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1.
Medicina (Kaunas) ; 60(4)2024 Apr 04.
Artigo em Inglês | MEDLINE | ID: mdl-38674242

RESUMO

(1) Background and Objectives: The COVID-19 pandemic influenced the management of patients with immune-mediated rheumatic and musculoskeletal diseases (imRMDs) in various ways. The goal of our systematic review was to determine the influence of the first period of the COVID-19 pandemic (February 2020 to July 2020) on the management of imRMDs regarding the availability of drugs, adherence to therapy and therapy changes and on healthcare delivery. (2) Materials and Methods: We conducted a systematic literature search of PubMed, Cochrane and Embase databases (carried out 20-26 October 2021), including studies with adult patients, on the influence of the COVID-19 pandemic on the management of imRMDs. There were no restrictions regarding to study design except for systematic reviews and case reports that were excluded as well as articles on the disease outcomes in case of SARS-CoV-2 infection. Two reviewers screened the studies for inclusion, and in case of disagreement, a consensus was reached after discussion. (3) Results: A total of 5969 potentially relevant studies were found, and after title, abstract and full-text screening, 34 studies were included with data from 182,746 patients and 2018 rheumatologists. The non-availability of drugs (the impossibility or increased difficulty to obtain a drug), e.g., hydroxychloroquine and tocilizumab, was frequent (in 16-69% of patients). Further, medication non-adherence was reported among patients with different imRMDs and between different drugs in 4-46% of patients. Changes to preexisting medication were reported in up to 33% of patients (e.g., reducing the dose of steroids or the cessation of biological disease-modifying anti-rheumatic drugs). Physical in-office consultations and laboratory testing decreased, and therefore, newly implemented remote consultations (particularly telemedicine) increased greatly, with an increase of up to 80%. (4) Conclusions: The COVID-19 pandemic influenced the management of imRMDs, especially at the beginning. The influences were wide-ranging, affecting the availability of pharmacies, adherence to medication or medication changes, avoidance of doctor visits and laboratory testing. Remote and telehealth consultations were newly implemented. These new forms of healthcare delivery should be spread and implemented worldwide to routine clinical practice to be ready for future pandemics. Every healthcare service provider treating patients with imRMDs should check with his IT provider how these new forms of visits can be used and how they are offered in daily clinical practice. Therefore, this is not only a digitalization topic but also an organization theme for hospitals or outpatient clinics.


Assuntos
COVID-19 , Atenção à Saúde , Doenças Musculoesqueléticas , Doenças Reumáticas , Telemedicina , Humanos , Antirreumáticos/uso terapêutico , Atenção à Saúde/organização & administração , Hidroxicloroquina/uso terapêutico , Adesão à Medicação/estatística & dados numéricos , Doenças Musculoesqueléticas/tratamento farmacológico , Pandemias , Doenças Reumáticas/tratamento farmacológico , SARS-CoV-2 , Telemedicina/métodos , Telemedicina/organização & administração
2.
Rheum Dis Clin North Am ; 50(2): 181-199, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38670720

RESUMO

Immune checkpoint inhibitors (ICIs) have greatly improved survival of several cancers with historically very poor prognosis. ICIs act by stimulating the patient's own immune system to fight cancer. Simultaneously, this immune activation can lead to immune-related adverse events (irAEs), including rheumatic manifestations (Rh-irAEs). Rh-irAEs mimic primary rheumatic diseases including arthritis, polymyalgia rheumatica, myositis, vasculitis, sarcoidosis, and sicca. This article summarizes the latest evidence regarding the utility of laboratory investigations in Rh-irAEs.


Assuntos
Inibidores de Checkpoint Imunológico , Doenças Reumáticas , Humanos , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/imunologia , Inibidores de Checkpoint Imunológico/efeitos adversos , Neoplasias/imunologia , Neoplasias/tratamento farmacológico
3.
Pol Arch Intern Med ; 134(4)2024 04 26.
Artigo em Inglês | MEDLINE | ID: mdl-38165391

