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1.
Ann Rheum Dis ; 83(2): 177-183, 2024 Jan 11.
Artigo em Inglês | MEDLINE | ID: mdl-37932010

RESUMO

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.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Neoplasias Cutâneas , Humanos , Abatacepte/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/complicações , Produtos Biológicos/uso terapêutico , Incidência , Ensaios Clínicos Controlados Aleatórios como Assunto , Neoplasias Cutâneas/induzido quimicamente , Neoplasias Cutâneas/epidemiologia
2.
Artigo em Inglês | MEDLINE | ID: mdl-38243722

RESUMO

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.
J Exp Child Psychol ; 245: 105977, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38824689

RESUMO

Previous evidence has shown that pseudowords made up of real morphemes take more time to process and generate more errors than pseudowords without morphemes in a lexical decision task. The explanation for these results is controversial because two possible arguments may be posited; the first is related to the morphological composition of the stimuli, and the second is related to the larger semantic interpretability of pseudowords with morphemes in comparison with pseudowords without morphemes (a semantic-based explanation). To disentangle this issue, we conducted an experiment with 92 children and 42 adults. For this purpose, a lexical decision task was implemented, controlling for semantic interpretability while manipulating the morphological status of pseudowords. The results show that the morphological composition of pseudowords generates larger latencies and more errors than pseudowords without morphemes, thereby corroborating that morphemes are activated during pseudoword processing even in the case of young readers.


Assuntos
Tempo de Reação , Semântica , Humanos , Criança , Feminino , Masculino , Adulto , Leitura , Adulto Jovem , Tomada de Decisões
4.
Rheumatology (Oxford) ; 59(4): 820-827, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-31504972

RESUMO

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.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Bronquite/epidemiologia , Influenza Humana/epidemiologia , Pneumonia/epidemiologia , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Artrite Reumatoide/complicações , Progressão da Doença , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Doença Pulmonar Obstrutiva Crônica/complicações , Risco
5.
Ann Intern Med ; 170(12): 825-836, 2019 06 18.
Artigo em Inglês | MEDLINE | ID: mdl-31108503

RESUMO

Background: Patients with rheumatoid arthritis (RA) are at increased risk for infection after arthroplasty, yet risks of specific biologic medications are unknown. Objective: To compare risk for postoperative infection among biologics and to evaluate the risk associated with glucocorticoids. Design: Retrospective cohort study. Setting: Medicare and Truven MarketScan administrative data from January 2006 through September 2015. Patients: Adults with RA who were having elective inpatient total knee or hip arthroplasty, either primary or revision, and had a recent infusion of or prescription for abatacept, adalimumab, etanercept, infliximab, rituximab, or tocilizumab before surgery. Measurements: Propensity-adjusted analyses using inverse probability weights evaluated comparative risks for hospitalized infection within 30 days and prosthetic joint infection (PJI) within 1 year after surgery between biologics or with different dosages of glucocorticoids. Secondary analyses evaluated non-urinary tract hospitalized infections and 30-day readmissions. Results: Among 9911 patients treated with biologics, 10 923 surgical procedures were identified. Outcomes were similar in patients who received different biologics. Compared with an 8.16% risk for hospitalized infection with abatacept, predicted risk from propensity-weighted models ranged from 6.87% (95% CI, 5.30% to 8.90%) with adalimumab to 8.90% (CI, 5.70% to 13.52%) with rituximab. Compared with a 2.14% 1-year cumulative incidence of PJI with abatacept, predicted incidence ranged from 0.35% (CI, 0.11% to 1.12%) with rituximab to 3.67% (CI, 1.69% to 7.88%) with tocilizumab. Glucocorticoids were associated with a dose-dependent increase in postoperative risk for all outcomes. Propensity-weighted models showed that use of more than 10 mg of glucocorticoids per day (vs. no glucocorticoid use) resulted in a predicted risk for hospitalized infection of 13.25% (CI, 9.72% to 17.81%) (vs. 6.78%) and a predicted 1-year cumulative incidence of PJI of 3.83% (CI, 2.13% to 6.87%) (vs. 2.09%). Limitation: Residual confounding is possible, and sample sizes for rituximab and tocilizumab were small. Conclusion: Risks for hospitalized infection, PJI, and readmission after arthroplasty were similar across biologics. In contrast, glucocorticoid use, especially with dosages above 10 mg/d, was associated with greater risk for adverse outcomes. Primary Funding Source: Rheumatology Research Foundation, National Institutes of Health, and Bristol-Myers Squibb.


