Outcome of tocilizumab treatment in corticosteroid-resistant thyroid eye disease / Resultados del tratamiento con tocilizumab en la enfermedad ocular tiroidea resistente a glucocorticoides

Introduction: Thyroid eye disease (TED) is a complex and incompletely understood rare autoimmune disorder.ObjectivesTo analyze the experience and the outcomes obtained with the use of intravenous tocilizumab in the treatment of TED.MethodsA retrospective analysis of adult patients diagnosed with active TED resistant to intravenous corticosteroids treated in a tertiary hospital between May 2012 and May 2021.ResultsEleven patients were included with a mean age of 52±12 (range 35–67) years. Nine patients were female and two were male. Patients received a median of 5±3.2 doses. Twenty out of twenty-four eyes achieved inactivation of TED at week 16. Proptosis response was achieved in 6/8 patients and diplopia response in 3/8 patients. The GO-QOL questionnaire showed clinically significant improvement in 9/11 patients. No serious adverse effects were reported during tocilizumab treatment. One patient required decompressive surgery 15 months after tocilizumab therapy.ConclusionThe results obtained show that the use of tocilizumab in the treatment of this pathology can be a good alternative. (AU)

Introducción: La orbitopatía tiroidea (OT) es una enfermedad rara autoinmune compleja que no se conoce completamente.ObjetivosAnalizar la experiencia y los resultados obtenidos con el uso de tocilizumab intravenoso en el tratamiento de la OT.MétodosAnálisis retrospectivo de pacientes adultos diagnosticados de OT activa resistente a glucocorticoides por vía intravenosa tratados en un hospital terciario entre mayo del 2012 y mayo del 2021.ResultadosSe incluyó a 11 pacientes con una edad media de 52±12 (rango 35 a 67) años. Nueve pacientes eran mujeres y 2, hombres. Los pacientes recibieron una mediana de 5±3,2 dosis. Veinte de 24 ojos lograron la inactivación de la OT en la semana 16. Se logró respuesta a la proptosis en 6/8 pacientes y respuesta a diplopía en 3/8 pacientes. El cuestionario GO-QoL mostró una mejora clínicamente significativa en 9/11 pacientes. No se notificaron efectos adversos graves durante el tratamiento con tocilizumab. Un paciente requirió cirugía descompresiva 15 meses después del tratamiento con tocilizumab.ConclusionesLos resultados obtenidos muestran que el uso de tocilizumab en el tratamiento de esta enfermedad puede ser una buena alternativa. (AU)

Outcome of tocilizumab treatment in corticosteroid-resistant thyroid eye disease.

INTRODUCTION: Thyroid eye disease (TED) is a complex and incompletely understood rare autoimmune disorder. OBJECTIVES: To analyze the experience and the outcomes obtained with the use of intravenous tocilizumab in the treatment of TED. METHODS: A retrospective analysis of adult patients diagnosed with active TED resistant to intravenous corticosteroids treated in a tertiary hospital between May 2012 and May 2021. RESULTS: Eleven patients were included with a mean age of 52±12 (range 35-67) years. Nine patients were female and two were male. Patients received a median of 5±3.2 doses. Twenty out of twenty-four eyes achieved inactivation of TED at week 16. Proptosis response was achieved in 6/8 patients and diplopia response in 3/8 patients. The GO-QOL questionnaire showed clinically significant improvement in 9/11 patients. No serious adverse effects were reported during tocilizumab treatment. One patient required decompressive surgery 15 months after tocilizumab therapy. CONCLUSION: The results obtained show that the use of tocilizumab in the treatment of this pathology can be a good alternative.

