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espanolObjetivos Analizar las caracteristicas clinicas y de metabolismo oseo de una serie de pacientes con fracturas vertebrales tras la suspension de denosumab (DMab). Metodos Estudio observacional retrospectivo de 10 pacientes con fracturas vertebrales tras suspender DMab atendidas en el Servicio de Reumatologia de un hospital espanol de tercer nivel entre 2015 y 2018. Resultados Se registraron un total de 49 fracturas espontaneas tras una media de 6 dosis de DMab y transcurridos 10,9 meses desde la suspension del farmaco. El 90% habia recibido tratamiento previo, 7 de 10 bisfosfonatos orales. Tras la suspension, CTX y P1NP estaban elevados y la media de T-score en cuello femoral y columna lumbar fue menor que previo a DMab. Las vertebras mas afectadas fueron L3, L5, D6, D7, D9 y D11. Conclusion La descripcion de nuevos casos de fracturas vertebrales multiples en los meses posteriores a la suspension de DMab subraya la preocupacion emergente en la comunidad cientifica siendo preciso apoyar en evidencias solidas las nuevas recomendaciones sobre su manejo. EnglishObjectives Analyse clinical and bone metabolism features in a case series of patients with multiple vertebral fractures after discontinuation of denosumab (DMab). Methods An observational descriptive study analysing data from ten patients with multiple vertebral fractures after DMab discontinuation that were admitted to our rheumatology department between 2015 and 2018. Results There were a total of 49 spontaneous fractures after an average of 6 DMab doses and 10.9 months from discontinuation. Ninety percent had already received treatment other than DMab 7 of 10 oral bisphosphonates. After discontinuation, CTX and P1NP remained elevated and mean T-score for femoral neck and lumbar spine was lower than before treatment. The most affected vertebrae were L3, L5, D6, D7, D9 and D11. Conclusion This report of ten new cases suffering multiple vertebral fractures early after discontinuation of DMab highlights the emerging concern on the subject in the scientific community and the need to clarify its pathogenic mechanism, and to support by solid evidence the new recommendations on its management.

Resumen La enfermedad gonococica diseminada es una manifestacion infrecuente de la afectacion por Neisseria gonorrhoeae, que presenta una clinica variada y no bien definida, siendo la afectacion articular un hallazgo caracteristico. Presentamos el caso de una mujer de 64 anos con enfermedad gonococica diseminada de inicio agudo, que comenzo con deterioro generalizado y oligoartritis. Se realizo artrocentesis de carpo, obteniendose un liquido sinovial de aspecto purulento, cuyo estudio microbiologico identifico Neisseira gonorrhoeae. En el estudio se objetivo un complemento hemolitico total (CH50) de cero, no detectandose la fraccion C2 del complemento. Son muy pocos los casos descritos en la literatura de enfermedad gonococica diseminada asociada a deficit de C2. Presentamos un nuevo caso y revisamos los previamente publicados.

Objectives Issue recommendations on practical aspects of the monitoring of levels of biological drugs that may be useful for rheumatologists. Methods We conducted a systematic review of studies in which drug and anti-drug antibody levels were determined in patients with rheumatoid arthritis (RA) or spondyloarthritis (SpA) to study whether they could predict different outcomes. In light of the results of the review, a group of experts discussed under what circumstances testing biological drug levels and their antibodies could be useful. The discussion resulted in a series of clinical questions that were answered with the scientific evidence collected, and in algorithms that facilitate decision making. Results It was established that the determination of drug levels can be especially useful in two clinical situations, on treatment failure (primary or secondary) and on sustained remission. It is also reviewed which laboratory technique and timing for sample drawing are the most suitable for the measurement. Recommendations are issued on the interpretation of drug levels and on factors to be taken into account (for example, body mass index and disease modifying drugs). Conclusions Evidence-based algorithms and guidelines have been established to test drug levels and anti-drug antibodies in patients with RA and SpA, which can help clinical decision making.