Assuntos
Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/cirurgia , Artroplastia de Quadril , Artroplastia do Joelho , Produtos Biológicos/efeitos adversos , Infecção Hospitalar/etiologia , Glucocorticoides/efeitos adversos , Infecção da Ferida Cirúrgica/etiologia , Idoso , Antirreumáticos/administração & dosagem , Antirreumáticos/uso terapêutico , Artroplastia de Quadril/efeitos adversos , Artroplastia do Joelho/efeitos adversos , Produtos Biológicos/administração & dosagem , Produtos Biológicos/uso terapêutico , Esquema de Medicação , Feminino , Glucocorticoides/administração & dosagem , Glucocorticoides/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente , Complicações Pós-Operatórias , Pontuação de Propensão , Estudos Retrospectivos , Fatores de Risco
6.
BMC Med Educ ; 20(1): 109, 2020 Apr 09.
Artigo em Inglês | MEDLINE | ID: mdl-32272926

RESUMO

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.


Assuntos
Anatomia/educação , Ansiedade/psicologia , Dissecação/educação , Educação de Graduação em Medicina/métodos , Estresse Psicológico/prevenção & controle , Estudantes de Medicina/psicologia , Adaptação Psicológica , Adulto , Ansiedade/prevenção & controle , Cadáver , Dissecação/psicologia , Feminino , Humanos , Masculino , Espanha , Estresse Psicológico/psicologia
7.
Rheumatology (Oxford) ; 58(4): 683-691, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30535094

RESUMO

OBJECTIVE: To assess whether abatacept as initial biological DMARD (bDMARD) in the treatment of RA, when compared with other bDMARDs, is associated with an increased risk of cancer overall and by specific cancer sites (breast, lung, lymphoma, melanoma and non-melanoma skin cancer). METHODS: We performed a population-based cohort study among patients newly treated with bDMARDs within the US-based Truven MarketScan population and Supplemental US Medicare from 2007 to 2014. Cox proportional hazards models were used to estimate hazard ratios and 95% CIs of any cancer (and specific cancers) associated with initiation of abatacept, compared with initiation of other bDMARDs, adjusted for age and deciles of the propensity score. RESULTS: The cohort included 4328 patients on abatacept and 59 860 on other bDMARDs, of whom 409 and 4197 were diagnosed with any cancer during follow-up (incidence rates 4.76 per 100 per year and 3.41 per 100 per year, respectively). Compared with other bDMARDs, the use of abatacept was associated with an increased incidence of cancer overall (hazard ratioadjusted 1.17; 95% CI 1.06, 1.30). Analyses by specific cancer sites showed a significantly increased incidence of non-melanoma skin cancer (hazard ratioadjusted 1.20; 95% CI 1.03, 1.39), but no significant difference for other specific cancer sites. CONCLUSION: The use of abatacept as first bDMARD in the treatment of RA was associated with a slight increased risk of cancer overall and particularly non-melanoma skin cancer, compared with other bDMARDs. This potential signal needs to be replicated in other settings.


Assuntos
Abatacepte/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/efeitos adversos , Neoplasias/induzido quimicamente , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Incidência , Masculino , Medicare , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Modelos de Riscos Proporcionais , Sistema de Registros , Estudos Retrospectivos , Fatores de Risco , Estados Unidos/epidemiologia
8.
Am J Ther ; 22(4): 248-56, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-24326696

RESUMO

Vitamin K antagonist (VKA) and aspirin (ASA) are recommended for stroke prevention in patients with atrial fibrillation (AF). This study examined VKA and ASA use and their clinical correlates, including CHADS2 stroke risk scores, among adult patients with AF in the general population. Participants included 1290 (1.72%) adults reporting diagnosis with AF (mean age, 64.9 years; 65% men) from the 2009 US National Health and Wellness Survey, an online, self-administered, nationwide, stratified random sample survey of 75,000 adults. Antithrombotic use patterns, including VKA, ASA, VKA+ASA, and non-VKA/ASA, and their correlates were examined using logistic regressions. Respondents with AF were treated with VKA (26.6%), ASA (34.5%), VKA+ASA (15.4%), or neither (23.5%). Among those with CHADS2 ≥1, 19.3% did not report use of VKA or ASA. Among those with CHADS2 ≥2, 35.7% were treated only with ASA. Adjusting for covariates in logistic regressions, CHADS2 ≥1 was associated with VKA and/or ASA (vs. non-VKA/ASA) use (P ≤ 0.02), but CHADS2 score did not differentiate VKA versus ASA use (P > 0.4). Comorbidities were associated with ASA versus VKA use (P ≤ 0.01). Older age, male gender, married status, and obesity were each associated with use of at least one of the treatments investigated (all P < 0.05). One-in-five AF patients with CHADS2 ≥1 were untreated and more than one-third with CHADS2 ≥2 treated with only ASA for stroke prevention. Our findings suggest that although patient characteristics including CHADS2 score were associated with either VKA or ASA use, CHADS2 score was unrelated to VKA versus ASA treatment.


