Biosimilars and access to biologic therapy in immune-mediated diseases.

BACKGROUND: The rise of biologic agents has been a major breakthrough in treating immune-mediated inflammatory diseases (IMIDs). However, their high cost underscores the need for strategies to optimize treatment efficiency. Biosimilars offer cost-effective alternatives to biologics. This study aimed to assess biosimilar drug availability's impact on biologic therapy access for IMIDs. RESEARCH DESIGN AND METHODS: A retrospective observational study in 15 Spanish hospitals analyzed IMID patients (arthropathies, inflammatory bowel disease and psoriasis) initiating biologic therapy with originator or biosimilar drugs (infliximab, etanercept, adalimumab). Time to availability and initiation of biologic therapy were assessed. RESULTS: 267 patients were included, with 58.4% starting on biosimilars. The mean time to availability of the biologic drugs in the hospitals was 15.9 ± 6.7 months, (20.0 ± 12.4 for originator and 11.8 ± 5.2 for biosimilars). Mean time to biologic treatment was 7.7 ± 9.0 years (8.6 ± 8.9 for originators and 7.0 ± 9.0 for biosimilars). Showing statistically significant differences among conditions. CONCLUSION: The emergence of biosimilar drugs has enhanced market competition and accelerated their adoption into hospitals' therapeutic regimens over original reference drugs. This has significantly improved access to biologic therapy for patients with IMIDs, evidenced by a notable 1.6-year reduction in access time for biosimilar drugs.

Lack of awareness of systemic lupus erythematosus and its consequences in a cohort of moderate and severe patients in Spain: The LupusVoice study.

BACKGROUND AND OBJECTIVES: Systemic lupus erythematosus (SLE) is an autoimmune condition that can highly impact patients' quality of life (QoL). However, there is a lack of knowledge about SLE, affecting the general population and health care professionals (HCPs) alike. This lack of knowledge has negative implications for patients and the healthcare system, worsening prognosis, negatively impacting QoL, and increasing healthcare utilization. The aim of this paper is to draw attention, according to the perspective of the participants of this study, to the lack of awareness of SLE and its consequences in Spain, and to suggest improvements. PATIENTS AND METHODS: This qualitative, descriptive, observational, multicenter, and cross-sectional study included 40 patients with moderate or severe SLE, recruited during their routine visits in six university hospitals in Spain. The study also included 11 caregivers and 9 HCPs. All participants were individually interviewed. Data from the interviews were coded and analyzed thematically by two anthropologists following a phenomenological perspective. RESULTS: Our study identified a lack of disease awareness among primary care physicians, emergency medicine doctors, and other specialists treating SLE symptomatology. This led to diagnostic delays, which had a clinical and emotional impact on patients. Furthermore, symptom awareness was found to be context dependent. Differences in symptom awareness between HCPs and patients led to a mismatch between the severity evaluation made by doctors and patients. Some HCPs did not consider the limitations of the current severity evaluation of SLE, and therefore attributed symptoms potentially caused by SLE to the unfavorable socioeconomic conditions patients lived in. Finally, a lack of social awareness among friends, family members, and romantic partners led to lower social support, increased isolation, and negative physical and emotional impact for patients. Gender differences in the provision of support were identified. CONCLUSION: This study highlights the need to increase SLE awareness among patients, HCPs, and the broader public in order to improve patient QoL. Being aware of the clinical and emotional impact of such lack of awareness, as well as the role played by context on the patient experience of SLE, is a crucial step towards achieving this goal.

Integration of persistence in the 5P-medicine approach for age-related chronic diseases.

5P medicine is defined as Personalized, Predictive, Preventive, Participatory, and Population-based. 5P medicine may be improved by including a factor that could provide information about the therapeutic value of a particular drug treatment and measure its effectiveness in clinical practice. We propose that this factor may be treatment persistence, and that its addition to 5P medicine would allow to define a new improved 6P medicine. Persistence is the length of time between initiation and the last dose, which immediately precedes discontinuation, that is, a definitive suspension of the treatment. By including this sixth P, the persistence, we would be able to present the value of a treatment for each individual patient with its own characteristics, state of the disease, with more than one age-related diseases and patient journey. Persistence is a concept of the value of a treatment that includes the three main stakeholders of the pharmacotherapeutic process: Patient, Physician, and Pharmacist. Persistence is becoming a useful measure to evaluate the long-term effectiveness of therapies in real-world setting in chronic diseases. Drug treatments with longer persistence are more likely to provide better disease control and to be amenable to dose adjustment in order to optimize treatment cost in age-related chronic diseases. Long-term persistence could be a measure of a drug´s real-world performance and has been shown to aid in clinical decision-making.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis / Consenso de la Sociedad Española de Farmacia Hospitalaria en manejo fármacoterapéutico óptimo de la dermatitis atópica

