Safety of etanercept in psoriasis: a critical review.

Conventional systemic treatments for patients with psoriasis are associated with multiple adverse effects that require continuous monitoring. The introduction of new biological agents such as etanercept, a fully human fusion protein, has permitted individualisation of patients' treatment according to disease stage. The drug is a competitive inhibitor of tumour necrosis factor-alpha (TNFalpha) that prevents interaction between this cytokine and its cell surface receptors. Etanercept also modulates the activity of other inflammatory cytokines and does not induce complement-mediated cell lysis in vitro. The main source of information regarding etanercept safety comes from studies in patients with rheumatoid arthritis. The most common adverse effect during drug administration is mild injection site reactions. There is no increase in the overall incidence of infections compared with placebo, although there have been several reports of infections caused by intracellular organisms (Mycobacterium tuberculosis, Listeria monocytogenes, and Mycobacterium avium intracellulare). Therefore, combination of this drug with corticosteroids must be carefully monitored and should be avoided in patients with established sepsis. There are no data showing that treatment with etanercept results in an increase in the occurrence of malignant neoplasms. However, caution is recommended in use of etanercept in patients with a current or past history of demyelinating disease. Etanercept must be used with extreme caution in patients with heart failure because of several reports indicating a worsening or de novo occurrence of congestive heart failure while receiving the drug. Monitoring of autoantibodies is not currently considered necessary as they do not predict response, toxicity or autoimmune events. The presence of non-neutralising antibodies to the TNF receptor fragment or other protein components of etanercept has not been related to a decrease in drug response or adverse reactions. Etanercept does not generally modify the course of inflammatory bowel disease. When combined with other systemic therapies for psoriasis, current data do not show an increase in adverse events. In patients with hepatitis C viral infection, etanercept does not increase transaminase levels or viral load and in some instances has allowed the concomitant use of interferon which had previously been discontinued because of a worsening of psoriasis. Etanercept is rated as a US FDA category B drug in pregnancy. However, its use is not recommended in pregnant women unless the benefit-risk ratio greatly favours its use. Etanercept is not recommended for use in lactating women. Etanercept represents a relevant treatment for psoriasis, efficacious over many weeks and safe but special care should be taken to avoid the potential risks.

[Streptococcal toxic shock syndrome: ten years' experience at a tertiary hospital]. / Síndrome del shock tóxico estreptocócico: experiencia de los últimos 10 años en un hospital terciario.

INTRODUCTION: In the last two decades there has been a reported increase in the incidence of streptococcal toxic shock syndrome (STSS). The objective of this study was to determine the clinical and epidemiological characteristics of this infection. METHODS: Retrospective study of all cases of STSS diagnosed at a single tertiary hospital over the last ten years. RESULTS: We report 13 cases of STSS (8 men, mean age 62 years). The mean annual incidence was 0.19 episodes/100,000 population from 1994 to 1998 and 0.53 episodes/100,000 population from 1999 to 2003 (p = 0.059). All patients had at least one underlying disease and there were no intravenous drug users. The most common portals of entry were the skin and soft tissues (85%) and all but one patient had a positive blood culture. Two cases were nosocomial and five patients required surgery (amputation and/or debridement). There was a high mortality rate (85%) and a rapid course from onset to death; nine patients died within four days after establishing the diagnosis. CONCLUSION: The incidence of SSTS has increased over the last five years at our hospital. Elderly patients with underlying medical conditions were more susceptible to acquiring this infection. Early mortality was very high.

