Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting.

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.

Perfil dos pacientes evasores atendidos no ambulatório de queimados do Conjunto Hospitalar de Sorocaba / Perfil de los pacientes evasores en atención ambulatoria por quemaduras en el Conjunto Hospitalar de Sorocaba / Profile of evaders patients in the burn clinic of the hospital set of Sorocaba

Identificar o perfil dos pacientes desistentes do tratamento ambulatorial de queimados do Conjunto Hospitalar de Sorocaba (CHS). Método: Estudo exploratório, descritivo de característica transversal e quantitativo com pacientes acima de 18 anos que sofreram queimaduras de 2° grau, com abandono do tratamento em regime ambulatorial da Unidade de Tratamento de Queimados (UTQ) do CHS, no período de novembro de 2013 a maio de 2014, por meio da busca no Serviço de Arquivo Médico e Estatística (SAME) e posterior visita domiciliária para a realização de entrevista semiestruturada. As variáveis analisadas foram as características sociodemográficas, clínicas e terapêuticas. Resultados: A amostra constitui-se de nove participantes; destes, 55,5% do gênero masculino, 44,4% possuíam vínculo profissional informal, 66,6% dos acidentes ocorreram em ambiente domiciliar, 88,8% por escaldo, sendo a mão o membro mais afetado (44%). A média de tratamento foi de 2 dias e a fase cicatricial identificada foi a hiperpigmentação (55,5%). Quanto ao tratamento tópico, foi utilizado em 44,4% a hidrofibra de carboximetilcelulose e prata a 1,2% e a colagenase e cloranfenicol (33,3%). Conclusão: A maioria dos envolvidos são pessoas economicamente ativas, que sofreram lesões, principalmente em mãos, o que impossibilitou sua produtividade, fator contribuinte para a desistência do tratamento. Visto a dificuldade em contatar todos os desistentes do tratamento, aliado à escassez de publicações, evidencia-se a necessidade de estudos sobre a temática...

Identificar el perfil de los pacientes desistentes del tratamiento ambulatorio de quemaduras del Conjunto Hospitalar de Sorocaba (CHS). Método: Investigación exploratoria descriptivo de carácter transversal y cuantitativos con pacientes mayores de 18 años que sufrió quemaduras de segundo grado con abandono en el tratamiento de la Unidad de Tratamiento de Quemados (UTQ) de CHS, desde noviembre 2013 a mayo 2014, mediante la investigación en los registros y estadísticas del Servicio Médico (SAME) y la posterior visita a la casa para llevar a cabo la entrevista semiestructurada. Las variables analizadas fueron las características demográficas, socio clínicas y terapéuticas. Resultados: La muestra consistió en nueve participantes, de éstos el 55,5% eran hombres, 44,4% tenian condición de empleo la condición de empleo informal, 66,6% de los accidentes se produjo en el entorno del hogar, 88,8% para el escaldado y la mano era el miembro más afectado (44%). La media del tratamiento fue de dos días y la fase de cicatrización fue de hiperpigmentación (55,5%). En cuanto al tratamiento tópico, 44,4% se utilizó en la carboximetilcelulosa hidrofibra y la plata 1,2% y la colagenasa y cloranfenicol (33,3%). Conclusión: La mayoría de los involucrados son personas económicamente activas, que sufrió lesiones, especialmente en las manos, lo que afectó su productividad, factor que contribuye al abandono del tratamiento. Dado que la dificultad para ponerse en contacto con todos los que abandonaron el tratamiento, en combinación con la escasez de publicaciones, se destaca la necesidad de estudios sobre el tema...

To identify the profile of dropouts patients in the outpatient treatment of burns of the Hospital Complex of Sorocaba (HCS). Method: Exploratory descriptive study of transversal and quantitative characteristic with patients older than 18 who suffered 2nd degree burns, with dropout in outpatient of Burn Care Unit of HCS in November 2013 to May 2014, by searching in Medical Records and Statistics Service (MRSS) and subsequent home visit to conduct semi-structured interview. The variables analyzed were the demographic characteristics, clinical and therapeutic partner. Results: The sample is constituted of nine participants, of these 55.5% were male, 44.4% had informal employment status, 66.6% of the accidents occurred in the home environment, 88.8% by scalding, being the hand over the affected limb (44%). The average treatment was 2 days and was identified scar hyperpigmentation phase (55.5%). As regards topical treatment, 44.4% was used in the hydrofiber carboxymethylcellulose and the silver and 1.2% collagenase and chloramphenicol (33.3%). Conclusion: The majority of those involved are economically active people, who have suffered injuries, especially in the hands, which prevented their productivity, contributing factor to the withdrawal of treatment. Since the difficulty in contacting all dropouts of treatment, combined with the scarcity of publications, highlights the need for studies on the subject...

Biological drugs for the treatment of psoriasis in a public health system.

UNLABELLED: OBJECTIVE; To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil. METHODS: This is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions. RESULTS: A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes. CONCLUSIONS: The plaintiffs resorted to legal action to get access to biological medications because they were either unaware or had difficulty in accessing them through institutional public health system procedures. Access by means of legal action facilitated long-term use of this type of medication through irregular prescriptions and led to a high rate of adverse drug reactions as well as inappropriate clinical monitoring.

