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1.
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 , Acesso 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
2.
Arthritis Res Ther ; 23(1): 228, 2021 08 31.
Artigo em Inglês | MEDLINE | ID: mdl-34465391

RESUMO

OBJECTIVES: The aim of this study was to compare the clinical effectiveness of tofacitinib and abatacept and clarify the impact of the HLA-DRB1 shared epitope (SE) on responses to these treatments in patients with rheumatoid arthritis (RA). METHODS: After adjustments by propensity score matching, 70 out of 161 patients receiving tofacitinib and 70 out of 131 receiving abatacept were extracted. The clinical effectiveness of both drugs over 24 weeks and the impact of the copy numbers of SE on effectiveness outcomes were investigated. RESULTS: The percentage of patients in remission in the 28-joint count disease activity score using the erythrocyte sedimentation rate (DAS28-ESR) did not significantly differ between patients receiving tofacitinib and abatacept at week 24 (32% vs 37%, p = 0.359). The mean change at week 4 in DAS28-ESR from baseline was significantly greater in patients receiving tofacitinib than in those receiving abatacept (- 1.516 vs - 0.827, p = 0.0003). The percentage of patients in remission at week 4 was 30% with tofacitinib and 15% with abatacept (p = 0.016). When patients were stratified by the copy numbers of SE alleles, differences in these numbers did not affect DAS28-ESR scores of patients receiving tofacitinib. However, among patients receiving abatacept, DAS28-ESR scores were significantly lower in patients carrying 2 copies of SE alleles than in those carrying 0 copies at each time point throughout the 24-week period. Furthermore, the percentage of patients in remission with DAS28-ESR at week 24 was not affected by the copy numbers of SE alleles in patients receiving tofacitinib (p = 0.947), whereas it significantly increased as the copy numbers became higher in patients receiving abatacept (p = 0.00309). Multivariable logistic regression analyses showed a correlation between the presence of SE and DAS28-ESR remission in patients receiving abatacept (OR = 25.881, 95% CI = 3.140-213.351, p = 0.0025), but not in those receiving tofacitinib (OR = 1.473, 95% CI = 0.291-7.446, p = 0.639). CONCLUSIONS: Although the clinical effectiveness of tofacitinib and abatacept was similar at week 24, tofacitinib was superior to abatacept for changes from baseline in DAS28-ESR and the achievement of remission at week 4. SE positivity was associated with the achievement of DAS28-ESR remission by week 24 in patients receiving abatacept, but not in those receiving tofacitinib.


Assuntos
Antirreumáticos , Artrite Reumatoide , Abatacepte/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/genética , Epitopos , Cadeias HLA-DRB1 , Humanos , Piperidinas , Pirimidinas , Resultado do Tratamento
4.
Am J Dent ; 34(4): 211-214, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34370914

RESUMO

PURPOSE: To assess the prevalence of periapical abscesses in patients with rheumatoid arthritis, and to evaluate the effect of commonly used antirheumatic medications on such prevalence. METHODS: Integrated data of hospital patients was used. Data from the corresponding diagnosis codes for rheumatoid arthritis and periapical abscess was retrieved by searching the appropriate query in the database. The odd ratio (OR) of periapical abscesses, its association with rheumatoid arthritis and intake of three commonly prescribed antirheumatic medications were calculated and analyzed statistically. RESULTS: The prevalence of periapical abscesses in patients with rheumatoid arthritis was 1.53% as compared to 0.51% in the general patient population of the hospital. The OR was 2.60 and the difference was statistically significant (P< 0.0001). In patients treated with either Methotrexate, Sulfasalazine, or Etanercept, the ORs were 2.88, 3.1, and 1.07, respectively. The differences between Methotrexate and Sulfasalazine were statistically significant (P< 0.0001). The OR for prevalence of periapical abscesses in patients treated with Etanercept was significantly lower than that of patients treated with either Methotrexate or Sulfasalazine (P< 0.005). CLINICAL SIGNIFICANCE: Oral healthcare providers should be aware of the possible association between rheumatoid arthritis and occurrence of periapical abscesses. Patients with rheumatoid arthritis, mainly women, may exhibit higher prevalence of periapical abscesses. Treatment with TNF alpha inhibitors may lower the prevalence of periapical abscesses in such patients.