Síndrome del shock tóxico estreptocócico: experiencia de los últimos 10 años en un hospital terciario / Streptococcal toxic shock syndrome: ten years, experience at a tertiary hospital

Introducción. En las dos últimas décadas, diferentes estudios han señalado un aumento de la incidencia del síndrome del shock tóxico estreptocócico (SSTE). El objetivo de este estudio ha sido determinar las características clinicoepidemiológicas del SSTE en nuestro medio. Métodos. Estudio retrospectivo de los casos de SSTE diagnosticados en los últimos 10 años en un hospital terciario. Resultados. Se diagnosticaron 13 casos de SSTE (edad media: 62 años, 8 varones). La tasa de incidencia media anual entre 1994 y 1998 fue de 0,19 casos/100.000 habitantes, y entre 1999 y 2003, de 0,53 casos/100.000 habitantes (p 5 0,059). Todos los pacientes presentaron alguna enfermedad subyacente, pero ninguno fue adicto a drogas por vía parenteral. El foco de origen más frecuente se localizó en la piel y los tejidos blandos (85%). Hubo bacteriemia en 12 casos y la infección fue nosocomial en 2 casos; se realizó cirugía mayor (amputación y/o desbridamiento) en 5 casos. La mortalidad fue muy elevada (85%), y la mayoría (82%) fallecieron en los primeros 4 días tras el diagnóstico. Conclusión. La incidencia del SSTE aumentó en los últimos 5 años. Afectó sobre todo a pacientes de edad avanzada con importante comorbilidad y la mortalidad precoz fue muy elevada (AU)

Introduction. In the last two decades there has been a reported increase in the incidence of streptococcal toxic shock syndrome (STSS). The objective of this study was to determine the clinical and epidemiological characteristics of this infection. Methods. Retrospective study of all cases of STSS diagnosed at a single tertiary hospital over the last ten years. Results. We report 13 cases of STSS (8 men, mean age 62 years). The mean annual incidence was 0.19 episodes/100,000 population from 1994 to 1998 and 0.53 episodes/100,000 population from 1999 to 2003 (p 5 0.059). All patients had at least one underlying disease and there were no intravenous drug users. The most common portals of entry were the skin and soft tissues (85%) and all but one patient had a positive blood culture. Two cases were nosocomial and five patients required surgery (amputation and/or debridement). There was a high mortality rate (85%) and a rapid course from onset to death; nine patients died within four days after establishing the diagnosis. Conclusion. The incidence of SSTS has increased over the last five years at our hospital. Elderly patients with underlying medical conditions were more susceptible to acquiring this infection. Early mortality was very high (AU)

[Refractory psoriasis treatment with etanercept]. / Tratamiento de la psoriasis refractaria con etanercept.

BACKGROUND AND OBJECTIVES: Etanercept is a dimeric fusion protein that binds to tumor necrosis factor and blocks inflammatory response. The purpose of this study was to assess the effects of etanercept and its maintenance in patients with severe and refractory psoriasis. PATIENTS AND METHOD: Twenty two patients with severe and refractory psoriasis in an open-label clinical trial were studied. Patients received etanercept 50 mg/week subcutaneously during 6 months. PASI (Psoriasis Assessment and Severity Index) was used to monitor disease activity in each month of treatment and in the follow up. Results at weeks 12 and 24 are shown. RESULTS: 96% of patients improved their PASI basal score early at week 12. This improvement was maintained until week 24. Etanercept was well tolerated without any significant adverse reaction. Time until relapse was 2.27 +/- 0.59 months (CI 95%: 1.94-2.60). CONCLUSION: Etanercept seems an effective therapy for severe and refractory psoriasis yet long-term dosing and safety studies of etanercept in psoriasic patients are needed.

Tratamiento de la psoriasis refractaria con etanercept / Refractory psoriasis treatment with etanercept