Assuntos
Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Fibrinolíticos/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Varfarina/uso terapêutico , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Fatores Sexuais , Estados Unidos
9.
J Thromb Thrombolysis ; 39(4): 508-15, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25371108

RESUMO

This retrospective analysis investigated the impact of baseline clinical characteristics, including atrial fibrillation (AF), on hospital discharge status (to home or continuing care), mortality, length of hospital stay, and treatment costs in patients hospitalized for stroke. The analysis included adult patients hospitalized with a primary diagnosis of ischemic or hemorrhagic stroke between January 2006 and June 2011 from the premier alliance database, a large nationally representative database of inpatient health records. Patients included in the analysis were categorized as with or without AF, based on the presence or absence of a secondary listed diagnosis of AF. Irrespective of stroke type (ischemic or hemorrhagic), AF was associated with an increased risk of mortality during the index hospitalization event, as well as a higher probability of discharge to a continuing care facility, longer duration of stay, and higher treatment costs. In patients hospitalized for a stroke event, AF appears to be an independent risk factor of in-hospital mortality, discharge to continuing care, length of hospital stay, and increased treatment costs.


Assuntos
Fibrilação Atrial , Isquemia Encefálica , Hemorragia Cerebral , Bases de Dados Factuais , Alta do Paciente/economia , Acidente Vascular Cerebral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/complicações , Fibrilação Atrial/economia , Fibrilação Atrial/mortalidade , Fibrilação Atrial/terapia , Isquemia Encefálica/complicações , Isquemia Encefálica/economia , Isquemia Encefálica/mortalidade , Isquemia Encefálica/terapia , Hemorragia Cerebral/complicações , Hemorragia Cerebral/economia , Hemorragia Cerebral/mortalidade , Hemorragia Cerebral/terapia , Custos e Análise de Custo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/economia , Acidente Vascular Cerebral/mortalidade , Acidente Vascular Cerebral/terapia , Estados Unidos/epidemiologia
10.
Eur Heart J ; 35(28): 1881-7, 2014 Jul 21.
Artigo em Inglês | MEDLINE | ID: mdl-24353282

RESUMO

AIMS: An increased risk of stroke was observed in two atrial fibrillation (AF) trials of oral factor Xa inhibitors, when patients were transitioned to open label warfarin at the end of the study. The objective of this study is to determine whether initiation of warfarin is associated with an increased risk of stroke in patients with AF. METHODS AND RESULTS: Using the UK Clinical Practice Research Datalink, a nested case-control analysis was conducted within a cohort of 70 766 patients with AF between 1993 and 2008. Stroke cases were randomly matched with up to 10 controls on age, sex, date of AF diagnosis, and time since AF diagnosis. Conditional logistic regression was used to estimate adjusted rate ratios (RRs) with 95% confidence intervals (CIs) of stroke associated with current warfarin use classified according to time since initiation of treatment (<30 days, 31-90 days, and >90 days), when compared with non-use. A total of 5519 patients experienced a stroke during follow-up. Warfarin was associated with a 71% increased risk of stroke in the first 30 days of use (RR: 1.71, 95% CI: 1.39-2.12), while decreased risks were observed with initiation >30 days before the event (31-90 days: RR: 0.50, 95% CI: 0.34-0.75 and >90 days: RR: 0.55, 95% CI: 0.50-0.61, respectively). CONCLUSION: Patients initiating warfarin may be at an increased risk of stroke during the first 30 days of treatment, supporting the biological plausibility of a transient hypercoagulable state at the start of the treatment, although additional studies are needed to confirm these findings.


Assuntos
Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Isquemia Encefálica/induzido quimicamente , Acidente Vascular Cerebral/induzido quimicamente , Varfarina/efeitos adversos , Idoso , Isquemia Encefálica/prevenção & controle , Estudos de Casos e Controles , Substituição de Medicamentos , Inibidores do Fator Xa/uso terapêutico , Feminino , Humanos , Masculino , Fatores de Risco , Acidente Vascular Cerebral/prevenção & controle , Fatores de Tempo
11.
Artigo em Inglês | MEDLINE | ID: mdl-38351719

RESUMO

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.