OBJECTIVE: To draft recommendations on interleukin 6 (IL-6) blockade in rheumatoid arthritis (RA), based on best evidence and experience.; METHODS: A group of 10 experts on IL-6 blockade in RA was selected. The 2 coordinators formulated 23 questions about IL-6 blockade (indications, efficacy, safety, etc.). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (Medline, EMBASE and the Cochrane Library were searched). Two different reviewers selected the articles. Evidence tables were created. At the same time, European League Against Rheumatism and American College of Rheumatology abstracts were evaluated. Based on this evidence, the coordinators proposed preliminary recommendations that the experts discussed and voted on in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Centre for Evidence Based Medicine and the level of agreement with the Delphi technique (2 rounds). Agreement was established if at least 80% of the experts voted yes (yes/no).; RESULTS: The 8 preliminary recommendations were accepted after the Delphi process. They covered aspects such as the use of these therapies in monotherapy, in combination, in patients with refractory disease or intolerant patients, response evaluation, optimization and risk management.; CONCLUSIONS: The manuscript aims to solve frequently asked questions and aid in decision making strategies when treating RA patients with IL-6 blockade. Copyright © 2018 Elsevier Espana, S.L.U. and Sociedad Espanola de Reumatologia y Colegio Mexicano de Reumatologia. All rights reserved.

Resumen Describimos un caso de artritis septica de rodilla por Corynebacterium striatum, bacilo Gram positivo colonizador habitual de la flora de la piel y mucosas, que rara vez ha sido implicado en artritis septicas de articulaciones nativas. Se trata de un varon de 84 anos diagnosticado de artritis septica de rodilla izquierda por Corynebacterium striatum que evoluciona de forma torpida con antibioterapia convencional, por lo que se solicita tratamiento compasivo con dalbavancina, con excelente respuesta clinica. Este caso resalta el potencial papel patogeno que las especies del genero Corynebacterium pueden tener en artritis septicas de articulaciones nativas y subraya la importancia de su deteccion precoz y tratamiento dirigido para obtener resultados clinicos satisfactorios.

Disseminated gonococcal infection is a rare presentation of the sexually transmitted pathogen, Neisseria gonorrhoeae. Here, we report the case of a 64-year-old woman with disseminated gonococcal infection, which started with symptoms of oligoarthritis and malaise. Neisseria gonorrhoeae was identified in the carpal synovial fluid. The follow-up study revealed an absence of total hemolytic complement and complement C2 was not detected. Being relatively common, C2 deficiency has been associated with disseminated gonococcal infection in a few cases. We present a new case and discuss those previously published.

Objectives: To describe the prevalence of comorbidities in patients with RA in Spain and discuss their management and implications using data from the Spanish cohort of the multinational study on COMOrbidities in Rheumatoid Arthritis (COMORA). Methods: This is a national sub-analysis of the COMORA study. We studied the demographics and disease characteristics of 200 adults patients diagnosed with RA (1987 ACR), and routine practices for screening and preventing the following selected comorbidities: cardiovascular, infections, cancer, gastrointestinal, pulmonary, osteoporosis and depression. Results: Patients had a mean age of 58 years and a mean RA duration of 10 years. Mean DAS28 score was 3.3 and approximately 25% of patients were in remission (DAS28 20% (51%), hypercholesterolemia (46%) or hypertension (41%) and smoking (25%) were the most common CV risk factors. For prostate, colon and skin cancers, only 9%, 10% and 18% of patients, respectively, were optimally monitored. Infections were also inadequately managed, with 7% and 17% of patients vaccinated against influenza and pneumococcal, respectively, as was osteoporosis, with 47% of patients supplemented with vitamin D and 56% with a bone densitometry performed. Conclusions: In Spain, the prevalence of comorbidities and CV risk factors in RA patients with established and advanced disease is relatively high, and their management in clinical daily practice remains suboptimal. Objetivos: Describir la prevalencia de comorbilidades en pacientes con AR en España y discutir sobre su manejo en la clínica diaria utilizando los datos de la cohorte española del estudio internacional COMORA. Métodos: Subanálisis nacional del estudio COMORA en el que se analizaron las características demográficas y clínicas de 200 pacientes con AR (1987 ACR) y las prácticas rutinarias para el cribado y la prevención de eventos cardiovasculares (CV), gastrointestinales y pulmonares, infecciones, cáncer, osteoporosis y depresión. Resultados: Los pacientes tenían una edad media de 58 años, una duración media de la enfermedad de 10 años, un DAS28 de 3,3 y el 25% estaba en remisión (DAS28 20% (51%), tener hipercolesterolemia (46%), hipertensión (41%) y fumar (25%) fueron los factores de riesgo CV más comunes. En relación con el cáncer de próstata, colon y piel, solo el 9, 10 y el 18% de los pacientes, respectivamente, estaban óptimamente controlados. Las infecciones tampoco se manejaban de forma óptima, con solo el 7 y el 17% de los pacientes vacunados contra la influenza y neumococo, respectivamente, al igual que la osteoporosis, con el 47% suplementados con la vitamina D y el 56% con una densitometría realizada. Conclusiones: En España, la prevalencia de comorbilidades y factores de riesgo CV en pacientes con AR establecida y avanzada es relativamente alta, y su manejo en la clínica diaria continúa siendo subóptimo. Sin financiación No data JCR 2019 0.256 SJR (2019) Q4, 49/64 Rheumatology No data IDR 2019 UEM

