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Objective: To describe the prevalence of persistent hypogammaglobulinemia in patients receiving Rituximab as a treatment for autoimmune rheumatological diseases., Methods: A transversal, retrospective and unicentric study, carried out in patients with autoimmune rheumatic diseases who were admitted to the Rheumatology service of the Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, Mexico City, to receive treatment with rituximab between January 2013 and January 2018. Descriptive and inferential statistics of serum levels of immunoglobulins, clinical-demographic characteristics, diagnosis, and treatment received were performed., Results: from 262 patients with autoimmune rheumatological disease who received treatment with Rituximab; We identified 8 patients with persistent hypogammaglobulinemia (6 women and 2 men), this is a prevalence of 3.1%. No associated factors with the development of hypogammaglobulinemia were identified., Conclusions: Until now, no associated prognostic or predictive factors have been identified with persistent hypogammaglobulinemia. Additional prospective studies are required to understand more precisely the implications of persistent hypogammaglobulinemia in patients with autoimmune diseases., Competing Interests: Los autores declaran no tener ningún conflicto de intereses.

Background: To assess pain in patients with rheumatic disease under biological therapy treatment., Methods: Observational retrospective study of patients with rheumatic disease under biological therapy treatment who visited the health care center as outpatients in February/August 2020. We collected demographic (sex and age), clinical (diagnosis, pain presence, intensity, and location), and pharmacological (biological therapy, concomitant treatment with traditional DMARDs, and analgesic treatment) variables from the electronic medical records and Farmatools Dominion®., Results: We included 138 patients; mean age was 56 years and 71% were female. The most frequent diagnosis (47%) was ankylosing spondylitis. Anti-TNF-a was the most prescribed biological drug (64%); 60.1% of study patients received traditional drugs, particularly methotrexate and leflunomide (51.8 and 28.9%, respectively). Pain was reported in 81% of the cases, particularly in hands (73.2%) and knees (69.6%); mean pain intensity was 6.5 (VAS). Although 83.3% of the patients had been prescribed analgesics, pain persisted in 84.8% of the cases (VAS >4), being severe or very severe in 67.9%. Over half of the patients (52.2%) used more than one analgesic. The most frequently prescribed medications were non-steroidal anti-inflammatory drugs (NSAIDs) (60%), paracetamol (52.2%), and opioids (56.5%). NSAIDs controlled pain (14.5%) better than opioids (8.3%); there was no post-treatment improvement of pain in 29.6% of the patients. The number of prescribed drugs increased with pain intensity (rho= 0.264; p= 0.006)., Conclusion: Almost 70% of study patients had uncontrolled severe rheumatic-related pain. This implies a challenge for esta­blishing effective treatments for this type of pain.

Controversies still exist regarding the humoral response to the virus SARS-CoV-2 in convalescent patients and seroconversion in patients with autoimmune diseases. There are few reports on the clinical and evolution of COVID-19 in the latter group. The objective was to examine the clinical and evolutionary characteristics associated with COVID-19 and the percentage of seroconversion in people with rheumatic diseases. Fifty-three patients were included, mainly with rheumatoid arthritis and lupus. The majority were female and average age 48 ± 14 years. Symptoms: fever (56%), anosmia (35.8%), dyspnea (34%), headache (30.2%) and cough (30.2%). Duration of infection 12 ± 7 days. Almost half of the patients were hospitalized (23, 43.4%), 5 in critical care units (9.4%) and 3 died (5.6%). The prevalence of steroid use was 56.6% (30), with an average dose of 8 mg/d, and 17 (32%) used immunosuppressive biopharmaceuticals. There was a correlation between age and the need for hospitalization with a risk of 9.4% per year. There were no differences with other variables. The presence in serum of IgG immunoglobulin against SARS-CoV-2 protein S was determined in 23/53 patients (43.4%), with detectable levels in 15 (62.2%), and in the 23 without autoimmune connective tissue diseases who suffered from COVID-19, 12 had detectable antibodies. Death in this group of rheumatic diseases was low, similar to the general population. More than half had specific antibodies against the virus regardless of the medication used.

