvenile idiopathic arthritis (JIA) have not been conducted. METHODS: We performed a cross-sectional study using two United States administrative healthcare claims databases (Truven Health MarketScan® Commercial Database and IMS PharMetrics database) to screen for the prevalence of multiple autoimmune diseases in patients with JIA and in a control group with attention deficit hyperactivity disorder (ADHD). Patients with a diagnosis code for JIA or ADHD between January 1, 2006 and September 30, 2017 were separated into two age cohorts (< 18 and ≥ 18 years) and matched (maximum 1:5) based on age, sex, number of medical encounters, and calendar year of diagnosis. The prevalence rates of 30 pre-specified autoimmune diseases during the 12-month periods before and after diagnosis were compared. RESULTS: Overall, 29,215 patients with JIA and 134,625 matched control patients with ADHD were evaluated. Among patients in the MarketScan database, 28/30 autoimmune diseases were more prevalent in patients with JIA aged < 18 years and 29/30 were more prevalent in patients aged ≥ 18 years when compared with a matched cohort of patients with ADHD. In the PharMetrics database, 29/30 and 30/30 autoimmune diseases were more prevalent in patients with JIA aged < 18 and ≥ 18 years, respectively, compared with a matched cohort of patients with ADHD. Among patients with JIA aged < 18 years, the greatest odds ratios (ORs) were seen for Sjögren's syndrome/sicca syndrome and uveitis. Among patients aged ≥ 18 years in the MarketScan database, the greatest ORs were recorded for uveitis. Data from the PharMetrics database indicated that the greatest ORs were for uveitis and chronic glomerulonephritis. CONCLUSIONS: Patients with JIA are more likely to have concurrent autoimmune diseases than matched patients with ADHD. Having an awareness of the co-existence of autoimmune diseases among patients with JIA may play an important role in patient management, treatment decisions, and outcomes. TRIAL REGISTRATION: Not applicable.


Asunto(s)
Artritis Juvenil/epidemiología , Enfermedades Autoinmunes/epidemiología , Adolescente , Adulto , Alopecia Areata/epidemiología , Estudios de Casos y Controles , Niño , Urticaria Crónica/epidemiología , Comorbilidad , Enfermedad de Crohn/epidemiología , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Prevalencia , Estudios Retrospectivos , Esclerodermia Sistémica/epidemiología , Síndrome de Sjögren/epidemiología , Tiroiditis Autoinmune/epidemiología , Uveítis/epidemiología , Adulto Joven
17.
ACR Open Rheumatol ; 2(6): 335-343, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-32311836

RESUMEN

OBJECTIVE: Patients with rheumatic diseases such as rheumatoid arthritis (RA) and lupus have increased risk of infection and are treated with medications that may increase this risk yet are also hypothesized to help treat COVID-19. We set out to understand how the COVID-19 pandemic has impacted the lives of these patients in the United States. METHODS: Participants in a US-wide longitudinal observational registry responded to a supplemental COVID-19 questionnaire by e-mail on March 25, 2020, about their symptoms, COVID-19 testing, health care changes, and related experiences during the prior 2 weeks. Analysis compared responses by diagnosis, disease activity, and new onset of symptoms. Qualitative analysis was conducted on optional free-text comment fields. RESULTS: Of the 7061 participants invited to participate, 530 responded, with RA as the most frequent diagnosis (61%). Eleven participants met COVID-19 screening criteria, of whom two sought testing unsuccessfully. Six others sought testing, three of whom were successful, and all test results were negative. Not quite half of participants (42%) reported a change to their care in the prior 2 weeks. Qualitative analysis revealed four key themes: emotions in response to the pandemic, perceptions of risks from immunosuppressive medications, protective measures to reduce risk of COVID-19 infection, and disruptions in accessing rheumatic disease medications, including hydroxychloroquine. CONCLUSION: After 2 weeks, many participants with rheumatic diseases already had important changes to their health care, with many altering medications without professional consultation or because of hydroxychloroquine shortage. As evidence accumulates on the effectiveness of potential COVID-19 treatments, effort is needed to safeguard access to established treatments for rheumatic diseases.

18.
BMC Med Educ ; 20(1): 109, 2020 Apr 09.
Artículo en Inglés | MEDLINE | ID: mdl-32272926

RESUMEN

BACKGROUND: The teaching of human anatomy is often based on practices of cadaver dissection and prosected specimens. However, exposure to human cadavers might be stressful and anxiety-inducing for students. The aim of this study is to explore the degree of satisfaction and anxiety among first-year students in the Medicine, Occupational Therapy, Speech Therapy and Nursing programmes at the Universidad de Castilla-La Mancha (Spain) who are experiencing their first dissection/prosection practice to develop stress coping strategies. METHODS: A total of 204 health sciences students participated in this study. The State-Trait Anxiety Inventory was used to evaluate anxiety. RESULTS: 'State Anxiety' (SA) decreased significantly throughout the course (p < 0.05), from 20.7 ± 19.29 to 13.7 ± 11.65 points. Statistical differences (p < 0.05) in SA were found between the different health sciences, and pre-practice SA was significantly different from post-practice SA. The students with the highest pre-practice SA levels were nursing students (31.8 ± 33.7 points), but medical students had the highest post-practice SA levels (18.4 ± 12.82 points). CONCLUSIONS: Although students were satisfied with dissection practices (96.8% of them recommended that the practices be retained for future courses), the experience can provoke stressful responses that must be addressed using advanced preparation and coping mechanisms, especially among medical and nursing students.