RESUMO

INTRODUCTION: By reducing treatment costs, biosimilars provide an opportunity to improve accessibility to highly effective drugs. OBJECTIVES: This study aimed to evaluate access to biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase inhibitors (JAKis) among patients with rheumatic musculoskeletal diseases within a 10 year timeframe in Poland. PATIENTS AND METHODS: We performed a retrospective analysis using a nationwide public payer database. RESULTS: By 2022, 11 102, 6602, and 4400 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) were treated with bDMARDs or JAKis. Peak drug utilization was observed for adalimumab, followed by etanercept and tocilizumab. Within the study timeframe, the estimated access to innovative drugs increased from 0.8%, 1.4%, and 0.8% to 3.2%, 8.7%, and 3.5% for RA, PsA, and axSpA patients, respectively. Affordable tumor necrosis factor inhibitors (TNFis) still predominate among innovative therapeutics, but their market share declined from 87% to 46%. The number of patients treated with other bDMARDs/JAKis almost doubled within the prespecified timeframe. Overall, the average annual treatment cost per patient decreased by 60%, from 7315 EUR to 2886 EUR. Despite recent safety warnings, JAKis appear to be increasingly utilized. Additional analyses regarding the COVID­19 pandemic showed impaired access to intravenous therapies, but not subcutaneous or oral formulations. CONCLUSIONS: In Poland, biosimilars­related savings improved availability of higher­priced innovative drugs rather than less costly TNFis. Data­driven resource allocation and dedicated policy solutions facilitating access to affordable biologics are recommended.


Assuntos
Antirreumáticos , Medicamentos Biossimilares , Inibidores de Janus Quinases , Doenças Reumáticas , Humanos , Polônia , Medicamentos Biossimilares/uso terapêutico , Medicamentos Biossimilares/economia , Estudos Retrospectivos , Antirreumáticos/uso terapêutico , Antirreumáticos/economia , Inibidores de Janus Quinases/uso terapêutico , Doenças Reumáticas/tratamento farmacológico , Masculino , Feminino , Pessoa de Meia-Idade , Produtos Biológicos/uso terapêutico , Produtos Biológicos/economia , Adulto , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Etanercepte/uso terapêutico , Etanercepte/economia
4.
Semin Arthritis Rheum ; 63: 152302, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37951128

RESUMO

OBJECTIVE: The benefits of TDM-guided TNFi therapy in patients with rheumatic disease was still controversial. This systematic review and meta-analysis was conducted to explore if the TDM-guided TNFi therapy is superior to empirical-guided therapy. METHODS: We systematically searched PubMed, Web of Science, Cochrane Library, and EMBASE databases for articles published between database inception and October 05, 2023. Studies reporting endpoints in TDM-guided TNFi therapy and empirical therapy were included. Results would be presented in risk ratio (RR) and mean difference, with 95 % confidence interval (CI) reported. This study is registered with PROSPERO (CRD42022353956). RESULTS: A total of 14 studies (eight RCTs and six cohort studies) involving 2427 patients were included in this meta-analysis. In the scenario of response prediction, compared with empirical-guided therapy, TDM-guided TNFi therapy had association with higher treat-to-target rates (RR 1.30, 95 % CI 1.02-1.65, P=0.03, I2=79 %), more specifically, higher low disease activity rates (RR 2.11, 95 % CI 1.22-3.66, P=0.007, I2=61 %), but no difference in clinical remission rates (RR 0.98,95 % CI 0.87-1.11, P=0.75, I2=0 %). In the scenario of dose reduction prediction, lower relapse rates (RR 0.73, 95 % CI 0.65-0.82, P <0.00001, I2=0 %) were observed compared with empirical-guided dose reduction strategy, but no difference (RR 1.24, 95 % CI 0.85-1.80, P=0.27, I2=57 %) between TDM-guided dose reduction and standard-dosing therapy. No significant difference was observed in change of disease activity score, mean disease activity score, radiographic progression, and safety. And TDM-guided therapy was associated with reduced cost per patient per year calculated as the total accumulated sum of therapy cost. CONCLUSION: TDM-guided TNFi therapy was associated with increased rates of low disease activity and decreased risks of relapse, and may save cost compared with empirical-guided therapy in patients with rheumatic disease. But this does not mean that the use of TDM-guided TNFi therapy can be advocated, because there is no difference in clinical remission rates and many other outcomes. More researches, especially randomized clinical trials are needed to verify this conclusion in the future.