Aim: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. Methods: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). Results: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. Conclusions: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes. (AU)

Objetivos: Los objetivos de este estudio son: 1) Determinar, mediante el método Delphi, el grado de consenso existente entre los farmacéuticos de hospital (FH) en cuanto a los factores que intervienen en el abordaje actual de los pacientes con dermatitis atópica (DA); 2) Identificar posibles áreas de mejora en la farmacia hospitalaria en cuanto al abordaje de los pacientes con DA grave; y 3) Contribuir a una adecuada atención farmacéutica a los pacientes con DA mediante la elaboración de recomendaciones. Método: Una encuesta Delphi con participación de FHs de toda España. Se establecieron tres bloques temáticos: 1) DA; 2) Manejo de pacientes con DA grave desde Farmacia Hospitalaria; y 3) Necesidades no cubiertas (patología, paciente, tratamiento y manejo). Resultados: Los 42 FHs participantes llegaron a un consenso en el reconocimiento del impacto de la DA grave en los pacientes, la necesidad de fomentar la adherencia y las recomendaciones de utilizar escalas que tengan en cuenta la calidad de vida del paciente e indicadores de la experiencia. También se muestra la conveniencia de evaluar los resultados en la práctica clínica real en consenso con otros especialistas del equipo multidisciplinar. Por último, es aconsejable utilizar fármacos que hayan demostrado eficacia y seguridad a largo plazo para los pacientes con DA grave, dado el carácter crónico de la enfermedad. Conclusiones: Este consenso Delphi pone de manifiesto el impacto de la DA grave en los pacientes, la importancia del abordaje multidisciplinar y holístico, en el que el FH juega un papel de gran importancia. También se resalta la importancia de un mayor acceso a nuevos fármacos que permitan mejorar resultados en salud. (AU)

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis. / [Artículo traducido] Consenso de la Sociedad Española de Farmacia Hospitalaria sobre el manejo fármacoterapéutico óptimo de la dermatitis atópica.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among HPs as regards the factors involved in the current approach to patients with AD; 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognizing the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease´s chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Consensus of Spanish Society of Hospital Pharmacy on optimal medication therapy management of atopic dermatitis.

AIM: This study's aims are: 1) To use the Delphi method to determine the level of consensus among hospital pharmacists (HPs) as regards the factors involved in the current approach to patients with atopic dermatitis (AD); 2) To identify potential areas for improvement in hospital pharmacy in terms of dealing with patients with severe AD; and 3) To contribute to adequate pharmaceutical care for patients with AD by drawing up recommendations. METHODS: A two-round Delphi survey with participation from HPs from all over Spain. Three theme-based blocks were set out: 1) AD; 2) Management of patients with severe AD in the Hospital Pharmacy setting; and 3) Unmet needs (pathology, patient, treatment and management). RESULTS: The 42 HPs participating reached a consensus in recognising the impact of severe AD on the patients suffering from it, the need to encourage adherence and the recommendations to use scales that take into account the patient's quality of life and indicators of the patient's experience. It has also been demonstrated that it is worthwhile evaluating the results in real clinical practice in consensus with other specialists from the multidisciplinary team. Finally, it is advisable to use drugs that have demonstrated long-term effectiveness and safety for patients with severe AD, given the disease's chronic nature. CONCLUSIONS: This Delphi consensus highlights the impact of severe AD on patients, the importance of a multidisciplinary and holistic approach, in which HP play a major role. It also highlights the importance of increased access to new drugs to improve health outcomes.

Humanization Guide of the Spanish Society of Hospital Pharmacy for patients with inflammatory immune-mediated diseases.