We describe a case of septic arthritis in a native knee due to Corynebacterium striatum, gram-positive bacilli that are usually commensal organisms of skin and mucosal membranes, but are seldom implicated in native septic arthritis. An 84-year-old man with Corynebacterium striatum septic arthritis of his native left knee and no response to conventional antibiotic therapy. Thus, the patient was allowed to take dalbavancin for compassionate use, with an excellent clinical outcome. This case emphasizes de role of Corynebacterium striatum in native joint infections and highlights the importance of early detection and appropriate treatment in improving the clinical outcome.

Objective To establish recommendations for the management of patients with rheumatoid arthritis (RA) to serve as a reference for all health professionals involved in the care of these patients, and focusing on the role of available synthetic and biologic disease-modifying antirheumatic drugs (DMARDs). Methods Consensual recommendations were agreed on by a panel of 14 experts selected by the Spanish Society of Rheumatology (SER). The available scientific evidence was collected by updating three systematic reviews (SR) used for the EULAR 2013 recommendations. A new SR was added to answer an additional question. The literature review of the scientific evidence was made by the SER reviewer's group. The level of evidence and the degree of recommendation was classified according to the Oxford Centre for Evidence-Based Medicine system. A Delphi panel was used to evaluate the level of agreement between panellists (strength of recommendation). Results Thirteen recommendations for the management of adult RA were emitted. The therapeutic objective should be to treat patients in the early phases of the disease with the aim of achieving clinical remission, with methotrexate playing a central role in the therapeutic strategy of RA as the reference synthetic DMARD. Indications for biologic DMARDs were updated and the concept of the optimisation of biologicals was introduced. Conclusions We present the fifth update of the SER recommendations for the management of RA with synthetic and biologic DMARDs.

Background In recent years, the Rheumatology Day-Care Hospital Units (DHUs) have undergone extensive development. However, the quality standards are poorly documented and mainly limited to structure items rather than including broad and specific areas of this specialty. Objective To develop specific quality standards for Rheumatology DHUs. Methods After a systematic review of the literature and related documents, a working group (WG) involving 8 DHU-experienced rheumatologists developed an initial proposal of the quality standards, under the supervision of an expert methodologist. A second round was held by the WG group to review the initial proposal and to consider further suggestions. Once the content was agreed upon by consensus, a final report was prepared. Results Seventeen structure standards, 25 process standards and 10 results standards were defined, with special emphasis on specific aspects of the Rheumatology DHU. The proposal includes: (1) essential standards to (2) excellent standards, (3) a Rheumatology DHU services portfolio and (4) performance criteria. Conclusions The proposed quality standards are the basis for developing the indicators and other management tools for Rheumatology DHU, thereby ensuring a patient-oriented practice based on both the evidence and the experience.

