Post-switch Effectiveness of Etanercept Biosimilar Versus Continued Etanercept in Rheumatoid Arthritis Patients with Stable Disease: A Prospective Multinational Observational Study.

INTRODUCTION: To better inform clinicians about the use of etanercept biosimilar (SB4) in patients with rheumatoid arthritis (RA), COMPANION-B, a prospective real-world observational study, evaluated the effectiveness of the voluntary switch from originator (etanercept, ETN) to SB4 in patients with stable RA (low-disease activity/remission). METHODS: The study recruited adult patients (18 years or older) with RA (2010 American College of Rheumatology criteria) prescribed ETN as their first or second biologic for at least 6 months across 14 sites in Canada and five in Australia. Patients had stable disease (Disease Activity Score-28 using erythrocyte sedimentation rate [DAS28-ESR] less than 3.2) at enrollment with no evidence of flare within the previous 3 months. Concomitant disease-modifying antirheumatic drugs (DMARDs) were permitted. Patients could elect to continue ETN or voluntarily switch to SB4 in consultation with their doctors. The primary effectiveness measure was the proportion of patients with disease worsening (defined as a DAS28-ESR increase of at least 1.2 from baseline and minimum score of at least 3.2 or a defined modification in RA treatment) during 12 months of follow-up. The secondary effectiveness measure was the proportion of patients with disease worsening at month 6. Serious adverse events (SAEs) and non-serious adverse reactions (NSARs) were recorded. RESULTS: Of 163 patients enrolled, 109 elected to continue on ETN and 54 switched to SB4; 65.8% of patients received non-biologic DMARD(s), 52.6% methotrexate, and 10.5% oral corticosteroid(s). At month 12, the proportion of patients with disease worsening was comparable in the ETN group (22.8% [95% CI 15.0-32.2]) and SB4 group (17.6% [95% CI 8.4-30.9]). Similarly, the proportions of patients with disease worsening were also comparable at month 6 (ETN: 7.9% [95% CI 3.5-15.0]; SB4: 7.8% [95% CI 2.2-18.9]). SAEs were low and similar across both groups (ETN: 8.7%; SB4: 5.7%). NSARs were slightly higher in the SB4 vs. ETN group (13.2% vs. 2.9%). CONCLUSIONS: SB4 demonstrated comparable effectiveness to ETN over 12 months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

Patient and Healthcare Professionals Preference for Brenzys vs. Enbrel Autoinjector for Rheumatoid Arthritis: A Randomized Crossover Simulated-Use Study.

INTRODUCTION: Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys autoinjector compared to the currently available marketed Enbrel MYCLIC autoinjector (Australia) and Enbrel SureClick autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy. METHODS: Patients (N = 191) reporting a diagnosis of RA and nurses and rheumatologists (N = 90) with experience managing RA were shown how to use Brenzys and Enbrel autoinjectors (in counterbalanced order between participants), then they used each autoinjector by injecting into a pad simulating skin, and completed a questionnaire. Study sessions took place in Australia and Canada. RESULTS: A binomial test showed that significantly more patients indicated that the Brenzys autoinjector was easier to use than the Enbrel autoinjector (79% reporting Brenzys easier to use; p < 0.001, two-sided, 95% CI [73%, 85%]). In addition, significantly more nurses and rheumatologists with experience managing RA also indicated that the Brenzys autoinjector was easier to use (86%; p < 0.001, two-sided, 95% CI [77%, 92%) and that they would recommend the buttonless Brenzys autoinjector over the Enbrel autoinjector to patients (83%; p < 0.001, two-sided, 95% CI [74%, 90%]). Almost all patients who reported past experience using an Enbrel autoinjector (N = 17) reported on the basis of using the two devices in the study that they would prefer to switch their device to the Brenzys autoinjector rather than continue their course of therapy using the Enbrel autoinjector (16/17, 94%, 95% CI [71%, 100%]). CONCLUSION: On the basis of the study results, the Brenzys autoinjector was rated statistically significantly easier to use, and was overall preferred by patients and healthcare professionals with experience managing RA patients. FUNDING: Merck & Co., Inc.

Uso indiscriminado de antibióticos en pacientes histerectomizadas / Indiscriminate use of antibiotics in hysterectomized patients

Se realizó un estudio longitudinal y retrospectivo en el Servicio de Ginecología del Hospital General Docente “Guillermo Domínguez López”, del Municipio de Puerto padre, en el período comprendido desde el 1ro de Enero del 2004 al 31 de Diciembre del 2005 en pacientes a las cuales se le realizó histerectomía abdominal. El universo estuvo formado por 469 pacientes y la muestra escogida fue de 434 pacientes histerectomizadas en el periodo de estudio, quedaron excluidas las que se le realizó histerectomía por causas sépticas y obstétricas. Los datos se obtuvieron de las historias clínicas con el objetivo de demostrar que con el uso de la profilaxis antibiótica es innecesaria la utilización indiscriminada de antibióticos postoperatorios y de esta forma se reducen los costos. El diagnóstico más frecuente fue el fibroma uterino, las complicaciones sépticas aparecieron en mayor magnitud en el grupo que se les aplicó antibióticoterapia postoperatoria, no sucedió así con las pacientes que solo se les aplicó profilaxis. Se reducieron los costos y prevaleció una mayor calidad en la atención al paciente(AU)