OBJECTIVE: This study reports on the results of a project conducted by the Spanish Society of Hospital Pharmacy with patients with immune-mediated inflammatory diseases, with the following objectives: to understand  the experience of patients living with these diseases and the role of healthcare workers in such experience, and to identify opportunities to promote or boost humanization in hospital pharmacy units. METHOD: A user-centered design methodology was used, implementing exploratory and qualitative research tools. Led by a managing  team made up of experts in the methodology, a variety of people participated  in this project. The team comprised representatives of patients with  immunemediated inflammatory diseases, healthcare workers responsible for  their care, members of the immune-mediated inflammatory disease working  group of the Spanish Society of Hospital Pharmacy, and members of two patient advocacy organizations (Spanish Association of Persons with Chronic Immune-Mediated Inflammatory Diseases and the Spanish  association of Patients with Psoriasis). The research tools used included  indepth interviews, patients' diaries, ethnographic studies, and co-creation workshops. RESULTS: Five initiatives were identified as best practices to be implemented: The creation of functional or comprehensive care units; shared  medical records; integration of patient-reported outcomes with patient  experiences; implementation of the "capacity, motivation, opportunity"  pharmaceutical care model; and a closer interaction with patient advocacy  organizations. Six opportunities to improve the current situation were selected  as priority areas for hospital pharmacy departments: spreading knowledge  about immune-mediated inflammatory diseases; promoting a multidisciplinary  approach to these diseases; generating awareness on the  role of hospital pharmacists; revisiting the internal organization of pharmacy  departments; establishing closer relationships with patients; and seeing things  from the patients' point of view. Ten smart humanization initiatives were  proposed and classified in an impact-effort matrix: "Demystifying IMID", "IMID  teen challenge", "Patient­care academy", "Satellite consultation", "IMID  network", "A click away from the pharmacy", Medicines poker", "Patient-to- patient consultation", "Pharma-friendly consultation", and "Patient-centered  IMID sessions". CONCLUSIONS: This Annex to the Spanish Society of Hospital Pharmacy's Guidelines for the Humanization of Hospital Pharmacy Units intends  to promote a humanizing culture, bringing to the fore the unique value  of every single patient suffering from an immune-mediated  inflammatory disease, including their family and friends and their beliefs and  needs, preserving their dignity.

OBJETIVO: Describir el proyecto de humanización para los pacientes con  enfermedades inflamatorias mediadas por la inmunidad de la Sociedad  Española de Farmacia Hospitalaria encaminado a comprender la experiencia de  los pacientes con enfermedades inmunomediadas inflamatorias,  comprender el papel de los profesionales en la experiencia del paciente e  identificar oportunidades para impulsar la humanización desde los servicios de  farmacia hospitalaria.Método: Se empleó la metodología del diseño centrado en las personas, aplicando herramientas de investigación cualitativa y exploratoria. Participaron pacientes con enfermedades inflamatorias mediadas  por la inmunidad, profesionales de todos los perfiles que les atienden, el Grupo de trabajo de Enfermedades Inmunomediadas Inflamatorias de la  Sociedad Española de Farmacia Hospitalaria y representantes de pacientes (Asociación de personas con enfermedades crónicas inflamatorias  inmunomediadas y Asociación de pacientes Acción Psoriasis). Todo ello con la dirección de un equipo experto en diseño centrado en las personas. Entre las  dinámicas empleadas se encuentran: entrevistas en profundidad, diarios de  pacientes, observaciones etnográficas y talleres de cocreación. RESULTADOS: Se identificaron cinco iniciativas consideradas buenas prácticas a  implementar (creación de unidades funcionales o de atención integrada,  historia clínica compartida, integración de los resultados reportados por los  pacientes y de su experiencia, modelo "capacidad, motivación y oportunidad"  de atención farmacéutica y acercamiento a las asociaciones de pacientes). Se  seleccionaron seis oportunidades sobre las que diseñar soluciones en los  servicios de farmacia (favorecer el conocimiento de estas enfermedades,  impulsar su abordaje multidisciplinar, difundir las atribuciones del farmacéutico  de hospital, revisar la organización interna del servicio,  establecer el vínculo con el paciente y adoptar la visión del paciente). Se  propusieron diez grandes ideas para humanizar clasificadas en una matriz de  impacto-esfuerzo ("Remitente IMID", "IMID teen challenge", "Escuela de  familiares", "Consulta satélite", "Redemid", "A un botón de farmacia", "Póquer  de fármacos", "Consulta de paciente a paciente", "Farma friendly", "Sesiones  IMID Patient-Centric"). CONCLUSIONES: Con este anexo a la Guía de Humanización de la Sociedad  Española de Farmacia Hospitalaria se pretende promover una cultura de  humanización, que ponga en valor a la persona que hay detrás de todo  paciente con enfermedades inmunomediadas inflamatorias, teniendo en  consideración su familia, entorno, creencias y necesidades y preservando su  dignidad.

Six months multicentre pilot open label single-arm study to evaluate patient experience, acceptability and satisfaction of switching certolizumab pegol from a prefilled syringe or autoinjection pen to an AVA® e-Device in rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis patients.

