Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.

Although anti-tumor necrosis factor (TNF) agents have greatly improved the management of rheumatic diseases, their cost limits access to many patients throughout the world. As a result, patients and clinicians have turned to biosimilars to provide similar efficacy at a lower cost. Many of the regulatory guidelines in the Asia Pacific region are largely based on those of the European Medicines Agency and the World Health Organization; however, there are variations between countries. Additionally, in some countries, intended copies are available that were approved prior to the development of guidelines and have not fulfilled the requirements of a biosimilar. We review the various regulatory requirements for biosimilars in the Asia Pacific region, the anti-TNF biosimilars and intended copies approved in the region, and whether clinical data are available for these agents. We discuss concerns about the need for additional regulations and education, and we provide recommendations for a multidisciplinary pharmacovigilance approach that closely monitors the safety of biosimilar use.

Electronic health records in rheumatology: emphasis on automated scoring and additional use.

Electronic health records are increasingly used and frequently required from various regulatory authorities. Apart from their day-to-day use by health care professionals for routine clinical practice and/or the improvement of quality of care processes, patients with chronic inflammatory disease may become increasingly involved in the data retrieval process by self-monitoring and providing patient-reported (outcome) data. Among key features of electronic health records are automated scoring, visualisation of validated measures, and long-term systematic patient-centered data collection in a structured and standardised manner. Data derived from electronic health records are increasingly incorporated into patient-centered research, registries, and other secondary uses. Thus, electronic health records offer opportunities to improve knowledge and to create new process flows in rheumatology health care. The article summarises some of these opportunities in patient care, as well as an overview of secondary use scenarios. In addition, the article focuses on patients' active involvement in the disease management process via health information applications, reports on patients' perspectives, as well as some legal and regulatory matters concerning electronic health records.

Documento de posicionamiento de la Sociedad Española de Reumatología sobre fármacos biosimilares / Position paper from the Spanish Society of Rheumatology on biosimilar drugs

Un biosimilar (BS) es un fármaco biológico que contiene una versión de la sustancia activa de un producto biológico original ya autorizado. Los BS se comercializan al terminar el periodo de patente del fármaco original y tras demostrar que las diferencias con respecto al medicamento innovador no tienen ningún efecto relevante sobre su seguridad y su eficacia clínica. La Sociedad Española de Reumatología, en consonancia con la Agencia Europea del Medicamento, considera que por su naturaleza y complejidad de producción no se puede equiparar un BS a un genérico. La Sociedad Española de Reumatología manifiesta un compromiso inequívoco con la sostenibilidad del sistema sanitario y apoya medidas que, sin reducir la calidad asistencial, estén encaminadas a asegurar su continuidad. Por esto considera que, probablemente, la llegada de los BS mejorará el acceso de los pacientes con enfermedades reumáticas a los fármacos biológicos. Este artículo revisa la normativa de la Agencia Europea del Medicamento, el marco legal español y las controversias sobre los BS, y presenta el posicionamiento de la Sociedad Española de Reumatología sobre estos fármacos (AU)

A biosimilar (BS) is a biological drug that contains a version of the active substance of an already authorized original biological product. The BSs are marketed after patent period of the original drug has ended and once it has been demonstrated that the differences regarding the innovative medicine have no relevant effect on its safety or clinical efficacy. The Spanish Society of Rheumatology, in line with the European Medicines Agency, considers that because of its nature and complexity of production, a BS cannot be considered to be the same as a generic drug. The Spanish Society of Rheumatology expresses an unequivocal commitment to the sustainability of the health system in our country and our steadfast alignment with all measures designed to ensure continuity, without reducing the quality of care. Therefore, we believe that the advent of BSs will likely facilitate access of patients with rheumatic diseases to the biological drugs. This article reviews the European Medicines Agency requirements for authorization, the Spanish legal framework and controversies on BS and presents the position paper of the Spanish Society of Rheumatology on these drugs (AU)

[Hospital financing in 2014. Relevant changes for rheumatology]. / Krankenhausfinanzierung 2014. Relevantes für die internistische Rheumatologie.

As with others medical disciplines hospitals specialized in rheumatology again face heavy economic burdens in 2014. To meet the challenges knowledge of the new German diagnosis-related groups (G-DRG) system, the legislative framework and current jurisprudence can be helpful. The following article presents the major changes and discusses the consequences for hospitals specialized in rheumatology.

Impact of the European paediatric legislation in paediatric rheumatology: past, present and future.

