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This guideline will provide up-to-date, evidence-based recommendations on the safe use of non-biologic DMARDs, also called conventional synthetic DMARDs (csDMARD), across the full spectrum of autoimmune rheumatic diseases. The guideline will update the guideline published in 2017 and will be expanded to include people of all ages. Updated information on the monitoring of DMARDs and vaccinations will be included. The guideline will be developed using the methods and processes described in the British Society for Rheumatology's 'Creating clinical guidelines: our protocol', updated 2023.
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OBJECTIVES: The National Health Service in England funds 12 months of weekly subcutaneous tocilizumab (qwTCZ) for patients with relapsing or refractory giant cell arteritis (GCA). During the COVID-19 pandemic, some patients were allowed longer treatment. We sought to describe what happened to patients after cessation of qwTCZ. METHODS: Multicentre service evaluation of relapse after stopping qwTCZ for GCA. The log-rank test was used to identify significant differences in time to relapse. RESULTS: 336 GCA patients were analysed from 40 centres, treated with qwTCZ for a median (interquartile range, IQR) of 12 (12-17) months. At time of stopping qwTCZ, median (IQR) prednisolone dose was 2 (0-5) mg/day. By 6, 12 and 24 months after stopping qwTCZ, 21.4%, 35.4% and 48.6% respectively had relapsed, requiring an increase in prednisolone dose to a median (IQR) of 20 (10-40) mg/day. 33.6% of relapsers had a major relapse as defined by EULAR. Time to relapse was shorter in those that had previously also relapsed during qwTCZ treatment (P = 0.0017); in those not in remission at qwTCZ cessation (P = 0.0036); and in those with large vessel involvement on imaging (P = 0.0296). Age ≥65, gender, GCA-related sight loss, qwTCZ treatment duration, TCZ taper, prednisolone dosing, and conventional synthetic DMARD use were not associated with time to relapse. CONCLUSION: Up to half our patients with GCA relapsed after stopping qwTCZ, often requiring a substantial increase in prednisolone dose. One third of relapsers had a major relapse. Extended use of TCZ or repeat treatment for relapse should be considered for these patients.
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BACKGROUND: There has been extensive research into adverse childhood experiences (ACEs), however, less consideration has been given to the prevalence and impact of ACEs for staff working with people with intellectual disabilities. METHOD: Participants were staff employed by agencies that care for people with intellectual disabilities. An online survey collected demographic information and measures of ACEs, resilience, trauma-informed organisational climate, burnout and secondary traumatic stress. Correlation, regression, mediation and moderation analyses were used. RESULTS: 81.7% of 109 participants had experienced at least one ACE. Burnout, secondary traumatic stress and resilience were greater in the present study than in comparable samples. Trauma-informed organisational climate significantly predicted burnout and secondary traumatic stress. Resilience significantly predicted burnout. CONCLUSIONS: Staff working with people with intellectual disabilities are likely to have experienced ACEs. Working in a trauma-informed organisational climate and resilience may be effective avenues for reducing burnout and secondary traumatic stress.