WHAT IS KNOWN AND OBJECTIVE: The study aimed to assess acceptability and patient experience of Certolizumab (CZP) self-injection with AVA® and clarify patient device preference after switching CZP from the syringe or auto-injection pen to AVA® in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) patients. METHOD: A multicentre open-label, cross-sectional and prospective study among four Spanish hospitals was performed. Adult RA, PsA, axSpA patients treated for at least 6 months with the CZP syringe or pen were recruited. At the first visit, patients completed Pre-AVA® questionnaire. Patients were instructed on proper administration of CZP by AVA®. After 2 and 6 months of CZP self-injections using the AVA®, patient experience, adherence, preference and safety of each administration was assessed using post-AVA® questionnaire. RESULTS AND DISCUSSION: Thirty four patients were included (28 women). All patients self-administered CZP AVA® the full dose of CZP was injected. Patients reported >90% adherence to CZP AVA® assessed with the injection log. Pain at the injection site was reduced after switching to AVA®. Twenty nine patients preferred CZP AVA® and five patients preferred the CZP pen. No safety-related findings related to AVA® CZP administration were identified. WHAT IS NEW AND CONCLUSION: The AVA® is an advantageous delivery option for CZP in patients with RA, PsA, axSpA.

Evaluation of persistence, retention "rate" and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïve patients with ulcerative colitis.

OBJECTIVE: To compare the persistence, retention rate and prescription pattern  of original infliximab and infliximab CT-P13 in biologic- naïve patients with ulcerative colitis. METHOD: This was an ambispective study of biologic-naive patients with  ulcerative colitis who received non-simultaneous first-line treatment with  Remicade ® (infliximab) and Remsima® (infliximab CT-P13) over a 10-year  study period (2012-2021). Data on their age, weight, persistence, retention  rate and on whether they required intensification or deintensification  throughout the study period was collected. The real patient/year cost of  Remicade® and Remsima® was determined individually based on the amounts  administered during the study period. RESULTS: 27 biologic-naive patients were treated with Remicade® and 53 with  Remsima®. Neither patient group presented with differences in terms of  weight and age. Persistence (median ± interquartile range) with Remicade ®  was 42.49 ± 57.48 months, as compared to 27.50 ± 58.50 months for  Remsima®, without significant differences (p = 0.455). The retention rate at  6, 12, and 24 months was 81%, 63%, and 33%, respectively, for the Remicade® group and 71%, 47%, and 37%, respectively, for the Remsima® group. Nine subjects in the Remicade® group vs 11 patients in the Remsima ® group were intensified. Regarding deintensification, five patients treated with  Remicade® were deintensified, as compared with 7 patients on Remsima®.  Savings obtained with the use of Remsima® amounted to 203,649 €, which  would allow treating an additional 118 patients with biosimilar infliximab for  one year. CONCLUSIONS: There are no significant differences in persistence, retention, and number of intensifications or deintensifications between  iologicnaïve patients treated with Remicade® and those treated with  Remsima®, the latter being an effective, safe and economical alternative for  the treatment of ulcerative colitis.

OBJETIVO: Comparar la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive a biológicos con colitis ulcerosa.Método: Estudio ambispectivo de pacientes naive a biológicos en colitis ulcerosa que recibieron tratamiento en primera línea con Remicade® (infliximab) y Remsima® (infliximab CT-P13) de forma no  simultánea durante un periodo de estudio de 10 años (2012-2021). Se  tomaron datos de su edad, peso, persistencia, tasa de retención y si precisó de  intensificación o desintensificación a lo largo del periodo de estudio. Se  determinó el coste paciente/año real de Remicade® y Remsima® de forma  individualizada en función de las administraciones durante el periodo del  estudio. RESULTADOS: Un total de 27 pacientes naive a biológicos fueron tratados con  Remicade® y 53 con Remsima®. Ambos grupos de pacientes no presentaron diferencias en cuanto al peso y edad. La persistencia (mediana ±  rango intercuartílico) con Remicade® fue de 42,49 ± 57,48 meses frente a  27,50 ± 58,50 meses para Remsima®, sin demostrar diferencias significativas (p = 0,455). La tasa de retención a los 6, 12 y 24 meses fue del  81%, 63% y 33%, respectivamente, para el grupo de Remicade®, y del 71%, 47% y 37%, respectivamente, para el grupo de Remsima®. En el grupo de pacientes tratados con Remicade®, 9 pacientes fueron intensificados frente a  11 pacientes en el grupo de Remsima®. En cuanto a las desintensificaciones, 5  pacientes que recibieron tratamiento con Remicade® fueron  desintensificados frente a 7 pacientes en tratamiento con Remsima®. El ahorro obtenido con el uso de Remsima® fue de 203.649 €, que equivaldría a tratar a  118 pacientes adicionales con infliximab biosimilar durante un año. CONCLUSIONES: No existen diferencias significativas en la persistencia, tasa de  retención y número de intensificaciones y desintensificaciones entre los  pacientes naive que fueron tratados con Remicade® y aquellos tratados con  Remsima®, siendo una alternativa eficaz, segura y económica en el  tratamiento biológico de la colitis ulcerosa.