Objective: To produce recommendations for patients with rheumatological diseases receiving immunomodulatory and immunosuppressive therapies (conventional drugs, biologicals, and small molecules) during the COVID-19 pandemic., Materials and Methods: The recommendations were determined using the Delphi method as an agreement tool. A panel of experts was formed, with academic backgrounds and research experience in rheumatology. A literature search was conducted and 42 questions were generated. The level of agreement was made with 80% of approval by the participants., Results: A group of eleven rheumatologists from 7 cities in the country participated. The response rate was 100% for the three consultation rounds. In the first round, agreement was reached on 35 questions, on 37 in the second round, and on 42 questions in the third round., Conclusion: The recommendation for the majority of the pharmacological treatments used in rheumatology is to continue with immunomodulatory or immunosuppressive therapies in patients who do not have the infection, and to suspend it in patients with a diagnosis of SARS-CoV-2/COVID-19., (Copyright © 2020 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objective: Vaccination coverage for seasonal influenza and pneumococcus in rheumatology patients receiving biological treatment. To identify variables that predict vaccination adherence., Material and Method: Descriptive cross-sectional study. The study involved rheumatology patients who initiated biological therapy between 01/01/2016 and 12/31/2016 in a regional referral hospital. Variables included sociodemographic information, diagnostic data, treating physician, referral to the vaccine unit and vaccination against pneumococcus with 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23), as well as seasonal influenza (2016/17). Univariate, bivariate (Chi-square) and multivariate analysis (logistic regression) were performed. The differences were considered significant (P<.05) and the PASW v.18 software package was used., Results: In all, 222 patients were included. Vaccination coverage was: PCV13, 80.2%; PPSV23, 77.9%; influenza 2016/17, 78.8%; PCV13+PPSV23, 75.2%; PCV13+PPSV23+influenza 2016/17, 68.9%. Axial spondylitis had the highest coverage (>80%) for pneumococcal vaccination and combination of pneumococcal with influenza. Overall, 27% of the patients were not referred to the unit. The treating physician was associated with statistical significance in each vaccine alone or combined, but referral to the vaccine unit was independently associated with the highest vaccination coverage (P<.001) in all cases., Conclusions: Compared to the scientific literature, we consider that the coverage of our patients against pneumococcus and influenza is high. Referral of these patients to the vaccine unit is the key to guarantee a correct immunization and to minimize some of the possible infectious adverse effects of biological therapies., (Copyright © 2018 Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. Publicado por Elsevier España, S.L.U. All rights reserved.)

Background and Objectives: Influenza vaccine is recommended for patients with autoimmune inflammatory rheumatic diseases who receive biological therapy. To evaluate if biological therapy impairs immunization after seasonal influenza vaccine., Material and Methods: Patients with inflammatory arthopathies, psoriasis, inflammatory bowel disease or connective tissue diseases who were receiving or were going to initiate biological therapy were included and vaccinated during 2014-2015 influenza season. ELISA was used to measure influenza antigen A and B antibodies, before and after vaccination. Demographic parameters, diagnosis and kind of treatment were recorded and their influence on the final serological status against influenza was studied., Results: 253 subjects were analyzed. After vaccination, 77% of participants presented detectable antibodies against antigen A and 50.6% of them had detectable antibodies against antigen B. Final seropositivity rate against antigen B antibodies increased from baseline (50.6% vs 43.5%, p<0.001). Anti-TNF drugs were associated with better response and rituximab with the worst (79.2% vs 55.0% for final seropositivity against antigen A, p=0.020). Vaccine response in the rituximab group tended to improve when the interval between the drug administration and the vaccination was at least 12 weeks (seropositivity rate 80.0% in those with the longer interval vs 25.0% in the other group, p=0.054)., Conclusions: Among the patients on biological therapy vaccinated against influenza, anti-TNF therapy was identified as a predictive factor of final seropositivity. Rituximab presented a lower rate of final seropositivity, which could be increased with an accurate administration schedule., (Copyright © 2019 Elsevier España, S.L.U. All rights reserved.)