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OBJECTIVE: To systematically review papers reporting the prevalence of adverse childhood experiences (ACEs) in health and social care workers, as well as any personal or professional factors they were associated with. METHOD: CINAHL, EMCARE, PsychInfo, and Medline were searched to find studies utilizing the ACE questionnaire (Felitti et al., 1998) in health and social care worker populations. RESULTS: The initial search returned 1,764 papers, with 17 studies meeting the inclusion criteria to be in the review. CONCLUSIONS: ACEs among health and social care workers were frequently reported and occurred more often than in the general population. They were also associated with several personal and professional outcomes, including poor physical and mental health, and workplace stress. Understanding staff ACE characteristics can help organizations to consider ways to support staff, which may be individual or systemic. Trauma-responsive systems may be a possible answer among organizations to improve staff well-being, quality of service, and better outcomes for service users. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Experiencias Adversas de la Infancia , Humanos , Prevalencia , Personal de Salud , Salud Mental , Apoyo SocialRESUMEN
With ever increasing recognition and diagnosis of autism spectrum disorders (ASD) in children within mainstream schooling, there was a need for City and Hackney Child and Adolescent Mental Health Services to develop innovative interventions to meet the needs of a large client group, with limited clinician resource. The importance of psychoeducation about ASD for parents of children recently diagnosed is understood; however, feedback from our service users highlighted the additional need for ongoing access to a network of professional support. Using quality improvement (QI) methodology, we aimed to develop a sustainable regular group programme that was relevant for parents. The total number of parents attending each monthly group over a specific period of time was tracked (from February 2015 to May 2017). A service user questionnaire was devised to gain feedback from each group on parental confidence in managing a child with ASD and their satisfaction. These were given to parents at the end of each group. The Plan Do Study Act cycles were applied and evaluated in the QI framework to assess the impact of the following change ideas: letter reminders, a focus group, an email information and reminder system, and a parent co-lead group. Overall, attendance at the monthly groups increased and remained stable. Satisfaction with the groups was high (eg, 91% of the attendees were either 'Quite Satisfied' or 'Extremely Satisfied'). Of those attending, 82% reported increases in their own confidence in managing their child with ASD. The QI approach allowed us to systematically develop efficient systems and cost-effective ways to run interventions within our ASD pathway. Parents reported high levels of satisfaction with the groups and increased confidence in their ability to parent their child with ASD.
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Trastorno del Espectro Autista/terapia , Servicios de Salud Comunitaria/métodos , Educación/métodos , Instituciones Académicas/tendencias , Adolescente , Trastorno del Espectro Autista/complicaciones , Trastorno del Espectro Autista/psicología , Niño , Servicios de Salud Comunitaria/estadística & datos numéricos , Educación/estadística & datos numéricos , Femenino , Humanos , Masculino , Instituciones Académicas/estadística & datos numéricos , Encuestas y CuestionariosRESUMEN
Objective: The aim of this study was to compare the incidence of cancer and all-cause and cause-specific mortality rates among a cohort of patients with severe PsA receiving TNF inhibitor (TNFi) with those of the general UK population. Methods: Cancers and deaths were identified from the national cancer and the national death registers in patients with PsA included in the British Society for Rheumatology Biologics Register from start of TNFi until 31 December 2012. Standardized incidence ratios (SIRs) and standardized mortality ratios (SMRs) were calculated using published cancer and death rates for the general population. SIRs were calculated for both overall cancer risk and non-melanoma skin cancer. SMRs were calculated for (1) all-cause mortality, (2) death from malignancy and (3) death from circulatory disease. Gender-specific analyses were also performed. Results: Thirty-four cancers and 41 deaths among 709 patients were observed. The risk of malignancy overall was not increased (SIR 0.94; 95% CI: 0.65, 1.34). However, there was a significantly increased incidence of non-melanoma skin cancer (SIR 2.12; 95% CI: 1.19, 3.50). The all-cause mortality rate in our cohort was increased (SMR 1.56; CI: 1.12, 2.11). Death from malignancy was not increased, but death from coronary heart disease was increased (SMR 2.42; 95% CI: 1.11, 4.59). Conclusion: In our cohort of patients with severe PsA, the overall incidence of malignancy was similar to that of the general population, although the incidence of non-melanoma skin cancer was increased. All-cause mortality was significantly increased, in part due to excess of deaths attributed to coronary heart disease.