Fundamento y objetivos: Determinar el número y la proporción de pacientes con psoriasis extensa y refractaria que mejoraron tras la administración de etanercept, así como el tiempo medio de respuesta mantenida tras su retirada. Pacientes y método: Se incluyó en el estudio a 22 pacientes con psoriasis grave refractaria a otros tratamientos sistémicos a los que se les administraron 50 mg de etanercept a la semana durante 24 semanas. Presentamos los resultados en el Psoriasis Assessment and Severity Index (PASI) en las semanas 12 y 24, y la duración media de la mejoría. Resultados: Veintiún pacientes (96%) disminuyeron su puntuación en el PASI ya en la semana 12 respecto de la basal (p < 0,01), 9 (41%) alcanzaron el objetivo principal (PASI75) y 16 (73%) el objetivo secundario (PASI50). Dieciocho (82%) de los pacientes mejoraron su PASI respecto del basal en la semana 24 (p < 0,01). Catorce (63%) alcanzaron el PASI50 y 13 (59%) el PASI75. El tiempo medio (desviación estándar) libre de enfermedad hasta el rebrote tras el cese del tratamiento fue de 2,27 (0,59) (intervalo de confianza del 95%, 1,94-2,60). Conclusión: El etanercept parece una buena opción de tratamiento en los pacientes con psoriasis extensa y refractaria. El perfil de seguridad es adecuado y tiene una administración fácil

Background and objectives: Etanercept is a dimeric fusion protein that binds to tumor necrosis factor and blocks inflammatory response. The purpose of this study was to assess the effects of etanercept and its maintenance in patients with severe and refractory psoriasis. Patients and method: Twenty two patients with severe and refractory psoriasis in an open-label clinical trial were studied. Patients received etanercept 50 mg/week subcutaneously during 6 months. PASI (Psoriasis Assessment and Severity Index) was used to monitor disease activity in each month of treatment and in the follow up. Results at weeks 12 and 24 are shown. Results: 96% of patients improved their PASI basal score early at week 12. This improvement was mantained until week 24. Etanercept was well tolerated without any significant adverse reaction. Time until relapse was 2.27 ± 0.59 months (CI 95%: 1.94-2.60). Conclusion: Etanercept seems an effective therapy for severe and refractory psoriasis yet long-term dosing and safety studies of etanercept in psoriasic patients are needed

Tratamiento de la psoriasis extensa y refractaria con infliximab. Resultados tras un año de tratamiento / Treatment of severe refractory psoriasys with infliximab. Clinical outcomes after one of therapy

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[Treatment of severe refractory psoriasis with infliximab]. / Tratamiento de la psoriasis extensa y refractaria con infliximab.

BACKGROUND AND OBJECTIVE: Infliximab is a chimeric monoclonal antibody that binds to tumor necrosis factor alpha and blocks the inflammatory response. The purpose of this study was to assess the effects of infliximab in patients with severe and refractory psoriasis. PATIENTS AND METHOD: Eleven patients with severe and refractory psoriasis were included in an open-label clinical trial. Patients received infliximab 5 mg/kg intravenously at weeks 0, 2, 6 and every 8 weeks. Psoriasis Assessment and Severity Index (PASI) and BSA (Body Surface Assessment) were used to monitor disease activity with each dose. Results at weeks 6 and 30 are shown. RESULTS: 90% of patients improved their PASI and BSA basal scores early at sixth week, achieving 63.6% (PASI75) and 72.7% (BSA50). This improvement was maintained until the 30th week (54.5% and 72.7%, respectively). Infliximab was well tolerated and there was no significant adverse reaction. CONCLUSIONS: Infliximab seems an effective therapy for severe and refractory psoriasis.

Diagnóstico y tratamiento enzimático sustitutivo de la enfermedad de Fabry / Diagnosis and enzyme replacement therapy of Fabry´s disease

Las manifestaciones cutáneas de la enfermedad de Fabry tienen un papel importante para el diagnóstico precoz de la enfermedad. Con la introducción de terapias de sustitución enzimática pueden tener una relevancia aún mayor.Se describe un caso en el que la presencia de dolores lancinantes en los dedos de las manos tras el ejercicio y de angioqueratomas difusos sugirieron el diagnóstico, posteriormente confirmado mediante estudio enzimático y genético. En este caso, el tratamiento sustitutivo con alfa-galactosidasa es de utilidad para el paciente (AU)