Assuntos
Antirreumáticos , Artrite Reumatoide , Abscesso Periapical , Antirreumáticos/uso terapêutico , Artrite Reumatoide/complicações , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Estudos Transversais , Feminino , Humanos , Abscesso Periapical/tratamento farmacológico , Prevalência , Resultado do Tratamento
5.
BMJ Open ; 11(8): e047713, 2021 08 03.
Artigo em Inglês | MEDLINE | ID: mdl-34344678

RESUMO

OBJECTIVE: To evaluate the ability of fluorescence optical imaging (FOI) Xiralite in the discrimination between rheumatoid arthritis (RA) patients with and without need of rituximab (RTX) retherapy-in comparison to clinical, laboratory and musculoskeletal ultrasound parameters. PATIENTS AND METHODS: Patients with established RA were prospectively followed over 1 year by Disease Activity Score 28, patient's global disease activity (visual analogue scale 0-100 mm), C reactive protein and erythrocyte sedimentation rate, ultrasound seven joint (US7) score and FOI in phases 1-3 and automatically generated PrimaVista mode (PVM) at baseline (before RTX) and after 3, 6 and 12 months. The need for RTX retherapy was decided by the treating rheumatologist-blinded to imaging data. RESULTS: 31 patients (female 77.4%, mean age 60.1±11.4, mean disease duration 14.9±7.1 years) were included. Fourteen (45.2%) patients received RTX retherapy within 12 months. In the group with RTX retherapy, FOI in PVM mode was the only parameter that presented significant increase over time (ß: 0.40, 95% CI: 0.08 to 0.71, p=0.013)-compared with the group without retherapy. In the prediction model via ROC analysis, FOI in PVM reached the highest values of all imaging, clinical and laboratory parameters which was associated with retherapy over 1 year with an area under the curve (AUC) of 0.78 (OR: 0.84, 95% CI: 0.72 to 0.98, p=0.031). US7 GS synovitis score revealed similar association with an AUC of 0.73 (p=0.049). CONCLUSION: US7 GS synovitis score and FOI in PVM are able to discriminate between patients with and without need for RTX retherapy better than clinical and laboratory parameters.


Assuntos
Antirreumáticos , Artrite Reumatoide , Sinovite , Idoso , Antirreumáticos/uso terapêutico , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Estudos de Coortes , Feminino , Humanos , Pessoa de Meia-Idade , Imagem Óptica , Rituximab/uso terapêutico
6.
J Biomed Nanotechnol ; 17(7): 1293-1304, 2021 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-34446133

RESUMO

De novo designed lipidated methotrexate was synthesized and self-assembled into microbubbles for targeted rheumatoid arthritis theranostic treatment. Controlled lipidatedmethotrexate delivery was achieved by ultrasound-targetedmicrobubble destruction technique. Methotrexate was dissociated inflammatory microenvironment of synovial cavity, owing to representive low pH and enriched leucocyte esterase. We first manipulated methotrexate controlled release with RAW 264.7 cell line in vitro and further verified with rheumatoid arthritis rabbits in vivo. Results showed that lipidated methotrexate microbubbles precisely affected infection focus and significantly enhanced rheumatoid arthritis curative effect comparing with dissociative methotrexate. This study indicates that lipidated methotrexate microbubbles might be considered as a promising rheumatoid arthritis theranostics medicine.


Assuntos
Antirreumáticos , Artrite Reumatoide , Animais , Antirreumáticos/uso terapêutico , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Metotrexato , Microbolhas , Medicina de Precisão , Coelhos , Ultrassom
7.
Arthritis Res Ther ; 23(1): 221, 2021 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-34429152