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Antirreumáticos/efectos adversos , Artritis Psoriásica/mortalidad , Productos Biológicos/efectos adversos , Neoplasias/mortalidad , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adulto , Anciano , Artritis Psoriásica/tratamiento farmacológico , Causas de Muerte , Enfermedad Coronaria/inducido químicamente , Enfermedad Coronaria/mortalidad , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Neoplasias/inducido químicamente , Sistema de Registros , Neoplasias Cutáneas/inducido químicamente , Neoplasias Cutáneas/mortalidad , Reino Unido/epidemiologíaRESUMEN
OBJECTIVE: To explore the differences in access to, and outcomes of, psychological therapy for different ethnic groups across a South London Mental Health Trust. METHOD: This study used Trust data to explore the proportions of ethnic groups accessing psychological therapy as a proportion of all patients supported by the Trust, as well as their outcomes within broad diagnostic clusters. RESULTS: Compared to proportions in the local population, there were significantly more White/White British patients and significantly fewer patients from 'other ethnic groups' in the Trust (p < .05). There was also significantly greater proportion of Black/Black British patients with schizophrenia diagnoses compared to the proportion of Black/Black British people in the local population (p < .001). Of those accessing psychological therapy, there were significantly more White/White British and 'other ethnic group' patients and significantly fewer Black/Black British patients (p < .05). For schizophrenia diagnoses, significantly fewer Black/Black British and 'other ethnic group' patients were accessing psychological therapy (p < .05); however for behavioural and emotional disorders, there were significantly higher proportions of 'other ethnic group' and White/White British patients. Outcomes varied by diagnosis; Black/Black British patients experienced significantly higher distress scores at the beginning of therapy for depression and neurotic diagnoses (p < .05), with the latter persisting at the end of treatment. CONCLUSIONS: Across the Trust, there were significant differences in the proportion of ethnic groups in accessing psychological therapy, as well as in outcomes. More research is needed to understand the factors that may underlie these disparities.
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Población Negra/estadística & datos numéricos , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Trastornos Mentales/terapia , Servicios de Salud Mental , Psicoterapia/estadística & datos numéricos , Población Blanca/estadística & datos numéricos , Adulto , Trastornos de Ansiedad/psicología , Trastornos de Ansiedad/terapia , Población Negra/psicología , Servicios Comunitarios de Salud Mental , Trastorno Depresivo/psicología , Trastorno Depresivo/terapia , Etnicidad/psicología , Etnicidad/estadística & datos numéricos , Femenino , Humanos , Londres , Masculino , Trastornos Mentales/psicología , Trastornos Neuróticos/psicología , Trastornos Neuróticos/terapia , Distrés Psicológico , Esquizofrenia/terapia , Atención Secundaria de Salud , Población Blanca/psicologíaRESUMEN
BACKGROUND: Lymphomas comprise a heterogeneous group of malignant diseases with highly variable prognosis. Rheumatoid arthritis (RA) is associated with a twofold increased risk of both Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL). It is unknown whether treatment with biologic disease-modifying antirheumatic drugs (bDMARDs) affect the risk of specific lymphoma subtypes. METHODS: Patients never exposed to (bionaïve) or ever treated with bDMARDs from 12 European biologic registers were followed prospectively for the occurrence of first ever histologically confirmed lymphoma. Patients were considered exposed to a bDMARD after having received the first dose. Lymphomas were attributed to the most recently received bDMARD. RESULTS: Among 124 997 patients (mean age 59 years; 73.7% female), 533 lymphomas were reported. Of these, 9.5% were HL, 83.8% B-cell NHL and 6.8% T-cell NHL. No cases of hepatosplenic T-cell lymphoma were observed. Diffuse large B-cell lymphoma (DLBCL) was the most frequent B-cell NHL subtype (55.8% of all B-cell NHLs). The subtype distributions were similar between bionaïve patients and those treated with tumour necrosis factor inhibitors (TNFi). For other bDMARDs, the numbers of cases were too small to draw any conclusions. Patients with RA developed more DLBCLs and less chronic lymphocytic leukaemia compared with the general population. CONCLUSION: This large collaborative analysis of European registries has successfully collated subtype information on 533 lymphomas. While the subtype distribution differs between RA and the general population, there was no evidence of any modification of the distribution of lymphoma subtypes in patients with RA treated with TNFi compared with bionaïve patients.