Impact of the use of antibiotics on the clinical response to immune checkpoint inhibitors in patients with non-small cell lung cancer / Impacto del uso de antibióticos en la respuesta clínica de los inhibidores del punto de control en pacientes con carcinoma de pulmón no microcítico

Objectives. Recent research suggests that the use of antibiotics could reduce the efficacy of checkpoint inhibitors, in addition to other well-known factors. It could be due to gut microbiota modification, which impact over the immune system response. However, the information available so far is contradictory. The objective of this research was to clarify whether antibiotic use influences efficacy of checkpoint inhibitors treatments in non-small cell lung cancer patients in clinical practice. Methods. Therefore, a retrospective observational study was designed. Use of antibiotics among patients treated with atezolizumab, pembrolizumab or nivolumab was assessed within 2 months of checkpoint inhibitors treatments initiation. Results. A total of 140 patients were included, mostly men, with good performance status (ECOG 0-1), all of them previously treated with chemotherapy. An antibiotic prescription was identified in 31% of these patients, mainly fluoroquinolones or beta-lactams. The most frequent indication was respiratory infection. Both progression-free survival and overall survival were lower for patients treated with anti-infective drugs, although this difference was not statistically significant. Conclusion. More studies are needed to draw conclusions about the impact of antibiotics on the efficacy of immunotherapy. (AU)

Objetivos. Investigaciones recientes sugieren que el uso de antibióticos podría reducir la eficacia de los inhibidores del punto de control inmunológico, además de otros factores ya conocidos. Podría deberse a la modificación de la microbiota, por su impacto en la respuesta del sistema inmune. En cualquier caso, la información disponible hasta el momento es contradictoria. El objetivo de esta investigación es esclarecer si el uso de antibióticos influye en la eficacia de los inhibidores del punto de control para el tratamiento de pacientes con carcinoma de pulmón no microcítico en la práctica clínica. Métodos. Se diseñó un estudio observacional, retrospectivo. Se investigó el uso de antibióticos entre aquellos pacientes a tratamiento con atezolizumab, pembrolizumab o nivolumab en los 2 meses previos o posteriores a su inicio. Resultados. Se incluyeron 140 pacientes, principalmente hombres con aceptable estado general (ECOG 0-1), todos previamente tratados con quimioterapia. Se identificó una prescripción antibiótica en el 31% de la población, principalmente fluoroquinolonas o betalactámicos. La indicación más frecuente para dicha prescripción era la infección respiratoria. Tanto la supervivencia libre de progresión con la supervivencia global fue inferior en el grupo tratado con antiinfecciosos, aunque no se alcanzó significación estadística. Conclusiones. Son necesario más estudios para concluir acerca del impacto de los antibióticos en la eficacia de la inmunoterapia. (AU)

Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial.

Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).

Estudio observacional de práctica habitual con palbociclib y hormonoterapia para carcinoma de mama avanzado / Observational real world data with palbociclib associated to hormone therapy for advanced breast carcinoma

Objetivo: Los inhibidores de quinasas dependientes de ciclina CDK4y CDK6 poseen efecto sinérgico al asociarse con hormonoterapia. Suuso está extendido en primera y sucesivas líneas de carcinoma de mamaavanzado tipo luminal por mejorar la supervivencia libre de progresión.Los objetivos de nuestro estudio se basaron en analizar la evolución clínica y la toxicidad presentada en las pacientes tratadas en nuestro centrocon palbociclib, así como relacionar la evolución con las diferentes variables clínico-patológicas.Método: El estudio, de tipo observacional y retrospectivo, recogió datosde pacientes con cáncer de mama avanzado o metastásico tratados conhormonoterapia y palbociclib en el Hospital Universitario de Cabueñesentre los años 2017 y 2020. Se analizaron diferentes variables clínicopatológicas, así como información sobre toxicidad y supervivencia.Resultados: Un total de 72 mujeres y 1 varón con una mediana deedad de 63 años recibieron palbociclib asociado a inhibidor de aromatasa o fulvestrant. En primera línea la supervivencia libre de progresión fuede 22 meses, y en segunda o sucesivas líneas de 13 meses. El 95,9% de las pacientes presentaron algún tipo de efecto adverso, principalmentehematológico. No se produjo ningún abandono por toxicidad, aunquelos retrasos y los ajustes de dosis fueron frecuentes (61,7% y 42,7%, respectivamente). Solo la situación funcional al inicio del tratamiento influyóde manera significativa en la supervivencia libre de progresión (22 mesesen ECOG 0 versus 12 meses en ECOG ≥ 1; p = 0,021). (AU)