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., (Copyright © 2019 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objective: Describe the objectives, methods and results of the first year of the new version of the Spanish registry of adverse events involving biological therapies and synthetic drugs with an identifiable target in rheumatic diseases (BIOBADASER III)., Methodology: Multicenter prospective registry of patients with rheumatic inflammatory diseases being treated with biological drugs or synthetic drugs with an identifiable target in rheumatology departments in Spain. The main objective of BIOBADASER Phase III is the registry and analysis of adverse events; moreover, a secondary objective was added consisting of assessing the effectiveness by means of the registry of activity indexes. Patients in the registry are evaluated at least once every year and whenever they experience an adverse event or a change in treatment. The collection of data for phase iii began on 17 December 2015., Results: During the first year, 35 centers participated. The number of patients included in this new phase in December 2016 was 2,664. The mean age was 53.7 years and the median duration of treatment was 8.1 years. In all, 40.4% of the patients were diagnosed with rheumatoid arthritis. The most frequent adverse events were infections and infestations., Conclusions: BIOBADASER Phase III has been launched to adapt to a changing pharmacological environment, with the introduction of biosimilars and small molecules in the treatment of rheumatic diseases. This new stage is adapted to the changes in the reporting of adverse events and now includes information related to activity scores., (Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objective: To develop recommendations for the use of parenteral methotrexate (MTX) in rheumatic diseases, mainly rheumatoid arthritis, based on best evidence and experience., Methods: A group of 21 experts on parenteral MTX use was selected. The coordinator formulated 13 questions about parenteral MTX (indications, efficacy, safety and cost-effectiveness). A systematic review was conducted to answer the questions. Using this information, inclusion and exclusion criteria were established, as were the search strategies (involving Medline, EMBASE and the Cochrane Library). Three different reviewers selected the articles. Evidence tables were created. Abstracts from the European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) were evaluated. Based on this evidence, the coordinator proposed preliminary recommendations that the experts discussed and voted in a nominal group meeting. The level of evidence and grade of recommendation were established using the Oxford Center 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: Most of the evidence involved rheumatoid arthritis. A total of 13 preliminary recommendations on the use of parenteral MTX were proposed; 11 of them were accepted. Two of the 13 were not voted and are commented on in the main text., Conclusions: The manuscript aims to solve frequent questions and help in decision-making strategies when treating patients with parenteral MTX., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

The present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar., (Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Objectives: Spanish clinical guidelines recommend screening patients for tuberculosis (TB) before TNF inhibitors (TNFi) treatment. Our objective was to estimate the prevalence of TST seroconversion as an estimation of the prevalence of latent TB in patients with rheumatic diseases and TNFi treatment that have already been screened for tuberculosis., Methods: TST, booster and chest x-ray were performed to patients with rheumatic diseases, TNFi treatment, negative tuberculin skin tests before treatment and that were attending the rheumatology Department of three different hospitals in Barcelona. According to the Spanish Society Rheumatology guidelines, these patients had not received TB prophylaxis treatment., Results: One hundred and forty patients were included in the study. The tuberculin skin test was positive in 4.28% (n=6) of the patients. 50% of the patients were undergoing TNFi ≤ 2 years, being two of the patients only one year on the TNFi when a positive TST was detected. This shows that a conversion of the TST can occur even few months or years after the TNFi is started., Conclusions: The present study observed that 4.28% of patients with rheumatic diseases on TNFi who did not have performed a pre-treatment TB prophylaxis, had a conversion of the TST. Moreover, the conversion of the TST had been within the first two years of treatment in half of the patients of our cohort. In spite of these results, false TST positives in the diagnosis of latent TB cannot be excluded as an explanation for our results., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Biological therapy has changed the course of inflammatory rheumatic diseases. The safety is well documented in national and international studies. Neurological manifestations are uncommon and it is difficult to establish a clear causal relationship. The neurological signs and symptoms that may appear are multiple and sometimes mimic demyelinating neurological diseases and/or neurodegenerative diseases. Knowledge and disclosure of these cases is essential for a comprehensive management of biological therapy in our patients., (Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.)