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Linfoma/epidemiología , Linfoma/etiología , Europa (Continente)/epidemiología , Femenino , Humanos , Linfoma/patología , Linfoma de Células B/epidemiología , Linfoma de Células B/etiología , Linfoma no Hodgkin/epidemiología , Linfoma no Hodgkin/etiología , Linfoma de Células T/epidemiología , Linfoma de Células T/etiología , Masculino , Persona de Mediana Edad , Sistema de Registros , Factores de Riesgo , Inhibidores del Factor de Necrosis TumoralRESUMEN
OBJECTIVE: To investigate the effectiveness of psychological therapy in reducing psychological distress for adults with autism spectrum conditions (ASC) and co-morbid mental health conditions in routine clinical practice. To explore the effect of individual characteristics and service factors on change in general distress. METHOD: In a specialist psychological therapies service for adults with ASC, the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) self-report questionnaire of psychological distress is completed by clients at start and end of therapy. Change over time and reliable and clinical change was assessed for 81 of a total of 122 clients (66.4%). Factors which may influence change over time were explored using available clinical information. RESULTS: Overall, there was a significant reduction in CORE-OM score during therapy with a small effect size. Most clients showed an improvement in psychological distress over therapy (75.4% improved, with 36.9% of these showing reliable changes). Significant and comparable reductions from pre-therapy to post-therapy were seen across the sample, showing that individual differences did not mediate therapy effectiveness. CORE-OM scores mediate the association between age of ASD diagnosis and hours of therapeutic input required, with greater age at diagnosis and higher distress associated with longer therapy duration. CONCLUSIONS: Our preliminary findings suggest that psychological therapy may be effective in reducing general distress for clients with ASC and co-morbid mental health conditions and should be routinely offered. Individuals who are diagnosed with ASD in adulthood are likely to require a longer course of therapy when their general distress scores are high.
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Trastorno del Espectro Autista/complicaciones , Trastorno del Espectro Autista/psicología , Psicoterapia/métodos , Estrés Psicológico/complicaciones , Estrés Psicológico/terapia , Adulto , Femenino , Humanos , Masculino , Trastornos Mentales/complicaciones , Trastornos Mentales/psicología , Trastornos Mentales/terapia , Psicometría , Estrés Psicológico/psicología , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
OBJECTIVES: Patients with rheumatoid arthritis (RA) are at increased risk of myocardial infarction (MI) compared with subjects without RA, with the increased risk driven potentially by inflammation. Tumour necrosis factor inhibitors (TNFi) may modulate the risk and severity of MI. We compared the risk and severity of MI in patients treated with TNFi with that in those receiving synthetic disease-modifying antirheumatic drugs (sDMARDs). METHODS: This analysis included patients with RA recruited from 2001 to 2009 to the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis starting TNFi (etanercept/infliximab/adalimumab) and a biologic-naïve comparator cohort receiving sDMARD. All patients were followed via physician and patient questionnaires and national death register linkage. Additionally, all patients were linked to the Myocardial Ischaemia National Audit Project, a national registry of hospitalisations for MI. Patients were censored at first verified MI, death, 90â days following TNFi discontinuation, last physician follow-up or 20 April 2010, whichever came first. The risk of first MI was compared between cohorts using COX regression, adjusted with propensity score deciles (PD). MI phenotype and severity were compared using descriptive statistics. 