Asunto(s)
Anatomía/educación , Ansiedad/psicología , Disección/educación , Educación de Pregrado en Medicina/métodos , Estrés Psicológico/prevención & control , Estudiantes de Medicina/psicología , Adaptación Psicológica , Adulto , Ansiedad/prevención & control , Cadáver , Disección/psicología , Femenino , Humanos , Masculino , España , Estrés Psicológico/psicología
19.
Rheumatology (Oxford) ; 59(4): 820-827, 2020 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-31504972

RESUMEN

OBJECTIVES: Abatacept, a biologic DMARD, was associated with respiratory adverse events in a small subgroup of RA patients with chronic obstructive pulmonary disease (COPD) in a trial. Whether this potential risk is specific to abatacept or extends to all biologics and targeted synthetic DMARDs (tsDMARDs) is unclear. We assessed the risk of adverse respiratory events associated with biologic and tsDMARDs compared with conventional synthetic DMARDs (csDMARDs) among RA patients with concomitant COPD in a large, real-world cohort. METHODS: We used a prevalent new-user design to study RA patients with COPD in the US-based MarketScan databases. New users of biologic DMARDs and/or tsDMARDs were matched on time-conditional propensity scores to new users of csDMARDs. Adverse respiratory events were estimated using Cox models comparing current use of biologic/tsDMARDs with csDMARDs. RESULTS: The cohort included 7424 patients initiating biologic/tsDMARDs and 7424 matched patients initiating csDMARDs. The adjusted hazard ratio of hospitalized COPD exacerbation comparing biologic/tsDMARD vs csDMARD was 0.76 (95% CI: 0.55, 1.06), while it was 1.02 (95% CI: 0.82, 1.27) for bronchitis, 1.21 (95% CI: 0.92, 1.58) for hospitalized pneumonia or influenza and 0.99 (95% CI: 0.87, 1.12) for outpatient pneumonia or influenza. The hazard ratio of the combined end point of COPD exacerbation, bronchitis and hospitalized pneumonia or influenza was 1.04 (95% CI: 0.89, 1.21). CONCLUSION: In this large, real-world comparative safety study, biologic and tsDMARDs, including abatacept, were not associated with an increased risk of adverse respiratory events when compared with csDMARDs in patients with RA and COPD.


Asunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Productos Biológicos/uso terapéutico , Bronquitis/epidemiología , Gripe Humana/epidemiología , Neumonía/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Anciano , Anciano de 80 o más Años , Atención Ambulatoria , Artritis Reumatoide/complicaciones , Progresión de la Enfermedad , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Enfermedad Pulmonar Obstructiva Crónica/complicaciones , Riesgo
20.
Arthritis Care Res (Hoboken) ; 72(9): 1257-1265, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-31282121

RESUMEN

OBJECTIVE: Resilience, the ability to recover from and adapt successfully to stressful situations, is a valuable resource for patients who live with chronic conditions. This qualitative study examines the development of resilience among rheumatoid arthritis (RA) patients. We aimed to describe the resilience development process and to describe strategies used by patients to cultivate resilience. METHODS: Our approach combined ethnographic data collection and narrative analysis methods. Semistructured interviews were conducted with adult RA patients in the US. Interviewees were asked to discuss their experiences with diagnosis, living with RA, coping with challenges, treatment, and health care providers. The interviews were audiorecorded, transcribed, and analyzed to describe the stages of resilience development and to identify patients' strategies for building/maintaining resilience. RESULTS: Eighteen patients were interviewed, ages 27-80 years and with RA duration of 5-41 years. Patient responses to challenging situations were grouped into 3 stages: 1) lacking capacity to handle the situation, 2) struggling but growing in capacity to handle the situation, and 3) attaining mastery. Patients used 10 strategies to cultivate resilience: perseverance, exchanging social support, pursuing valued activities, flexibility, positive reframing, acceptance, humor, avoiding threatening thoughts, equanimity, and maintaining a sense of control. CONCLUSION: RA patients acquire resilience in a dynamic process of learning in response to new challenges. Patients use a combination of behavioral and emotion management strategies to cultivate resilience. Awareness of these strategies may benefit patients, health care providers, and researchers developing behavioral interventions and social support programs in the context of RA and other chronic diseases.


Asunto(s)
Adaptación Psicológica , Artritis Reumatoide/psicología , Resiliencia Psicológica , Apoyo Social , Adulto , Anciano , Anciano de 80 o más Años , Emociones , Femenino , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa
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