Conducting clinical trials in paediatric rheumatology has been difficult mainly because of the lack of funding for academic studies and the lack of interest by pharmaceutical companies in the small and non-rewarding paediatric market. The situation changed dramatically a few years ago with the introduction of the Best Pharmaceuticals for Children Act in the USA and of specific legislation for the development of paediatric medicines (Paediatric Regulation) in the European Union (EU). The EU Paediatric Regulation had a positive impact in paediatric rheumatology-in particular, on the development of new treatments for children with juvenile idiopathic arthritis (JIA). Some problems remain, however, such as greater harmonisation of the regulatory aspects of medicines, how to handle me-too agents, how to conduct adequate pharmacokinetic studies and develop age-appropriate formulations, ethical problems in study review and implementation, and a change in the current JIA classification. The introduction of specific legislation, coupled with the existence of large international networks such as the Pediatric Rheumatology Collaborative Study Group (PRCSG at http://www.prcsg.org), covering North America, and the Paediatric Rheumatology International Trials Organisation (PRINTO at http://www.printo.it), covering more than 50 countries, has led to great advances in paediatric rheumatology. Future changes might increase the possibility of conducting trials with similar approaches in other paediatric rheumatological conditions and provide evidence-based treatments for children affected by rheumatic diseases.

Estándares de calidad asistencial para las consultas de enfermería en reumatología / Quality of care standards for nursing clinics in rheumatology

Introducción. Las consultas de enfermería en reumatología (CER) son modelos organizativos asistenciales en el ámbito de competencias de enfermería. Hay diversos modelos de CER, pero no existe una definición operacional. El objetivo del proyecto es elaborar estándares de calidad para definir y caracterizar una CER. Método. Estudio Delphi a 2 rondas. El panel estuvo constituido por 67 expertos: reumatólogos y enfermeras del Grupo de Trabajo de Enfermería de la Sociedad Española de Reumatología (SER). El cuestionario se elaboró tras revisión bibliográfica y experiencias de proyectos previos de la SER. El cuestionario consta de 7 apartados: consideraciones generales, estándares de estructura, de proceso, de tratamiento y seguimiento, educación sanitaria, formación e investigación y calidad asistencial. Cada ítem se puntuó de 1 (menos importante) a 9 (más importante) o mediante una cifra. El grado de acuerdo de los expertos se categorizó según el coeficiente de variación (CV) entre muy alto (CV ≤ 25%) y muy bajo (CV > 100%). Resultados. El cuestionario de la segunda ronda (182 ítems) fue respondido por 46 panelistas (34 reumatólogos y 12 enfermeras). Se obtuvo un grado de acuerdo muy importante en los estándares generales, de estructura, de proceso, de tratamiento y seguimiento, educación sanitaria y calidad asistencial. Se encontró menor acuerdo en los estándares relacionados con el tiempo para formación, el número de proyectos de investigación propios de enfermería y de publicaciones recomendables. Conclusión. Los estándares desarrollados en este estudio permitirían establecer mínimos deseables de calidad de estructura, proceso, labor asistencial, investigadora y docente que se pueden utilizar para desarrollar y evaluar las CER (AU)

Background. Nursing clinics in rheumatology (NCR) are organizational models in the field of nursing care. There are various NCR models, but there is no consensus on its operational definition. Our objective is to develop quality standards to define and characterize a NCR. Method. Two-round Delphi method. The panel consisted of 67 experts: rheumatologists and nurses of the nursing working group of the Spanish Society of Rheumatology (SSR). The Delphi questionnaire was developed after a literature and experience review from previous SSR projects. The questionnaire consists of 7 sections: general considerations, standards of structure, process, treatment and monitoring, health education, training and research and quality of care. Each item was scored from 1 (least important) to 9 (most important) or by assigning a number (e.g. waiting days). The degree of agreement among the experts was categorized according to the coefficient of variation (CoV) between very high (CoV≤25%) and very low (CoV>100%). Results. The second round questionnaire (182 items) was answered by 46 panelists (34 rheumatologists and 12 nurses). A very important agreement was reached on the general standards of structure, process, treatment and monitoring, health education and quality of care. Less agreement was observed on standards related to training time, number of recommended nurses’ research projects and publications. Conclusion. The standards developed in this study would be useful for establishing desirable quality standards of structure and process, and criteria for clinical work, research and teaching that can be used to develop and evaluate the NCRs (AU)

[Hospital financing in 2013: relevant changes for rheumatology]. / Krankenhausfinanzierung 2013 : Relevantes für die internistische Rheumatologie.

Hospital financing is again subjected to a multitude of reforms that can be of relevance for rheumatology in 2013. Besides changes in the German diagnosis-related group (G-DRG) classification system and coding, modifications in the legislation and legal framework conditions have a growing impact on the economic situation and strategy of hospitals. The following article presents the major changes and discusses consequences for hospitals specialized in rheumatology.

Rate of adjudication of radiological progression in rheumatoid arthritis randomized controlled trials depending on preset limits of agreement: a pooled analysis from 15 randomized trials.

OBJECTIVE: The aim of this study is to provide data on the adjudication rate for a predetermined threshold of difference in change score between two readers in randomized controlled trials (RCTs). METHODS: Fifteen datasets from RCTs in RA were scored by 13 experienced readers as pairs according to the modified Sharp-van der Heijde method. The theoretical adjudication rates for thresholds of between 3 and 20 units were calculated. We investigated the influence of the number of time points within the same session, the length of the interval and disease duration on the adjudication rates. RESULTS: A total of 21,295 time points from 7643 patients from 15 databases were included in the analysis. The adjudication rate was inversely related to the threshold. Higher adjudication rates were observed with a higher number of time points, longer time intervals and in early versus established RA. The adjudication rates ranged from 0% to 22% depending on the scenario. CONCLUSION: With trained and experienced readers, the adjudication rate in RA RCTs is low even with very conservative adjudication thresholds.

