RESUMO
BACKGROUND AND OBJECTIVES: Some patients have insufficient treatment response to conventional disease-modifying antirheumatic drugs (cDMARD); although biologics have proven to be an effective treatment for RA, the effects that bDMARDs have on integumentary, cardiac, and immune systems and the high costs associated with these treatments, make that mesenchymal stem cell-based therapies (MSCs) for RA are being considered potential treatment methods. This work analyses the performance in safety and efficacy terms of MSCs techniques. METHODS AND FINDING: A literature search was performed in PubMed, EMBASE, Cochrane Library, Web of Science, and Open Grey databases from inception to October 28, 2022. Three randomized controlled trials (RCTs) and one non-randomized controlled trial (non-RCTs), including 358 patients met our inclusion criteria and were included in qualitative synthesis; only RCTs were eligible for quantitative synthesis (meta-analysis). Meta-analysis of adverse events (AE) in RCTs showed no significant differences in the incidence of AE in the MSCs group compared to the control group (Risk ratio: 2.35; 95% CI, 0.58 to 9.58; I2 = 58.80%). The pooled Risk ratio for non-serious and serious adverse events showed no statistical difference between intervention and control groups concerning the incidence of non-serious and serious adverse events (Risk ratio: 2.35; 95% CI, 0.58 to 9.51; I2 = 58.62%) and (Risk ratio: 1.10; 95% CI, 0.15 to 7.97; I2 = 0.0%) respectively. The Health Assessment Questionnaire (HAQ) and Disease Activity Score (DAS28) decreased in agreement with the decreasing values of C-reactive protein (CRP) and Erythrocyte sedimentation rate (ESR). Additionally, a trend toward clinical efficacy was observed; however, this improvement was not shown in the studies after 12 months of follow-up without continuous treatment administration. CONCLUSION: This Systematic review and meta-analysis showed a favorable safety profile, without life-threatening events in subjects with RA, and a trend toward clinical efficacy that must be confirmed through high-quality RCTs, considerable sample size, and extended follow-up in subjects with RA.
Assuntos
Antirreumáticos , Artrite Reumatoide , Humanos , Antirreumáticos/efeitos adversos , Artrite Reumatoide/tratamento farmacológico , Metotrexato/uso terapêutico , Resultado do Tratamento , Ensaios Clínicos Controlados como AssuntoRESUMO
resumen está disponible en el texto completo
ABSTRACT Introduction: Models in health care have been static for a long time, but recently there has been a change in recognising that technology in the area of information and communication could lead to a change in improving health services. Telemedicine has been increasing and its use now extends to the entire process of health care. It is beginning to be implemented in the rheumatology area, in Colombia. The characteristics of a tele-rheumatology service are described, as well as a more detailed observation of a cohort of patients with rheumatoid arthritis (RA), in order to identify strengths and improvements. Methods: A descriptive observational cross-sectional study was conducted on the total population of patients who were treated by the tele-rheumatology service in the synchronous modality for a period of 30 months. As regards the follow-up of patients with RA, all patients were included who were treated exclusively by means of synchronous telemedicine for a minimum period of 6 months with at least three follow-ups, in which it was possible to calculate the clinimetry by Das28 with the use of C reactive protein (CRP). Measures of frequency, central tendency and dispersion according to type of variable will be used for the descriptive analysis. Results: Data was collected from 1905 patients during the period between August 2017 and March 2020. A total of 4864 consultations were made. Non-attendance of 368 (7.85%) consultations was registered. There were 1784 (83%) patients with a definitive diagnosis by the rheumatologist. A total of 284 patients (14.9%) were discharged by the rheumatology service, and 85 (4.46%) were referred for an exclusively face-to-face evaluation. Auxiliary medical care at the place of origin was provided by a general practitioner in 1,749 (91%) cases. There was no security during the care process as regards the physical examination in 46 (2.4%) cases. Of the total number of patients, 184 (9.6%) cases came from rural areas or municipalities far from the place of care. Biological therapies were prescribed in 139 patients, 56 new prescription during the 30 months. Of 479 RA patients, 200 met the criteria for follow-up. Of these, according to the activity measured by DAS28 with the use of ultrasensitive CRP, 54 patients (27%) were found on admission to the program in remission, 23 (11.5%) patients had low activity, 81 (40.5%) patients had moderate activity, and high activity was found in 42 (21%) patients. Regarding the start of follow-up, there was a 47% increase in the number of patients in remission, and low activity to 19.5%, in contrast to a reduction of 25% in patients with moderate activity and in 9% increase high activity in their last measurement, possible during monitoring. In the group of 200 patients from long-term follow-up, biological therapies were used 61 times. Of the 166 patients during follow-up without biological therapies on admission, these were required in 16%. Discussion: A detailed follow-up of the patients was carried out in the telemedicine service in a synchronous way for a period of two and a half years. The low percentage of absences shows a good adherence to the program. Physical examination, the main reason for medical care at the remission site, was not without difficulties, in this minority it was necessary to carry out diagnostic images. It would be important to assess this group of patients where there are doubts regarding the physical examination, those who have a certain number of appointments without a definitive diagnosis, or in whom biological or high-cost therapies would be used should necessarily be referred to face-to-face consultation. In the group of patients with RA, the percentage of biological use is considered high in relation to the expected standards. This may be for several reasons, such as the high number of patients with prior use of biological agents, the majority of patients with long-term disease, and difficulties in accessing follow-up due to rheumatology, as well as the small number of sero-negative patients in the study population, and practices related to non-presential medical practice may overestimate the activity of the disease. In conclusion, telemedicine has great advantages in the care of rheumatology patients, although it requires modifications to improve these services in favour of patients.
Assuntos
Humanos , Adulto , Reumatologia , Telemedicina , Ocupações em Saúde , MedicinaRESUMO
RESUMEN La enfermedad por Coronavirus 2019 (COVID-19) es una pandemia inesperada que ha pro vocado un estado de emergencia y que ha generado cambios drásticos en los protocolos de atención clínica. Para su tratamiento se ha descrito el papel de algunos medicamen tos usados habitualmente en artritis reumatoide, lupus eritematoso sistémico y otras enfermedades autoinmunitarias sistémicas. Debido a ello, existe un inminente riesgo de desabastecimiento, por lo cual el objetivo de esta revisión narrativa y opinión de expertos es formular recomendaciones generales clínicas y administrativas sobre el manejo de pacien tes ambulatorios con enfermedad autoinmunitaria o inflamatoria sistémica en el contexto de la pandemia por COVID-19.
ABSTRACT Coronavirus 2019 (COVID-19) is an unexpected pandemic that has caused a state of emergency, as well as generating drastic changes in clinical care protocols. Some drugs commonly used in rheumatoid arthritis, systemic lupus erythematosus, and other systemic autoimmune diseases have been described for its treatment. Therefore, there is an imminent risk of shortages. The aim of this narrative review and expert opinion is to present general recommendations on the clinical and administrative management of outpatients with autoimmune or systemic inflammatory disease, in the context of the COVID-19 pandemic.