Assuntos
Doenças Reumáticas , Inibidores do Fator de Necrose Tumoral , Humanos , Análise Custo-Benefício , Monitoramento de Medicamentos , Recidiva , Doenças Reumáticas/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/efeitos adversos , Inibidores do Fator de Necrose Tumoral/uso terapêutico
5.
Ann Rheum Dis ; 82(9): 1171-1180, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37328194

RESUMO

OBJECTIVES: Although several years have passed since biologic disease modifying antirheumatic drugs were introduced to the market, considerable disparities in access still remain. Tumour necrosis factor inhibitors (TNFi) have proven to be highly effective and safe for treating patients with rheumatic musculoskeletal diseases (RMDs). The emergence of biosimilars is promising for cost reduction and more equitable, widespread access. METHODS: A retrospective budget impact analysis based on final drug prices was conducted using 12 687 treatment courses for infliximab, etanercept and adalimumab. Estimated and real-life savings for public payer were calculated from an 8-year perspective of TNFi use. Data on the treatment cost and on the evolution in the number of patients treated was provided. RESULTS: From a public payer perspective, the estimated total savings amount to over €243 million for TNFi, with over €166 million attributed to treatment cost reduction in RMDs. Real-life savings were calculated as €133 million and €107 million, respectively. The rheumatology sector generated between 68% and 92% of total savings across models, depending on the adopted scenario. The overall decrease in mean annual cost of treatment ranged between 75% and 89% in the study frame. If all budget savings were spent on reimbursement of additional TNFi, a hypothetical total of almost 45 000 patients with RMDs could be treated in 2021. CONCLUSIONS: This is the first nation-level analysis that shows estimated and real-life direct cost-savings for TNFi biosimilars. Transparent criteria for reinvesting savings should be developed on both a local and an international levels.


Assuntos
Antirreumáticos , Medicamentos Biossimilares , Doenças Reumáticas , Humanos , Medicamentos Biossimilares/uso terapêutico , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Polônia , Estudos Retrospectivos , Infliximab/uso terapêutico , Antirreumáticos/uso terapêutico , Adalimumab , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/induzido quimicamente
6.
Ann Rheum Dis ; 82(1): 65-73, 2023 01.
Artigo em Inglês | MEDLINE | ID: mdl-35551063

RESUMO

OBJECTIVE: To develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs). METHODS: The points-to-consider were developed in accordance with EULAR standardised operation procedures by a multidisciplinary task force from eight European countries, based on a systematic literature review and expert consensus. Level of evidence and strength of the points-to-consider were determined, and mean levels of agreement among the task force were calculated using a 10-point rating scale. RESULTS: Six overarching principles and 13 points-to-consider were formulated. The level of agreement among the task force for the overarching principles and points-to-consider ranged from 8.4 to 9.9.The overarching principles define TDM and its subtypes, and reinforce the underlying pharmacokinetic/pharmacodynamic principles, which are relevant to all biopharmaceutical classes. The points-to-consider highlight the clinical utility of the measurement and interpretation of biopharmaceutical blood concentrations and antidrug antibodies in specific clinical scenarios, including factors that influence these parameters. In general, proactive use of TDM is not recommended but reactive TDM could be considered in certain clinical situations. An important factor limiting wider adoption of TDM is the lack of both high quality trials addressing effectiveness and safety of TDM and robust economic evaluation in patients with RMDs. Future research should focus on providing this evidence, as well as on further understanding of pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals. CONCLUSION: These points-to-consider are evidence-based and consensus-based statements for the use of TDM of biopharmaceuticals in inflammatory RMDs, addressing the clinical utility of TDM.


Assuntos
Produtos Biológicos , Doenças Musculoesqueléticas , Doenças Reumáticas , Humanos , Produtos Biológicos/uso terapêutico , Monitoramento de Medicamentos , Doenças Musculoesqueléticas/tratamento farmacológico , Anticorpos , Europa (Continente) , Doenças Reumáticas/tratamento farmacológico
7.
An Sist Sanit Navar ; 45(3)2022 11 22.
Artigo em Espanhol | MEDLINE | ID: mdl-36413005

