Hypogammaglobulinemia after front-line immunochemotherapy in patients with follicular lymphoma.

INTRODUCTION: Hypogammaglobulinemia after front-line immunochemotherapy for follicular lymphoma is a poorly studied adverse event that could be related to the appearance of severe and/or recurrent non-neutropenic infections which could affect the quality of life of the patients, even motivating a need of long-term replacement therapy with human immunoglobulins. METHODS: Observational, retrospective study aiming to estimate the incidence of hypogammaglobulinemia, as well as its severity and clinical consequences, and to explore possible predictive factors for its development. Specific immunoglobulin deficiencies were also studied. RESULTS: 76.5% of patients had hypogammaglobulinemia during or after front-line treatment, mostly grade 1-2; with 38.8% patients who developed clinically relevant infections and 20% patients requiring human immunoglobulins replacement therapy. A high-risk FLIPI score was identified as a risk factor for hypogammaglobulinemia (ods ratio: 4.51; 95% confidence interval: 1.29-15.68; p < 0.001) and basal gamma globulin level as a protective factor (odds ratio: 0.92; 95% confidence interval: 0.988-0.996; p = 0.018). Any type of immunochemotherapy regimen was associated with different risks of hypogammaglobulinemia in our study. CONCLUSIONS: Hypogammaglobulinemia appears in a high percentage of patients with follicular lymphoma in a real-world population, identifying a high-risk FLIPI score as a risk factor for its development and basal gamma globulins as a protective factor.

Effectiveness and safety of eribulin for human epidermal growth factor receptor 2 negative metastatic breast cancer in a real-world population.

BACKGROUND: Eribulin's clinical benefit remains unclear; so, studies analyzing its effectiveness in routine clinical practice are interesting. PATIENTS AND METHODS: This is a multicenter, retrospective study including patients with human epidermal growth factor receptor-2-negative metastatic breast cancer which assesses effectiveness and safety of eribulin. RESULTS: A total of 140 women were included, with a median age of 57 years. The median overall survival and progression-free survival were 8.8 (95% confidence interval: 6.1-11.4) and 2.8 months (95% confidence interval: 2.5-3.1), respectively. For patients with hormonal receptor expression, a significantly longer progression-free survival was observed: 3.4 (95%confidence interval: 2.3-4.5) versus triple negative: 2.0 (95%confidence interval: 1.7-2.3) months, p = 0.003. Also, those who had received capecitabine prior to eribulin had a higher median overall survival than those who had not received it (9.5 months, 95% confidence interval: 6.6-12.5 vs. 4.8 months, 95% confidence interval: 3.4-6.2; p = 0.001). When only triple-negative patients were included, median overall survival was 6.5 (95% confidence interval: 0.1-16.2) for those who had received previous capecitabine versus 4.3 (95% confidence interval: 2.8-5.8) months for patients who had not received it; p =0.006. The safety profile of eribulin was adequate. CONCLUSION: Effectiveness of eribulin in a real-life human epidermal growth factor receptor-2--negative population is lower than that observed in clinical trials. Its benefit seems to be higher in patients with hormonal receptor expression and patients who had received capecitabine prior to eribulin. The safety profile of eribulin is adequate.

Impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection.

OBJECTIVE: To investigate the impact of COVID19 pandemic on the incidence of health-care associated Clostridioides difficile infection (HA-CDI). METHODS: Retrospective study conducted in the Hospital Universitario de Valme (HUV) and the Hospital General Universitario de Alicante (HGUA) in Spain between January 2019 and February 2021. The study period was divided into non-COVID19 period (2019 and months from 2020 to 2021 with ≤30 hospitalized COVID19 patients) and COVID19 period (months from 2020 to 2021 with >30 COVID19 patients). HA-CDI incidence rates (IR) were calculated as the number of new CDI cases per 10.000 occupied bed-days (OBD) and antimicrobial consumption by means of the defined daily dose (DDD) per 1000 OBD. RESULTS: During the COVID19 period, HA-CDI IR in the HUV was 2.6 per 10.000 OBD, which was lower than what was observed during the non-COVID19 period (4.1 per 10.000 OBD; p = 0.1). In the HGUA, HA-CDI IR during COVID19 period was 3.9 per 10.000 OBD, which was not significantly different to the IR observed during the non-COVID19 period (3.7 per 10.000 OBD; p = 0.8). There was a slight increase in the total antibiotic consumption during COVID19 period in both hospitals, with significant increases of certain high-risk antibiotics as cephalosporins. CONCLSUSIONS: HA-CDI incidence has not increased during the COVID19 pandemic in two tertiary centers in Spain, in spite of a slightly higher antibiotic consumption during the COVID19 period in both hospitals. These findings suggest that, in the presence of strict infection control measures, hospital antibiotic consumption might have a lower impact than expected on HA-CDI.

