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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. [ABSTRACT FROM AUTHOR]

Introduction: Complex regional pain syndrome (CRPS) type 1 is characterized by the presence of pain, edema, functional impotence, impaired mobility, trophic changes, vasomotor instability and bone demineralization. Material and methods: We carried out a retrospective and prospective, descriptive, observational study of 108 patients over 18 years of age with suspected CRPS who met Doury’s criteria. We recorded demographic data, clinical characteristics, comorbidities, previous predisposing conditions and triggering factors, such as injury or fracture. We evaluated laboratory data, serial plain X-rays, 3-phase bone scintigraphy with technetium 99 and bone density scan, as well as drug treatment, rehabilitation and disease course. Results: In all, 89% of the 108 patients were women with an average age of 54.8 ± 12.4 years. The time between the onset of the symptoms and the first visit to a physician was 3.1 months. The most common triggering factor was injury (91.7%). The most frequent psychological factor was anxiety (42.6%). All the patients reported pain and 99.07% had impaired mobility. The most frequently affected part of the body was the hand (75%; 81/108 patients) followed by the shoulder, in the shoulder-hand syndrome. All the patients had serial X-rays and changes were observed in 93.5%. Three-phase bone scintigraphy revealed evidence of disease in all 32 of the patients who underwent this study. Bone density scanning was performed in 54 patients (50%). All the patients were treated with nonsteroidal anti-inflammatory drugs, mainly diclofenac (60%). Calcium therapy was initiated in 106 patients (98.2%) and vitamin D3 therapy in 97.2%. All the patients received bisphosphonates, primarily alendronate and ibandronate (67.6% and 27.8%, respectively). Thirty-six patients (33.3%) received corticosteroids. All of the evaluated patients underwent rehabilitation involving occupational therapy. The average time to recovery was 6.31 months (range, 4-24). The outcome was favorable in 88.9% of the patients. Conclusion: This paper describes the clinical characteristics, therapeutic features and outcome of CRPS type 1 in 108 patients. This syndrome is known to be heterogeneous, and does not always present with the wellknown symptoms. We recommend establishing a differential diagnosis including other infectious and inflammatory conditions, and point out the importance of early referral, which enables early treatment. [ABSTRACT FROM AUTHOR]

Introduction: The aim of the systematic review was to evaluate the safety and efficacy of rituximab for the treatment of rheumatoid arthritis patients, as part of the Consensus on the use of rituximab in rheumatoid arthritis. A document with evidence based recommendations5. Methods: All papers published from January 2003 to September 2009 were reviewed in a systematic way in Medline, EMBASE and Cochrane Library database. The Mesh terms used were: «Rituximab», «Rheumatoid arthritis», «and Anti-CD20», «Biologics». The abstracts of the EULAR and ACR congress of 2003 to 2009 were also reviewed, as well data of Roche Pharma. Two rheumatologists (BHC y MGH) made the bibliographic review by title and summary of each work. Two authors (BHC y RAA) selected them by quality according the GRADE SCALE after they review. The data were collected in paper. The outcomes evaluated were of efficacy in agreement with OMERACT13 (Outcome Measurements in Rheumatoid Arthritis Clinical Trials) and The Musculoskeletal Cochrane Study Group. The outcomes of safety evaluated were: mortality, severe infections, severe adverse events, withdraw for any cause, for severe adverse events, and for infusion related reactions. The review was conducted with Cochrane methodology. The odds ratio and relative risk for dichotomist variables; and mean difference between baseline and final measurements for continuous variables, and risk differences were calculated with RevMan 519. The number of patients needed to treat was calculated with Cares' calculator20. Results: RTX is an effective drug in three groups of patients with RA: patients who fail to MTX, those who fail anti-TNF and in patients with no prior exposure to MTX. It is necessary to treat 7 (5-10) patients with RTX vs. placebo to obtain an ACR70 response; 9 (6-15) to achieve a DAS28 < 2.6: and 5 (4-8) to achieve a HAQ improvement >0.2. Safety of the drug was similar to that of placebo except for infusion reactions where 12 (8-26) patients need to be treated with RTX vs. placebo to see a reaction to the first infusion with steroid premeditation. Severe adverse events to the infusion had an incidence of 0.7% in patients of the RTX treated group. It was impossible to identify a larger increase in the number of severe infections, probably due to methodological problems, however, the risk of developing infections in patients treated with RTX seems to be comparable to that of other anti-TNF and biologics. [ABSTRACT FROM AUTHOR]

