ABSTRACT
ABSTRACT Background: Despite the abundance of information concerning ocrelizumab in phase III clinical trials, there is scarce evidence regarding real-world patient profiles. Objective: The aim of this study was to investigate patient profiles, effectiveness and persistence with treatment among patients who used ocrelizumab for treatment of multiple sclerosis in Latin America. Methods: This was a retrospective multicenter study in Argentina, Chile and Mexico. Medical record databases on patients who received ocrelizumab were analyzed. Demographic and clinical variables were described, along with effectiveness outcomes, which included the proportions of patients free from clinical relapses, from disability progression and from new or enlarging T2 or T1 gadolinium-enhancing lesions, on annual magnetic resonance imaging. Results: A total of 81 patients were included. The most frequent phenotype was relapsing-remitting MS, in 64.2% of the patients. The mean age at study entry was 41.3 ± 12.0 years and 51.8% were women. A total of 38% had had relapse activity during the 12 months before starting on ocrelizumab, with a mean relapse rate of 1.3 ± 0.6 during that period. 75% were free from clinical relapses and 91% were free from gadolinium-enhancing lesions in the relapsing-remitting course. Ocrelizumab discontinuation during the first 12 months was observed in three patients (3.7%). The mean persistence observed during the first-year follow-up was 338 ± 24 days. Conclusions: Our study is in line with previous randomized clinical trials and recent real-world studies describing patient profiles, effectiveness and persistence regarding ocrelizumab treatment in multiple sclerosis patients in Latin America.
RESUMEN Introducción: A pesar de la abundante información sobre ocrelizumab proveniente de los ensayos clínicos de fase III, todavía se tiene poca evidencia sobre la efectividad y el perfil de pacientes provenientes de la vida real. Objetivo: Evaluar el perfil clínico y demográfico, la efectividad y la persistencia al tratamiento en pacientes que usaron el ocrelizumab para el tratamiento de esclerosis múltiple (EM) en Latinoamérica. Métodos: Estudio retrospectivo multicéntrico en Argentina, Chile y México. Se analizaron los datos de los pacientes que recibieron ocrelizumab. Se describieron las variables demográficas y clínicas, así como los resultados de efectividad que incluyeron la proporción de pacientes libres de recaídas clínicas, libres de progresión de la discapacidad, libres de nuevas lesiones en la secuencia T2 o T1 con gadolinio durante el seguimiento. Resultados: Se incluyeron 81 pacientes. El fenotipo más frecuente fue EM remitente recurrente (EMRR) en el 64,2% de los pacientes. La edad media fue de 41.3±12 años, y el 51,8% eran mujeres. Un total de 38% tuvo recaídas durante los 12 meses previos al inicio de ocrelizumab, con una tasa anualizada de recaídas media de 1.3±0.6 durante ese período. En el seguimiento a 12 meses, el 75% estuvo libre de recaídas clínicas y el 91%, libre de nuevas lesiones en RM. Tres pacientes interrumpieron el tratamiento durante el seguimiento (3,7%). La persistencia al tratamiento observada durante el primer año de seguimiento fue de 338±24 días. Conclusión: Nuestro estudio está en línea con los datos provenientes de ensayos clínicos aleatorizados previos y estudios recientes del mundo real que describen la efectividad de los perfiles de pacientes y la persistencia al tratamiento con ocrelizumab en pacientes con EM en Latinoamérica.
Subject(s)
Humans , Female , Multiple Sclerosis, Relapsing-Remitting , Multiple Sclerosis , Argentina , Magnetic Resonance Imaging , Chile , Retrospective Studies , Antibodies, Monoclonal, Humanized , Latin America , MexicoABSTRACT
El perro (Canis familiaris) ha sido la primera especie domesticada por el hombre como resultado de un proceso interactivo de miles de años, el cual produjo relaciones de competencia, cooperación y coevolución. Durante este proceso, los perros han adquirido habilidades comunicativas que favorecieron su relación con los humanos, la cual representa una expresión de apego. El rol de la oxitocina ha sido destacado en la formación de los vínculos de apego y en los comportamientos prosociales que facilitan las relaciones intraespecies. Se realizó una revisión sistemática de las investigaciones focalizadas en los efectos de la oxitocina sobre las interacciones entre humanos y perros. Se discuten los resultados en función de hallazgos de investigaciones referidas a la oxitocina y sus efectos intraespecies, así como en función de desarrollos en Antrozoología en general. Se destaca el posible rol de la oxitocina en distintos aspectos del vínculo humano-perro, como el efecto mascota, la cercanía emocional, el antropomorfismo y las respuestas a las características neoténicas. Finalmente, se describen posibles campos de investigación.
Dog (Canis familiaris) has been the first species to be domesticated by humans. This was the result of an interactive process that took place throughout thousands of years and led to competence, cooperation and coevolution relationships. Through a convergent evolution process, dogs have been able to acquire social abilities, similar to those of humans, which enabled particular communication ways between the two species. Dogs' remarkable ability to understand human social and communicative behaviors (even better than genetically related species, such as primates) favored their relationship with humans. Although some debate arose about the accuracy of the concept attachment, evidence of the most recent investigations on behavioral and endocrine responses in human-dog interactions have supported the idea that this relationship represents an expression of attachment. The oxytocin role has stood out in the formation of attachment bonds and in prosocial behavior that encourages intraspecies relationships. It achieves this by inducing maternal behaviors in a persistent fashion, influencing on pairing and increasing interpersonal trust through eye contact, empathy, etc. Moreover, the participation of oxytocin in the social bond processes is complex, as it has shown to play multiple roles. Oxytocin influences on the stress by reducing the cortisol levels, modulates the amygdala activity linked to fear, and increases the pain threshold, among other actions. Research in the human-animal interaction field, or Anthrozoology, has highlighted the companion animals' contribution to people wellbeing and particularly the buffering effect on daily life stress. The idea that living with an animal can have a positive influence on human health has been called pet effect and has been studied understanding physiological, psychosocial and therapeutic aspects. We carried out a systematic bibliographic review of the empiric studies about human-dog interactions in which oxytocin levels were assessed or oxytocin was administered, in dogs and / or humans. We present the employed procedures and the main results, and analyze the limitations and relevance of the investigations' findings, as well as their consistencies and contradictions. The results are discussed in function of the findings related to oxytocin and its intraspecies effects, and also in function of the development in Anthrozoology in general. The possible role of the oxytocin in the different aspects of the human-dog relationship is analyzed. Among these aspects we highlight: the pet effect, and the reported benefits of the relationship human-companion dog, mainly related to a decrease in stress symptoms; anthropomorphism and the mental states attribution necessary so that pet keeping makes sense; and the cute response, which implies an instinctive reaction to give parental care as a response to the infantile scheme, thought to be involved in the origin of pet keeping. The oxytocin role as an underlying neuroendocrine substrate that explains the benefits of the positive social experience that implies the human-dog bond and promotes the strengthening of this reciprocate and shared bond is emphasized. Finally, new lines of investigation are considered, such as the empiric study of the relationship of this neurohormone with the anthropomorphism and the response to the infantile scheme. We lay stress on the importance of developing studies with samples that include humans and dogs of different ages, with the object of assessing the influence of age on the response to oxytocin. We also make a point of the relevance of carrying out comparisons in relation to the human and dog gender, which has been usually controlled rather that investigated. Furthermore, we discuss the validity of the techniques employed to measure and administer the oxytocin. We make recommendations about these techniques and their use for considering the investigations goals. We highlight the least invasive methods such as the urine oxytocin measure, which are related to a more spontaneous behaviors and are more in agreement with animal welfare.