[International clinical practice guidelines and management of rheumatology in Madagascar]. / Recommandations internationales et prise en charge de la rhumatologie à Madagascar.

Developed countries issue recommendations regarding healthcare that aren't constantly appropriate for emergent countries. We suggest some remarks concerning rheumatology in Madagascar, taking account of scientific data, medical ethics, equality and equity. We have studied the minimal cost of care of medical conditions found in our hospital department if we were to follow international recommendations for their management. Then, we have estimated treatment expenses as a percentage of the SMIC (Malagasy minimum monthly salary). Out of 517 patients examined yearly, we have found 62.8% osteoarthritis cases, 6.3% rheumatoid arthritis (RA), and 4,2% septic arthritis. Therefore, the first month of treatment for an arthritis of the knee would absorb 147.3% of the SMIC; diagnosis and treatment of a case of septic arthritis would take up 1762.8% of the minimum wage, and a case of RA without biotherapy would require 175%. According to the American College of Rheumatology criteria which are used as a reference, the treatment of an arthritis of the knee would take only 23% of the SMIC. Caring for septic arthritis would demand 57.5% of the SMIC and while it would yield more arguments for diagnosis such as clinical examination, CRP, and Gram coloration on joint liquid aspiration. We can proceed to RA diagnosis with an acceptable security through precise clinical examination, blood cell count, ESR, CRP, rheumatoid factor and radiography. This means 56% of the SMIC. From this 517 patients, our suggestions would reduce the expense by 35,850% of the SMIC per year. The allocation of such funds onto the treatment of complicated forms of rheumatism would be fair. By refining and evaluating these suggestions, we would come up with appropriate recommendations for emergent countries.

[Amendment of the structural quality for inpatient rheumatology. A forward-looking concept]. / Neufassung der Strukturqualität der akut-stationären Rheumatologie. Ein zukunftsweisendes Projekt.

In 2010 a total of 9 guidelines on structural quality were endorsed by the Association of Rheumatology Clinics in Germany (VRA). These 9 structural criteria replace the regulations published in 2002 and were elaborated with the support of the German Rheumatology League. With guideline number 9 even the structural requirements for university hospitals are defined for the first time.Along with taking part in the quality project "Kobra" (continuous outcome benchmarking in rheumatology inpatient treatment) compliance with the new structural criteria constitutes a prerequisite for acquiring a quality certificate, which is awarded by an external institution.By this means the VRA sets the stage for its members to be prepared for future challenges and quality competition among hospitals. Furthermore, the provision of a high quality treatment for chronically diseased patients in rheumatology clinics will be effectively supported.

[The role of rheumatologists in multidisciplinary expert opinions]. / Die Rolle des Rheumatologen bei der polydisziplinären Begutachtung.

Diseases of the musculoskeletal system are among the foremost reasons for premature health-related loss of employment. In giving expert opinions, physicians need a change of perspective from a therapeutic patient-doctor relationship where the well-being of the patient is important, to the expert consultant setting where the goal is to find an objective truth. Both ways of thinking demand a scientific evidence-based approach. Chronic pain syndromes often revolve around the borderline between soma and psyche. In the perception of modern pain research, a strict distinction between somatically and psychically caused pains is obsolete. In expert assessments of chronic pain a close cooperation between rheumatologist and psychiatrist is mandatory. This article focuses on the role of the rheumatologist in multidisciplinary expert assessment and also highlights some peculiarities of Swiss jurisdiction.

Computer applications in clinical practice.

PURPOSE OF REVIEW: The prospects of improved practice efficiencies and better treatment outcomes have recently focused political attention at high levels upon the use of information technology (IT) in routine clinical care in the US, UK and elsewhere. Providers who treat musculoskeletal diseases need to become familiar with emerging governmental policies, IT industry trends, data standards and communication protocols to equip themselves with a basis on which to evaluate and influence the development of these technologies, which in turn will influence the shape of clinical practice. RECENT FINDINGS: The articles cited are categorized into the topics of government policy regarding electronic medical records (EMRs); data definitions and databases; computers in outpatient clinical encounters; EMRs; patient self-entry of historical data; computer physician order entry; personal digital assistants; and e-mail, the Internet, and the patient/physician encounter. SUMMARY: Government agencies in the US, UK, and elsewhere are at various stages in the implementation of national health information infrastructures. US officials are playing a greater role in prompting physicians to use EMRs and in setting standards for EMR systems. A study by the American College of Rheumatology observed, 'Increasing requirements for provider compliance with quality and outcomes reporting, HIPAA regulations, medical error reduction, including Medicare e-prescribing mandates, and downward pressure on practice revenues will ultimately drive the adoption of EMRs in office practice.' Nonuse will equate to a non-viable practice. Rheumatologists who would control their own destinies must acquaint themselves with, adopt, and exert influence on the development of these technologies with all deliberate speed.