The aim of this descriptive study is to analyze the scientific productivity of doctorate programs in Clinical and/or Health Psychology in Spain. That productivity is assessed from teachers of doctorate programs. A second aim is to find out whether doctorate programs with quality mention have a higher scientific productivity than those programs without quality mention. Scientific productivity of 375 teachers that participated in 17 doctorate programs was examined. Specifically, papers published in journals included in Web of Science and IN-RECS data bases were analyzed as well as the number of dissertations registered in TESEO data base. A total of 2,772 papers of Web of Science, 2,479 papers of IN-RECS and 604 dissertations included in TESEO were obtained. According to these results, a ranking of doctorate programs was made for each criterion. Subsequently, a global ranking was made through adjusting each criterion according to the weight that was assigned by scientific community to each indicator. Finally, a comparison of global results of programs with and without quality mention was carried out. Results showed that programs with Quality Mention doubled scientific productivity in all criteria compared to programs without Quality Mention. [ABSTRACT FROM AUTHOR]

Abstract: The most recent results in the dynamics of infinite systems of particles have shown there is no necessary connection between the performance of a deterministic supertask and the non-conservation of energy. Much more difficult to prove is the non-existence of any necessary connection between the performance of an indeterministic supertask and the non-conservation of energy; however, this paper does just that. So the requirement that energy be conserved does not mean we can exclude as “non-physical” either of the two major types of supertask considered to date. The paper also proposes, in this context, a “hidden variables method” to prove general results of compatibility in dynamics. [Copyright &y& Elsevier]

Introduction: Hemophagocytic syndrome (HS) occurs in autoimmune diseases and belongs to the hemophagocytic lymphohistiocytosis group of diseases. This paper describes the features of 2 patients with systemic lupus erythematosus (SLE) who presented HS as the initial clinical manifestation. Clinical observations: Both patients had prolonged fever not associated to an infectious process and did not respond to broad-spectrum antibiotics. Discussion: The diagnosis of HS secondary to SLE is complicated, because it has some features in common, but HS is characterized by hyperferritinemia, hipofibrinogemia, hypertriglyceridemia and a decrease in the erythrocyte sedimentation rate, unlike SLE. HS treatment when associated to SLE is not well established, but steroids and/or immunoglobulins are effective as the initial treatment, and in refractory cases, cyclosporine or cyclophosphamide may be associated. Conclusions: HS can be the initial manifestation of SLE and should be suspected in patients with organ enlargement, cytopenias, clotting disorders, liver disorders and prolonged fever unresponsive to antibiotics. Anakinra may be a treatment option in adult HS associated to SLE. [ABSTRACT FROM AUTHOR]

Transforming growth factor-beta (TGF-β) is a cytokine with pleiotropic functions in hematopoiesis, angiogenesis, cell proliferation, differentiation, migration and apoptosis. Although its role in rheumatoid arthritis is not well defined, TGF-β activation leads to functional immunomodulatory effects according to environmental conditions. The function of TGF-β in the development of arthritis in murine models has been extensively studied with controversial results. Recent findings point to a non-relevant role for TGF-p in a mice model of collagen-induced arthritis. The study of TGF-β on T-cell responses has shown controversial results as an inhibitor or promoter of the inflammatory response. This paper presents a review of the role of TGF-β in animal models of arthritis. [ABSTRACT FROM AUTHOR]

Enthesitis is one of the characteristic etiopathogenic manifestations of spondyloarthritis. However, in clinical practice, its presence often goes unnoticed because of the lack of precision and sensitivity of physical examination to detect it. Viable, valid and reliable imaging tests are needed for early diagnosis, as well as a good sensitivity to change to monitor therapeutic response. In this paper we review the most relevant aspects of current knowledge of the enthesis and discusses the validity of ultrasound for assessing enthesitis in spondyloarthritis and its sensitivity to change to monitor therapeutic response. [ABSTRACT FROM AUTHOR]