Patient reports of the frequency and severity of adverse reactions associated with biological agents prescribed for psoriasis in Brazil.

BACKGROUND: The safety of biological agents used to treat psoriasis remains uncertain. OBJECTIVE: The authors determined the frequency and severity of adverse effects associated with use of biologic agents for psoriasis through patient-registered lawsuits to the government of Sao Paulo, Brazil. METHODS: Sources of information included legal records, dispensing pharmacy data and interviews with patients. Research staff conducted telephone interviews with patients who used biologic drugs during 2004 - 2011, inquiring about medication-related adverse drug reactions (ADRs) and serious adverse events (SAEs). RESULTS: Of the 218 patients identified, 15 proved ineligible or refused participation. 203 patients were interviewed, with 111 (54.7%) taking infliximab, 43 (21.2%) efalizumab, 35 (17.2%) etanercept and 14 (6.9%) adalimumab. Of 84 (41.4%) patients who experienced one or more ADR related to biological agents, 57 (67.9%) experienced one or more SAE. The only risk factor associated with ADRs was comorbidity odds ratio = 6.54 (95% confident interval [CI] 3.20 - 13.32), p < 0.0001. CONCLUSION: 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.

Biological drugs for the treatment of psoriasis in a public health system / Medicamentos biológicos para o tratamento de psoríase em sistema público de saúde

OBJECTIVE To analyze the access and utilization profile of biological medications for psoriasis provided by the judicial system in Brazil. METHODS This is a cross-sectional study. We interviewed a total of 203 patients with psoriasis who were on biological medications obtained by the judicial system of the State of Sao Paulo, from 2004 to 2010. Sociodemographics, medical, and political-administrative characteristics were complemented with data obtained from dispensation orders that included biological medications to treat psoriasis and the legal actions involved. The data was analyzed using an electronic data base and shown as simple variable frequencies. The prescriptions contained in the lawsuits were analyzed according to legal provisions. RESULTS A total of 190 lawsuits requesting several biological drugs (adalimumab, efalizumab, etanercept, and infliximab) were analyzed. Patients obtained these medications as a result of injunctions (59.5%) or without having ever demanded biological medication from any health institution (86.2%), i.e., public or private health services. They used the prerogative of free legal aid (72.6%), even though they were represented by private lawyers (91.1%) and treated in private facilities (69.5%). Most of the patients used a biological medication for more than 13 months (66.0%), and some patients were undergoing treatment with this medication when interviewed (44.9%). Approximately one third of the patients discontinued treatment due to worsening of their illness (26.6%), adverse drug reactions (20.5%), lack of efficacy, or because the doctor discontinued this medication (13.8%). None of the analyzed medical prescriptions matched the legal prescribing requirements. Clinical monitoring results showed that 70.3% of the patients had not undergone laboratory examinations (blood work, liver and kidney function tests) for treatment control purposes. CONCLUSIONS The plaintiffs resorted to legal action ...

OBJETIVO Analisar o acesso e o perfil de utilização, por via judicial, de medicamentos biológicos para o tratamento de psoríase. MÉTODOS Estudo transversal descritivo. Foram entrevistados 203 pacientes com psoríase que demandaram medicamentos biológicos, por via judicial, ao Estado de São Paulo, entre 2004 e 2010. Informações sobre características sociodemográficas, médico-sanitárias e político-administrativas foram complementadas com dados obtidos das respectivas ordens de dispensação quanto a medicamento biológico para tratamento de psoríase e autos correspondentes. Os dados foram analisados em banco eletrônico e as variáveis sumarizadas por frequência simples. As prescrições contidas nos processos foram analisadas quanto aos preceitos legais contidos na lei. RESULTADOS Foram analisados 190 autos referentes aos medicamentos biológicos: adalimumabe, efalizumabe, etanercepte e infliximabe. Os proponentes obtiveram o medicamento por mandado de segurança (59,5%), sem nunca ter solicitado o medicamento biológico para outra instituição (86,2%), por sistema de saúde público ou privado. Utilizaram-se da prerrogativa de gratuidade de justiça (72,6%), embora fossem representados por advogado particular (91,1%) e atendidos em consultórios médicos privados (69,5%). Utilizaram o medicamento biológico por período > 13 meses (66,0%) e 44,9% faziam uso do medicamento no momento da entrevista. Quase um terço daqueles que deixaram de usar os medicamentos abandonou o tratamento por piora do quadro (26,6%), efeitos adversos (20,5%), falta de eficácia ou suspensão pelo médico (13,8%). Nenhuma prescrição médica atendeu aos preceitos legais; 70,3% dos pacientes não haviam realizado exames laboratoriais (hemograma, função ...

Adherence to guidelines in the use of biological agents to treat psoriasis in Brazil.

OBJECTIVE: In 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. METHODS: We 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. RESULTS: Of 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. CONCLUSIONS: Important discrepancies exist between clinical practice and the recommendations of guidelines in the management of plaintiffs using biological drugs to treat psoriasis.