Efficacy and safety of certolizumab pegol for Crohn's disease in clinical practice.

BACKGROUND: Certolizumab pegol (CZP) is Food and Drug Administration (FDA)-approved to treat Crohn's disease (CD). However, the efficacy and safety of CZP outside clinical trials are not well established. AIM: To report the efficacy, safety and predictors of response to CZP in CD patients treated during a 6-year period since FDA-approval at a tertiary care centre. METHODS: All CD patients who received CZP at our institution between 2008 and 2013 were evaluated through retrospective medical record-based review of steroid-free complete response (SCR), loss of response and safety. RESULTS: A total of 358 patients were included. One hundred twelve patients (31.3%) and 189 (52.8%) received CZP as their second and third biological agent, respectively. The probability of SCR at 26 week was 19.9% (95% CI, 15.9-24.5). The probability of survival free of loss of response at 2 year was 45.7% (95% CI, 32.5-59.5). A predictor of SCR was age at CD diagnosis of >40 years old (hazard ratio, HR relative to those <17, 4.69; 95% CI, 1.75-12.61). Negative predictors included present perianal fistula (HR, 0.39; 95% CI, 0.16-0.98) and prior primary nonresponse to adalimumab (ADA; HR relative to secondary loss of response, 0.18; 95% CI, 0.04-0.76). Twenty-three patients (6.4%) experienced serious adverse events and 19 patients (5.3%) discontinued CZP due to adverse events. CONCLUSIONS: Certolizumab pegol was both effective and well tolerated for the treatment of Crohn's disease in this large tertiary care centre enriched with biologics-exposed patients. It may be more effective in patients without early-aged Crohn's disease diagnosis, prior primary nonresponse to adalimumab and present perianal fistula.

Comparison of the 1987 ACR criteria and the 2010 ACR/EULAR criteria in an inception cohort of patients with recent-onset inflammatory polyarthritis.

OBJECTIVES: To compare the performance of the 1987 American College of Rheumatology (ACR) and the 2010 ACR/European League Against Rheumatism criteria for the classification of rheumatoid arthritis (RA). METHODS: Two-hundred and one patients aged 16 years or older with a 4-week to 12-month history of swelling of at least two joints and not previously treated with corticosteroids or disease-modifying anti-rheumatic drugs (DMARDs) were studied. The fulfilment of the 1987 and 2010 criteria was determined at baseline and at the end of the 1-year follow-up period. The sensitivity, specificity, positive and negative predictive values, positive and negative likelihood ratios, and accuracy of both sets of criteria were determined against three outcome measures: initiation of therapy with either methotrexate or any DMARD within the first year of follow-up, and clinical diagnosis according to physician's opinion after one year. RESULTS: At presentation, 145 patients fulfilled the 2010 criteria, and 108 the 1987 criteria for RA. The sensitivity, specificity and accuracy of the 2010 criteria were 0.80, 0.62 and 0.77 (0.58, 0.64 and 0.59 for the 1987 criteria) against the initiation of methotrexate therapy, 0.75, 0.73 and 0.75 (0.56, 0.91; 0.58 for the 1987 criteria) against the initiation of any DMARD therapy, and 0.87, 0.73 and 0.84 (0.69, 0.94; 0.75 for the 1987 criteria) against clinical diagnosis. CONCLUSIONS: Compared with the 1987 criteria, the 2010 criteria are more sensitive and accurate, but less specific against two of the three outcome measures used, and classify more patients with RA at earlier stages of the disease.

Frecuencia de aislamientos microbiológicos en hemocultivos / Frequency of microbiological isolations in blood cultures

El objetivo del presente es calcular la frecuencia de aislamientos microbiológicos a partir de hemocultivos obtenidos de pacientes pediátricos y adultos internados en nuestro hospital durante 25 meses. Se analizaron las muestras de pacientes internados en unidad coronaria, terapia intensiva y cuidado intermedio (tanto adultas como pediátricas) del Hospital El Cruce de Florencio Varela. Se concluye que la frecuencia de aislamientos microbiológicos en hemocultivos fue algo menor que lo reportado en la bibliografía (aproximadamente 9%). El uso previo de antibióticos en los pacientes, a pesar del uso de metodología apropiada, disminuye el índice de recuperación de microorganismos. Se observó un ligero predominio de gérmenes Gram (-) a expensas principalmente de infecciones asociadas a asistencia respiratoria mecánica. Debido al tipo de pacientes que se internan en el hospital, con amplios y variados tratamientos antibióticos e internaciones previas, fue posible la recuperación de levaduras.

