Analysis of the situation of pharmaceutical care for patients with immune-mediated inflammatory diseases before and after the COVID-19 pandemic. / Análisis de la situación de la atención farmacéutica a pacientes con enfermedades inflamatorias inmunomediadas antes y después de la pandemia COVID-19.

OBJECTIVE: To describe, analyze and compare the situation of pharmaceutical care consultations for outpatients with immune-mediated inflammatory diseases of the Pharmacy Services of Spain at two different times. METHOD: Longitudinal, multicenter and unidisciplinary descriptive observational study, carried out by the Immune-mediated Inflammatory Diseases Working Group of the Spanish Society of Hospital Pharmacy through a virtual survey in 2019 and 2021. Variables were collected regarding coordination, resources, biosimilars, unmet needs and telepharmacy. Numerical results were presented in absolute value and percentage and free text responses were grouped by topic areas. To compare the results between the two collection times, the Chi-Square test was used with a significance level of p<0.05. RESULTS: The level of participation was 70 pharmacists in 2019 and 53 in 2021. The main significant findings obtained were an increase in participation in asthma biologic committees (p=0.044) and care coordination in dermatology (p=0.003) and digestive system (p=0.022). The wide use of biosimilar biological medicines stood out, with a 15% increase in the exchange of the reference biological to the biosimilar. The lack of research in the field and insufficient human resources, among other unmet needs, were revealed. In the outpatient units, the use of the stratification model of the MAPEX project was a minority and an increase in the use of information and communication technologies was promoted. Motivated by the pandemic derived from COVID-19, telepharmacy was established for the first time in 85% of the centers, maintaining the service at 66% at the time of the second survey. CONCLUSIONS: Outpatient units are undergoing constant change to adapt to new times, for which institutional support is needed to invest more resources to promote the development of strategies to reduce unmet needs. We must continue working to achieve a pharmaceutical practice that provides efficiency, safety, quality of life and access to innovative drugs in patients with immune-mediated inflammatory diseases.

Knowledge of biological therapy for patients with immune-mediated diseases. BIOINFO Study. / Conocimiento de la terapia biológica en pacientes con enfermedades inmunomediadas. Estudio BIOINFO.

OBJECTIVE: To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units. METHODS: Observational, prospective and multicenter study during the period May 2020-March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed. RESULTS: A total of 169 patients were included in the study. The average value for the different questions was 3.3 ± 0.6 out of 5, while the average final result was 29.4 points out of 45. Sixty-four percent of the patients had an acceptable level before starting the medication (>27 points). The multivariate analysis showed a statistically significant correlation (p<0.05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology. CONCLUSIONS: In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.

The Real-World Effectiveness, Persistence, Adherence, and Safety of Janus Kinase Inhibitor Baricitinib in Rheumatoid Arthritis: A Long-Term Study.

Background/Aim: Baricitinib (BAR) is the first oral selective Janus kinase inhibitor approved in Europe for rheumatoid arthritis (RA). Real-world data are still needed to clarify its long-term benefits/risk profile. This study aimed to evaluate the effectiveness, persistence, adherence, and safety of BAR in a real-world setting. Methods: An ambispective study was conducted between October 2017 and December 2021 in RA patients starting BAR. The effectiveness was evaluated, assessing changes from the baseline of the Disease Activity Score using 28-joint counts-C reactive protein (DAS28CRP), and the achievement of low disease activity/remission. Drug persistence was evaluated using Kaplan-Meier analysis. Adherence was estimated using the medication possession ratio (MPR) and the 5-item Compliance Questionnaire for Rheumatology. Safety was assessed determining global incidence proportion and adverse event adjusted incidence rates. Results: In total, 61/64 recruited patients were finally analyzed, 83.6% were female, 78.7% were seropositive, the mean age was 58.1 (15.4) years, and the disease duration was 13.9 (8.3) years. A total of 32.8% of patients were naïve to biologics and 16.4% received BAR as monotherapy. The median exposure to BAR was 12.4 (6.6-31.2) months (range 3.1-51.4). A significant change in DAS28CRP was observed after treatment (difference -1.2, p = 0.000). 70.5% and 60.7% of patients achieved low disease activity or remission, respectively, and 50.8% (31/61) remained on BAR throughout the follow-up, with a median persistence of 31.2 (9.3-53.1) months. The average MPR was 0.96 (0.08) and all patients exhibited "good adherence" according to the questionnaire. In total, 21.3% of patients discontinued baricitinib due to toxicity. Conclusions: In our real-world practice, BAR demonstrated effectiveness, large persistence, high adherence to treatment, and an acceptable safety profile.

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.

[Translated article] Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases.