Indirect comparison of anti-interleukin 17 targeted biological treatments for moderate-to-severe psoriasis.

WHAT IS KNOWN AND OBJECTIVE: Psoriasis is an inflammatory skin disease with an important disease burden worldwide and its treatment includes systemic therapies which have advanced over time to target specific immune cytokines such as interleukin-17. The main objective of this study was to compare the relative efficacy of brodalumab, ixekizumab and secukinumab (three anti-interleukin-17 drugs) through adjusted indirect treatment comparisons (ITCs). METHODS: A search was carried out in June 2019, consulting these databases: MEDLINE, EMBASE, Web of Science and the Cochrane Library. Studies including patients with moderate to severe psoriasis randomized to receive treatment with anti-interleukin-17 drugs or ustekinumab and with outcomes such as Psoriasis Area and Severity Index (PASI) 75, PASI 90 and PASI 100 scores or static Physician's Global Assessment (sPGA), were included. ITCs were carried out using the method proposed by Bucher et al RESULTS AND DISCUSSION: Five randomized clinical trials were included. Analysing short-term data, there were no statistically significant differences between any pair of drugs in terms of PASI 75, PASI 100 or sPGA/sIGA 0/1. Analysing long-term data, statistically significant differences were only observed for secukinumab versus brodalumab in terms of PASI 100 (Absolute risk reduction -12.9%; 95% confidence interval -22.7% to -3.1%). WHAT IS NEW AND CONCLUSION: The ITCs indicated no efficacy differences between anti-interleukin-17 drugs, except for secukinumab versus brodalumab 52-week analysis in terms of achieving PASI 100. All three drugs appear to act as equivalent clinical treatments for psoriasis. However, independent head-to-head trials should be carried out.

Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy.

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health  crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacy to optimize clinical  outcomes and reduce the risk of contagion. The purpose of this article is to  describe and analyze the experience of HPSs with outpatient Telepharmacy  during the COVID-19 pandemic and expose the lessons learned. Measures have  been adopted in on-site outpatient pharmacy clinics to prevent exposure of  patients and professionals to the virus. These measures are based on national  and international recommendations on social distancing and hygiene. With  regard to remote outpatient pharmacy services, teleconsultation with drug  dispensing has been promoted based on five basic procedures, each with its  advantages and limitations: home drug delivery from HPSs, with the advantage  of universal access and the limitation of entailing a substantial investment in  resources; HPS coordination with primary care pharmacists, which requires no  investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which  requires the patient to go to the pharmacy, without confidentiality being  guaranteed for any patient; geolocation and hospital-based medication  dispensing, which provides universal access and direct traceability, but entails  investment in human resources; and HPS coordination with associations of  patients, which does not entail any additional cost but limits the information  available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of  medication (with a high level of satisfaction among patients); and the need to  foster Telepharmacy as a complementary tool through a mixed model of  outpatient pharmacy consultation service that incorporates the advantages of  each procedure and adapts to the individual needs of each patient in a context of humanized healthcare.

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados  por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus  procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en  salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y  analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar  las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de  pacientes y profesionales, siguiendo las recomendaciones nacionales e  internacionales de referencia de distanciamiento temporal, espacial y  recomendaciones higiénicas. En cuanto a las consultas externas de AF no  presenciales, se han potenciado las teleconsultas con dispensación del  tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus  ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las  ventajas de la universalidad de acceso, pero requiere una elevada inversión en  recursos; coordinación del SHF con farmacéuticos de atención primaria, que  conlleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que  utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del  paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con  asociaciones de pacientes, que no requiere inversión económica, pero limita el  acceso a las patologías de los asociados. Destacamos finalmente tres lecciones  aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la  utilidad de la Telefarmacia para el seguimiento clínico, la coordinación  asistencial, información al PE, dispensación y entrega informada (con elevada  satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las  ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia  sanitaria.

