Background: Biological agents used for the treatment of psoriatic arthritis (PsA) and rheumatoid arthritis (RA) are associated with serious adverse effects (SAEs). Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third line therapies due to a relative lack of long-term safety data. Objective: To determine the frequency and severity of adverse effects associated with the long-term use of biologics in the treatment of PsA and RA, and possible risk factors for such events in a real-life setting. Methods: We conducted a longitudinal study in PsA and RA patients only taking long-term biological agents from 2003 to 2011. Sources of information included dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients inquiring about any apparent medication-related adverse drug reactions (ADRs) or SAEs. ADR/SAE’s data was based on pharmacy reports. We conducted a multivariate analysis to identify the factors associated with the risk of ADRs. Results: Of the 305 patients identified, we interviewed 268 patients. Most of these were taking adalimumab 127 (47.4%), 52 (19.4%) etanercept, 42 (15.7%) infliximab, 25 (9.3%) rituximab, 10 (3.7%) abatacept, 9 (3.4%) efalizumab, and 3 (1.1%) tocilizumab. Of the 268 patients, 116 (43.3%) experienced one or more adverse events related to biological agents with 1.6 events per patient, and of these 29 (25%) experienced one or more SAEs, with majority subjected to hospitalizations. The most frequently reported ADRs were administration site reactions as observed in 73 patients (27.2%), infections in 30 patients (11.2%), effects on nervous system in 22 patients (8.2%), and 15 (5.6%) patients withdrew due to ADRs. The use of rituximab was related with less risk of ADR [PR 0.42, 95% CI 0.18–0.96; p = 0.04] than other agents. No other predisposing factors were associated with risk of ADR. The monitoring of patients (medical consultation and laboratory test) was only completed by 48 patients (30.4%). Conclusion: These data showed the early biological experience in Brazil that were associated with ADRs, withdrawals due to ADRs and SAEs. The quantification of adverse effects (serious or nonserious) considering close monitoring and patients’ perceptions are increasingly important for future decision-making.

ObjectiveIn São Paolo, Brazil, patients can appeal to the courts, registering law suits against the government claiming the need for biological agents for treatment of psoriasis. If the lawsuits are successful, which is usually the case, the government then pays for the biologic agent. The extent to which the management of such patients, after gaining access to government payment for their biologic agents, adheres to authoritative guidelines, is uncertain.MethodsWe identified patients through records of the State Health Secretariat of São Paulo from 2004 to 2011. We consulted guidelines from five countries and chose as standards only those recommendations that the guidelines uniformly endorsed. Pharmacy records provided data regarding biological use. Guidelines not only recommended biological agents only in patients with severe psoriasis who had failed to respond to topical and systemic therapies (eg, ciclosporin and methotrexate) but also yearly monitoring of blood counts and liver function.ResultsOf 218 patients identified in the database, 3 did not meet eligibility criteria and 12 declined participation. Of the 203 patients interviewed, 91 were still using biological medicine; we established adherence to laboratory monitoring in these patients. In the total sample, management failed to meet standards of prior use of topical and systemic medication in 169 (83.2%) patients. Of the 91 patients using biological medicine at the time of the survey, 23 (25.2%) did not undergo appropriate laboratory tests.ConclusionsImportant discrepancies exist between clinical practice and the recommendations of guidelines in the management of plaintiffs using biological drugs to treat psoriasis.

Biologic agents were associated with high rates of ADRs and SAEs. The data suggests that for patients taking a biologic agent to treat psoriasis and who have one or more comorbidities, warnings of possible adverse events and enhanced surveillance are warranted.

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Purpose: The aim of the present study was to determine whether de-escalation guided by blood cultures for patients with a diagnosis of sepsis, severe sepsis or septic shock reduces mortality, and antimicrobial drug resistance (ADR).Methods: A prospective, single-center, cohort study was conducted with adults admitted to the ICU with a diagnosis of sepsis, severe sepsis, or septic shock at a public hospital in Sorocaba, State of São Paulo, Brazil, from January 2013 to December 2013. We excluded patients who had negative blood cultures. Patients who had replaced the initial empirical broad-spectrum antibiotic therapy (EAT) by the antibiotic therapy guided by blood cultures were compared with those who continued receiving EAT. The outcome included mortality and antimicrobial drug resistance. We used the Cox regression (proportional hazards regression) and the Poisson regression to analyze the association between antibiotic therapy guided by blood cultures (ATGBC) and outcomes. The statistical adjustment in all models included the following variables: sex, age, APACHE II (Acute Physiology And Chronic Health Evaluation II) score and SOFA (Sequential Organ Failure Assessment) score.Results: Among the 686 patients who were admitted to the intensive care unit, 91 were included in this study. The mean age of the patients was 52.7 years (standard deviation = 18.5 years) and 70.3% were male. EAT was replaced by ATGBC in 33 patients (36.3%) while 58 patients (63.7%) continued receiving EAT. Overall hospital mortality decreased from 56.9% in patients who received EAT to 48.5% in patients who received ATGBC [Hazard ratio- HR 0.44 (95% CI 0.24–0.82), p = 0.009]. There was no association between ATGBC and ADR [HR 0.90 (95% CI 0.78 – 1.03) p = 0.15].Conclusions: Although the early and appropriate empirical EAT is undoubtedly an important factor prognostic, ATGBC can reduce the mortality in these patients.