Objective: Cyclin-dependent kinase 4/6 inhibitors have a synergisticeffect in combination with endocrine therapy. This combination is usedas first and subsequent-line treatment for advanced luminal breast carcinoma because it increases progression-free survival. We analysed clinicalcourse and toxicity in patients treated with palbociclib in our hospital anddetermined potential associations between these variables and clinicopathological variables.Method: Observational retrospective study including patients withadvanced or metastatic breast cancer treated with palbociclib plus endocrine therapy at the Hospital Universitario de Cabueñes between 2017and 2020. We analysed clinicopathological variables, toxicity, and survival.Results: In total, 72 women and 1 man (median age: 63 years) receivedpalbociclib plus an aromatase inhibitor or fulvestrant. When used as firstline treatment, progression-free survival was 22 months, and as secondand subsequent-line treatment, progression-free survival was 13 months.Adverse effects (mainly haematological) were experienced by nearly all patients (95.9%). Treatment was not discontinued because of toxicity inany patient, although delays and dose adjustments were common (61.7%and 42.7%, respectively). Performance status alone had a significantimpact on progression-free survival (22 months in patients with ECOG 0vs 12 months in patients with ECOG ≥ 1; P = 0.021). (AU)

Observational real world data with palbociclib associated to hormone therapy for advanced breast carcinoma.

OBJECTIVE: Cyclin-dependent kinase 4/6 inhibitors have a synergistic effect  in combination with endocrine therapy. This combination is used as first and  subsequent-line treatment for advanced luminal breast carcinoma because it  increases progression-free survival. We analysed clinical course and toxicity  in patients treated with palbociclib in our hospital and determined potential  associations between these variables and clinicopathological variables. METHOD: Observational retrospective study including patients with advanced  or metastatic breast cancer treated with palbociclib plus endocrine therapy at  the Hospital Universitario de Cabueñes between 2017 and 2020. We  analysed clinicopathological variables, toxicity, and survival. Results: In total, 72 women and 1 man (median age: 63 years) received palbociclib plus an  aromatase inhibitor or fulvestrant. When used as firstline treatment,  progression-free survival was 22 months, and as second and subsequent-line treatment, progression-free survival was 13 months. Adverse effects (mainly haematological) were experienced by nearly all any patient, although delays  and dose adjustments were common (61.7% and 42.7%, respectively).  Performance status alone had a significant impact on progression-free  survival (22 months in patients with ECOG 0 vs 12 months in patients with  ECOG ≥ 1; P = 0.021). CONCLUSIONS: Disease stage, age, and performance status do not limit the  use of treatment with palbociclib, nor its combination with aromatase inhibitors or fulvestrant for first or subsequent-line treatment.  Toxicity is easily managed. Real-world results are equivalent to those  published to date.

Objetivo: Los inhibidores de quinasas dependientes de ciclina CDK4 y CDK6  poseen efecto sinérgico al asociarse con hormonoterapia. Su uso está  extendido en primera y sucesivas líneas de carcinoma de mama avanzado  tipo luminal por mejorar la supervivencia libre de progresión. Los objetivos  de nuestro estudio se basaron en analizar la evolución clínica y la toxicidad  presentada en las pacientes tratadas en nuestro centro con palbociclib, así  como relacionar la evolución con las diferentes variables clínico-patológicas.Método: El estudio, de tipo observacional y retrospectivo, recogió datos de  pacientes con cáncer de mama avanzado o metastásico tratados con hormonoterapia y palbociclib en el Hospital Universitario de Cabueñes  entre los años 2017 y 2020. Se analizaron diferentes variables  clínicopatológicas, así como información sobre toxicidad y supervivencia. Resultados: Un total de 72 mujeres y 1 varón con una mediana de edad de  63 años recibieron palbociclib asociado a inhibidor de aromatasa o  fulvestrant. En primera línea la supervivencia libre de progresión fue de 22  meses, y en segunda o sucesivas líneas de 13 meses. El 95,9% de Abstract las pacientes presentaron algún tipo de efecto adverso, principalmente hematológico. No se produjo ningún abandono por toxicidad, aunque los  retrasos y los ajustes de dosis fueron frecuentes (61,7% y 42,7%,  respectivamente). Solo la situación funcional al inicio del tratamiento influyó de manera significativa en la supervivencia libre de progresión (22 meses en  ECOG 0 versus 12 meses en ECOG ≥ 1; p = 0,021).Conclusiones: La extensión de la enfermedad, edad o status menopáusico no impiden el tratamiento con palbociclib, ya se administre con inhibidores de aromatasa o fulvestrant y en una u otra línea  metastásica. La toxicidad del fármaco es manejable, y los resultados de vida  real obtenidos son superponibles a los de los ensayos publicados hasta la actualidad.