Rheumatic and systemic autoimmune diseases occur in women and, to a lesser degree, men of reproductive age. These disorders have to be clinically nonactive before conception, which is usually only possible after anti-inflammatory and immunosuppressive treatment. We must be alert since 50% of pregnancies are unplanned. Physicians should know the embryo-foetal toxicity of these drugs during pregnancy and lactation. This January 2016-updated review allows us to conclude that the majority of immunosuppressives available -anti-TNF inhibitors included- can be used before and during pregnancy, with the exception of cyclophosphamide, methotrexate, mycophenolate and leflunomide. Lactation is permitted with all drugs except methotrexate, leflunomide, mycophenolate and cyclophosphamide. Although data on abatacept, belimumab, rituximab, tocilizumab and anakinra are scant, preliminary reports agree on their safety during pregnancy and, probably, lactation. Cyclophosphamide and sulfasalazine apart, no negative effects on sperm quality, or embryo-foetal anomalies in men treated with immunosuppressives have been described., (Copyright © 2016 Elsevier España, S.L.U. All rights reserved.)

Antimalarial drugs are widely used in several countries for control of rheumatologic diseases such as systemic lupus erythematosus and rheumatoid arthritis. They are still used in Mexico because of their low cost and few secondary effects, most of which are mild and reversible. Even so, at an ophthalmological level, they could produce irreversible visual damage, which is why it is important to have ophthalmological evaluation and proper follow up. We present a clinical case as an example of characteristic ophthalmological findings as well as risk factors for retinal toxicity. We then discuss guidelines for diagnosis and follow up of patients who use antimalarial drugs for the treatment of rheumatologic illnesses.

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., (Copyright © 2015 Elsevier España, S.L.U. All rights reserved.)

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 was 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 for 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., (Copyright © 2013 Elsevier España, S.L. All rights reserved.)

A great diversity of infectious agents can affect patients that use steroids at immunosuppressive doses or tumor necrosis factor alpha (TNF-alpha) antagonists. The list of participating microorganisms is more restricted in the case of anti TNF-alpha blockers. Overlapping agents include intracellular bacteria, Mycobacterium tuberculosis, geographic fungal agents that have the ability to establish granulamotous infections, herpes zoster, and reactivation of chronic hepatitis B virus infection. An important conceptual issue for these infections is the existence of a threshold prednisone daily dose for the emergence of opportunistic infections but higher levels of immunosuppression and cofactors are required in the case of Pneumocystis jiroveci and cytomegalovirus infections. In order to prevent these threats, a detailed medical evaluation is needed before prescription to detect potential risks and manage them properly. Prevention rules must be prescribed in every case, that include common sense behaviors, vaccines, and in selected cases, chemoprophylaxis for latent tuberculosis (TB) infection, P. jiroveci pneumonia (PCP) or other specific requirements. Latent TB infection is probable and requires chemoprophylaxis in the case of remote or recent exposure to a patient with lung TB, a positive tuberculin or interferon-gamma release assay result or residual lung scars in a chest x-ray exam. PCP prevention is suggested when the patient reaches a daily dose of prednisone of 30 mg but might be needed at lower doses in case of other concomitant immunosuppressive drugs or when lymphopenia arises shortly after prednisone initiation.

This article outlines key recommendations for the appropriate prescription of non steroidal anti-inflammatory drugs to patients with different musculoskeletal problems. These recommendations are based on current scientific evidence, and takes into consideration gastrointestinal and cardiovascular safety issues. The recommendations have been agreed on by experts from three scientific societies (Spanish Society of Rheumatology [SER], Spanish Association of Gastroenterology [AEG] and Spanish Society of Cardiology [SEC]), following a two-round Delphi methodology. Areas that have been taken into account encompass: efficiency, cardiovascular risk, gastrointestinal risk, liver risk, renal risk, inflammatory bowel disease, anemia, post-operative pain, and prevention strategies. We propose a patient management algorithm that summarizes the main aspects of the recommendations., (Copyright © 2013 Elsevier España, S.L. and AEEH y AEG. All rights reserved.)