RESUMO

BACKGROUND: To assess pain in patients with rheumatic disease under biological therapy treatment. METHODS: Observational retrospective study of patients with rheumatic disease under biological therapy treatment who visited the health care center as outpatients in February/August 2020. We collected demographic (sex and age), clinical (diagnosis, pain presence, intensity, and location), and pharmacological (biological therapy, concomitant treatment with traditional DMARDs, and analgesic treatment) variables from the electronic medical records and Farmatools Dominion®. RESULTS: We included 138 patients; mean age was 56 years and 71% were female. The most frequent diagnosis (47%) was ankylosing spondylitis. Anti-TNF-a was the most prescribed biological drug (64%); 60.1% of study patients received traditional drugs, particularly methotrexate and leflunomide (51.8 and 28.9%, respectively). Pain was reported in 81% of the cases, particularly in hands (73.2%) and knees (69.6%); mean pain intensity was 6.5 (VAS). Although 83.3% of the patients had been prescribed analgesics, pain persisted in 84.8% of the cases (VAS >4), being severe or very severe in 67.9%. Over half of the patients (52.2%) used more than one analgesic. The most frequently prescribed medications were non-steroidal anti-inflammatory drugs (NSAIDs) (60%), paracetamol (52.2%), and opioids (56.5%). NSAIDs controlled pain (14.5%) better than opioids (8.3%); there was no post-treatment improvement of pain in 29.6% of the patients. The number of prescribed drugs increased with pain intensity (rho= 0.264; p= 0.006). CONCLUSION: Almost 70% of study patients had uncontrolled severe rheumatic-related pain. This implies a challenge for esta­blishing effective treatments for this type of pain.


Assuntos
Doenças Reumáticas , Inibidores do Fator de Necrose Tumoral , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Medição da Dor , Estudos Retrospectivos , Dor , Doenças Reumáticas/complicações , Doenças Reumáticas/tratamento farmacológico , Analgésicos/uso terapêutico , Analgésicos Opioides , Anti-Inflamatórios não Esteroides/uso terapêutico , Terapia Biológica
8.
Einstein (Sao Paulo) ; 20: eAO6453, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35416831

RESUMO

OBJECTIVE: To evaluate the therapeutic response (functionality) and its associated factors in patients on biological drugs on the Public Health System for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. METHODS: An open prospective cohort was carried out from 2011 to 2019, in Belo Horizonte (MG). Functionality was assessed using the Health Assessment Questionnaire Disability-Index at baseline, and after 6 and 12 months of follow-up. Factors associated with poor functionality were identified through logistic regression. RESULTS: The median Health Assessment Questionnaire Disability-Index at baseline was 1.5 (interquartile range of 0.8-1.9), with poor functionality observed in patients with rheumatoid arthritis. Improved functionality was seen at 6 months of treatment for the three diseases. The predictors of poor functionality at 6 months for psoriatic arthritis and ankylosing spondylitis were female sex, low education levels, and high disease activity; and for rheumatoid arthritis and psoriatic arthritis were female sex, advanced age, and high disease activity. In 12 months, the three diseases had predictors of worse functionality: female sex, low education, and high disease activity. CONCLUSION: There was a significant improvement in functionality during the follow-up, with better response at 6 months of treatment. Poor functionality was observed in older, female patients, with low education and high disease activity.


Assuntos
Antirreumáticos , Artrite Psoriásica , Artrite Reumatoide , Doenças Reumáticas , Espondilite Anquilosante , Idoso , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Artrite Reumatoide/tratamento farmacológico , Feminino , Humanos , Masculino , Estudos Prospectivos , Saúde Pública , Doenças Reumáticas/tratamento farmacológico , Espondilite Anquilosante/tratamento farmacológico
9.
Joint Bone Spine ; 89(3): 105312, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34883243

