Direct costs in patients with chronic inflammatory arthropathies on biological therapy: a real-world data study.

OBJECTIVES: The aim of the study was to assess the direct costs for the Spanish Health System of patients with chronic inflammatory arthropathies treated with biological therapies in daily clinical practice and to establish possible factors associated with lower costs. METHODS: A descriptive, observational and retrospective study was conducted. Patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis who started a biological therapy between 1 January 2009 and 31 December 2016 were included. Variables related to socioeconomic status, disease and biological therapy were included. The annual cost of biological treatment and other direct medical costs were calculated for each disease. The analysis of costs was based on the National Health Service perspective. The time horizon comprised the 8-year long study period. RESULTS: A total of 422 biological therapy lines were analysed. The annual biological therapy cost per patient was €12,494±3,865 for rheumatoid arthritis, €11,248±2,763 for ankylosing spondylitis and €12,263±35,155 for psoriatic arthritis (p=0.008). The cost of biological therapies entailed about 80% of the total cost of these diseases. Hospital admission was a factor which contributed to an increasing cost in all these conditions. A longer duration of the biological therapy was associated with lower cost in all the diseases. CONCLUSIONS: The cost of ankylosing spondylitis is lower than that of rheumatoid arthritis and psoriatic arthritis. The biological therapy is the factor with the highest impact on the overall cost of these diseases. Preventing hospital admissions and a higher persistence to the biological therapy can contribute to lower costs for the system.

Medication persistence on biological therapies prescribed for the treatment of chronic inflammatory arthropathies: a real-world data study.

OBJECTIVES: Medication persistence, defined as the duration of time from its initiation to its discontinuation, is a surrogate for treatment effectiveness. The aim of the study was to evaluate persistence and causes of biological therapy (BT) suspension in patients with chronic inflammatory arthropathies: rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis. METHODS: Single institution, descriptive, retrospective cohort study. Adult patients with chronic inflammatory arthropathies on BT between January 2009 and December 2016 were included. Persistence to BT was compared considering the type of pathology and treatment. The Kaplan-Meier test was used to analyse medication persistanence and factors associated with it. An analysis of reasons for therapy discontinuation was performed. RESULTS: Three hundred and sixty-two patients were included in the study, which comprised 478 BT lines. For all patients, the 12-month persistence rate was 71.3% (341 out of 478). At the end of the study, 45.2% of the patients continued on their initial BT. Median treatment persistence was 1489 days (CI 95% 1195 to 1783). Longer BT persistence was associated with naïve BT patients: 1945 days (95% CI 1523 to 2367; P<0.001) and ankylosing spondylitis diagnosis: 2402 days (95% CI 1604 to 3200; P=0.014). The most frequent causes of treatment discontinuation were therapeutic failure (47.6%) and adverse drug events (28.2%). CONCLUSIONS: We found good long-term persistence in patients with chronic inflammatory arthropathies treated with BT. Patients with rheumatoid arthritis had significantly shorter persistence compared with those with ankylosing spondylitis and psoriatic arthritis. Naïve BT was associated with longer persistence. Therapeutic failure was the main cause of BT withdrawal.

Adherence to biological therapies in patients with chronic inflammatory arthropathies.

INTRODUCTION: The aims of the study were to quantify adherence, determine the factors that can  predict adherence and identify the consequences of poorer adherence in patients with chronic  inflammatory arthropathies treated with biological therapies in daily clinical practice. METHOD: A descriptive, observational and retrospective study was carried out. Patients with  rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis who started a biologic therapy  between 1 January 2009 and 31 December 2016 were included. Variables related to socioeconomic  status, the disease, the biological therapy and hospital resources were included. Adherence was  calculated by using the medication possession ratio. RESULTS: Three hundred and sixty-two patients and 423 lines of biological therapy were included.  Mean age ± standard deviation was 50.3 ± 13.9 years, and 228 (53.9%) were women. The  percentage of adherent patients was 187 out of 216 (87%) in rheumatoid arthritis, 91 out of 107  (85%) in ankylosing spondylitis and 84 out of 100 (84%) in psoriatic arthritis. Greater adherence was  associated with more frequent visits to the pharmacy service (odds ratio 1.2, 95% confidence  interval: 1.1-1.3 [p = 0.001]) and poorer adherence with a failure to attend scheduled appointments  at the rheumatology clinic (odds ratio 0.2, 95% confidence interval: 0.1-0.9 [p = 0.030]). There were  no differences between  adherent and non-adherent patients in terms of the number of hospital resources used. CONCLUSIONS: There are no differences in adherence to biological therapies among patients with  chronic inflammatory arthropathies. Adherence correlates with attendance at outpatient  appointments, but this does not imply an increase in the use of hospital resources.