The introduction of magnetic resonance imaging in spondyloarthritis constitutes the main improvement in imaging over the past two decades. X-rays remains the cornerstone of diagnosis, although magnetic resonance imaging is more sensitive in early stages of the disease. The primary advantage of magnetic resonance imagingI is its ability to visualize soft tissue inflammation and inflammatory lesions within bone in three dimensions. Studies continue to appear describing its diagnostic utility, its sensitivity in early disease, its reliability, its predictive value for the detection of damage progression and its value in the assessment of certain complications. In this paper we review the characteristics of this imaging technique and the advantages and limitations of magnetic resonance imaging in spondyloarthritis. [ABSTRACT FROM AUTHOR]

The advent of biological therapies has revolutionized the management of rheumatoid arthritis, demonstrating effectiveness in controlling clinical and radiological damage. However, 20 to 40% of the patients will not respond to these therapies, which are associated to a very high cost. In addition, non-responder patients are exposed to possible adverse effects. For these reasons, we need to identify predictors of response to these treatments. These predictors are reviewed in this evidence-based paper and classified into genetic and non-genetic. Despite extensive search, nowadays there are no predictors powerful enough to be used in regular clinical practice. Serum factors, the presence of rheumatoid factor and anti-cyclic citrullinated peptide antibodies, are the only factors currently being used to predict the response to specific biological therapy. In the future, probably thanks to new technologies based on genomics, transcriptomics and proteomics, it will be possible to identify genetic predictors of response to biological drugs that will allow us to select suitable patients for a specific biological therapy. [ABSTRACT FROM AUTHOR]

Resistance to insulin action is a feature that accompanies certain diseases among which chronic inflammatory states like rheumatoid arthritis are included. What is, what its pathogenesis is, how it is measured, and what clinical and therapeutic implications have in rheumatoid arthritis patients is a topic not familiar to rheumatologists that is reviewed in this paper. [ABSTRACT FROM AUTHOR]

The antiphospolipid syndrome (APS) is an autoimmune disease characterized by recurrent fetal loss, thrombotic events (arterial or venous) and hemocytopenic disorders associated to high titers of circulating aPL Two variants of the APS have been described. Primary APS is a clinical entity without evidence of any other autoimmune disease and secondary APS is a clinical disorder mainly associated with Systemic Lupus Erithematosus (SLE). aPL are a widely group of immunoglobulins directed against different components or proteins factors. In 1990 three groups of researchers identified that β2GP-I is the mainly antigenic target of aPL in APS patients. There are evidences that show that more than one pathogenic mechanism is involved in the development of the APS. The best documented clinical manifestations associated with the APS are recurrent fetal loss and thrombotic disorders. The latter is based on observations in vivo in animal models and in vitro on the effects caused by β2GP-I antibodies from patients with APS or from animals which cause experimental APS. The objective of the present paper is to show the pathogenic mechanisms that participate in the development of the APS. We also presented evidence that shows that β2GP-I induces pro-inflammatory, pro-adhesive and pro-coagulant disorder. [ABSTRACT FROM AUTHOR]

During the past few years technological advance have been allowed the developing of techniques that help to the diagnosis of multiple diseases. In the case of the autoimmune diseases, immunological techniques are helpful since they allow the detection of multiple autoantibodies at the same time with small volumes of sample. Together with the development of the new techniques, sensitivity and specificity in the detection of the antibodies specificities' also have been increased, in such a way that the clinicians can count with tests that allow them to make early diagnoses with greater certainty and also to follow the course of the disease based on the variation of the antibodies presents in the patient's samples. It is important to emphasize that the new techniques of laboratory that are used for the support of the diagnosis of autoimmune diseases, no longer are exclusive for research laboratories but by their facility of standardization, quality control and reproducibility they can be used in clinical laboratory of medium and small sizes. In the present paper we describe those techniques with greater application in the clinical laboratory of autoimmune diseases. [ABSTRACT FROM AUTHOR]