RESUMO

OBJECTIVES: To estimate the seroprevalence of SARS-CoV-2 infection in patients with rheumatic diseases and to specify the proportion of asymptomatic and symptomatic forms of COVID-19. METHODS: We screened for SARS-CoV-2 infection among spondyloarthritis (SpA, n=143) or rheumatoid arthritis (RA, n=140) patients in our outpatient clinic at Cochin Hospital in Paris between June and August 2020. We performed a qualitative SARS-CoV-2 serological test which detects IgG directed against the N nucleocapsid protein (anti-N) and, for some patients, against the Spike protein (anti-S). Descriptive analyses were managed. RESULTS: During June-August 2020, the SARS-CoV-2 seroprevalence rate in our population was 2.83% (8/283 patients) without significant difference between RA and SpA patients (2.14% and 3.5%, respectively). We report 11 out of 283 patients (3.8%) with a diagnosis of SARS-CoV-2 infection. Among these 11 patients, 1 patient was asymptomatic (9%) with a confirmed diagnosis of COVID-19 by anti-S serology. Of the 283 patients, 85% were under bDMARDs, mainly on rituximab (RTX) (n=44) and infliximab (IFX) (n=136). CONCLUSIONS: The seroprevalence of SARS-CoV-2 in patients with rheumatic diseases, mainly under bDMARDs treatments, was 2.83%. Among infected patients, 9% were asymptomatic. Detecting SARS-CoV-2 infections could be based on the strategy using patients' interview and anti-N serology.


Assuntos
COVID-19 , Doenças Reumáticas , COVID-19/epidemiologia , Humanos , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/epidemiologia , SARS-CoV-2 , Estudos Soroepidemiológicos , Testes Sorológicos
10.
Reumatol Clin (Engl Ed) ; 17(9): 491-493, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34756308

RESUMO

SARS-COV-2 infection has spread worldwide since it originated in December 2019, in Wuhan, China. The pandemic has largely demonstrated the resilience of the world's health systems and is the greatest health emergency since World War II. There is no single therapeutic approach to the treatment of COVID-19 and the associated immune disorder. The lack of randomised clinical trials (RCTs) has led different countries to tackle the disease based on case series, or from results of observational studies with off-label drugs. We as rheumatologists in general, and specifically rheumatology fellows, have been on the front line of the pandemic, modifying our activities and altering our training itinerary. We have attended patients, we have learned about the management of the disease and from our previous experience with drugs for arthritis and giant cell arteritis, we have used these drugs to treat COVID-19.


Assuntos
Antivirais/uso terapêutico , Fatores Biológicos/uso terapêutico , Tratamento Farmacológico da COVID-19 , Imunossupressores/uso terapêutico , Papel do Médico , Reumatologistas , Doenças Autoimunes/complicações , Doenças Autoimunes/tratamento farmacológico , Doenças Autoimunes/imunologia , COVID-19/complicações , COVID-19/epidemiologia , COVID-19/imunologia , Quimioterapia Combinada , Educação de Pós-Graduação em Medicina , Bolsas de Estudo , Saúde Global , Humanos , Hospedeiro Imunocomprometido , Infecções Oportunistas/complicações , Infecções Oportunistas/tratamento farmacológico , Infecções Oportunistas/imunologia , Equipe de Assistência ao Paciente/organização & administração , Padrões de Prática Médica , Doenças Reumáticas/complicações , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/imunologia , Reumatologistas/educação , Reumatologistas/organização & administração , Reumatologia/educação , Reumatologia/métodos , Reumatologia/organização & administração , Espanha/epidemiologia
11.
Adv Rheumatol ; 61(1): 55, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34479631

RESUMO

BACKGROUND: Anti-rheumatic drugs can increase the predisposition to infection, and patients may be unaware of continuing their treatment during the COVID-19 pandemic. OBJECTIVE: This study aimed to assess whether patients maintain their treatment for rheumatic conditions during the pandemic period and determine the factors responsible for discontinuation. METHODS: Patients were randomly selected from the prospectively collected database of our tertiary referral center. The patients were interviewed by telephone through a standardized closed-ended questionnaire, which is targeting the continuity of the treatment plan and the considerations related to the individual choice. The patients were asked whether they hesitated to visit the hospital for follow-up or intravenous drug administration. RESULTS: A total of 278 patients completed the questionnaire. While 62 of the patients (22.3%) had reduced or interrupted the treatment, only 11 patients (3.9%) stopped the treatment completely. A significant difference was observed between the duration of illness and the discontinuation of treatment. (p = 0.023) There was a significant difference in disease activity between the group that stopped treatment and continued treatment. (p = 0.001) There was no statistically significant difference in other demographic characteristics. One hundred thirty-five patients (48.6%) made the treatment decision by themselves, and 80% continued the treatment. Reasons for stopping the treatment were anxiety (48.4%), not being able to go to the hospital for intravenous treatment (45.1%), and not being able to find the drug (6.5%). CONCLUSION: Since patients with long-term illnesses were found to be significantly more likely to stop their treatment, this group of patients should be monitored.