Objective To review the clinical evidence on subcutaneous (SC) abatacept and to formulate recommendations in order to clear up points related to its use in rheumatology. Method An expert panel of rheumatologists objectively summarized the evidence on the mechanism of action, practicality, effectiveness, and safety of abatacept sc and formulated recommendations after a literature review. Results The efficacy and safety of abatacept sc were studied in 7 clinical trials, 3 double-blind, 3 open, and one mixed, with the following endpoints: comparison against abatacept iv, impact on immunogenicity, effect of replacing iv by sc, abatacept sc in monotherapy, and non-inferiority to adalimumab. No significant differences were found between sc and iv abatacept on efficacy or safety. The development of sc abatacept has allowed a complementary study to the iv, formulation, thus making the abatacept profile better defined. Conclusions This is a practical document to supplement the summary of product characteristics. In summary, abatacept sc is presented as an effective and safe drug and, therefore, as an alternative to use within the broad armamentarium the rheumatologist has to treat RA. It also has the advantage of being the only biological agent that can be administered iv and sc which can facilitate its use in certain patients.

Objective To review the clinical evidence on abatacept and to formulate recommendations in order to clear up points related to its use in rheumatology. Method An expert panel of rheumatologists objectively summarized the evidence on the mechanism of action, practicalities, effectiveness and safety of abatacept, and formulated recommendations following a literature review. The level of evidence and degree of recommendation was established. Results The document presents 21 statements focused on evidence or recommendations on abatacept (14 evidence summaries and 9 recommendations). The level of evidence was 2b or higher according to the Oxford Centre for Evidence-Based Medicine scale on 14 occasions. The degree of the recommendation was A in two recommendations, C in one, and D in the rest. It was considered important to make recommendations on aspects with lower levels of evidence. Conclusions This is a practical document to supplement the summary of product characteristics.

Objective Due to the increasing use of biologic therapy in rheumatic diseases and the importance of its risk management, the Spanish Society of Rheumatology (SER) has promoted the development of recommendations based on the best evidence available. These recommendations should be a reference to rheumatologists and those involved in the treatment of patients who are using, or about to use biologic therapy irrespectively of the rheumatic disease. Methods Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. Evidence from previous consensus and clinical guidelines was used. Results We have produced recommendations on risk management of biologic therapy in rheumatic patients. These recommendations include indication risk management, risk management before the use of biologic therapy, risk management during follow-up, attitude to adverse events, and attitude to special situations. Conclusions We present the SER recommendations related to biologic therapy risk management.

Remission is the ideal treatment objective in the management of rheumatoid arthritis. To define remission, stringent criteria are needed which allow clinicians to assess the presence of active disease and which should be reliable enough to support therapeutic decisions. Currently there are many different remission classifications and none has been validated against important outcome measures such as the absence of progression of joint damage and disability. Recently, a subcommittee of the ACR and EULAR has proposed new criteria for remission based on a categorical classification and a composite score like SDAI allowing their use in clinical practice.

Rituximab has been employed successfully for the treatment of Rheumatoid Arthritis (RA). However, its particular mechanism of action, as well as a lack of concrete guidelines for its management have generated doubts on its use.To establish recommendations that facilitates the use of rituximab in common clinical practice.In a first Delphi round, 9 expert rheumatologists got together to develop questions on those subjects generating most doubts on the efficacy and safety of the drug. These were adapted to perform a systematic review of the evidence, which was presented in a second meeting. Nominal groups were formed to respond to each question and give a recommendation. These recommendations were presented in a second Delphi round to a larger group of experts in rheumatology. Once again recommendations were discussed, modified and voted upon. Once approved, a vote on the degree of agreement for each recommendation was carried out.17 recommendations were established, 10 regarding efficacy and 7 safety. All of the efficacy recommendations except 3 presented a good or moderate degree of evidence. Among the safety recommendations, 3 had a good or moderate degree of evidence while in the rest it was indirect, scarce or non-existent and a product of expert recommendation. The degree of agreement between experts was elevated for most of the recommendations.These recommendations attempt to clear doubts on the use of rituximab and establish guidelines for its use in daily practice. Efficacy recommendations have a high degree of evidence, allowing the clinician to be guided in therapeutic decisions. Safety recommendations have a lower degree of evidence.