12.
Semin Arthritis Rheum ; 64: 152240, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37500379

RESUMO

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.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Neoplasias Pulmonares , Linfoma , Humanos , Abatacepte/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Artrite Reumatoide/induzido quimicamente , Neoplasias Pulmonares/tratamento farmacológico , Linfoma/induzido quimicamente , Linfoma/tratamento farmacológico , Marketing , Produtos Biológicos/uso terapêutico
13.
Semin Arthritis Rheum ; 64: 152313, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38044241

RESUMO

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.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Infecções Oportunistas , Tuberculose , Humanos , Abatacepte/efeitos adversos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/epidemiologia , Infecções Oportunistas/induzido quimicamente , Infecções Oportunistas/epidemiologia , Produtos Biológicos/efeitos adversos , Tuberculose/induzido quimicamente , Tuberculose/epidemiologia , Marketing
14.
Int J Psychol ; 48(4): 704-14, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-22963727

RESUMO

The aim of this study was to analyze whether one of the supposed gains of aging--positive bias--discriminates between young and older participants to the same extent as some of the losses in cognitive performance--recall and source monitoring--that come with age. Two age groups (N = 120)--young (M = 22.08, SD = 3.30) and older (M = 72.78, SD = 6.57)--carried out three tasks with varying levels of difficulty that included recall, recognition, and source monitoring using pictures, faces, and personal descriptors exchanged in a conversation as stimuli. The results of the discriminant analysis performed on 20 dependent variables indicated that six of them were key in discriminating between young and older participants. Younger participants outperformed older participants in recalling pictures, and in recognizing the descriptors exchanged in a conversation, as well as in monitoring their source. Just as important in discriminating between the two groups were the ability to recognize previously seen pictures, the likability rating they produced, and the recognition of faces with positive expressions--all superior in older participants. Thus, variables related to a positive bias--likability ratings and recognition of positive expressions--characterize the differences as a function of age as well as variables related to cognitive performance, such as recall and source monitoring. In addition, the likability ratings evoked by both pictures and faces were also significantly higher in the older participants with better cognitive performance than in those who performed poorly. This effect was not present in younger participants. The results are interpreted within the framework of socioemotional selectivity theory as evidence for a positive bias in old age. The connection between a positive bias and the maintenance of cognitive performance is also discussed.


Assuntos
Envelhecimento/psicologia , Cognição , Rememoração Mental , Reconhecimento Psicológico , Adulto , Idoso , Envelhecimento/fisiologia , Análise Discriminante , Emoções , Face , Feminino , Humanos , Masculino
15.
Aten Primaria ; 45(8): 418-25, 2013 Oct.
Artigo em Espanhol | MEDLINE | ID: mdl-23856134

RESUMO

OBJECTIVES: To design and validate a questionnaire for young women on gender-determinant factors in contraception. METHOD: A questionnaire was developed from conversations with young women attending contraception clinic in the Health Promotion Municpal Centre, Zaragoza. A total of 200 young women between the ages of 13 and 24 self-completed the questionnaire, with only one no response. Several items were analysed: reliability, using Cronbach's alpha coefficient, and construct validity by analysis of the main components with eigenvalues above 1, and Quartimax rotation with Kaiser normalisation. RESULTS: The questionnaire contained 36 items and took 10minutes to self-complete. There was good internal consistency, with a Cronbach's alpha 0,853. Twelve factors were established with an explanation of 61.42% variance, and three descriptive lines: relationship dimension («submissive attitude¼, «blind attitude¼, «let go due to affection¼, «dominant partner¼), gender identity («maternity as identity¼, «non-idealised maternity¼, «traditional role¼, «insecurity¼, «shame¼) and caring. CONCLUSIONS: This questionnaire enabled gender determinant-factors that take part in contraception to be identified, and will be useful to find out how the different ways of relating between the sexes influence the problems of sexual and reproductive health in young women in our environment.


Assuntos
Comportamento Contraceptivo/psicologia , Inquéritos e Questionários , Adolescente , Feminino , Humanos , Fatores Sexuais , Adulto Jovem
16.
Drug Healthc Patient Saf ; 15: 25-38, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36742440

RESUMO

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.

17.
Semin Arthritis Rheum ; 62: 152249, 2023 10.
Artigo em Inglês | MEDLINE | ID: mdl-37573754

RESUMO

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.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Humanos , Artrite Reumatoide/terapia , Antirreumáticos/uso terapêutico , Resultado do Tratamento , Produtos Biológicos/uso terapêutico , Estudos Multicêntricos como Assunto
18.
Arthritis Res Ther ; 25(1): 101, 2023 06 12.
Artigo em Inglês | MEDLINE | ID: mdl-37308978

RESUMO

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.