Assuntos
Antirreumáticos/uso terapêutico , Atitude Frente a Saúde , COVID-19/epidemiologia , Pandemias , Doenças Reumáticas/tratamento farmacológico , Suspensão de Tratamento/estatística & dados numéricos , Adulto , Idoso , Antirreumáticos/provisão & distribuição , Ansiedade , Continuidade da Assistência ao Paciente , Bases de Dados Factuais , Tomada de Decisões , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Reumáticas/psicologia , Inquéritos e Questionários/estatística & dados numéricos , Centros de Atenção Terciária , Adulto Jovem
12.
Horm Metab Res ; 53(8): 499-503, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34384106

RESUMO

Chronic glucocorticoid therapy is associated with osteoporosis and can cause fractures in up to 50% of patients. Increased risk of fractures in patients with glucocorticoid-induced osteoporosis does not result only from the decreased bone mineral density (BMD) but also bone microarchitecture deterioration. Trabecular bone score (TBS) is a method complementary to DXA, providing additional information about trabecular bone structure. The aim of this study was to assess the clinical utility of TBS in fracture risk assessment of patients treated with glucocorticoids. Patients with rheumatic diseases treated with glucocorticoids for at least 3 months were enrolled. All recruited patients underwent DXA with additional TBS assessment. We analyzed the frequency of osteoporosis and osteoporotic fractures and assessed factors that might be associated with the risk of osteoporotic fractures. A total of 64 patients were enrolled. TBS and TBS T-score values were significantly lower in patients with osteoporosis compared to patients without osteoporosis. Low energy fractures occurred in 19 patients. The disturbed bone microarchitecture was found in 30% of patients with fractures without osteoporosis diagnosis based on BMD. In the multivariate analysis, only TBS and age were significantly associated with the occurrence of osteoporotic fractures. TBS reflects the influence of glucocorticoid therapy on bone quality better than DXA measured BMD and provides an added value to DXA in identifying the group of patients particularly prone to fractures.


Assuntos
Glucocorticoides/efeitos adversos , Fraturas por Osteoporose/induzido quimicamente , Doenças Reumáticas/tratamento farmacológico , Medição de Risco , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Densidade Óssea/efeitos dos fármacos , Osso Esponjoso/efeitos dos fármacos , Osso Esponjoso/metabolismo , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fraturas por Osteoporose/epidemiologia , Adulto Jovem
13.
Semin Arthritis Rheum ; 51(5): 1139-1145, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34253398

RESUMO

OBJECTIVE: Our primary objective was to develop an Outcome Measures in Rheumatology (OMERACT) core domain set to capture the impact of glucocorticoids (GC), both positive and negative, on patients with Rheumatic conditions. METHODS: The OMERACT Filter 2.1 was used to guide core domain selection. Systematic literature reviews, qualitative studies and quantitative surveys were conducted by the OMERACT GC Impact working group to identify candidate domains for a core domain set. A summary of prior work and Delphi exercise were presented at the OMERACT 2020 virtual GC workshop. A proposed GC Impact core domain set derived from this work was presented for discussion in facilitated breakout groups. Participants voted on the proposed GC Impact core domain set. RESULTS: 113 people, including 23 patient research partners, participated in two virtual workshops conducted at different times on the same day. The proposed mandatory domains to be evaluated in clinical trials involving GCs were: infection, bone fragility, hypertension, diabetes, weight, fatigue, mood disturbance and death. In addition, collection of disease specific outcomes was included in the core domain set as "mandatory in specific circumstances". The proposed core domain set was endorsed by 100% (23/23) of the patient research partners and 92% (83/90) of the remaining participants, including clinicians, researchers and industry stakeholders. CONCLUSION: A GC Impact core domain set was endorsed at the OMERACT 2020 virtual workshop. The OMERACT GC Impact working group will now progress to identify, develop and validate measurement tools to best address these domains in clinical trials.