Dosificación de cefazolina prequirúrgica en pacientes obesos y no obesos. ¿Importa el peso? / Dosage of presurgical cefazolin in obese and non-obese patients. Does weight matter?

OBJETIVO: Actualmente no existe evidencia clara que guíe la dosificación de cefazolina en pacientes obesos en profilaxis quirúrgica. El objetivo fue evaluar la efectividad de este antibiótico con una dosis estándar de 2 g en la prevención de infección de herida quirúrgica (IHQ) en pacientes obesos en comparación con no obesos. MATERIAL Y MÉTODOS: Revisión retrospectiva de varones ≥100 kg con cefazolina profiláctica entre 1 enero y 30 junio de 2019 en un hospital universitario en el servicio de traumatología. Los pacientes fueron estratificados en 2 grupos: obesos (≥ 100 kg e índice masa corporal (IMC)>30 kg/m2) y no obesos. Fueron excluidos aquellos que carecían de seguimiento en los 90 días posteriores a la intervención quirúrgica (IQ), aquellos con infección activa en el momento de la IQ o tratados con inmunosupresores. Se recogieron datos demográficos, altura, peso real, tabaquismo, diabetes, uso concomitante de inmunosupresores, datos de la IQ y presencia de infección hasta el día 90. RESULTADOS: 57 pacientes fueron sometidos a IQ traumatológica con cefazolina profiláctica, 26 no obesos y 23 obesos. Ambos grupos presentaron diferencias estadísticamente significativas en cuanto a peso, IMC y uso de cefazolina post-IQ. No se observaron diferencias significativas en el resto de variables. Dos (8,7%) obesos y dos (7,7%) pacientes no obesos desarrollaron IHQ, siendo la diferencia entre los grupos estadísticamente no significativa, tras 63 días post-IQ de media. CONCLUSIÓN: Este estudio demuestra que no existe diferencia significativa en IHQ con la dosis profiláctica de 2 g de cefazolina entre obesos y no obesos

OBJECTIVE: Evaluation of the effectiveness of a standard dose of cefalozin 2 grams for surgical site infection (SSI) prevention in obese patients compared to non-obese patients. There is no still controversy surrounding which is the best dosage of this antibiotic in obese patients for surgical prophylaxis. MATERIAL AND METHODS: Retrospective review of men who received prophylactic cefazolin between January 1st, 2019 and June 30th, 2019 in a traumatology department of a university hospital. Patients were stratified into 2 groups: obese (≥ 100 kg and body mass index (BMI)> 30 kg / m2) and non-obese. Patients without a 90 days follow-up after surgery and/or with an active infection at the time of surgery and/or treated with immunosuppressants were excluded. Demographic data, height, real weight, smoking, diabetes, concomitant use of immunosuppressants, surgery data and presence of infection until day 90 were collected. RESULTS: A total of 57 patients underwent traumatic surgery with prophylactic cefazolin, 26 non-obese and 23 obese, were studied. Both groups presented statistically significant differences in weight, BMI and post-surgery use of cefazolin. No significant differences were observed in the other variables. Two obese (8.7%) and two non-obese (7.7%) patients developed SSIs after 63 days post-surgery on average, following the difference between the groups being statistically non-significant. CONCLUSION: This study shows that there is no significant difference in SSI with a standard prophylactic dose of two grams of cefazolin between obese and non-obese patients

Alemtuzumab for relapsing multiple sclerosis in clinical practice: A four-year retrospective one-center study.

BACKGROUND: Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. OBJECTIVE: The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). METHOD: This retrospective observational study (2015-2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabueñes University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. RESULTS: 39 patients were included, 23 of them received at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). CONCLUSION: In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug.