Since the discovery of glucocorticoids (GCs), their important anti-inflammatory effect, rapid mechanism of action, low cost, and accessibility have made them one of the mainstays of treatment for Systemic lupus erythematosus (SLE). Although their use has allowed controlling the disease and reducing acute mortality in severe conditions, the implementation of a scheme based on high doses for long periods has inevitably been accompanied by an increase in adverse effects and infections, including long-term damage. The objective of this review is to answer some important questions that may arise from its use in daily clinical practice, and to propose a paradigm based on the use of methylprednisolone pulses followed by medium-low doses and a rapid decrease of prednisone.
Objective The objective is to describe the main characteristics of patients with systemic lupus erythematosus (SLE) in Argentina and to examine the influence of ethnicity on the expression of the disease. Patients and methods RELESSAR is a multicentre register carried out by 106 researchers from 67 rheumatologic Argentine centres. It is a cross-sectional study of SLE (1982/1997 ACR) patients. RELESSAR electronic database includes demographic, cumulative SLE manifestations, SELENA-SLEDAI, SLICC-SDI, Katz’s severity and Charlson’s comorbidity indexes and treatment patterns. Results We included 1,610 patients, 91.7% were female with a median age at diagnosis of 28.1 ± 12.8; 96.2% met ≥4 ACR 1982/97 criteria. Frequent manifestations were arthritis (83.5%), malar rash (79.5%), photosensitivity (75.3%), haematological (63.8%) and renal disease (47.4%), antinuclear antibodies (96%), anti-dsDNA (66.5%) and anti-Smith antibodies (29%). The mean Selena-SLEDAI score at last visit was 3.18 (SD 4.3) and mean SDI was 1 (SD 1.3). The accumulated treatments most frequently used were antimalarials (90.4%), corticosteroids (90%), azathioprine (31.8%), intravenous cyclophosphamide (30.2%), mycophenolate mofetil or mycophenolic acid (24.5%), methotrexate (19.3%), belimumab 5.3% and rituximab 5.1%. Refractory lupus was diagnosed in 9.3% of the cases. The main causes of death were lupus activity (25.0%), activity and concomitant infections (25.0%), infections (18.2%), vascular disease (13.6%) and cancer (4.5%). Mortality was associated with higher SLEDAI, Katz, damage indexes and comorbidities. Of the 1610 patients included, 44.6% were Caucasian, 44.5% Mestizo, 8.1% Amerindian and 1.2% Afro-Latin American. Mestizo patients had higher male representation, low socioeconomic status, more inadequate medical coverage, fewer formal years of education and shorter disease duration. Polyadenopathies and Raynaud’s phenomenon were more frequent in Caucasians. In the logistic regression analysis higher damage index (OR 1.28, CI 95% 1.02–1.61, p = 0.03) remained associated to mestizo ethnicity. Conclusions This study represents the largest number of adult patients with SLE studied in Argentina. Caucasian patients were differentiated by having Raynaud’s phenomenon and polyadenopathy more frequently, while patients of Mestizo origin had higher damage indexes.
Objective To assess key aspects of transportation and storage of biological therapies (BTs) on the part of the patients, from the time they collect them from the pharmacy up until the moment of administration. Methods This was a cross-sectional study in the form of a survey completed by outpatients older than 18 years who were administered BTs. The survey was carried out by the authors between August 2016 and January 2017. Results A total of 83 outpatients were interviewed (mean age, 53; standard deviation, 15; 76% female). Sixty percent had rheumatoid arthritis, 24% had psoriatic arthritis, and 16% sustained other rheumatic and inflammatory diseases. Twenty percent had not been informed of the importance of proper refrigeration when they were first prescribed BTs; 77% had acquired the medication at least 7 days before administration; 28% had misplaced the drug in the fridge (65% of them in the freezer); 90% was unaware of the temperature range at which the BT should be kept in the fridge, and only one (1%) of them had once used a thermometer to find out the fridge temperature. Fifty-three percent had suffered frequent power outages the previous summer, 22% had experienced blackouts longer than 48 hours; 37% had taken the BT to another house to avoid wasting it, and four (5%) patients had disposed of the drug due to a prolonged power outage. Conclusion Upon prescribing BTs, it is imperative that physicians brief patients on the relevance of suitable transportation and storage methods, and a treatment failure should prompt a thorough assessment of transportation and storage conditions.
The aim of this study was to ascertain the frequency of use, search intent (SI), level of accessibility, and degree of reliability of sources of information (SOIs) in rheumatology. Methods:A survey among adult outpatients with rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, and spondyloarthritis was conducted. They were asked if they had procured information from 12 selected SOIs during the past year. Search intent was defined as the source they would like to consult. Accessibility and reliability were assessed through 0-to-10 scales (minimum and maximum, respectively).Results: Four hundred two patients were surveyed. They had consulted a median of 3 SOIs (interquartile range, 2-6) but described a higher SI: median of 5 SOIs (interquartile range 3-8); p = 0.001.The most consulted SOIs were the physician (83%), other patients (45%), and Facebook (36%). The main differences between SI and the searches actually performed were observed in community lectures by health care professionals (49%), scientific societies (48%), and associations of patients (27%); p < 0.001. These 3 sources showed low level of accessibility. Facebook, press, radio, and YouTube were the least reliable sources.Conclusions: Patients consulted a median of 3 SOIs but reported a significantly higher SI. Although patients demand more information, the request is leveled at SOIs with difficult accessibility but high reliability.
