Survival of TNF antagonists in spondylarthritis is better than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER

The aim of the present work is to compare drug survival and safety of infliximab, etanercept, and adalimumab (tumor necrosis factor [TNF] antagonists) in spondylarthritis (SpA) with those of rheumatoid arthritis (RA). To this purpose, we analysed the data in BIOBADASER (2000–2005), a drug registry launched in 2000 for long-term follow-up of the safety of these biologics in rheumatic diseases. The rates of drug discontinuation and adverse events (AEs) in SpA (n = 1,524) were estimated and compared with those of RA (n = 4,006). Cox regression analyses were used to adjust for independent factors. Total exposure to TNF antagonists for SpA was 2,430 patient-years and 7,865 for RA. Drug survival in SpA was significantly greater than in RA at 1, 2, and 3 years. The hazard ratio (HR) for discontinuation in SpA compared with RA was 0.66 (95% confidence interval [CI], 0.57–0.76) after adjustment for age, gender, and use of infliximab. The difference remained after controlling for the individual medication and its place in the sequence of treatment. There were fewer SpA patients with AEs (17%) than RA patients (26%; p < 0.001). The HR for AEs in SpA was 0.80 (95% CI, 0.70–0.91) compared with RA after adjustment for age, disease duration, and use of infliximab. In conclusion, due in part to a better safety profile, survival of TNF antagonists in SpA is better than in RA. TNF antagonists are at present a safe and effective therapeutic option for long-term treatment of patients with SpA failing to respond to traditional drugs. Because chronic therapy is necessary, continual review of this issue is necessary

Switching TNF antagonists in patients with chronic arthritis: an observational study of 488 patients over a four-year period

The objective of this work is to analyze the survival of infliximab, etanercept and adalimumab in patients who have switched among tumor necrosis factor (TNF) antagonists for the treatment of chronic arthritis. BIOBADASER is a national registry of patients with different forms of chronic arthritis who are treated with biologics. Using this registry, we have analyzed patient switching of TNF antagonists. The cumulative discontinuation rate was calculated using the actuarial method. The log-rank test was used to compare survival curves, and Cox regression models were used to assess independent factors associated with discontinuing medication. Between February 2000 and September 2004, 4,706 patients were registered in BIOBADASER, of whom 68% had rheumatoid arthritis, 11% ankylosing spondylitis, 10% psoriatic arthritis, and 11% other forms of chronic arthritis. One- and two-year drug survival rates of the TNF antagonist were 0.83 and 0.75, respectively. There were 488 patients treated with more than one TNF antagonist. In this situation, survival of the second TNF antagonist decreased to 0.68 and 0.60 at 1 and 2 years, respectively. Survival was better in patients replacing the first TNF antagonist because of adverse events (hazard ratio (HR) for discontinuation 0.55 (95% confidence interval (CI), 0.34–0.84)), and worse in patients older than 60 years (HR 1.10 (95% CI 0.97–2.49)) or who were treated with infliximab (HR 3.22 (95% CI 2.13–4.87)). In summary, in patients who require continuous therapy and have failed to respond to a TNF antagonist, replacement with a different TNF antagonist may be of use under certain situations. This issue will deserve continuous reassessment with the arrival of new medications

current clinical practice and available resources

Objective To assess European pediatric rheumatology providers’ current clinical practices and resources used in the transition from child-centered to adult-oriented care. Methods European pediatric rheumatologists were invited to complete a 17-item anonymized e-survey assessing current transition practices, transition policy awareness, and needs in advance of the publication of EULAR/PReS recommendations on transition. Results The response rate was 121/276 (44%), including responses from 115 centers in 22 European Union countries. Although 32/121 (26%) responded that their centers did not offer transition services, the majority (99%) agreed that a formalized process in transitioning patients to adult care is necessary. A minority (<30%) of respondents stated that they have a written transition policy although 46% have an informal transition process. Designated staff to support transitional care were available in a minority of centers: nurse (35%), physiotherapist (15%), psychologist (15%), social worker (8%), and occupational therapist (2%). The existence of a designated team member to coordinate transition was acknowledged in many centers (64% of respondents) although just 36% use a checklist for young people as part of individualized transitional care. Conclusion This survey of European pediatric rheumatology providers regarding transitional care practices demonstrates agreement that transitional care is important, and wide variation in current provision of transition services exists