A recent onset inflammatory polyarthritis register in Spain: factors that predict remission.

OBJECTIVE: To identify baseline variables that predict remission at 1 year in patients with recent onset inflammatory polyarthritis (IP). METHODS: We prospectively studied 167 patients aged >or=16 years with a 4-week to 12-month history of swelling of >or=2 joints. At baseline, no patient had previously received corticosteroids or disease-modifying anti-rheumatic drugs (DMARDs). To adjust for differences in baseline variables associated with the type of treatment given (a surrogate marker of disease severity), we used regression analysis. The classification probability of treatment thus obtained was entered, along with other significant baseline variables, in a second separate regression analysis to identify variables that predicted remission (no swollen joints). RESULTS: Frequency of remission was 50.9% at 1 year. In the first regression analysis, variables associated with treatment with DMARDs or DMARDs and corticosteroids versus corticosteroids alone included age, morning stiffness, swollen joint count (SJC), disease severity according to the patient, and rheumatoid factor (RF) level; the strongest association was for higher SJC. In the second regression analysis, the model that best predicted remission (correct in 70.1% of cases) included age, tender joint count (TJC), erythrocyte sedimentation rate (ESR), RF, total Sharp score, disease severity according to the physician, and the 1987 American Rheumatism Association (ARA) criteria for rheumatoid arthritis (RA); the strongest association was for failure to meet these criteria. The model's sensitivity, specificity, and area under the receiver operating characteristic (ROC) curve were 70.6%, 70.9%, and 75.4%, respectively. CONCLUSION: Although we identified some predictors of remission, no model accurately predicted remission at 1 year in this cohort.

[Depression]. / Depressão.

The Portuguese Medical Association, through its Colleges of Specialistes, has decided to establish working groups to establish Therapeutic Guidelines in pathologies of great interest and current relevance in order to improve and rationalize health care. The group in charge of establishing the Therapeutic Recommendations in Depression, whose work I had the responsability and pleasure of coordinating during part of 1998 and 1999, is comprised of colleagues selected by the Portuguese Medical Association (Ordem dos Médicos). In the last few years, there has been rapidly increasing clinical and scientific interest in the study and treatment of depression throughout the life cycle, in different contexts and levels of medical practice. The rapid progress made in the neurosciences and psychopharmacology, new research in the field of psychotherapies and improved knowledge of relevant psychosocial aspects has not only broadened our knowledge of the aetiology and pathogenesis of depression, but also improved our criteria of diagnosis and classification. This has allowed the development of new therapeutic approaches and new drugs of proven efficacy. These Recommendations are aimed at systematizing and disseminating a consensus on interventions in depression, supported by evidence and the most recent scientific developments, in a way that will optimise therapeutic treatment. Due to some delay in the publication of these Recommendations (through no fault of the working group), and the rapid evolution of knowledge in this area, some of the contents may shortly need to be revised and updated. The writers and publishers of this document are fully aware of this and in accordance.

Multicenter double-blind study of moclobemide and maprotiline.

A randomized double-blind, multicenter 6-week study was undertaken in 80 depressed patients to compare the effects of moclobemide, a selective and reversible monoamine oxidase-A inhibitor (300 mg daily), and maprotiline (75 mg daily). Efficacy was assessed by Hamilton Depression Rating Scale (HDRS) and Clinical Global Impression (CGI). Tolerability was assessed by adverse events reports. After 6 weeks of therapy, both groups of patients showed significant improvement in HDRS and CGI. Speed of onset of action was faster with moclobemide (significant difference at week 3, p = 0.025). There was a significant reduction of depression ratings (HDRS) in both the moclobemide and maprotiline group in all types of depression according to ICD-9 criteria (major depressive disorder, neurotic depression and adjustment-prolonged depressive reaction). Significantly fewer patients in the moclobemide group reported adverse events (28.9% compared with 70.2%) including weight gain (2.6% compared to 21.6%). Anticholinergic side effects were less frequent with moclobemide. It is concluded that both drugs are at least equivalent in terms of therapeutic efficacy, but moclobemide is better tolerated.