Biotechnological drugs (BTDs) are complex molecules whose manufacturing process precludes the ability to identically reproduce the structure of the original product, and therefore there cannot be an absolute equivalence between the original (innovative) medication and its biosimilar counterpart. BTDs have been proven useful in the treatment of several rheumatic diseases, however their high cost has prevented their use in many patients. Several BTD patents have expired or are close to expire, triggering the development of structurally similar drugs with efficacy and safety profiles comparable to the innovative compound; however, these must be evaluated through evidence based medicine. The Mexican General Health Law contemplates the registry of these biosimilar drugs for their use in our country. This document is a forethought from members of the Mexican College of Rheumatology, pharmacologists, and epidemiologists, in accordance with Mexican health authorities regarding the necessary scientific evidence required to evaluate the efficacy and safety of biosimilar drugs before and after their arrival to the Mexican market., (Copyright © 2012 Elsevier España, S.L. All rights reserved.)

The objective of this paper is make recommendations for the perioperative management of antirheumatic treatment based on the best available evidence. A systematic review was performed including studies in which patients with rheumatic diseases treated with biological and non-biological disease-modifying antirheumatic drugs (DMARDs) had undergone surgery. A total of 5,285 studies were recorded, of which 27 were finally included. These contained information on 5,268 patients and 7,933 surgeries. The majority were women (mean age 55 years) were diagnosed with rheumatoid arthritis, and the most studied drug was methotrexate (MTX). The final recommendations include: maintaining treatment with MTX or leflunomide in the perioperative period in the absence of other risk factors for postoperative complications (Level of Evidence 1c, Grade D recommendation). Biological DMARDs should be temporarily suspended, or the surgery scheduled as far as possible from the last dose, and, if there were other risk factors a space at least two doses (Level of Evidence 2c; Grade D recommendation)., (Copyright © 2012 SECOT. Published by Elsevier Espana. All rights reserved.)

This work reports patient treatment survival and adverse events related to Biologic Therapy (BT), identified by a multicenter ambispective registry of 2047 rheumatic patients undergoing BT and including a control group of Rheumatoid Arthritis (RA) patients not using BT. The most common diagnoses were: RA 79.09%, Ankylosing Spondilytis 7.96%, Psoriatic Arthritis 4.40%, Systemic Lupus Erythematosus 3.37%, Juvenile Idiopathic Arthritis 1.17%. A secondary analysis included 1514 cases from the total sample and was performed calculating an incidence rate of any adverse events of 178 × 1000/BT patients per year vs 1009 × 1000/control group patients per year with a 1.6 RR (95% CI 1.4-1.9). For serious adverse events the RR was: 15.4 (95% CI 3.7-63.0, P<.0001). Global BT survival was 80% at 12 months, 61% at 24 months, 52% at 36 months and 45% at 48 months and SMR: 0.23 (95% CI 0.0-49.0) for BT vs 0.00 (95% CI 0.0-0.2) for the control group. In conclusion, BT was associated to a higher infection risk and adverse events, compared to other patients. Mortality using BT was not higher than expected for general population with same gender and age., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