Risk of tuberculosis in patients with chronic immune-mediated inflammatory diseases treated with biologics and tofacitinib: a systematic review and meta-analysis of randomized controlled trials and long-term extension studies

OBJECTIVE: The aim of this study was to assess the risk of active tuberculosis (TB) in patients with immune-mediated inflammatory diseases treated with biologics and tofacitinib in randomized controlled trials (RCTs) and long-term extension (LTE) studies. METHODS: A systematic review of the English-language literature by was performed by searching the Medline, Embase, Cochrane and Web of Knowledge databases. The search strategy focused on synonyms of diseases, biologics and tofacitinib. Data from RCTs were combined to assess the rate of TB using a random effects model. The incidence rate (IR) of TB and its association with disease, location and treatment were assessed in LTE studies. RESULTS: The search captured 11 130 articles and abstracts. One-hundred RCTs (75 000 patients) and 63 LTE studies (80 774.45 patient-years) met the inclusion criteria. There were 31 TB cases with TNF inhibitors, 1 with abatacept and none with rituximab, tocilizumab, ustekinumab or tofacitinib. The odds ratio for TNF inhibitors was 1.92 (95% CI 0.91, 4.03, P = 0.085). In LTE studies, the IR of TB was >40/100 000 with tofacitinib and all biologics except rituximab. IR was higher in RA patients with anti-TNF monoclonal antibodies [307.71 (95% CI 184.79, 454.93)] than in those with rituximab [20.0 (95% CI 0.10, 60)] and etanercept [67.58 (95% CI 12.1, 163.94)] or AS, PsA and psoriasis with etanercept [60.01 (95% CI 3.6, 184.79)]. The IR of TB was higher in high-background TB areas. CONCLUSION: RCTs are not sensitive enough to assess the risk of reactivation of latent TB infection (LTBI). Disease, treatment and background TB rate are associated with different frequencies of active TB. The benefit/risk balance of preventing reactivation of LTBI in different backgrounds should be considered in clinical practice

Percepciones de los pacientes con enfermedades reumáticas tratados con biológicos subcutáneos sobre su nivel de información. encuesta RHEU-LIFE

[Abstract] Objective: To investigate, in Spanish patients with rheumatic diseases treated with subcutaneous biological drugs, their sources of information, which sources they consider most relevant, and their satisfaction with the information received in the hospital. Methods: Rheumatologists from 50 hospitals handed out an anonymous survey to 20 consecutive patients with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis treated with subcutaneous biologicals. The survey was developed ad hoc by 4 rheumatologists and 3 patients, and included questions with closed-ended responses on sources of information and satisfaction. Results: The survey was handed-out to 1,000 patients, 592 of whom completed it (response rate: 59.2%). The rheumatologist was mentioned as the most important source of information (75%), followed by the primary care physician, nurses, and electronic resources; 45.2% received oral and written information about the biological, 46.1% oral only, and 6.0% written only; 8.7% stated that they had not been taught to inject the biological. The percentage of patients satisfied with the information received was high (87.2%), although the satisfaction was lower in relation to safety. If the information came from the rheumatologist, the satisfaction was higher (89.6%) than when coming from other sources (59.6%; P<.001). Satisfaction was also higher if the information was provided orally and written (92.8%) than if provided only orally (86.1%; P=.013); 45.2% reported having sought information from sources outside the hospital. Conclusions: The rheumatologist is key in transmitting satisfactory information on biological treatment to patients. He or she must also act as a guide, since a high percentage of patients seeks information in other different sources.[Resumen] Objetivo. Conocer las fuentes de las que los pacientes españoles con enfermedades reumáticas tratados con fármacos biológicos subcutáneos obtienen información, cuáles consideran más relevantes y su satisfacción con la información recibida en el hospital. Métodos. Reumatólogos de 50 hospitales entregaron una encuesta anónima, desarrollada ad hoc por 4 reumatólogos y 3 pacientes, a 20 pacientes consecutivos con artritis reumatoide, espondiloartritis axial o artritis psoriásica tratados con biológicos subcutáneos. La encuesta incluyó preguntas con respuestas cerradas sobre los aspectos mencionados previamente. Resultados. Recibieron la encuesta 1.000 pacientes, 592 la devolvieron cumplimentada (tasa de respuesta: 59,2%). El reumatólogo fue mencionado como la fuente de información más importante (75%), seguido del médico de atención primaria, la enfermería y los recursos electrónicos. El 45,2% recibió información oral y por escrito sobre el biológico, el 46,1% solo oral, el 6% solo por escrito. Un 8,7% declaró no haber sido enseñado a inyectarse el biológico. El porcentaje de pacientes satisfechos con la información recibida fue elevado (87,2%), aunque la satisfacción fue menor en temas relacionados con la seguridad. Si la información provenía del reumatólogo, la satisfacción era mayor (89,6%) que cuando provenía de otras vías (59,6%; p < 0,001). La satisfacción también era mayor si se dio oral y por escrito (92,8%) frente a solo oral (86,1%; p = 0,013). Un 45,2% declaró haber buscado información en fuentes fuera del hospital. Conclusiones. El reumatólogo es clave a la hora de transmitir información satisfactoria al paciente en tratamiento biológico. Debe además actuar de guía, ya que un elevado porcentaje busca información en fuentes distintas