This theoretical study deals with a review of empirical research and theoretical papers in which typologies of the men who are violent against their intimate partners are analyzed. First, the most relevant typologies and the aspects that have in common are described. Specifically, most studies about batterer men have distinguished three categories: a) Family only batterer; b) Borderline/Disforic; and c) Generally Violent/Antisocial. Recently, other studies have identified new subtypes of aggressors (for example, Low-level Antisocial Batterers) or they have focused on other variables of classification (personality and psychopathological characteristics or stages and processes of change). Second, some of the current questions on typologies (temporal stability of the typologies and categorical versus continuous antisocial type) are examined. Third, it is also considered the possibility of tailoring specific therapeutic interventions to specific typology. Implications of this study for clinical practice and future research in this field are commented upon. [ABSTRACT FROM AUTHOR]

The aim of this paper was to evaluate an individual 20 sessions cognitive- behavioral programme in the treatment of male batterers after implementing it for ten years in a community setting. The sample consisted of 196 subjects who voluntarily participated in the study. An experimental design with repeated measures (pre-treatment, posttreatment and 1-, 3-, 6- and 12-month follow-up) was used. The success rate was of 88% in the treatment completers. In spite of the lost patients in the follow-ups (46% at the end of twelve months), the results were maintained in the contacted patients at follow-up (53% in the 12-month-follow-up), with a high impact on reducing recidivism. However, the rate of refusals and drop-outs of the treatment was rather high. Therefore it is necessary to develop strategies to improve motivation for treatment. Implications of this study for clinical practice, policy decisions and future research in this field are commented upon. [ABSTRACT FROM AUTHOR]

Abstract: In this paper, a model of carnivore taphonomic action in the Argentinean Puna is applied to archaeological site Inca Cueva-cueva 4, on the Eastern Fringe of the Puna East of the Andes cordillera, which contains hunter–gatherer occupations dating to the early and middle Holocene. Different indicators, such as the low levels of bone modifications (ca. 2 to 8% NISP), consisting mainly in subtle marks, suggest a low intensity of the intervention of carnivores during the formation of these deposits. Variables such as the frequency of carnivore scats attest to repeated carnivore visits to the cave, but the “dilution effect” upon the small faunal assemblages these carnivores tend to accumulate in a context of larger zooarchaeological assemblages would have faded their traces away. [Copyright &y& Elsevier]

Abstract: This paper employs artificial neural network and decision tree to derive knowledge about the job attitudes of Generation Xers. The sample frame consisted of 1000 large Manufacturing Industries and 500 large Service Industries, randomly selected from the Common Wealth Magazine 1000 index of Taiwan Manufacturing Industries and Service Firms. Then, we exploited the ART2 neural model to take the collected data as inputs and form performance classes according to their similarities. Finally, the decision tree was employed to determine definitions for each class, resulting in 52 rules associated with certainty factors. The results could be used to develop an intelligent decision support system for the recruitment and management of Generation Xers. [Copyright &y& Elsevier]

Abstract: Taxonomy of 57 bivalves, internal and external molds is described in this paper, corresponding to three paleotaxodontids genera Praectenodonta, Praenucula and Notonucula. Samples were collected from nine sites, where stratigraphic columns were measured in Silurian to Devonian series from Altiplano, Cordillera Oriental and Interandean of Bolivia. For the first time in Bolivia, Praectenodonta and Notonucula have been identified. Four species have been described, three of them are new: Praectenodonta boliviensis n. sp., Praenucula quichua n. sp. and Notonucula altiplanica n. sp. Paleogeography of new species and genera is proposed. [Copyright &y& Elsevier]

Most of the material review in this paper was included in the work of Sudre et al. (1983), some other provides from new sites. Two new species of primitive artiodactyls are described here: Diacodexis corsaensis n. sp. and Eygalayodon isavenaensis n. sp., which is considered the most plesiomorphic form of the subfamily Eurodexeinae and probable derived from Diacodexis corsaensis n. sp. It is for the first time that a representative of the Eurodexeinae is found in the Iberian Peninsula, where they might originate. [Copyright &y& Elsevier]