6-month mortality post MI was compared using logistic regression. RESULTS: 252 verified first MIs were analysed: 58 in 3058 patients receiving sDMARD and 194 in 11â 200 patients receiving TNFi (median follow-up per person 3.5â years and 5.3â years, respectively). The PD-adjusted HR of MI in TNFi referent to sDMARD was 0.61 (95% CI 0.41 to 0.89). No statistically significant differences in MI severity or mortality were observed between treatment groups. CONCLUSIONS: Patients with RA receiving TNFi had a decreased risk of MI compared with patients with RA receiving sDMARD therapy over the medium term. This might be attributed to a direct action of TNFi on the atherosclerotic process or better overall disease control.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Infarto del Miocardio/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab/uso terapéutico , Adulto , Anciano , Etanercept/uso terapéutico , Femenino , Humanos , Incidencia , Infliximab/uso terapéutico , Masculino , Persona de Mediana Edad , Infarto del Miocardio/mortalidad , Índice de Severidad de la Enfermedad , Reino Unido/epidemiologíaRESUMEN
OBJECTIVES: Patients with rheumatoid arthritis (RA) are at increased risk of lymphoma compared with the general population. There are concerns that tumour necrosis factor inhibitors (TNFi) may exacerbate this risk. However, since the excess risk of lymphoma in RA is related to the cumulative burden of inflammation, TNFi may conversely reduce the risk of lymphoma by decreasing the burden of inflammation. The aim of this study was to compare the risk of lymphoma in subjects with RA treated with TNFi with those treated with non-biological therapy. METHODS: Subjects diagnosed by a rheumatologist with RA enrolled in the British Society for Rheumatology Rheumatoid Arthritis Register (BSRBR-RA), a prospective cohort study, were followed until first lymphoma, death or until 30 November 2013. Rates of lymphoma in the TNFi and non-biological-treated cohorts were compared using Cox regression. RESULTS: 11â 931 TNFi-treated patients were compared with 3367 biological-naive patients. 84 lymphomas (88 (95% CI 70 to 109) per 100â 000 person-years) were reported in the TNFi cohort and 30 lymphomas (154 (95% CI 104 to 220)) in the biological-naive cohort. After adjusting for differences in baseline characteristics, there was no difference in the risk of lymphoma for the TNFi versus the biological-naive group: HR 1.00 (95% CI 0.56 to 1.80). No risk differences were observed for individual TNFi. CONCLUSIONS: In medium-term follow-up, there is no evidence that tumour necrosis factor inhibition influences the risk of lymphoma over the background risk in subjects with RA.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Linfoma/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab/uso terapéutico , Adulto , Anciano , Estudios de Casos y Controles , Etanercept/uso terapéutico , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Infliximab/uso terapéutico , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Sistema de Registros , Medición de Riesgo , Reino Unido/epidemiologíaRESUMEN
OBJECTIVES: Some studies have reported a possible association between exposure to tumour necrosis factor (TNF) inhibitors and an increased risk of melanoma. The aim of this study was to investigate the incidence of invasive cutaneous melanomas in patients with rheumatoid arthritis (RA) treated with TNF inhibitors (TNFi), other biologic disease modifying drugs and non-biologic therapy. METHODS: Eleven biologic registers from nine European countries participated in this collaborative project. According to predefined exposure definitions, cohorts of patients with RA were selected. Using the country-specific general population of each register as reference, age, sex and calendar year standardised incidence ratios (SIRs) of invasive histology-confirmed cutaneous melanoma were calculated within each register. Pooled SIR and incidence rate ratios (IRRs) comparing biologic cohorts to biologic-naïve were calculated across countries by taking the size of the register into account. RESULTS: Overall 130â 315 RA patients with a mean age of 58â years contributing 579â 983 person-years were available for the analysis and 287 developed a first melanoma. Pooled SIRs for biologic-naïve, TNFi and rituximab-exposed patients were 1.1 (95% CI 0.9 to 1.4), 1.2 (0.99 to 1.6) and 1.3 (0.6 to 2.6), respectively. Incidence rates in tocilizumab and abatacept-exposed patients were also not significantly increased. IRR versus biologic-naïve patients were: TNFi 1.1 (95% CI 0.8 to 1.6); rituximab 1.2 (0.5 to 2.9). CONCLUSIONS: This large European collaborative project did not confirm an overall increased risk of melanoma following exposure to TNFi.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Melanoma/epidemiología , Sistema de Registros , Neoplasias Cutáneas/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Abatacept/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/uso terapéutico , Productos Biológicos/uso terapéutico , Europa (Continente)/epidemiología , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Factores de Riesgo , Rituximab/uso terapéuticoRESUMEN