Assuntos
Antirreumáticos , Artrite Reumatoide , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Abatacepte , Inibidores do Fator de Necrose Tumoral , Sistema de Registros
19.
Am J Ther ; 19(5): 330-7, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22964558

RESUMO

Compared with usual practice, clinical trials often exclude patients with relative contraindications. A study of real-world warfarin use could help inform trials of new medications that could potentially replace warfarin. The objective of this study was to describe potential barriers to warfarin use among patients with atrial fibrillation. This was a retrospective study of electronic medical records (1998-2007) from an inner-city public hospital and affiliated primary care clinics and included adults aged 18 years or more with atrial fibrillation. Exclusions included mitral or aortic valve replacement, hyperthyroidism, or no clinical encounter within 1 year after first diagnosis. Warfarin exposure was defined by electronic pharmacy or physician order data or, in a second definition, international normalized ratio > 1.3. A history of potential barriers to warfarin was defined by International Classification of Diagnoses, 9th revision codes or electronic medical record "dictionary" terms. Among 3329 patients, CHADS2 scores were 0 (17%), 1 (26%), 2-6 (57%). Among 1276 patients with CHADS2 scores >0 who were prescribed warfarin, rates of potential barriers to warfarin were gastrointestinal or genitourinary hemorrhage (20%), alcohol abuse (16%), renal insufficiency (15%), predisposition to falls (8%), cirrhosis/hepatitis (5%), intracranial hemorrhage (1%), other hemorrhage (6%), and age 75 years or more (23%). Among 1475 patients with CHADS2 scores >0 who were not prescribed warfarin, these rates differed by not >3% except for predisposition to falls (16%) and age 75 years or more (43%). In real-world practice, many patients given warfarin have contraindications that would exclude them from clinical trials, and many patients apparently eligible for warfarin do not receive it.


Assuntos
Anticoagulantes/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Varfarina/uso terapêutico , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Estudos de Coortes , Registros Eletrônicos de Saúde/estatística & dados numéricos , Feminino , Seguimentos , Humanos , Coeficiente Internacional Normatizado , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores de Risco , Varfarina/efeitos adversos
20.
BMC Cardiovasc Disord ; 12: 49, 2012 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-22734842

RESUMO

BACKGROUND: As the management of patients treated with anticoagulants and antiplatelet drugs entails balancing coagulation levels, we evaluated the net clinical benefit of warfarin and aspirin on stroke in a large cohort of patients with atrial fibrillation (AF). METHODS: A population-based cohort study of all patients at least 18 years of age with a first-ever diagnosis of chronic AF during the period 1993-2008 was conducted within the United Kingdom General Practice Research Database. A nested case-control analysis was conducted to estimate the risk of ischemic stroke and intracranial hemorrhage associated with the use of warfarin and aspirin. Cases were matched up to 10 controls on age, sex, and date of cohort entry. The adjusted net clinical benefit of warfarin and aspirin (expressed as the number of strokes prevented per 100 persons per year) was calculated by subtracting the ischemic stroke rate (prevented by therapy) from the intracranial hemorrhage (ICH) rate (increased by therapy). RESULTS: The cohort included 70,766 patients newly-diagnosed with chronic AF, of whom 5519 experienced an ischemic stroke and 689 an ICH during follow-up. The adjusted net clinical benefit of warfarin was 0.59 (95% CI: 0.45, 0.73). However, the benefit was not seen for patients below (0.08, 95%: -0.38, 0.54) and above (-0.49, 95% CI: -1.13, 0.15) therapeutic range. The net clinical benefit of warfarin, apparent after 3 months of continuous use, increased as a function of CHADS2 score. The net clinical benefit was not significant with aspirin (-0.07, 95% CI: -0.22, 0.08), though it was seen in certain subgroups. CONCLUSIONS: Warfarin provides a net clinical benefit in patients with atrial fibrillation, which is maintained with longer duration of use, particularly when used within therapeutic range. A similar net effect is not as clear with aspirin.


Assuntos
Anticoagulantes/uso terapêutico , Aspirina/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Inibidores da Agregação Plaquetária/uso terapêutico , Serviços Preventivos de Saúde , Acidente Vascular Cerebral/prevenção & controle , Varfarina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/efeitos adversos , Aspirina/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/mortalidade , Doença Crônica , Bases de Dados Factuais , Feminino , Medicina Geral , Humanos , Hemorragias Intracranianas/induzido quimicamente , Modelos Logísticos , Masculino , Razão de Chances , Inibidores da Agregação Plaquetária/efeitos adversos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento , Reino Unido/epidemiologia , Varfarina/efeitos adversos
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