A longitudinal and retrospective study was done in the gynecological service of the General Teaching Hospital “Guillermo Domínguez López” of Puerto Padre municipality from January 1 st 2004 to December 31 st 2005 with abdominal hysterectomized patients. The universe of study was formed by 469 patients and the selected sample was 434 hysterectomized patients, those patients who hysterectomized due to septic and obstetrical causes were excluded. The data were collected from medical history in order to demonstrate that with the use of antibiotic prophylaxis is not necessary the indiscriminate use of postoperative use of antibiotics and this way costs are reduced. The more frequent diagnose was uterine fibroma, septic complications mostly appeared in the group with postoperative antibiotic therapy; it did not happen in patients who only received prophylaxis. Costs were reduced and a greater quality in patient attention predominated(AU)

Hipertensión Arterial en el Embarazo: algunos aspectos epidemiológicos: 2do Semestre del 2004 / Arterial hypertension in pregnancy: some epidemiological aspects: second semester 2004

Se realizó un estudio longitudinal prospectivo en el Hospital General Docente “Guillermo Domínguez López” del municipio Puerto Padre, provincia Las Tunas, para determinar algunos aspectos epidemiológicos de la hipertensión en el embarazo, en el período comprendido desde el 1ro de Julio hasta el 31 de Diciembre del 2004. Se tomó una muestra de 50 pacientes atendidas en el servicio de Obstetricia con diagnóstico de hipertensión en el embarazo escogidas al azar, se concluyó que el grupo de edad que predominó fue el de 25 29 años, conjuntamente al de las pacientes con edad gestacional entre 28 36,6 semanas. La multiparidad, desnutrición y antecedentes familiares de hipertensión constituyeron los factores de riesgo de mayor incidencia y la preeclampsia leve fue el diagnóstico que predominó, así como el parto eutócico. Se recomendó la capacitación del personal médico(AU)

A longitudinal and prospective study was done in the General Teaching Hospital “Guillermo Domínguez López” of Puerto Padre municipality in Las Tunas province in order to determine some epidemiological aspects of hypertension in pregnancy from July 1 st to December 31 st 2004 . The sample was constituted by 50 patients selected at random in the obstetrical service with diagnose of hypertension in pregnancy. It was concluded that the group of 25 29 years old prevailed among the others together with the group of patients with gestational time between 28 36.6 weeks. Multiparity, malnutrition and family antecedents of hypertension constituted the greater incident risk factors and light preeclampsia was the prevailing diagnose as well as eutocia. Qualification of medical staff was recommended(AU)

Algunas características generales de las Hernias Incisionales / Some general characteristics of incisional hernias

Se realizó un estudio descriptivo y retrospectivo de todos los pacientes operados en el servicio de Cirugía General del Hospital General Docente “Guillermo Domínguez López” con el diagnóstico de Hernia Incisional durante el año 2003 y 2004. Se revisaron las Historias Clínicas de 280 pacientes, según sexo y grupo de edades, el sexo femenino y el grupo de edades entre 45 54 fueron los más afectados; las heridas localizadas en la línea media infraumbilical fueron las más frecuentes, además fue la histerectomía la operación anterior en el mayor número de los casos, así como la presencia de complicaciones en el post operatorio de la intervención anterior siendo la primera causa la sepsis de la herida quirúrgica (AU)

A descriptive and retrospective study of all patients operated on with the diagnosis of incisional hernia during year 2003 and 2004 was done in “Guillermo Domínguez López” General Teaching Training Hospital. The clinical records of 280 patients were revised. The principal objetives were to distribute patients according to sex and age groups, to identify the most frequent localization, to determine de previous operation, and de previous interventions´ post operative complications with major incidence. The female sex and de group of age between 45 54 years old were the most affected. The wounds localized in the middle intraumbilical line were the most frequent. The previous operation with the major number of cases was histerectomy. Therf were post - operative complications in the previous intervention I being the sepsis of surgical wound the first cause(AU)

Estudio comparativo de bezafibrato y lovastatina en pacientes con hiperlipemia / Comparative study of bezafibrate and lovastatin in patients with hyperlipemia

La prevalencia y la morbimortalidad por aterosclerosis es elevada tanto a nivel nacional como internacional. Las manifestaciones clínicas incluyen enfermedad coronaria, infartos cerecrales, accidentes trombóticos e isquemia de miembros inferiores. La hiperlipemia está relacionada estrechamente con la génesis de estos problemas. En el presente artículo se comparó la eficacia terapéutica de dos medicamentos hipolipemiantes con diferente mecanismo de acción, se determinó que el efecto del bezafibrato es superior en la reduccion de triglicéridos y que la lovastatina actúa mejor en la reducción del colesterol. El bezafibrato elevó en mayor proporción el colesterol de lipoproteínas de alta densidad. El grupo fue pequeño pero la respuesta en general fue satisfactoria. NO hubo efectos colaterales o indeseables con los medicamentos que, en general, fueron bien tolerados. Cabe señalar que el tratamiento debe ser permanente.