Perceptions of patients with rheumatic diseases on the impact on daily life and satisfaction with their medications: RHEU-LIFE, a survey to patients treated with subcutaneous biological products

[Abstract] Objective: The aim of this study was to explore perceptions of patients with rheumatic diseases treated with subcutaneous (SC) biological drugs on the impact on daily life and satisfaction with current therapy, including preferred attributes. Methods: A survey was developed ad hoc by four rheumatologists and three patients, including Likert questions on the impact of disease and treatment on daily life and preferred attributes of treatment. Rheumatologists from 50 participating centers were instructed to handout the survey to 20 consecutive patients with rheumatoid arthritis (RA), axial spondyloarthritis (ax-SpA), or psoriatic arthritis (PsA) receiving SC biological drugs. Patients responded to the survey at home and sent it to a central facility by prepaid mail. Results: A total of 592 patients returned the survey (response rate: 59.2%), 51.4% of whom had RA, 23.8% had ax-SpA, and 19.6% had PsA. Patients reported moderate-to-severe impact of their disease on their quality of life (QoL) (51.9%), work/daily activities (49.2%), emotional well-being (41.0%), personal relationships (26.0%), and close relatives’ life (32.3%); 30%–50% patients reported seldom/never being inquired about these aspects by their rheumatologists. Treatment attributes ranked as most important were the normalization of QoL (43.6%) and the relief from symptoms (35.2%). The satisfaction with their current antirheumatic therapy was high (>80% were “satisfied” or “very satisfied”), despite moderate/severe impact of disease. Conclusion: Patients with rheumatic diseases on SC biological therapy perceive a high disease impact on different aspects of daily life, despite being highly satisfied with their treatment; the perception is that physicians do not frequently address personal problems. Normalization of QoL is the most important attribute of therapies to patients

The burden of disease in Spain: results from the global burden of disease study 2010

BackgroundWe herein evaluate the Spanish population¿s trends in health burden by comparing results of two Global Burden of Diseases, Injuries, and Risk Factors Studies (the GBD studies) performed 20 years apart.MethodsData is part of the GBD study for 1990 and 2010. We present results for mortality, years of life lost (YLLs), years lived with disability, and disability-adjusted life years (DALYs) for the Spanish population. Uncertainty intervals for all measures have been estimated.ResultsNon-communicable diseases accounted for 3,703,400 (95% CI 3,648,270¿3,766,720) (91.3%) of 4,057,400 total deaths, in the Spanish population. Cardiovascular and circulatory diseases were the main cause of mortality among non-communicable diseases (34.7% of total deaths), followed by neoplasms (27.1% of total deaths). Neoplasms, cardiovascular and circulatory diseases, and chronic respiratory diseases were the top three leading causes for YLLs. The most important causes of DALYs in 2010 were neoplasms, cardiovascular and circulatory diseases, musculoskeletal disorders, and mental and behavioral disorders.ConclusionsMortality and disability in Spain have become even more linked to non-communicable diseases over the last years, following the worldwide trends. Cardiovascular and circulatory diseases, neoplasms, mental and behavioral disorders, and neurological disorders are the leading causes of mortality and disability. Specific focus is needed from health care providers and policy makers to develop health promotion and health education programs directed towards non-communicable disorders