Patient satisfaction survey: substitution of reference etanercept with a biosimilar product.

OBJECTIVES: To assess patient satisfaction after pharmacy-mediated replacement of the originator etanercept prefilled syringe with its biosimilar prefilled pen. METHODS: Prospective observational study from March to May 2018, to assess satisfaction with the new drug dispensed. Patients were asked to answer a paper questionnaire with three questions: pain at injection site, ease of administration, and overall patient satisfaction with the change, rated on a scale from 1 (not satisfied) to 5 (extremely satisfied). RESULTS: The questionnaire was given to 134 patients (74 men, 60 women), with an average age of 55 years. 118 patients (88%) were from the Rheumatology Service and 16 patients (12%) from Dermatology. The median treatment duration with etanercept was 61 months. 87 (65%) completed questionnaires were collected. The mean pain score was 3.4. Most patients found administration easy with the biosimilar pen, with an average score of 3.7. Mean overall satisfaction was rated at 3.3, being higher among men, younger patients, and those with shorter duration of treatment. CONCLUSIONS: The change of the original product from etanercept to a biosimilar product was acceptable for most of the patients who responded to the survey. Surveys allow us to determine the opinion and preferences of patients, thus achieving higher satisfaction with their treatment. Further research is needed to evaluate the effect of automatic replacement. A collaborative multidisciplinary switching programme should be implemented based on the feedback provided by patients.

Natalizumab: safety and risk in patients with relapsing-remitting multiple sclerosis.

OBJECTIVE: To estimate the risk of progressive multifocal leukoencephalopathy (PML) and the safety of natalizumab administration in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: A descriptive retrospective observational study including all patients with RRMS treated with natalizumab followed-up after 10 years.The likelihood of developing PML was estimated based on three risk factors: anti-John Cunningham virus antibody index, previous immunosuppressive therapy, and duration of treatment. Patients were classified into five categories: minimum probability (<0.1/1000); low (0.1/1000); medium-low (0.2-0.6/1000); medium-high (0.8-3/1000); high probability (3-10/1000). RESULTS: 34 patients were included. The probability of PML in the last cycle was: 55.9% minimum, 8.8% low, 11.8% medium-low, 3% medium-high, and 20.5% high. 12 patients continue with active treatment with natalizumab. No cases of PML have been confirmed. Adverse effects were detected in 50% of patients. CONCLUSIONS: Quantifying risk factors allows us to estimate the probability of PML appearance, thus assessing the maintenance or suspension of natalizumab.

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.