Objective To provide a reference to rheumatologists and to those involved in the treatment of RA who are using, or about to use biologic therapy. Methods Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and grade of recommendation were classified according to the model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through Delphi technique. Results We have produced recommendations on the use of the seven biologic agents available for RA in our country. The objective of treatment is to achieve the remission of the disease as quickly as possible. Indications and nuances regarding the use of biologic therapy were reviewed as well as the evaluation that should be performed prior to administration and the follow up of patients undergoing this therapy. Conclusions We present an update on the SER recommendations for the use of biologic therapy in patients with RA.

To analyze the effect of the TNF blocking agents (aTNF) on the serum levels of interleukin 15 (IL-15). To determine whether baseline IL15 serum levels or their response to aTNF therapy can predict the clinical response to this treatment.We studied 75 patients suffering from rheumatoid arthritis that were selected to start aTNF therapy. Serum samples were obtained at baseline visit and after three months of aTNF treatment. Measurement of IL-15 serum concentration was performed through immune-enzyme assay. We collected the clinical and analytical parameters needed to calculate DAS28 both at baseline and final visit, as well as sociodemographic variables and other such as rheumatoid factor, previous disease modifying anti-rheumatic drugs (DMARD), etc. We defined remission as a DAS282.6 and clinical response when the decrease in DAS28 value was higher than 1.2.There was a significant correlation between IL-15 serum level and the number of previous DMARD. We also detected a significant decrease in the concentration of serum IL-15 after three months of treatment with aTNF. However, neither the baseline IL-15 serum level nor the decrease in the concentration of IL-15 were associated with a specific pattern of response to aTNF.Our data seem to support previous in vitro findings suggesting that TNF is involved in the regulation of IL-15 expression. Nevertheless, the measurement of IL-15 serum levels does not seem to be a useful tool to select those patients that should be treated with aTNF therapy.

Rheumatoid arthritis (RA) is a chronic disease that particularly affects the joints, causing their destruction, changes in its functional capacity and considerably compromising the quality of life. It is known that early treatment can reduce structural damage and improve the disability in the long term, but the optimal therapeutic strategies are still not universally accepted. As with diabetes and hypertension, strict control of the disease is required, with the objective of achieving no disease activity, which may be seen as a remission, or if this is not possible, to keep the inflammatory activity as low as possible so that the unfavourable consequences, such as the articular damage process and the risks that the patients assume deriving from treatment, do not occur. The improvement criteria of the American College of Rheumatology (ACR) are useful for comparing the efficacy of treatment in clinical trials, but they must not be used as a therapeutic objective, since they do not evaluate the final activity, which can be as important as having an improvement. To evaluate the response, the most logical and convenient for the doctor is to use the same tools that are used to evaluate the activity of the disease in clinical practice, such as the DAS and SDAI activity scores. Some limits which separate the different levels of activity have been proposed to improve their interpretation and establish therapeutic objectives. The categorisation into classes according to activity is important for starting or changing treatment (when it is moderate or high) and to define stages of conceptually different activity (activity or remission). The cut-off points that separate these categories were proposed years ago when the therapeutic possibilities of RA were limited and their long term consequences were not known. The therapeutic objective of remission or lower activity is much easier to achieve these days, therefore the therapeutic categories need to be reconsidered and the definition of lower activity levels as a potential objective. Nowadays, to assume moderate or high activity as a result of treatment is unacceptable, particularly when our therapeutic arsenal is already considerable and strategies and therapeutic combinations have been proposed which have demonstrated higher efficacy with tolerable risks. Although changes happen gradually in all aspects of life, there is no reason not to accept remission of RA as not only a desirable objective, but also an achievable one.