Objective: To evaluate the duration of etanercept (ETN) treatment and motives for discontinuation in our local cohort of patients with rheumatic pathology and compare them to the group with other biological treatments., Patients and Methods: Prospective observational cohort study. Disease diagnosis, start and end date and motive for discontinuation were recorded. Survival estimation was explored using Kaplan-Meier analysis with remaining patients censored at 1-year, 2-years and 5-years follow-up., Results: Ninety-two (45%) out of 205 patients started ETN treatment. Disease diagnoses recorded were: 48% rheumatoid arthritis, 33% ankylosing spondylitis, 11% psoriatic arthritis, 8% others (juvenile idiopathic arthritis, inflammatory bowel disease related spondylitis, SAPHO syndrome). 52% of patients are still on the drug. The motives for discontinuation were: inefficacy (65%), adverse events (33%) and lack of compliance (2%). Two patients discontinued ETN due to prolonged disease control. Adverse events were: infection (4 patients), post-injection skin reaction (3), uveitis (3), neoplasia (2) and others (3). Using a Kaplan-Meier analysis, at 1-year 64% (CI(95%) 54-74) of patients with ETN treatment had not experienced treatment failure, at 2-years, 59% (48-69) and at 5-years, 43% (30-52). With the rest of biologicals estimated survival was 61% (51-68), 47,5% (40-55) and 23% (10,5-32) respectively. Statistical analysis revealed significant differences (log-rank: P=.024; Breslow: P=.068; Tarone-Ware: P=.040)., Conclusions: In our cohort of patients treated with ETN the estimated survival was better than patients treated with other biological drugs at 1-year, 2-years and 5-years., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

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., (Copyright © 2011 Elsevier España, S.L. All rights reserved.)

Introduction: Tumor necrosis factor-alpha antagonists (anti-TNFα) have shown an increasing consumption and generate a significant economic burden on health systems., Objectives: The prescribing patterns of tumor necrosis factor-alpha antagonists were determined in a patient population associated with the Sistema General de Seguridad Social en Salud in Colombia., Materials and Methods: A descriptive observational study was conducted in 316 patients with respect to use of tumor necrosis factor-alpha antagonists during a treatment period from January 2008 to June 2009. The database examined contained indications of use, inclusion criteria to medication, duration of illness, co-morbidities and adverse reactions. The data were retrieved from the clinical histories. Student's t test was used for the comparison of quantitative variables, and the chi-square test was used to establish associations between categorical variables and multivariate analysis were used., Results: Mean age was 44.613.9 years; 63.9% of participants were female. Of the 316 patients, 17.1% received monotherapy. The order of prescription drugs was as follows: adalimumab (37.3%), infliximab (37.3%) and etanercept (25.4%), all were prescribed in appropriately defined daily doses. Co-medication drugs most frequently prescribed were: disease-modifying anti-rheumatic (82.9%), NSAIDs (29.1%), omeprazole (22.5%), antihypertensives (21.2%), folic acid (19.9%) calcium plus vitamin D (9.8%), calcitriol (6.0%). 10.4% of patients had a record of some adverse drug reaction. The average cost of therapy per patient per year was US$23,464., Conclusions: Anti-TNFα are being used at recommended doses, particularly in rheumatoid arthritis and in combination with other anti-rheumatic drugs. The direct cost of therapy was high for the country's health system.

Objective: To evaluate whether the safety and efficacy of anti-TNF treatments in elderly patients with rheumatic diseases is similar than the safety and efficacy of the same drugs in younger patients., Methods: Systematic review. We performed a systematic search in MEDLINE (Pubmed), EMBASE (Ovid), and the Cochrane Library Plus. Abstracts published in the American and European rheumatology congresses and articles in Reumatología Clínica were also reviewed., Results: Ten studies fulfilled the inclusion criteria. Studies show a similar efficacy in elderly and younger patients. The differences between the young and the elderly regarding DAS28 reductions before and after are very small: 0.04 in the Geneway et al study and 0.0 in the Mariette et al study, as well as in the before and after HAQ: 0.04 (Geneway et al), 0.18 (Schiff et al) and 0.06 (Mariette et al).Adverse events reported in elderly and younger patients are 83.3% and 77.1% respectively with etanercept, as reported by Fleischmann; 27.2% vs 12.5%, p=0.19, as reported by Chevillotte, and the rate of withdrawal due to an adverse event was 57,8% vs 29,2% with infliximab, p=0.03, 36% vs 15% p=0.06 with adalimumab and 10,3% and 9,5%, with no significant p value, as reported by Massara., Conclusions: The information to assess the efficacy and safety of anti-TNF therapy in elderly patients was obtained in all cases from sub analyses and therefore bias is possible. We can say, with a low to moderate level of evidence, that elderly patients undergoing anti-TNF treatments have a higher number of adverse events, and similar efficacy, when compared with younger patients., (Copyright © 2009 Elsevier España, S.L. All rights reserved.)