Evaluación de la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive biológicos con colitis ulcerosa / Evaluation of persistence, retention “rate” and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïve patients with ulcerative colitis

Objetivo: Comparar la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive abiológicos con colitis ulcerosa.Método: Estudio ambispectivo de pacientes naive a biológicos en colitis ulcerosa que recibieron tratamiento en primera línea con Remicade®(infliximab) y Remsima® (infliximab CT-P13) de forma no simultánea duranteun periodo de estudio de 10 años (2012-2021). Se tomaron datos de suedad, peso, persistencia, tasa de retención y si precisó de intensificacióno desintensificación a lo largo del periodo de estudio. Se determinó elcoste paciente/año real de Remicade® y Remsima® de forma individualizada en función de las administraciones durante el periodo del estudio.Resultados: Un total de 27 pacientes naive a biológicos fueron tratadoscon Remicade® y 53 con Remsima®. Ambos grupos de pacientes no presentaron diferencias en cuanto al peso y edad. La persistencia (mediana ± rangointercuartílico) con Remicade® fue de 42,49 ± 57,48 meses frente a27,50 ± 58,50 meses para Remsima®, sin demostrar diferencias significati vas (p = 0,455). La tasa de retención a los 6, 12 y 24 meses fue del 81%,63% y 33%, respectivamente, para el grupo de Remicade®, y del 71%,47% y 37%, respectivamente, para el grupo de Remsima®. En el grupo depacientes tratados con Remicade®, 9 pacientes fueron intensificados frentea 11 pacientes en el grupo de Remsima®. En cuanto a las desintensificaciones, 5 pacientes que recibieron tratamiento con Remicade® fueron desintensificados frente a 7 pacientes en tratamiento con Remsima®. El ahorroobtenido con el uso de Remsima® fue de 203.649 €, que equivaldría atratar a 118 pacientes adicionales con infliximab biosimilar durante un año. (AU)

Objective: To compare the persistence, retention rate and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïvepatients with ulcerative colitis.Method: This was an ambispective study of biologic-naive patients withulcerative colitis who received non-simultaneous first-line treatment with Remicade® (infliximab) and Remsima® (infliximab CT-P13) over a 10-year studyperiod (2012-2021). Data on their age, weight, persistence, retention rateand on whether they required intensification or deintensification throughoutthe study period was collected. The real patient/year cost of Remicade®and Remsima® was determined individually based on the amounts administered during the study period.Results: 27 biologic-naive patients were treated with Remicade® and53 with Remsima®. Neither patient group presented with differences in termsof weight and age. Persistence (median ± interquartile range) with Remicade® was 42.49 ± 57.48 months, as compared to 27.50 ± 58.50 monthsfor Remsima®, without significant differences (p = 0.455). The retention rate at 6, 12, and 24 months was 81%, 63%, and 33%, respectively, for theRemicade® group and 71%, 47%, and 37%, respectively, for the Remsima®group. Nine subjects in the Remicade® group vs 11 patients in the Remsima® group were intensified. Regarding deintensification, five patientstreated with Remicade® were deintensified, as compared with 7 patientson Remsima®. Savings obtained with the use of Remsima® amounted to203,649 €, which would allow treating an additional 118 patients withbiosimilar infliximab for one year. (AU)

Cost-effectiveness analysis of ferric carboxymaltose versus iron sucrose for the treatment of iron deficiency anemia in patients with inflammatory bowel disease in Spain.