Assuntos
Doenças Reumáticas , Reumatologia , Glucocorticoides/uso terapêutico , Humanos , Avaliação de Resultados em Cuidados de Saúde , Doenças Reumáticas/tratamento farmacológico
14.
Med Clin North Am ; 105(2): 273-284, 2021 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-33589102

RESUMO

Patients with rheumatic disease, including those with systemic lupus erythematous, rheumatoid arthritis, and spondyloarthritis, use total hip and knee arthroplasties at high rates. They represent a particularly vulnerable population in the perioperative setting because of their diseases and the immunosuppressant therapies used to treat them. Careful planning among internists, medical specialists, and the surgical team must therefore occur preoperatively to minimize risks in the postoperative period, particularly infection. Management of immunosuppressant medications, such as conventional synthetic disease-modifying antirheumatic drugs and targeted therapies including biologics, is one avenue by which this infectious risk can be mitigated.


Assuntos
Artroplastia , Conduta do Tratamento Medicamentoso , Período Perioperatório/métodos , Doenças Reumáticas , Artroplastia/efeitos adversos , Artroplastia/métodos , Humanos , Doenças Reumáticas/tratamento farmacológico , Doenças Reumáticas/cirurgia , Risco Ajustado/métodos
16.
Clin Pharmacol Ther ; 109(3): 739-745, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32909249

RESUMO

In 2018, TNFα inhibitors were the highest cost drug class for Canadian public drug programs. In 2019, two Canadian provinces announced mandatory nonmedical switching policies in an attempt to reduce their costs by increasing biosimilar uptake. The national impact of similar policies across Canada is unknown. We conducted a cross-sectional analysis of monthly publicly funded prescription claims for infliximab, etanercept, and adalimumab between June 2015 and December 2019. We reported the market share of biosimilars for infliximab and etanercept in 2019 for each province and estimated the cost savings that public payers could have realized in 2019 if mandatory switching policies had been implemented across Canada, including a sensitivity analysis, which assumed that governments receive a 25% rebate on all biologics. Provincial drug programs spent CAD $991.84 million on infliximab, etanercept, and adalimumab in 2019, and, when biosimilars were available, they constituted only 15.5% of national utilization of these drugs. In British Columbia, the implementation of a mandatory switching policy for patients with rheumatic conditions increased the biosimilar market share of infliximab and etanercept by 299% (from 19.7% to 78.5%). If applied nationwide to all three biologics for all indications, we estimate such policies could lead to annual savings of between CAD $179.71 million and CAD $425.64 million nationally. The overall market share of biosimilars remains low in all provinces where mandatory switching policies have not been introduced. The cost implications of successfully increasing biosimilar uptake would be substantial, particularly as more biosimilars reach the Canadian market.


Assuntos
Produtos Biológicos/economia , Produtos Biológicos/uso terapêutico , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Custos de Medicamentos , Substituição de Medicamentos/economia , Doenças Inflamatórias Intestinais/tratamento farmacológico , Doenças Reumáticas/tratamento farmacológico , Inibidores do Fator de Necrose Tumoral/economia , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adalimumab/economia , Adalimumab/uso terapêutico , Produtos Biológicos/efeitos adversos , Medicamentos Biossimilares/efeitos adversos , Canadá , Redução de Custos , Análise Custo-Benefício , Estudos Transversais , Etanercepte/economia , Etanercepte/uso terapêutico , Humanos , Doenças Inflamatórias Intestinais/economia , Infliximab/economia , Infliximab/uso terapêutico , Formulação de Políticas , Saúde Pública/economia , Doenças Reumáticas/economia , Fatores de Tempo , Inibidores do Fator de Necrose Tumoral/efeitos adversos
17.
Ann Rheum Dis ; 80(6): 707-713, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33355152