Tetracyclines are a family of antibiotics very common in clinical practice that have been used in not infectious affections. One of their most studied actions is their ability to inhibit matrix metalloproteinases (MMPs), a group of proteinases that have been implicated in pathological processes as oncogenesis and inflammation. Tetracyclines have been shown to play an important role in malignant angiogenesis and cancer invasion, which is related with tumor aggressiveness and metastatic potential.They also show anti-inflammatory activity in neurological, respiratory, bone and heart diseases, and in rheumatologic and dermatologic processes. The aim of this review is to make an updating about the non antimicrobial actions of tetracyclines, specially their therapeutic applications in different diseases.

Tacrolimus is an immunosuppressive drug used most successfully as a primary drug to suppress the rejection of transplants. Tacrolimus may also be useful as a novel therapy for autoimmune disease. There are various reports in the bibliography about the use of tacrolimus in the treatment of some autoimmune diseases: inflammatory bowel disease, autoimmune hepatitis, cutaneous, neurologic, renal, endocrine or eye disease. In this review of more than 130 papers, we discuss the rationale for the use of tacrolimus in autoimmune disease and report the clinical experience with the drug in the management of a variety of autoimmune diseases. But, although there are a lot questions that require future research (dose, duration of treatment, when to begin tacrolimus treatment, how to monitor it, etc.), there is also wide experience with tacrolimus in the treatment of this type of disease.

Introduction: Vasculitis are characterised by the inflammatory infiltrate, chiefly of mononuclear cells, in the walls of the blood vessels, which can lead to occlusion with necrosis and the subsequent infarction of the affected tissue., Aims: The Objective of this study was to determine the clinical, anatomicopathological and neurophysiological aspects of vasculitic neuropathies in infancy., Patients and Methods: Each patient was submitted to the following tests: a complete hemogram, systemic lupus erythematosus cells (LE cells), lupus anticoagulant, antinuclear antibodies, neutrophil anticytoplasmic antibodies, venereal disease research laboratory test (VDRL), erythrocyte sedimentation rate, liver transaminases, serological testing for hepatitis C, B and A, cytochemical study of the cerebrospinal fluid, study of motor and sensory conduction, electromyography and nuclear magnetic resonance, when required; a biopsy of the sural nerve was performed, which was replaced by a necropsy if the patient died., Results: 15 patients from a total of 25 who were studied had vasculitic neuropathies; the most usual presentation was multiple mononeuropathy; aetiologies found included microscopic polyangiitis, systemic lupus erythematosus, JRA, overlap syndrome and several undetermined vasculitis. Of the patients who were submitted to a biopsy, 75% showed signs of vasculitis, which affected the small and medium sized vessels in 62.5% of patients., Conclusions: The presence of neuropathy in association with symptoms and signs of systemic involvement suggested the possibility of a neuropathy in the course of a vasculitis. The examination of biopsy specimens of the sural nerve is useful for the diagnosis and classification of the aetiology of vasculitis. Response to treatment with immunosuppressant drugs was good, both in the case of the neuropathy and of the underlying disease.

