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.

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).

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.

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.