RESUMEN
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.
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Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales/administración & dosificación , Artritis Reumatoide/tratamiento farmacológico , Inmunoglobulina G/administración & dosificación , Receptores del Factor de Necrosis Tumoral/administración & dosificación , Adalimumab , Anciano , Anticuerpos Monoclonales/economía , Anticuerpos Monoclonales Humanizados/economía , Antirreumáticos/administración & dosificación , Antirreumáticos/economía , Artritis Reumatoide/economía , Artritis Reumatoide/mortalidad , Relación Dosis-Respuesta a Droga , Costos de los Medicamentos , Etanercept , Femenino , Costos de la Atención en Salud , Humanos , Inmunoglobulina G/economía , Infliximab , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Estudios Retrospectivos , Análisis de SupervivenciaRESUMEN
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.
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Anticuerpos Monoclonales Humanizados/administración & dosificación , Anticuerpos Monoclonales/administración & dosificación , Antirreumáticos/administración & dosificación , Artritis Reumatoide/tratamiento farmacológico , Inmunoglobulina G/administración & dosificación , Receptores del Factor de Necrosis Tumoral/administración & dosificación , Adalimumab , Adulto , Anciano , Esquema de Medicación , Etanercept , Femenino , Humanos , Inmunoterapia/métodos , Infliximab , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Factor de Necrosis Tumoral alfa/inmunologíaRESUMEN
INTRODUCTION: In the last few years, a new T cell therapy, chimeric antigen receptor-T (CAR-T) cells, has been developed. CAR-T cells are highly effective at inhibiting antitumor activity, but they can cause a wide spectrum of unusual side effects. AREAS COVERED: The present review provides an overview of the adverse events of CAR-T cell therapy, focusing on cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, increased risk of infections, and other long-term complications. Representative studies addressing the safety and efficacy of CAR-T cell therapy are summarized. EXPERT OPINION: In the coming years, we predict a great expansion in the use of CAR-T cell therapy with it applied to a higher number of patients with both malignant neoplasms and immune-mediated diseases. Despite physicians and patient expectations about the potential of this therapy, there are still several barriers that may limit providers' ability to supply quality care. This exciting and powerful new therapy requires the formation of new multidisciplinary teams to carry out a safe treatment administration and to successfully manage the resultant complications. The follow-up of these therapies is important for two aspects: effectiveness in different populations and real-life safety in short and in long-term follow-up.
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Neoplasias , Síndromes de Neurotoxicidad , Receptores Quiméricos de Antígenos , Síndrome de Liberación de Citoquinas/etiología , Síndrome de Liberación de Citoquinas/prevención & control , Humanos , Inmunoterapia Adoptiva/efectos adversos , Neoplasias/etiología , Síndromes de Neurotoxicidad/etiologíaRESUMEN
INTRODUCTION: In the few last years, a new family of drugs, anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs), has been developed for migraine therapy. Anti-CGRP mAbs are highly effective, but the current limited experience with their use and their high-cost warrant establishing certain rules of use. AREAS COVERED: The present review provides an overview of the management of migraine patients, especially those who are undergoing treatment with anti-CGRP mAbs. EXPERT OPINION: Thanks to new research focused on the pathophysiology of migraine, and the discovery that CGRP plays a key role in its etiopathogenesis, new drugs targeting CGRP have been developed. These drugs have led to a paradigm shift, anticipating new and stimulating possibilities in migraine treatment. While physicians and patients are full of expectation about the advantages of this new family of drugs, there are still obstacles to overcome in order to make the best use of them. It is essential to form multidisciplinary teams that can identify patients who will benefit from these therapies, conducting cost-effective treatments. The follow-up of these therapies in the coming years is paramount due to the lack of experience in the management of these drugs and the peculiarity of disease evolution in migraine patients.
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Antineoplásicos Inmunológicos , Trastornos Migrañosos , Anticuerpos Monoclonales/efectos adversos , Antineoplásicos Inmunológicos/uso terapéutico , Péptido Relacionado con Gen de Calcitonina , Antagonistas del Receptor Peptídico Relacionado con el Gen de la Calcitonina/uso terapéutico , Humanos , Trastornos Migrañosos/tratamiento farmacológicoRESUMEN
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.