OBJECTIVE: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning. METHODS: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected. RESULTS: A total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation. Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2 mg/kg/day. CONCLUSIONS: In this context of chronic treatments with teratogenic potential, it is necessary to highlight the importance of pregnancy planning to select the safest drug. Given the quality of the available data, it is still necessary to continuously update the information, as well as to promote observational studies of cohorts of pregnant patients and men of childbearing age, including prospective studies, in order to generate more scientific evidence.

Biological and immunosuppressive medications in pregnancy, breastfeeding and fertility in immune mediated diseases. / Medicamentos inmunosupresores y biológicos en el embarazo, la lactancia y la fertilidad en enfermedades inmunomediadas.

OBJECTIVE: The objective of this review is to gather the available evidence on the different drugs used in immune-mediated inflammatory diseases in pregnancy, lactation, their influence on female and male fertility, advice on discontinuation before conception and to help in routine clinical practice for better patient advice on family planning. METHODS: A bibliographic search was carried out, where published articles (review studies, observational studies and case series) in English or Spanish until April 2020 that analyzed the management of pregnancy, lactation and/or fertility in patients on treatment in immune-mediated diseases were selected. RESULTS: A total of 95 references were selected and the information on each drug was synthesized in tables. Drugs contraindicated in pregnancy are topical retinoids, pimecrolimus, cyclooxygenase 2 inhibitors, methotrexate, mycophenolate mofetil, leflunomide, acitretin, and thiopurines. The lack of data advises against the use of apremilast, tofacitinib, baricitinib, anakinra, abatacept, tocilizumab and the new biologicals. Topical salicylates, paracetamol, ultraviolet therapy and hydroxychloroquine treatment are safe, and anti-TNF biological therapy are considered low risk, with certolizumab being the drug of choice throughout pregnancy and lactation. Most are compatible with paternal exposure except for sulfasalazine, mycophenolate and leflunomide, for which suspension of treatment prior to conception is recommended, and cyclosporine with dose requirements of less than 2mg/kg/day. CONCLUSIONS: In this context of chronic treatments with teratogenic potential, it is necessary to highlight the importance of pregnancy planning to select the safest drug. Given the quality of the available data, it is still necessary to continuously update the information, as well as to promote observational studies of cohorts of pregnant patients and men of childbearing age, including prospective studies, in order to generate more scientific evidence.

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.

Factores asociados a la persistencia a largo plazo de rituximab en artritis reumatoide en la práctica clínica: Estudio RITAR / Factors associated with long-term persistence of rituximab in rheumatoid arthritis In clinical practice: RITAR Study

ANTECEDENTES Y OBJETIVO: El tratamiento de la artritis reumatoide con rituximab (RTX) requiere ciclos repetidos y no existe una pauta bien establecida en dosis y frecuencia de retratamiento. El objetivo fue analizar la persistencia del tratamiento con RTX y los factores que influyen en condiciones de práctica clínica habitual. MATERIALES Y MÉTODOS: RITuximab en Artritis Reumatoide (Estudio RITAR) es un estudio observacional, retrospectivo que analiza la persistencia de RTX en una cohorte desde 2003 hasta 2015. La persistencia se calculó por análisis de Kaplan-Meier, las curvas se compararon con el test del Log-Rank. Para cuantificar el riesgo de suspensión se utilizó la regresión de Cox, se realizaron análisis multivariables para determinar los factores asociados a la persistencia del tratamiento. RESULTADOS: Se incluyeon 454 ciclos de RTX pertenecientes a 114 pacientes. La mediana de supervivencia fue 10 años y la tasa de incidencia de suspensión 7,7 por cada 100 pacientes-año. Los factores asociados a la persistencia fueron la seropositividad, el uso de RTX combinado con FAMEsc. No estuvieron asociados sexo, edad, n.° de comorbilidades, tiempo de evolución, n.° de complicaciones, DAS28 basal, HAQ basal, número de líneas de tratamiento, pauta de retratamiento fijo o a demanda, año de inicio de RTX. Los modelos multivariables confirmaron la relación entre seropositividad, uso en monoterapia y persistencia de RTX. CONCLUSIONES: La persistencia de RTX en la práctica clínica es elevada en pacientes seropositivos y en aquellos que están tratados con RTX asociado a un FAMEsc. La dosis por ciclo y la frecuencia de retratamiento no tienen un papel determinante en la persistencia