RESUMO

BACKGROUND: Peficitinib (ASP015K), a novel oral Janus kinase inhibitor, has demonstrated efficacy and safety in the treatment of patients with rheumatoid arthritis (RA). This study evaluated the effect of peficitinib on patient- and physician-reported outcomes in Asian patients with RA and an inadequate response to prior disease-modifying antirheumatic drugs (DMARDs). METHODS: Patients from two randomized, placebo-controlled, double-blind, phase 3 trials (RAJ3 and RAJ4) received once-daily peficitinib 100 mg, peficitinib 150 mg, or placebo, alone or in combination with DMARDs (RAJ3), or in combination with methotrexate (RAJ4). Mean changes in Work Productivity and Activity Impairment (WPAI) questionnaire domain scores from baseline, and percentages of patients achieving minimal clinically important differences (MCIDs) for patient- and physician-reported outcomes (WPAI, Health Assessment Questionnaire - Disability Index [HAQ-DI], and Subject's Global Assessment of Pain [SGAP]), and Physician's Global Assessment of disease activity (PGA) were evaluated at weeks 4, 8, 12, and 12/early termination (ET). RESULTS: Data from 1025 patients were analyzed. At week 12/ET in both studies, patients who received peficitinib 100 mg or 150 mg reported significantly improved WPAI domain scores from baseline (except for absenteeism in RAJ4) compared with placebo (both doses, p<0.05). A higher proportion of peficitinib- versus placebo-treated patients achieved MCID in WPAI, HAQ-DI, SGAP, and PGA in studies RAJ3 and RAJ4. Significant differences with peficitinib versus placebo were evident in both studies as early as week 4 in HAQ-DI (peficitinib 150 mg only), SGAP, and PGA, and week 8 in WPAI loss of work productivity and daily activity impairment. At week 12/ET, significantly higher proportions of patients receiving peficitinib versus placebo achieved MCID in HAQ-DI, SGAP, PGA, and WPAI domains of presenteeism (RAJ3 only), loss of work productivity (RAJ3 only), and daily activity impairment (p<0.05 for all comparisons). CONCLUSIONS: Peficitinib 100 mg or 150 mg administered daily over 12 weeks resulted in clinically meaningful improvements in outcomes that are important to RA patients, including pain, physical function, and work productivity and activity. These observations were reinforced through similar improvements in physicians' rating of disease activity. TRIAL REGISTRATION: RAJ3: ClinicalTrials.gov, NCT02308163 , registered 4 December 2014. RAJ4: ClinicalTrials.gov, NCT02305849 , registered 3 December 2014.


Assuntos
Antirreumáticos , Artrite Reumatoide , Médicos , Adamantano/análogos & derivados , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Método Duplo-Cego , Humanos , Metotrexato/uso terapêutico , Niacinamida/análogos & derivados , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento
8.
Arthritis Res Ther ; 23(1): 220, 2021 08 24.
Artigo em Inglês | MEDLINE | ID: mdl-34429160

RESUMO

BACKGROUND: This post hoc analysis assessed clinical and functional responses to tofacitinib monotherapy, tofacitinib + methotrexate (MTX), and adalimumab + MTX, in patients with rheumatoid arthritis enrolled in the ORAL Strategy study, including evaluation of patient-level data using cumulative probability plots. METHODS: In the 12-month, phase IIIb/IV ORAL Strategy study, patients with rheumatoid arthritis and an inadequate response to MTX were randomized to receive tofacitinib 5 mg twice daily (BID), tofacitinib 5 mg BID + MTX, or adalimumab 40 mg every other week + MTX. In this post hoc analysis, cumulative probability plots were generated for mean percent change from baseline (%∆) in the Clinical Disease Activity Index (CDAI; clinical response) and mean change from baseline (∆) in the Health Assessment Questionnaire-Disability Index (HAQ-DI; functional response) at month 12. Median C-reactive protein (CRP) levels by time period were summarized by CDAI remission (≤ 2.8) status at months 6 and 12. RESULTS: Data for 1146 patients were analyzed. At month 12, cumulative probability plots for %∆CDAI and ∆HAQ-DI were similar across treatments in patients with greater response. At lower levels of response, patients receiving tofacitinib monotherapy did not respond as well as those receiving combination therapies. With tofacitinib + MTX, numerically higher baseline CRP levels and numerically larger post-baseline CRP reductions were seen in patients achieving CDAI remission at months 6 and 12 vs those who did not. CONCLUSIONS: These results suggest that patients with a greater response did well, irrespective of which therapy they received. Patients with lesser response had better outcomes with combination therapies vs tofacitinib monotherapy, suggesting they benefitted from MTX. High pre-treatment CRP levels may be associated with better response to tofacitinib + MTX. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02187055. Registered on 08 July 2014.