Objetivo: Los objetivos del estudio fueron cuantificar la adherencia, determinar los factores  predictivos y conocer las consecuencias de una menor adherencia, en la práctica clínica diaria, en  pacientes con artropatías inflamatorias crónicas tratados con terapias biológicas. Método: Estudio descriptivo, observacional y retrospectivo. Se incluyeron pacientes con artritis  reumatoide, espondilitis anquilosante y artritis psoriásica que iniciaron una terapia biológica entre el 1  de enero de 2009 y el 31 de diciembre de 2016. Se recogieron variables sociodemográficas, relacionadas con la enfermedad, sobre las terapias biológicas y los recursos  hospitalarios. La adherencia se calculó mediante la ratio media de posesión.Resultados: Se incluyeron 362 pacientes y 423 líneas de terapia biológica. La media de edad ±  desviación estándar fue de 50,3 ± 13,9 años; 228 (53,9%) fueron mujeres. El porcentaje de  adherentes fue de 187 de 216 (87%) en artritis reumatoide, 91 de 107 (85%) en espondilitis  anquilosante y 84 de 100 (84%) en artritis psoriásica. La adherencia se relacionó con acudir con más  frecuencia a la consulta del servicio de farmacia(odds ratio de 1,2; intervalo de confianza 95%: 1,1- 1,3 [p = 0,001]) e inversamente con no acudir a las consultas de reumatología en la fecha prevista (odds ratio de 0,2; intervalo de confianza 95%: 0,1-0,9 [p = 0,030]). No hubo diferencias en  el número de recursos hospitalarios utilizados por pacientes adherentes y no adherentes.Conclusiones: La adherencia a las terapias biológicas entre las artropatías inflamatorias crónicas es  similar. Dicha adherencia se correlaciona con la frecuentación a consultas externas, pero no implica  un aumento del consumo de recursos.

Recomendaciones sobre actuaciones a seguir durante la edad fértil, el embarazo, posparto y lactancia en pacientes con enfermedades reumáticas inflamatorias y autoinmunes / Recommendations for the evaluation and management of patients with rheumatic autoimmune and inflammatory diseases during the reproductive age, pregnancy, postpartum and breastfeeding

Objetivo. Desarrollar recomendaciones basadas en la mejor evidencia y experiencia sobre el manejo de pacientes con enfermedades reumáticas inflamatorias y autoinmunes durante la edad fértil, el embarazo, posparto y lactancia. Métodos. Se siguió la metodología de grupos nominales. Se seleccionó un grupo nominal de expertos (12 reumatólogos). Se realizó una actualización de una revisión sistemática de la literatura, una revisión literaria, así como una encuesta a nivel nacional sobre el manejo de estos pacientes. El grupo de expertos se encargó de definir el alcance, usuarios, apartados del manuscrito y posibles recomendaciones. El GA con las recomendaciones se votó siguiendo la metodología Delphi según una escala de 1 (total desacuerdo) a 10 (total acuerdo), definiéndose el acuerdo como una puntuación ≥ 7 por al menos el 70% de los participantes. El NE y GR se clasificaron según el modelo del Center for Evidence Based Medicine de Oxford. El documento completo inicial fue revisado por los expertos y el proyecto estuvo coordinado, en todo momento, por un metodólogo experto. Resultados. Se generaron 14 recomendaciones sobre el periodo preconcepcional (anticoncepción, reproducción asistida), el embarazo (planificación, manejo farmacológico y seguimiento) y lactancia (manejo farmacológico y seguimiento). Incluye recomendaciones específicas sobre situaciones de especial riesgo como el lupus eritematoso sistémico y el síndrome antifosfolípido. Existió acuerdo > 90% con todas las recomendaciones menos en una de ellas. Conclusiones. En los pacientes con enfermedades inflamatorias y autoinmunes estas actuaciones pueden mejorar los resultados y el pronóstico de los mismos (AU)