Comparative effectiveness of treatment with the first TNF antagonist in monotherapy, the first TNF antagonist plus one conventional synthetic disease-modifying antirheumatic drug, and the first TNF antagonist plus two or more conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.

BACKGROUND: Rheumatoid arthritis (RA) patients are treated with a mean of 3-4 conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) with or without glucocorticoids (GCs), before the first biologic prescription. The main reasons for change are inefficacy in 30-40 % of patients, and toxicity ≈ 10 %. Thus, they are treated with the first TNF antagonists in monotherapy. The aim of this study was to analyse the csDMARD and GC prescription patterns before and during treatment with the first TNF antagonist, and compare their effectiveness in three groups of patients. METHODS: An observational, prospective, multicentre study in common clinical practice was designed. Treating rheumatologists recorded patient variables, including previous and concomitant csDMARDs and GCs in a database. The data were analysed using descriptive, inferential and multivariate statistics. RESULTS: There were 1136 patients included; 21 % received the first TNF antagonist in monotherapy, 67 % received the first TNF antagonist plus one csDMARD, and 12 % the first TNF antagonist plus two or more csDMARDs. Most patients were female (73 %), RF+, and ACPA+, and had erosions; mean age was 53.2 (±13.0) years, and duration of disease was 9.1 (±7.6) years. They had high activity with DAS28 of 5.8 ± 1.1, and poor physical function with HAQ of 1.43 ± 0.63, and significant differences between groups in clinical variables and comorbidities; 94 % had received treatment with GCs, MTX, LFN, or SSZ at any time before the first TNF antagonist, 5 % (n = 52) had been treated with CLQ or HCLQ, and 1 % (n = 13) had received neither GCs nor csDMARDs. Before the first TNF antagonist, the drugs most commonly used were GCs (78 %), MTX (50 %), LFN (44 %), and SSZ (21 %). Concomitantly with the first TNF antagonist, 977 patients (85 %) were receiving GCs, MTX, LFN, or SSZ; 15 % (n = 173) received their first TNF antagonist without any concomitant GCs or csDMARDs, true monotherapy, and 6 % received their first TNF antagonist with GCs. The drug most commonly used at the time of first TNF antagonist initiation was MTX (58 %). All treatment groups had clinically and statistically significant improvements in DAS and HAQ scores. Effectiveness analysis (controlling for confounders) showed mean drug survival of 16.7, 20.1 and 11.7 months in each group, respectively (p < 0.001). The model that best explained a good EULAR response included the baseline and 6-month DAS28. CONCLUSIONS: The three groups of patiernts, have different comorbidities and disease characteristics. Treatment with low or very low doses of GCs is common. True monotherapy with the first TNF antagonist without prednisone or csDMARDs is infrequent. After controlling for potential confounders, effectiveness was a little different.

Atención farmacéutica al paciente externo durante la pandemia COVID-19. Telefarmacia / Pharmaceutical care to hospital outpatients during the COVID-19 pandemic. Telepharmacy