Background: Iron deficiency anemia (IDA) is a common complication of inflammatory bowel disease (IBD) and can result in reduced quality of life and increased healthcare costs. IDA is treated with iron supplementation, commonly with intravenous iron formulations, such as ferric carboxymaltose (FCM), and iron sucrose (IS). Methods: This study assessed the cost-effectiveness of FCM compared with IS, in terms of additional cost per additional responder in patients with IDA subsequent to IBD in the Spanish setting. An economic model was developed to assess the additional cost per additional responder, defined as normalization or an increase of ⩾2 g/dl in hemoglobin levels, for FCM versus IS from a Spanish healthcare payer perspective. Efficacy inputs were taken from a randomized controlled trial comparing the two interventions (FERGIcor). Costs of treatment were calculated in 2021 Euros (EUR) using a microcosting approach and included the costs of intravenous iron, healthcare professional time, and consumables. Cost-effectiveness was assessed over one cycle of treatment, with a series of sensitivity analyses performed to test the robustness of the results. Results: FCM was more effective than IS, with 84% of patients achieving a response compared with 76%. When expressed as number needed to treat, 13 patients would need to switch treatment from IS to FCM in order to achieve one additional responder. Costs of treatment were EUR 323 with FCM compared with EUR 470 with IS, a cost saving of EUR 147 with FCM. Cost savings with FCM were driven by the reduced number of infusions required, resulting in a reduced requirement for healthcare professional time and use of consumables compared with the IS arm. Conclusion: The present analysis suggests that FCM is less costly and more effective than IS for the treatment of IDA subsequent to IBD in Spain and therefore was considered dominant.

Successful use of golimumab in a patient with ulcerative colitis refractory to infliximab and adalimumab.

OBJECTIVE: To report a case of successful use of golimumab (GLB) in a patient with ulcerative colitis (UC) refractory to infliximab (IFX) and adalimumab (ADA). CASE SUMMARY: A 60-year-old man was diagnosed with left UC and was given azathioprine 2.5 mg/kg to control UC symptoms and decrease corticosteroid patient dependence. Four years later, he developed adverse reaction to azathioprine and began treatment with mercaptopurine 1.5 mg/kg/day. Despite this treatment, he developed a severe relapse (Truelove-Witts modified: 15 points). Treatment with IFX 5 mg/kg at weeks 0, 2, 6, and every 8 weeks was started. After 1 year in clinical remission, the patient developed an infusion reaction to IFX, and IFX was suspended. The patient started treatment with ADA 40 mg every other week. After 2 years in clinical remission, ADA was suspended. 20 months after ADA discontinuation, the patient developed an acute episode of UC with a Truelove-Witts modified score of 16 points. ADA plus corticosteroid therapy was restarted. Despite these treatments, the patient's clinical condition did not improved. ADA 40 mg per week was started with not clinical improvement and with corticosteroid dependence after 4 months of ADA intensive therapy. The patient denied surgery, and cyclosporine was discarded because of its inability to be used as a maintenance drug. The patient started GLB with an induction dosage regimen of 200 mg subcutaneous at week 0, followed by 100 mg at week 2, and then maintenance therapy with 100 mg every 4 weeks (patient's weight = 84 kg), combined with mercaptopurine and corticosteroids. After 6 weeks of treatment, the patient achieved clinical remission, with just three non-bleeding stools per day, without stomach ache, apyretic, and no urgency or tenesmus rectal symptoms. One year later, the patient continued to be asymptomatic with a Truelove-Witts modified score of 2 points, corticoid-free treatment, and a complete clinical and endoscopic remission and normal calprotectin levels (< 15 µg/g). We decided to suspend mercaptopurine in order to avoid side effects derived from the combined treatment. After 1 year on GLB therapy, the patient continued in clinical remission. CONCLUSIONS: Based on our case, GLB could be selected as an effective approach for patients with UC refractory to IFX and ADA. However, further studies need to be performed to evaluate the efficacy of GLB therapy as a rescue treatment.

Legionella pneumophila pneumonia possibly due to ustekinumab therapy in a patient with Crohn's disease.

PURPOSE: A case report of Legionella pneumophila pneumonia associated with off-label use of ustekinumab in a patient with Crohn's disease (CD) is presented. SUMMARY: A 57-year-old man with longstanding CD was hospitalized with a four-day history of fever (38.5 °C), dyspnea, left pleuritic pain, and weight loss (more than 6 kg) about six weeks after beginning treatment with ustekinumab, a human monoclonal antibody approved in the United States for two indications (plaque psoriasis and psoriatic arthritis) and currently under investigation as a potential treatment for CD and other inflammatory disorders. During the preceding 25 years, the man had been treated for severe CD with a number of agents (e.g., infliximab, adalimumab, certolizumab); ultimately, off-label ustekinumab therapy (90 mg subcutaneously weekly) was initiated due to persistent severe CD symptoms. Chest x-ray studies at the time of admission demonstrated left upper lobar consolidation, and a urine antigen test was positive for L. pneumophila. The patient was treated with i.v. levofloxacin and methylprednisolone and discharged after two weeks. Ustekinumab was reintroduced (45 mg subcutaneously every two weeks), and the patient continued to receive the drug for 16 months, with clinical remission of CD symptoms and no further adverse events. A literature search identified two case reports of pneumonia associated with ustekinumab use, but neither case involved L. pneumophila. CONCLUSION: Pneumonia caused by L. pneumophila developed in a patient with CD treated with ustekinumab. Pneumonia symptoms resolved after ustekinumab was discontinued.