OBJECTIVE: Patients with rheumatoid arthritis (RA) are at an increased risk of ischemic stroke. Tumor necrosis factor inhibitors (TNFi) may influence risk and mortality after ischemic stroke by reducing inflammation. This study was undertaken to examine the association of TNFi with the risk of incident ischemic stroke and with 30-day and 1-year mortality after ischemic stroke. METHODS: Patients with RA starting therapy with TNFi and a biologics-naive comparator group treated with synthetic disease-modifying antirheumatic drugs (DMARDs) only were recruited to the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis from 2001 to 2009. Patients were followed up via clinical and patient questionnaires as well as the national death register. Incident strokes were classified as ischemic if brain imaging reports suggested ischemia or if ischemic stroke was reported as the underlying cause of death on a death certificate. Patients with a previous stroke were excluded. Risk of ischemic stroke was compared between patients receiving synthetic DMARDs only and those ever-exposed to TNFi using a Cox proportional hazards regression model adjusted for potential confounders. Mortality after ischemic stroke was compared between synthetic DMARD-treated patients and TNFi-treated patients using logistic regression, adjusted for age and sex. RESULTS: To April 2010, 127 verified incident ischemic strokes (21 in 3,271 synthetic DMARD-treated patients and 106 in 11,642 TNFi-treated patients) occurred during 11,973 and 61,226 person-years of observation, respectively (incidence rate 175 versus 173 per 100,000 person-years). After adjustment for confounders, there was no association between ever-exposure to TNFi and ischemic stroke (hazard ratio 0.99 [95% confidence interval (95% CI) 0.54-1.81]). Mortality 30 days or 1 year after ischemic stroke was not associated with concurrent TNFi exposure (odds ratio 0.18 [95% CI 0.03-1.21] and 0.60 [95% CI 0.16-2.28], respectively). CONCLUSION: Exposure to TNFi does not appear to influence the occurrence of ischemic stroke in the medium term in patients with RA. The impact on mortality after ischemic stroke remains inconclusive.
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Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Isquemia Encefálica/inducido químicamente , Accidente Cerebrovascular/inducido químicamente , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Isquemia Encefálica/mortalidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Medición de Riesgo , Accidente Cerebrovascular/mortalidadRESUMEN
Most individuals with schizophrenia suffer some cognitive dysfunction: such deficits are predictive of longer-term functioning; and current dopamine-blocking antipsychotics have made little impact on this domain. There is a pressing need to develop novel pharmacological agents to tackle this insidious but most disabling of problems. The acetylcholinergic system is involved in cognitive and attentional processing, and its metabotropic and nicotinic receptors are widespread throughout the brain. Deficits in acetylcholinergic functioning occur in schizophrenia, and high rates of tobacco smoking have been posited to represent a form of self-medication. The nicotinic acetylcholine receptor (nAChR) has emerged as a putative target to improve cognitive deficits in schizophrenia, and this study systematically reviewed the emerging data. Nineteen studies were identified, covering three compound classes: agonists at the α7 and α 4ß2 nAChRs, and positive allosteric modulators. Overall data are underwhelming: some studies showed significant improvements in cognition but as many studies had negative findings. It remains unclear if this represents drug limitations or nascent study methodology problems. The literature is particularly hindered by variability in inclusion of smokers, generally small sample sizes, and a lack of consensus on cognitive test batteries. Future work should evaluate longer-term outcomes, and, particularly, the effects of concomitant cognitive training.