Objective: To describe the incidence and characteristics of the infection caused by Mycobacterium tuberculosis in patients with autoimmune diseases., Patients and Methods: Searching in the database of the department at our institution, all new cases of tuberculosis from 1991 to 2000 were identified in patients with autoimmune diseases; the total follow-up time was calculated as the difference between first and last visits. Time with immunosuppressive drug therapy was obtained for patients with rheumatoid arthritis from a database oriented to the longitudinal follow-up of these patients. The incidence density was calculated as the quotient between the absolute frequency of cases and the sum of individual periods at risk for each subgroup., Results: Fifteen cases of tuberculosis were identified from 3,634 risk patients followed for an accumulated period of 9,795 years (overall incidence 153 per 100,000 patients-year). Fourteen patients were receiving disease-modifying drugs and eleven were receiving corticosteroids at diagnosis. The location of tuberculosis infection was the lung for 33.3% of cases. The incidence by drugs in patients with rheumatoid arthritis was 143 per 100,000 patients-year with methotrexate, 2,703 per 100,000 patients-year with azathioprin, 7,692 per 1,000 patients-year with cyclophosphamide, and 4,878 per 100,000 patients-year for anti-TNFalpha., Conclusions: Compared with the general population, the incidence density of tuberculosis is increasing in our population, with a higher frequency of extrapulmonary involvement. The incidence density is variable among patients with rheumatoid arthritis depending upon the used drugs.

Objective: To study the feasibility of local infiltration in primary care consultations., Design: Before-and-after intervention study., Setting: Two clinics at an urban health centre., Participants: Patients diagnosed with pathology of tender areas and treated with corticosteroid infiltration between May 1997 and May 1998., Intervention: Corticoid infiltration plus local anaesthetic. Weekly check-up. Analysis of the variables: sex, age, diagnosis, time elapsed between indication and start of treatment, subjective assessment of pain before and after treatment (VRS scale), number of infiltrations per patient, side-effects. Evaluation of overall and individual effectiveness., Results: 41 patients were infiltrated. Average age was 58. Most common pathologies were: rotary joint tendinitis (48.7%), anserine bursitis (24.4%), plantar fasciitis (7.3%). Average number of infiltrations per pathology: 1.3. Mean waiting time: 3.5 days. Comparison of pain by means of VRS (range 0-5) before and after treatment used the Wilcoxon test, with a statistically significant difference and p < 0.001 (z = -5.5109). For 35 patients (85.4%), pain was solved very well (values 0 and 1 on the VRS). For 3 patients (7.3%), improvement was moderate; and for 3 (7.3%) there was no improvement., Conclusions: 1. Treatment with local infiltration of corticosteroids is effective in dealing with pain, and is an alternative to treatment with NSAIDs. 2. It is feasible in primary care, and there are many advantages if the general practitioner employs this therapeutic technique.

Serial measurement of liver enzymes is useful to detect liver toxicity due to methotrexate in patients with rheumatoid arthritis or other rheumatic diseases. We have reviewed retrospectively 141 adult patients treated with methotrexate from 1988 to 1991. The more common diagnoses included rheumatoid arthritis (120 cases) and psoriatic arthritis (12 cases). In periodic studies carried our every 2-3 months, a transient increase in transaminase values associated with methotrexate in 13 patients (9.2%) was observed. Two patients developed a viral infection during therapy, one due to cytomegalovirus and the other due to the Epstein-Barr virus. Both patients had a favorable outcome once methotrexate was withdrawn.

NSAID's are largely used drugs. Among the reported side effects of this type of drugs is liver damage. 73 patients suffering from diverse rheumatological pathologies (arthrosis 46.6%, rotators 9.68%, rheumatoid arthritis 21.92%, lumbalgia 5.48%, other diagnosis 6.85%) were evaluated. Aceclofenac (AC) 100 mg. dose every 12 hours was administered. A Transaminase value determination was taken both at the beginning and end of medication for each patient. Average age of patients was 52.71 years, 78% being female. Treatment was administered as follows, 42.47% of the patients received a 60 days treatment, 28.8% a 45 days treatment, 23.3% a 30 days treatment and 5.47% received a 15 days treatment. Reported mean GOT value at the beginning was 16.6 U, at the end 17.01 U. GPT initial value was 15.84 U and final 16.53 U. A GOT increase, 20 U to 50 was observed in a single patient. GPT was also increased from 32 U to 47 U in one case. Results led us to a no liver damage report of the NSAID's AC in these group of patients.