Effectiveness of a systematic vaccination program in patients with autoimmune inflammatory disease treated with anti-TNF alpha drugs.

OBJECTIVE: The objective of this is manuscript is to evaluate the impact of a vaccination protocol in the prevention of infection in autoimmune inflammatory disease (AUTID) patients treated with Anti-TNF-alpha therapies. RESEARCH DESIGN AND METHODS: The authors conducted an observational study to test the effect of a vaccination program in AUTID patients that received anti-TNF-alpha therapies in hospital admissions related to infections. This effect was evaluated by comparing patients admitted before the program started (prevaccination period, 2009-2011) and after the program (postvaccination period, 2011-2014). RESULTS: The study included 581 patients: 280 in the pre-vaccination group and 301 in the post-vaccination group. During the prevaccination period, 27.3% of patients treated with anti-TNF-alpha drugs were vaccinated before biological therapy. During the postvaccination period, this percentage increased to 97.0%. Statistically significant differences were detected in emergency room visits per 10.000 treatment days, in hospital admissions related to an infectious disease and in the rate of invasive pneumococcal disease due to Streptococcus pneumoniae infection per 10.000 days of treatment. CONCLUSIONS: This vaccination program decreases infectious complications and was associated with a lower amount of hospital admissions due to infections, emergency room visits and the rate of invasive pneumococcal disease.

Successful use of infliximab and tacrolimus combination therapy in a patient with ulcerative colitis refractory to infliximab dose intensification plus azathioprine.

OBJECTIVE: To report of a case successful use of infliximab (IFX) and tacrolimus (TAC) in a patient with ulcerative colitis (UC). CASE SUMMARY: A 22-year-old woman diagnosed with UC started treatment with azathioprine 2.5 mg/kg. After 3 years of therapy, she developed a severe relapse. A colonoscopy was performed showing diffuse continuous mucosal disease and multiple erosions (< 5 mm) with no signs of spontaneous bleeding. Treatment with IFX 5 mg/kg at weeks 0, 2, and 6 was started. After IFX induction, she remained with symptoms: six stools per day, as well as presenting bloody diarrhea, tenesmus, and no abdominal pain. An IFX dose intensification of 5 mg/kg every 6 weeks was prescribed. After 6 months of azathioprine plus IFX therapy, patient's clinical condition was improved: 3 - 4 stools per day, 20% of bloody diarrhea, tenesmus, and no abdominal pain. Her Mayo endoscopic subscore was 6.3 months later, and a severe relapse of ulcerative colitis was presented. The patient refused a surgical treatment. Azathioprine 2.5 mg/kg/day was suspended and TAC 0.2 mg/kg/day (12 mg/day) as a compassionate use was added to IFX dose intensification of 10 mg/kg every 8 weeks and mesalamine 800 mg 3 times daily. After the first month of combined therapy, the patient's clinical condition improved with no bloody stools and abdominal pain. After 6 months of combination therapy, the patient was in remission, with two stools per day, no tenesmus and no abdominal pain. Due to the patient's clinical remission, IFX was suspended. Tacrolimus was continued on 10 mg/day. After 6 months of TAC monotherapy, the patient continued without symptoms (1 - 2 normal stools per day). CONCLUSIONS: Based on our case, the combination therapy of IFX and TAC could be selected as an effective approach for the patients with UC refractory to IFX dose intensification plus AZA. However, further studies need to be performed to evaluate the efficacy of this combination therapy.

Dealing with the high cost of biological therapies: developing and implementing a biological therapy prioritization protocol for ankylosing spondylitis patients in a tertiary hospital.