To analyse the level of consistency and updating of the information on pregnancy and lactation provided by patient information leaflets (PILs) of the antirheumatic drugs approved in Argentina. Inconsistencies between the 2016 EULAR Task Force recommendations on the use of anti-rheumatic drugs during pregnancy and lactation and the information provided by PILs of the same drugs approved in Argentina were analysed along with inconsistencies within the PILs of different registered trademarks of these drugs. Eighty-eight PILs of 32 drugs were analysed. Out of the 88 PILs, 50% presented information inconsistencies as to pregnancy. Medications comprised in this group were: hydroxychloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs (during the first two trimesters), celecoxib, some glucocorticoids, colchicine, and some anti-TNF drugs (etanercept, adalimumab and infliximab) during part of the pregnancy. As for lactation, 56% had information inconsistencies. Medications encompassed in this group were: hydroxychloroquine, chloroquine, sulfasalazine, azathioprine, tacrolimus, cyclosporine, NSAIDs, celecoxib, meprednisone, prednisone, colchicine, and anti-TNF drugs. Out of 17 drugs that had more than one registered trademark, information inconsistencies on pregnancy were found in the PILs of sulfasalazine, diclofenac, ibuprofen and methylprednisolone. Concerning lactation, inconsistencies were present in the PILs of hydroxychloroquine, sulfasalazine, diclofenac, ibuprofen, meprednisone, and colchicine. At least half of the PILs of anti-rheumatic drugs analysed in this study had information inconsistencies on pregnancy and lactation. This is a serious state of affairs because the consensual decision-making process between patient and professional may be compromised, which, in turn, may give rise to medical-legal issues.
Backgroundin order to ensure the pharmacological action of thermolabile drugs, it is mandatory to keep the cold chain unbroken from manufacturing to administration since lack of observance of these rules may compromise their efficacy. (1,2)Objectivesto ascertain key aspects of transportation and storage of Biological Therapy (BT) on the part of the patients.Methodssurvey among outpatients who either were treated in the centre or attended the centre for the administration of a BT. Inclusion criteria encompassed patients of over 18 years of age, who were receiving a BT (at least one dose over the last 12 months) whose patient information leaflet indicated, “... must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.” The survey comprised 31 questions about transportation and storage of the BT from the moment of collection from the pharmacy to its administration. This study was approved by the Bioethics Committee. Every patient signed an informed consent form.ResultsEighty-three patients were interviewed (76% female and 24% males), their average age was 53 years old, 60% had Rheumatoid Arthritis, 24% Psoriatic Arthritis, and 16% sustained other conditions. Sixty-four percent were undergoing BT for the first time. Forty-eight percent were enrolled in a patient assistance programme. Had patients been fully informed of the importance of proper transportation and storage of the drug? No, 20% acknowledged that the first time they dealt with a BT, they had not been made aware of the relevance of its correct preservation. Are patients administered the BT immediately after collecting it from the pharmacy? No, 77% collected the drug at least 7 days before administration and though they received the BT in a cooler with ice packs (except in 5 cases) 71% was uninformed of how long it could be kept in this condition. Is the BT duly stored in the patient's refrigerator? No, 28% misplaced the drug (65% in the freezer), and 90% did not know the temperature range at which it should be kept in the fridge. Only 1 patient used a thermometer to control the appliance temperature. Is there another crucial point as to BT storage at home? Yes, 53% of the 83 patients had experienced frequent power cuts in summer; out of these, 59% on a weekly basis. Forty percent of the 83 patients had power cuts of over 12 hours, 28% of over 24 hours, and 22% of over 48 hours. Out of the 83 patients, 37% took the BT to another house to avoid wasting it, and 4 had to dispose of it due to a protracted power cut. Five patients were away from home for over 48 hours during which the BT was in the fridge and they had not assigned another person to take care of the drug during their absence. Is the BT removed from the fridge only for its immediate administration? No, 46% of the respondents travelled to a centre, half of them for over an hour, carrying the BT.Conclusionsbefore administering a BT, it is imperative to brief patients on suitable transportation and storage methods. Thus, treatment failure should prompt a thorough assessment of transportation a...
Introducción: el lupus es una enfermedad compleja y varias veces de difícil abordaje. Alcanzar la remisión es uno de los objetivos, incorporando opciones terapéuticas. Objetivos: describir las características generales de los pacientes según el estado de la enfermedad y el uso de belimumab. Materiales y métodos: estudio de corte transversal, registro RELESSAR. Se definió el estado de la enfermedad como: remisión: SLEDAI=0 y sin corticoides; baja actividad de la enfermedad: SLEDAI >0 y ≤4 y sin corticoides; control no óptimo: SLEDAI >4 y cualquier dosis de corticoides. Resultados: se incluyeron 1.277 pacientes, 23,4% en remisión, 12,6% en baja actividad y 63,8% con control no óptimo. En este último grupo eran más jóvenes y con menor duración de la enfermedad; presentaban mayores índices de actividad y cronicidad, y mayor empleo de inmunosupresores. Solo el 22,3% de los pacientes con criterio potencial de uso de belimumab (lupus eritematoso sistémico activo a pesar del tratamiento estándar) lo recibía en ese momento. Las variables asociadas a hospitalizaciones fueron: terapia con corticoides, ciclofosfamida y mayor SLICC. Conclusiones: se refleja la complejidad del manejo de estos pacientes y se visualizan aspectos estructurales como la desigualdad. El uso del belimumab resultaría beneficioso en los pacientes seleccionados.
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