Objective. To develop recommendations on the evaluation and management of patients with rheumatic autoimmune and inflammatory diseases during the reproductive age, pregnancy, post-partum and breastfeeding based on the best evidence and experience. Methods. Recommendations were generated using nominal group and Delphi techniques. An expert panel of 12 rheumatologists was established. A systematic literature review and a narrative review (websites, clinical guidelines and other relevant documentation) were performed and presented to the panel in its 1st meeting to be discussed and to help define recommendations. A first draft of recommendations was generated and circulated for comments and wording refinement. A national survey analyzing different aspects of this topic was undertaken separately, followed by a Delphi process (2 rounds). Agreement with each recommendation was ranked on a scale of 1 (total disagreement) to 10 (total agreement), and was considered to be achieved if at least 70% voted ≥ 7. The level of evidence and grade of recommendation were assessed using the Oxford Centre for Evidence-based Medicine Levels of Evidence. Results. A total of 14 recommendations were generated for the preconception period (oral and hormonal contraception, reproductive techniques), pregnancy (planning, treatment and follow-up), and breastfeeding (treatment and follow-up). High-risk situations such as lupus or antiphospholipid syndrome were included. A consensus > 90% was reached for all but one recommendation. Conclusions. These recommendations are intended to provide rheumatologists, patients, families and other stakeholders with a consensus on the evaluation and management of patients with autoimmune and inflammatory diseases during the reproductive age, pregnancy, postpartum and breastfeeding (AU)

[Clinical practice guidelines for systemic lupus erythematosus: Recommendations for general clinical management]. / Guía de práctica clínica para el lupus eritematoso sistémico: recomendaciones para el abordaje clínico general.

Systemic lupus erythematosus (SLE) is a complex rheumatic multisystemic disease of autoimmune origin with significant potential morbidity and mortality. It is one of the most common autoimmune diseases with an estimated prevalence of 20-150 cases per 100,000 inhabitants. The clinical spectrum of SLE is wide and variable both in clinical manifestations and severity. This prompted the Spanish Ministry of Health, Social Services and Equality to promote and fund the development of a clinical practice guideline (CPG) for the clinical care of SLE patients within the Programme of CPG in the National Health System which coordinates GuiaSalud. This CPG is is intended as the reference tool in the Spanish National Health System in order to support the comprehensive clinical management of people with SLE by all health professionals involved, regardless of specialty and level of care, helping to standardize and improve the quality of clinical decisions in our context in order to improve the health outcomes of the people affected. The purpose of this document is to present and discuss the rationale of the recommendations on the general management of SLE, specifically, clinical follow-up, general therapeutic approach, healthy lifestyles, photoprotection, and training programmes for patients. These recommendations are based on the best available scientific evidence, on discussion and the consensus of expert groups.

SER consensus statement on the use of biologic therapy for systemic lupus erythematosus.

OBJECTIVE: To provide a reference to rheumatologists and other physicians involved in the treatment of systemic lupus erythematosus (SLE) who are using, or about to use biologic therapies. METHODS: Recommendations were developed following a nominal group methodology and based on systematic reviews. The level of evidence and degree of recommendation were classified according to a model proposed by the Center for Evidence Based Medicine at Oxford. The level of agreement was established through a Delphi technique. RESULTS: We have produced recommendations on the use of belimumab, the only biological agent with approved indications for SLE, and other biological agents without an indication for SLE. The objective of treatment is to achieve a complete clinical response, taken as the absence of perceived or evident disease activity. Nuances regarding the use of biologic therapies in SLE were reviewed as well, such as the evaluation that should be performed prior to administration and the follow up of patients undergoing these therapies. CONCLUSIONS: We present the SER recommendations for the use of biological therapies in patients with SLE.