BACKGROUND AND OBJECTIVE: Treatment of rheumatoid arthritis with rituximab (RTX) requires repeated cycles, but there is no well-established retreatment regimen in dose and frequency. The objective was to analyse the persistence of RTX treatment and factors that influence in terms of routine clinical practice. METHODS: Rituximab in Rheumatoid Arthritis (RITAR Study) is an observational, retrospective study that analyses the persistence of RTX in a cohort from 2003 to 2015. Persistence was calculated by the Kaplan-Meier analysis; curves were compared with the Log-Rank test. Cox regression was used to quantify the risk of discontinuation and multivariate analyses were conducted to determine the factors associated with the persistence of the treatment. RESULTS: 454 cycles of RTX in 114 patients were included. Median survival was 10.0 years and incidence rate of discontinuation was 7.7 per 100 patients/year. Factors associated with persistence were autoantibody positivity and use of RTX in combination with csDMARDs. Sex, age, number of comorbidities, rheumatoid arthritis evolution, number of complications, basal DAS28, basal HAQ, number of lines of treatment, fixed or on demand retreatment and year of RTX starting were not associated. Multivariable models confirmed the relationship between autoantibody positivity, monotherapy and persistence of RTX. CONCLUSIONS: The persistence of RTX in clinical practice is higher in seropositive patients and in those who are treated with RTX associated with a csDMARD. Dose per cycle and retreatment frequency do not have a decisive role in rituximab persistence

Factors associated with long-term persistence of rituximab in rheumatoid arthritis In clinical practice: RITAR Study. / Factores asociados a la persistencia a largo plazo de rituximab en artritis reumatoide en la práctica clínica: Estudio RITAR.

BACKGROUND AND OBJECTIVE: Treatment of rheumatoid arthritis with rituximab (RTX) requires repeated cycles, but there is no well-established retreatment regimen in dose and frequency. The objective was to analyse the persistence of RTX treatment and factors that influence in terms of routine clinical practice. METHODS: Rituximab in Rheumatoid Arthritis (RITAR Study) is an observational, retrospective study that analyses the persistence of RTX in a cohort from 2003 to 2015. Persistence was calculated by the Kaplan-Meier analysis; curves were compared with the Log-Rank test. Cox regression was used to quantify the risk of discontinuation and multivariate analyses were conducted to determine the factors associated with the persistence of the treatment. RESULTS: 454 cycles of RTX in 114 patients were included. Median survival was 10.0 years and incidence rate of discontinuation was 7.7 per 100 patients/year. Factors associated with persistence were autoantibody positivity and use of RTX in combination with csDMARDs. Sex, age, number of comorbidities, rheumatoid arthritis evolution, number of complications, basal DAS28, basal HAQ, number of lines of treatment, fixed or on demand retreatment and year of RTX starting were not associated. Multivariable models confirmed the relationship between autoantibody positivity, monotherapy and persistence of RTX. CONCLUSIONS: The persistence of RTX in clinical practice is higher in seropositive patients and in those who are treated with RTX associated with a csDMARD. Dose per cycle and retreatment frequency do not have a decisive role in rituximab persistence.

Adherence to disease-modifying treatments in patients with multiple sclerosis in Spain.

PURPOSE: Adherence to disease-modifying treatments is essential in order to maximize the beneficial effects of treatment for multiple sclerosis (MS). There are numerous treatments that have been approved. Treatment selection is essential in patient adherence. In addition, patient preference plays an increasingly significant role in treatment decision-making. This study aims to evaluate the degree of adherence, along with other variables that may influence this adherence, in Spain. METHODS: A cross-sectional study was conducted with 157 MS patients with disease-modifying treatments. Adherence was assessed using the Morisky Green scale, and other related factors were measured using a questionnaire that addressed demographics, disease characteristics, global perception of pathology, impact of medication on patient's life, and treatment decision-making. RESULTS: The adherence rate was 71% and was associated with the following variables: older age, more treatments received, time to diagnosis 5-10 years, absence of exacerbations, better cognitive status, being married/in a union, clear information about the disease, and higher treatment satisfaction. The main cause for non-compliance was forgetfulness (27%). CONCLUSION: The adherence rate is acceptable. It is widely known that treatment satisfaction is related to adherence. In our study, patients' level of satisfaction was higher with oral treatments. However, oral administration showed a greater lack of adherence. The main cause of lack of adherence was forgetfulness. In relation to other variables, cognitive status and family support showed a correlation with treatment adherence.

Efficiency of adalimumab, etanercept and infliximab in ankylosing spondylitis in clinical practice.