RESUMO

BACKGROUND: Non-adherence to treatment could preclude reaching an optimal outcome. Thirty to 80% of patients with rheumatic and musculoskeletal diseases (RMDs) do not adhere to the agreed treatment. OBJECTIVES: The objective was to establish points to consider (PtCs) for the prevention, screening, assessment and management of non-adherence to (non-)pharmacological treatments in people with RMDs. METHODS: An EULAR task force (TF) was established, and the EULAR standardised operating procedures for the development of PtCs were followed. The TF included healthcare providers (HCPs), comprising rheumatologists, nurses, pharmacists, psychologists, physiotherapists, occupational therapists and patient-representatives from 12 European countries. A review of systematic reviews was conducted in advance to support the TF in formulating the PtCs. The level of agreement among the TF was established by anonymous online voting. RESULTS: Four overarching principles and nine PtCs were formulated. The PtCs reflect the phases of action on non-adherence. HCPs should assess and discuss adherence with patients on a regular basis and support patients to treatment adherence. As adherence is an agreed behaviour, the treatment has to be tailored to the patients' needs. The level of agreement ranged from 9.5 to 9.9 out of 10. CONCLUSIONS: These PtCs can help HCPs to support people with RMDs to be more adherent to the agreed treatment plan. The basic scheme being prevent non-adherence by bonding with the patient and building trust, overcoming structural barriers, assessing in a blame-free environment and tailoring the solution to the problem.


Assuntos
Doenças Musculoesqueléticas , Fisioterapeutas , Doenças Reumáticas , Europa (Continente) , Humanos , Doenças Musculoesqueléticas/diagnóstico , Doenças Musculoesqueléticas/prevenção & controle , Terapeutas Ocupacionais , Doenças Reumáticas/diagnóstico , Doenças Reumáticas/tratamento farmacológico , Revisões Sistemáticas como Assunto
18.
Nat Rev Rheumatol ; 17(2): 81-97, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33318665

RESUMO

Biologic agents have become a core component of therapeutic strategies for many inflammatory rheumatic diseases. However, perhaps reflecting the specificity and generally high affinity of biologic agents, these therapeutics have been used by rheumatologists with less consideration of their pharmacokinetics than that of conventional synthetic DMARDs. Immunogenicity was recognized as a potential limitation to the use of biologic agents at an early stage in their development, although regulatory guidance was relatively limited and assays to measure immunogenicity were less sophisticated than today. The advent of biosimilars has sparked a renewed interest in immunogenicity that has resulted in the development of increasingly sensitive assays, an enhanced appreciation of the pharmacokinetic consequences of immunogenicity and the development of comprehensive and specific guidance from regulatory authorities. As a result, rheumatologists have a greatly improved understanding of the field in general, including the factors responsible for immunogenicity, its potential clinical consequences and the implications for everyday treatment. In some specialties, immunogenicity testing is becoming a part of routine clinical management, but definitive evidence of its cost-effectiveness in rheumatology is awaited.


Assuntos
Imunidade Adaptativa/efeitos dos fármacos , Fatores Biológicos/farmacocinética , Doenças Reumáticas/tratamento farmacológico , Reumatologia/normas , Imunidade Adaptativa/imunologia , Antirreumáticos/administração & dosagem , Antirreumáticos/uso terapêutico , Fatores Biológicos/imunologia , Fatores Biológicos/uso terapêutico , Medicamentos Biossimilares/farmacocinética , Medicamentos Biossimilares/uso terapêutico , Análise Custo-Benefício , Humanos , Doenças Reumáticas/imunologia , Reumatologistas/estatística & dados numéricos , Reumatologia/economia
19.
Ann Acad Med Singap ; 49(11): 905-908, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33381785

RESUMO

The ongoing pandemic in Singapore is part of a global pandemic caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). To control the spread of COVID-19 and prevent the healthcare system from being overwhelmed, 'circuit breaker' measures were introduced between 7 April and 1 June 2020 in Singapore. There is thus a crucial need for innovative approaches to the provision and delivery of healthcare in the context of safe-distancing by harnessing telemedicine, especially for patients with chronic diseases who have traditionally been managed in tertiary institutions. We present a summary of how the Virtual Monitoring Clinic has benefited the practice of our outpatient rheumatology service during the COVID-19 pandemic. The virtual consultations address the need for safe-distancing by limiting face-to-face appointments and unnecessary exposure of patients to the hospital where feasible. This approach ensures that the patients are monitored appropriately for drug toxicities and side-effects, maintained on good disease control, and provided with patient education.


Assuntos
Antirreumáticos/uso terapêutico , COVID-19 , Doenças Reumáticas/tratamento farmacológico , Reumatologia/métodos , Telemedicina/métodos , Assistência Ambulatorial/métodos , Atenção à Saúde , Humanos , Profissionais de Enfermagem , Farmacêuticos , SARS-CoV-2 , Singapura , Telemedicina/organização & administração , Centros de Atenção Terciária
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