Los servicios de farmacia hospitalaria (SFH) en España se han visto afectados por la crisis sanitaria provocada por SARS-CoV-2 y han tenido que adoptar sus procedimientos de atención farmacéutica (AF) al paciente externo (PE) mediante estrategias de Telefarmacia, con los objetivos de maximizar los resultados en salud y reducir el riesgo de contagio. El objetivo de ese artículo es describir y analizar los procedimientos AFPE durante la pandemia SARS-CoV-2 y comunicar las lecciones aprendidas en los SFH. En relación con las consultas externas de AF presenciales, se han adoptado medidas para minimizar el contagio viral de pacientes y profesionales, siguiendo las recomendaciones nacionales e internacionales de referencia de distanciamiento temporal, espacial y recomendaciones higiénicas. En cuanto a las consultas externas de AF no presenciales, se han potenciado las teleconsultas con dispensación del tratamiento en base a cinco procedimientos básicos, cada uno de ellos con sus ventajas y limitaciones: dispensación domiciliaria desde SFH que presenta las ventajas de la universalidad de acceso, pero requiere una elevada inversión en recursos; coordinación del SHF con farmacéuticos de atención primaria, que con-lleva una nula inversión en recursos, pero limita el acceso a determinadas zonas geográficas; coordinación del SFH con farmacéuticos comunitarios, que utiliza una amplia red de oficinas de farmacia, pero exige el desplazamiento del paciente sin garantías de confidencialidad para todos los casos; geolocalización y dispensación hospitalaria, que permite un acceso universal y trazabilidad directa, pero requiere un incremento en recursos humanos; y coordinación del SFH con asociaciones de pacientes, que no requiere inversión económica, pero limita el acceso a las patologías de los asociados. Destacamos finalmente tres lecciones aprendidas: la capacidad de AFPE de SFH españoles ante una crisis sanitaria; la utilidad de la Telefarmacia para el seguimiento clínico, la coordinación asistencial, información al PE, dispensación y entrega informada (con elevada satisfacción de los pacientes); y la necesidad de potenciar la Telefarmacia como herramienta complementaria, en un modelo mixto de AFPE que incorpore las ventajas de cada uno de los procedimientos adaptándose a las necesidades individuales de los pacientes en un entorno de humanización de la asistencia sanitaria

Hospital Pharmacy Service (HPS) in Spain have been impacted by the health crisis caused by the COVID-19 pandemic. Thus, the outbreak has forced HPSs to adapt their outpatient consultation services to Telepharmacyto optimize clinical outcomesand reduce the risk of contagion. The purpose of this article is to describe and analyze the experience of HPSs with out-patient Telepharmacy during the COVID-19 pandemic and expose the les-sons learned. Measures have been adopted in on-site outpatient pharmacy clinics to prevent exposure of patients and professionals to the virus. These measures are based on national and international recommendations on social distancing and hygiene. With regard to remote outpatient pharmacy services, teleconsultation with drug dispensing has been promoted based on five basic procedures, each with its advantages and limitations: home drug delivery from HPSs, with the advantage of universal access and the limitation of entailing a substantial investment in resources; HPS coordination with primary care pharmacists, which requires no investments but with limited access to some geographic areas; HPS coordination with community pharmacists based on a large network of pharmacies, which requires the patient to go to the pharmacy, without confidentiality being guaranteed for any patient; geolocation and hospital-based medication dispensing, which provides universal access and direct traceability, but entails investment in human resources; and HPS coordination with associations of patients, which does not entail any additional cost but limits the information available on the diseases of society members. Three main lessons have been learned during the pandemic: the satisfactory capacity of HPS to provide outpatient pharmacy consultation services in the setting of a public health crisis; the usefulness of Telepharmacy for the clinical follow-up, healthcare coordination, outpatient counseling, and informed dispensing and delivery of medication (with a high level of satisfaction among patients); and the need to foster Telepharmacy as a complementary tool through a mixed model of outpatient pharmacy consultation service that incorporates the advantages of each procedure and adapts to the individual needs of each patient in a context of humanized healthcare

Adecuación del tratamiento con ertapenem según los criterios aprobados por la comisión de infecciones de un hospital de especialidades / Adequacy of treatment with ertapenem according to the criterion approved for the infection´s commission of a specialty hospital