BACKGROUND: Information on the use of ankylosing spondylitis (AS) therapies in clinical practice is a key factor in decision making, as more efficient treatments may involve substantial savings while maintaining the clinical benefits for the patient. OBJECTIVE: To assess the mean annual doses and associated costs of the three main anti-tumour necrosis factor agents used in Spanish daily clinical practice in ankylosing spondylitis patients and to correlate these costs with disease activity. SETTING: This retrospective, observational study included adult ankylosing spondylitis patients over a 4-year period that had been treated for at least 6 months with adalimumab, etanercept or infliximab at two University Hospitals in Spain. METHODS: Disease activity was estimated with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores at the start of anti-tumour necrosis factor (anti-TNF) therapy and in the last visit or whenever the drug was switched. Mean costs were estimated for a 52-week horizon from the delivered doses registered by pharmacy records. Outcomes were the doses and costs of anti TNFs administered to each patient, and the BASDAI score. RESULTS: A total of 119 patients (137 cases) were included (28 cases treated with adalimumab, 48 cases with etanercept and 61 with infliximab). Mean doses of adalimumab and etanercept were 92.8 and 88.8% of the initially prescribed doses, respectively, while the mean dose of infliximab administered was 102%. There were no statistical differences among treatments in terms of clinical effectiveness. Associated mean patient-year costs were significantly higher in the infliximab group (€14,235), compared to the other treatments [adalimumab €11,934; etanercept €10,516; (P < 0.05)]. CONCLUSION: In certain ankylosing spondylitis patients, doses and associated costs of biological therapies can be reduced while controlling disease activity. Mean doses used in our clinical practice vary from the recommended doses and are significantly lower for adalimumab and etanercept than for infliximab. These differences impact directly on associated patient-year costs, and, thus, on treatment efficiency.

Efficiency of adalimumab, etanercept and infliximab in rheumatoid arthritis patients: dosing patterns and effectiveness in daily clinical practice.

OBJECTIVES: This retrospective, multicentre, observational study aimed to assess the mean annual doses and associated costs of three anti-tumour necrosis factor agents in daily clinical practice in rheumatoid arthritis patients, correlating these costs with disease activity. METHODS: Adult rheumatoid arthritis patients were treated and followed at the Rheumatology departments of two Spanish hospitals for at least 6 months, with adalimumab, etanercept or infliximab over a 4-year period. ANOVA and multivariate statistical analyses of dosing patterns, disease activity and annualised costs were carried out. RESULTS: A total of 198 patients, comprising 215 cases, met the inclusion criteria (73 on adalimumab, 81 etanercept and 61 infliximab). Compared to recommended doses, mean doses of adalimumab and etanercept decreased by 7% and 19%, respectively, while the mean dose of infliximab increased by 36%. There were no statistical differences between treatments in terms of clinical effectiveness. The hazard of dose escalation was significantly higher for either adalimumab (4.4-fold) or infliximab (11.8-fold) compared to etanercept (p<0.05). Clinical control was achieved and maintained in more than half of the patients treated with reduced doses of etanercept. Associated mean patient-year costs were significantly higher in adalimumab patients (€11.962.58) (etanercept €9.594.73; infliximab €10.094.53; [p<0.05]). CONCLUSIONS: In rheumatoid arthritis patients, it is possible to reduce doses and associated costs of biological therapies while controlling disease activity. Mean doses used in our clinical practice were significantly lower with etanercept than with the anti-TNF monoclonal antibodies, adalimumab and infliximab. Dose differences impact directly on associated patient-year costs, and thus on treatment efficiency.

Influence on effectiveness of early treatment with anti-TNF therapy in rheumatoid arthritis.

PURPOSE: To evaluate the association between starting early treatment with anti-TNF and effectiveness as well as the possibility of applying therapeutic spacing in daily practice in patients with rheumatoid arthritis (RA). METHODS: Observational, retrospective study conducted in two universitary hospitals in Spain. RA patients who received the first anti-TNF (adalimumab: ADA, etanercept: ETN or infliximab: IFX) during the study period (October 2006-2010) were included. Demographic data, time since diagnosis, disease activity (DAS28-ESR) and anti-TNF dosage were analyzed. Therapeutic objective was defined as DAS28 DAS28 < 2.6. Also the response related to criteria of the European League Against Rheumatism (EULAR) was evaluated. Therapeutic spacing was defined as the use of a lower dose or a higher interval according to label doses. The main endpoint was to assess the association between the effectiveness and the moment when the anti-TNF therapy begins. The secondary target was to evaluate the association between RA activity at the beginning of treatment with anti-TNF and dose used. Results. 82 patients were included. The prescription profile was: ADA (48.8%), ETN (31.7%) and IFX (19.5%). 71.4% of patients treated with anti-TNF during the first year since diagnosis, 57.1% of those who started after 1-5 years and 30.6% of patients who started after 5 years were in remission when the study ended. De-escalation strategy was performed in 25.6% of patients: ETN (38.5%), ADA (20.0%) and IFX (18.8%). The patients treated with a higher dose according to label doses were: IFX (81%), ADA, (12.5%) and ETN (7.7%). CONCLUSIONS: Results suggest that early treatment with anti-TNF can achieve a higher percentage of remissions. Therapeutic spacing is established as a strategy that improves the efficiency in those patients in remission, being the ETN the anti-TNF most susceptible for spacing, although a relation between the early beginning with anti-TNF and the used dose was not found.