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Antipsicóticos/uso terapéutico , Trastornos del Conocimiento/tratamiento farmacológico , Receptores Nicotínicos/metabolismo , Esquizofrenia/tratamiento farmacológico , Adolescente , Regulación Alostérica/efectos de los fármacos , Encéfalo/efectos de los fármacos , Encéfalo/metabolismo , Cognición/efectos de los fármacos , Trastornos del Conocimiento/metabolismo , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Esquizofrenia/metabolismoRESUMEN
BACKGROUND: Patients with rheumatoid arthritis (RA) have an increased risk of certain solid cancers, in particular lung cancer, compared to the general population. Treatment with tumour necrosis factor (TNF) inhibitors (TNFi) may further enhance this risk. OBJECTIVES: To compare the risk of solid cancer in patients with RA treated with TNFi to that in patients treated with non-biologic (synthetic) disease modifying antirheumatic drugs (sDMARDs). METHODS: Patients with a physician diagnosis of RA enrolled in the British Society for Rheumatology Biologics Register, a national prospective cohort study established in 2001 to monitor the long-term safety of TNFi, were followed via record linkage with the national cancer registries until first solid cancer, death, for 5â years, or until 2011. Rates of solid cancers in 11â 767 patients without prior cancer who received TNFi were compared to those in 3249 patients without prior cancer treated with sDMARDs. RESULTS: 427 solid cancers were reported in 52â 549 patient-years follow-up for the TNFi group (81 (95% CI 74 to 89) per 10â 000 patient-years) and 136 cancers were reported in 11â 672 patient-years in the sDMARD cohort (117 (95% CI 98 to 138) per 10â 000 patient-years). After adjusting for differences in baseline characteristics there was no difference in risk of solid cancer for TNFi compared to sDMARD treated patients: HR 0.83 (95% CI 0.64 to 1.07). There was no difference in the relative risk of cancer for any of the individual TNFi drugs. CONCLUSIONS: The addition of TNFi to sDMARD does not alter the risk of cancer in RA patients selected for TNFi in the UK.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales/uso terapéutico , Antirreumáticos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Inmunoglobulina G/uso terapéutico , Metotrexato/uso terapéutico , Neoplasias/epidemiología , Receptores del Factor de Necrosis Tumoral/uso terapéutico , Sistema de Registros , Adalimumab , Adulto , Anciano , Artritis Reumatoide/epidemiología , Neoplasias de la Mama/epidemiología , Estudios de Cohortes , Neoplasias Colorrectales/epidemiología , Etanercept , Femenino , Humanos , Infliximab , Neoplasias Pulmonares/epidemiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Fumar/epidemiología , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Reino Unido/epidemiologíaRESUMEN
OBJECTIVES: To evaluate the risk of gastrointestinal perforation (GIP) in subjects with rheumatoid arthritis (RA) treated with antitumour necrosis factor (anti-TNF) therapy compared with non-biological disease-modifying antirheumatic drugs (nbDMARDs). METHODS: Using data from the British Society for Rheumatology Biologics Register, we compared the incidence of GIPs between 11 881 anti-TNF-treated and 3393 nbDMARD-treated RA patients using Cox regression modelling. Hazard ratios (HRs) with confidence intervals (CI) were calculated. Adjustment was made for potential confounders including current steroid use. The study covered the time period between 2001 and 2011. RESULTS: There were 42 (upper 20, lower 22) GI perforations: five in the nbDMARD cohort and 37 in the anti-TNF cohort. After adjustment, treatment with TNF antagonists was associated with an HR of 1.6 (95% CI 0.4 to 6.0) for all GIPs, 2.7 (95% CI 0.4 to 18.1) for lower GIPs and 0.9 (95% CI 0.1 to 5.8) for upper GIPs. Current use of steroids was the single most important predictor of GI perforation with an adjusted HR of 2.9 (95% CI 1.5 to 5.4), but this risk was confined to lower GIPs (HR 8.0, 95% CI 2.6 to 24.1). CONCLUSIONS: We have not found a statistically significant association between anti-TNF treatment and the risk of GIP.