Introducción. La utilización inadecuada de antibióticos en nuestro medio aumenta el riesgo de aparición de bacterias multiresistentes, por ello, es necesario realizar estudios de adecuación con el fin conocer y propiciar el uso correcto de antimicrobianos. Material y métodos. Estudio observacional retrospectivo en el que se incluyeron los pacientes que recibieron ertapenem durante el periodo de estudio (5 meses y medio). Se evaluó el grado de adecuación de la indicación a las condiciones de uso acordadas en el Hospital y se realizó un seguimiento de la evolución del tratamiento hasta su finalización, determinando el grado de desescalada terapéutica realizada. Resultados. Se incluyeron 84 prescripciones de ertapenem. El principal servicio médico prescriptor fue Medicina Interna (41,7%) y la principal indicación fue la infección del tracto urinario (47,2%). En el 75% de los pacientes incluidos se solicitaron cultivos microbiológicos antes de la primera dosis de ertapenem. En 69 (82,14%) enfermos la prescripción de ertapenem se adecuó a los criterios aprobados en el Hospital. Respecto a la evolución de la antibioterapia, el tratamiento con ertapenem continuó hasta la resolución de la infección en el 58,33% de los pacientes. En 15 de los 23 (66,21%) enfermos con posibilidad de desescalada terapéutica se realizó la misma tras 2-3 días de tratamiento empírico. Conclusiones. La gran mayoría de los tratamientos con ertapenem se adecuan a los criterios de prescripción de nuestro Hospital. El elevado porcentaje de pacientes con resultados microbiológicos disponibles, permitió en muchos enfermos el reajuste adecuado del tratamiento en las primeras 72 horas (AU)

Introduction. The inappropriate use of antibiotics in our environment increases the risk of multi-resistant bacteria, therefore it is necessary to present studies to meet and promote the proper use of antimicrobial. Methods. Retrospective observational study in which patients who are receiving ertapenem during the period of stady (5 ½ months), were included. The adequacy of the indication to the conditions of use agreed in the Hospital was evaluated and the evolution of the treatment was monitored until the end, determining the degree of therapeutic de-escalation. Results. 84 ertapenem prescriptions were included. The vast mayority of the prescriptions were carried out by Internal Medicine (41.7%) and the main indication was urinary tract infection (47.2%). Microbiological cultures were requested in the 75% of the patients before the first dose of ertapenem. The prescription was adapted in 69 (82.14%) of ertapenem patients to the criteria approved by the Hospital. Regarding the evolution of antibiotic therapy, treatment with ertapenem continued until resolution of the infection in 58.33% of patients. In 15 of 23 (66.21%) patients with the possibility of therapeutic de-escalation it was performed after 2-3 days of empirical treatment. Conclusions. The vast majority of treatments ertapenem fit the criteria of prescription our Hospital. The high percentage of patients with microbiological results available, allowed in many patients the appropriate adjustment of the treatment in the first 72 hours (AU)

Bedaquiline in multidrug-resistant pulmonary tuberculosis GENESIS-SEFH drug evaluation report / Bedaquilina en tuberculosis pulmonar multirresistente

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Propranolol-induced angioedema in a patient with chronic hepatitis C virus infection.

PURPOSE: A case of angioedema secondary to propranolol therapy in a patient with chronic hepatitis C virus (HCV) infection is reported. SUMMARY: A 54-year-old Caucasian woman with chronic HCV infection started treatment with ribavirin and peginterferon alfa-2a. Four months later, oral propranolol hydrochloride 20 mg three times daily was initiated due to an episode of paroxysmal supraventricular tachycardia (PSVT). One month later, the patient developed a diffuse pruritic rash. Hydroxyzine and loratadine were prescribed for several days to treat the rash. Three weeks later, she arrived at the emergency department with generalized edema and a severe pruritic erythematous swelling that affected the face, forearms, hands, and lower extremities. The patient was diagnosed with angioedema. Blood tests revealed an increased eosinophil count (910 cells/microL), elevated aspartate transaminase and alanine transaminase concentrations (109 and 104 IU/L, respectively), and a high HCV RNA load (1,450,000 IU). Peginterferon alfa-2a, ribavirin, and propranolol were discontinued. A few days later, the edema and cutaneous lesions disappeared. Six months after the resolution of the angioedema, the patient was seen again in the emergency department because of another episode of PSVT. Oral propranolol 20 mg twice daily was reintroduced to control the tachycardia. Two days later, a similar episode of diffuse edematous swelling developed. At that time, the only drug she was taking was propranolol. Propranolol was discontinued, and the patient's symptoms spontaneously resolved. CONCLUSION: A 54-year-old Caucasian woman with chronic HCV infection developed propranolol-induced angioedema.

Daño hepático inducido por dronedarona. Descripción de un caso clínico / Dronedarone-induced liver injury. A case report

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