OBJECTIVE: In January 2011, a biological therapies commission was created in our hospital to fully address the management of biological drugs. A biological therapy prioritization protocol was developed for ankylosing spondylitis (AS) patients. Here, we describe it and report on its economic impact to illustrate how we are optimizing the use of these expensive new drugs. METHODS: The biological therapies commission established several procedures for the rational use of biological drugs such as cost-efficiency therapeutic protocols, pharmacovigilance, and therapeutic drug monitoring programs. The AS protocol was based on clinical and economic aspects. We estimated the economic impact of the protocol by comparing the cost of treating AS patients with biological drugs in the pre-commission (2009 - 2010) vs. post-commission period (2011 - 2013). AS patients treated with adalimumab (ADA), etanercept (ETN) or infliximab (IFX) for at least 6 months in the 2009 - 2013 period were included. RESULTS: 107 patients were included. In the pre-commission period, total expenses increased by +30,944 Euro (+4%). After protocol implementation, total expenses decreased by 11,441 Euro (-1%) during 2011, and by an additional 36,781 Euro (-4%) and 53,872 Euro (-8%) in 2012 and 2013, respectively. In the 2010 - 2013 period the cost of biological therapy per patient-year decreased by 869 €, suggesting the positive effects of the biological therapy prioritization protocol instauration. CONCLUSION: We describe the establishment of a multidisciplinary biological therapy commission to optimize the use of biological therapies. We illustrate its work in developing a protocol for the management of AS patients with such therapies. We show that after 3-years of implementation, the biological therapy prioritization protocol allowed us to steadily decrease the direct cost of biological drug therapies per patient, up to 869 Euro.

The use of adalimumab, etanercept, golimumab and infliximab in rheumatic pathologies: variation between label dosage and real-world use.

Rheumatoid arthritis (AR), psoriatic arthritis (PSA) and ankylosing spondylitis (AS) are autoimmune systemic diseases characterized by inflammation, pain and joint degeneration. The objective of this study is to evaluate, under the actual conditions of use, dosing patterns of adalimumab, etanercept, golimumab and infliximab in these pathologies, and compare them with the label regimens recommended, as well as evaluating the financial implications of these regimen modifications. The study population included all adult patients diagnosed with RA, PSA or AS who had been treated with adalimumab, etanercept, golimumab and infliximab for at least 6 months between 1 January 2011 and 31 December 2013. The main variable of this study was to assess the dose dispensed for drugs administered subcutaneously and the dose prepared/administered for drugs administered intravenously, and the annual costs of the treatment. A total of 5,428 episodes were included. The mean weekly dose was lower than the standard dose in the three pathologies studied in the patients treated with adalimumab and etanercept (84.3% vs 81.2% for RA, 85.0% vs 78.0% for PSA and 87.8% vs 81.6% for AS). The drugs with highest dose optimization in RA are etanercept (46.3%) followed by adalimumab (46%); however, the highest percentage of patients with major dose optimization corresponds to etanercept (11.6%). Both in the PA and the AS group, we also observed that etanercept is the drug more optimized, corresponding to 53.9 and 43% of patients, respectively. By contrast, 48.5% of patients with RA treated with infliximab required dose intensification; however, infliximab dose intensification in PSA and AS is not so pronounced. The practice of optimization of dose regimens in patients with rheumatic diseases under treatment with anti-TNFα is spreading among professionals, resulting in annual cost reduction in the treatment of rheumatic arthropathies. However, long term follow-up will be necessary to assess the influence of this optimization on health outcomes.

Successful use of infliximab and tacrolimus in a patient with Crohn's disease.

OBJECTIVE: To report a case of successful use of infliximab (IFX) and tacrolimus (TAC) in a patient with Crohn's disease (CD). CASE SUMMARY: A 42-year-old man with no significant previous medical history was referred to our emergency department because of a 3-month history of weight loss, severe abdominal pain, and bloody diarrhea. His Harvey Bradshaw Index was 39. Ileocolonoscopic revealed severe Crohn colitis. Treatment with IFX 5 mg/kg, azathioprine 2.5 mg/kg/day and corticosteroids was started. After a second IFX infusion, he remained with symptoms with a Harvey Bradshaw Index of 17. An IFX dose intensification of 10 mg/kg every 8 weeks was prescribed. After 16 weeks, a new colonoscopic examination revealed multiple deep ulcerations in sigma and rectum. IFX was intensified to 10 mg/kg every 6 weeks. After 4 doses of IFX intensified dose, the patient's clinical condition was not improved, with a Harvey Bradshaw Index of 10. Azathioprine (AZA) 2.5 mg/kg/day was suspended. Tacrolimus 0.2 mg/kg/day as a compassionate use was added to IFX 10 mg/kg every 6 weeks. After 6 months of combination therapy, the patient was in clinical remission. His Harvey Bradshaw Index was 3. After 1 year on combination IFX and TAC therapy, the patient continued in clinical remission. CONCLUSIONS: This case documents that the combination therapy of IFX and TAC could be selected as an effective approach for patients with CD refractory to IFX dose-intensification plus AZA. However, further studies need to be performed to evaluate the efficacy of this combination therapy.