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Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/epidemiología , Inmunosupresores/efectos adversos , Perforación Intestinal/epidemiología , Gastropatías/epidemiología , Adulto , Anciano , Antirreumáticos/administración & dosificación , Femenino , Humanos , Inmunosupresores/administración & dosificación , Incidencia , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Sistema de Registros/estadística & datos numéricos , Factores de Riesgo , Factor de Necrosis Tumoral alfa/antagonistas & inhibidoresRESUMEN
OBJECTIVES: To quantify the risk of cancer and compare it with that for the general population in a modern cohort of UK patients with RA and to identify risk factors for cancer among this cohort. METHODS: The study population comprised biologic-naïve RA subjects receiving non-biologic disease-modifying therapy recruited to the British Society for Rheumatology Biologics Register from 2002 to 2009. Standardized incidence ratios (SIRs) for cancers were calculated using age- and gender-specific cancer rates in the English population. Poisson regression models adjusted for age and gender using England general population data were used to determine the association of other predictors with incident malignancy. RESULTS: The cohort comprised 3771 individuals with RA contributing 13 315 person-years of follow-up. One hundred and eighty-two cancers were reported: 156 solid and 26 myelo- or lymphoproliferative cancers. The overall SIR was 1.28 (95% CI 1.10, 1.48). Risks of lung cancer (SIR 2.39, 95% CI 1.75, 3.19), Hodgkin lymphoma (SIR 12.82, 95% CI 4.16, 29.92) and non-Hodgkin lymphoma (SIR 3.12, 95% CI 1.79, 5.07) were higher compared with the general population and risks of prostate cancer (SIR 0.35, 95% CI 0.11, 0.82) and cancers of the female genital organs (SIR 0.35, 95% CI 0.10, 0.90) were reduced. Within the cohort, cancer risk was more than 2-fold higher in current or ex-smokers than in non-smokers. CONCLUSION: The overall incidence of cancer was increased in this national cohort of subjects with RA. The association of RA with certain cancers needs to be considered when studying the effects of biologic therapy, such as anti-TNF, on cancer risk.
Asunto(s)
Antirreumáticos/efectos adversos , Artritis Reumatoide/tratamiento farmacológico , Neoplasias/epidemiología , Adulto , Anciano , Anciano de 80 o más Años , Antirreumáticos/uso terapéutico , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Neoplasias/etiología , Sistema de Registros , Riesgo , Reino Unido/epidemiologíaAsunto(s)
Antirreumáticos/uso terapéutico , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Displasia del Cuello del Útero/epidemiología , Neoplasias del Cuello Uterino/epidemiología , Femenino , Humanos , Incidencia , Persona de Mediana Edad , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Neoplasias del Cuello Uterino/complicaciones , Displasia del Cuello del Útero/complicacionesRESUMEN
INTRODUCTION: Anti-tumour necrosis factor (TNF) therapy is a mainstay of treatment in rheumatoid arthritis (RA). In 2001, BSRBR was established to evaluate the safety of these agents. This paper addresses the safety of anti-TNF therapy in RA with specific reference to serious skin and soft tissue infections (SSSI) and shingles. METHODS: A cohort of anti-TNF-treated patients was recruited alongside a comparator group with active RA treated with non-biological disease-modifying antirheumatic drugs (nbDMARD). 11 881 anti-TNF and 3673 nbDMARD patients were analysed. Follow-up was by 6-monthly questionnaires to patients and clinicians. Analyses considered SSSI and shingles separately. Incidence rates (IR) were calculated and then compared using survival analyses. RESULTS: The crude IR for SSSI were: anti-TNF 1.6/100 patient-years (95% CI 1.4 to 1.8); nbDMARD 0.7/100 patient-years (95% CI 0.5 to 1.0) and shingles: anti-TNF 1.6/100 patient-years (95% CI 1.3 to 2.0); nbDMARD 0.8/100 patient-years (95% CI 0.6 to 1.1). Adjusted HR were SSSI 1.4 (95% CI 0.9 to 2.4), shingles 1.8 (95% CI 1.2 to 2.8). For SSSI, no significant differences were seen between anti-TNF agents. For shingles, the lowest risk was observed for adalimumab (adjusted HR vs nbDMARD) 1.5 (95% CI 1.1 to 2.0) and highest for infliximab (HR 2.2; 95% CI 1.4 to 3.4)). CONCLUSION: A significantly increased risk of shingles was observed in the anti-TNF-treated cohort. The risk of SSSI tended towards being greater with anti-TNF treatment but was not statistically significant. As with any observational dataset cause and effect cannot be established with certainty as residual confounding may remain. This finding would support the evaluation of zoster vaccination in this population.