Assuntos
Antirreumáticos , Metotrexato , Adalimumab , Antirreumáticos/uso terapêutico , Quimioterapia Combinada , Humanos , Piperidinas , Pirimidinas , Pirróis , Resultado do Tratamento
9.
Int J Rheum Dis ; 24(9): 1106-1111, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-34375036

RESUMO

Rheumatoid arthritis (RA) is a major health burden in Asia Pacific affecting the quality of life of patients and consuming healthcare resources. According to recent estimates from the World Health Organization-International League Against Rheumatism-Community Oriented Program for Control of Rheumatic Diseases, prevalence is around 0.3%-0.5%. Management guidelines have helped to improve treatment across this diverse region. To gain better insight into current real-world management applications in view of these guidelines, virtual meetings were conducted in mid-2020 to explore perspectives of rheumatologists and patients, as well as discuss the impact of coronavirus disease 2019 on RA management. Patients and rheumatologists from Hong Kong, Malaysia, Singapore, the Philippines, Thailand, India, Pakistan, and Taiwan were included, representing a diverse mix of healthcare systems, wealth, ethnicity and culture. Despite many countries having prospered in recent years, similar challenges in RA diagnosis and treatment were identified. The daily impact and patient experience of RA were also similar across countries, marked by "silent" pain and disability, and universal misunderstanding of the disease. Late diagnosis and treatment, and barriers to access to appropriate treatment, remain problematic. The experience shared by Taiwan offers a glimmer of hope, however, wherein patient advocacy groups have succeeded in being included in policy-making decisions and securing access to advanced treatment. Real-world solutions that pay heed to the unique local needs and diversity of Asia Pacific are required to improve RA management, which will take time. In the interim, help can be sought from the trained, non-rheumatologist community to reduce some of the disease burden.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , COVID-19 , Manejo da Dor/tendências , Padrões de Prática Médica/tendências , Antirreumáticos/efeitos adversos , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/epidemiologia , Ásia/epidemiologia , Humanos , Resultado do Tratamento
11.
Adv Ther ; 38(9): 4885-4899, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34370276

RESUMO

BACKGROUND: Targeted treatment of rheumatoid arthritis (RA) includes biological DMARDs (bDMARDs) and JAK inhibitors (JAKi). These agents are recommended at the same level on the basis of their efficacy and safety data. However, no local evidence of the impact of RA treatment regimens on total budget spending is available to date. This study aimed to explore the budget impact of different sequential targeted treatments in Thai patients with RA who failed at least three conventional synthetic DMARDs. METHODS: We used the adapted model to evaluate the budget impact of adding tofacitinib in different order to RA targeted treatment regimens. The Thai RA population eligible for treatment was assessed on the basis of local prevalence and experts' opinion. Cost-impact analysis was evaluated for the treatment sequences of four different lines of targeted therapies using inputs like clinical efficacy, safety, and costs. The model used a decision tree structure with treatment nodes corresponding to treatment response outcomes for a cohort of patients. The comparisons included five bDMARDs [etanercept (ETN), infliximab (IFX), golimumab (GOL), rituximab (RTX), tocilizumab (TCZ) intravenous formulation], two JAKi [tofacitinib (TOF) and baricitinib (BAR)], and two IFX biosimilars (PF-06438179/GP1111 and CT-P13). A total of 80 treatment sequences within each containing four sequential first-, second-, third-, and fourth-line options were generated. RESULTS: The findings of the base case scenario indicated the treatment sequence with RTX as first-line, followed by IFX biosimilar (PF-06438179/GP1111), TOF, and TCZ, respectively, produced the lowest budget impact of US $693.54 million. Sensitivity analyses confirmed the robustness of our findings. CONCLUSION: The order of targeted therapy starting with RTX, then IFX biosimilar, TOF, and finally TCZ incurred the lowest budget impact over a 5-year time horizon for treating moderate to severe RA. Our findings may help payers and policy makers consider appropriate budget allocation on chronic non-communicable diseases, especially RA.


Assuntos
Antirreumáticos , Artrite Reumatoide , Medicamentos Biossimilares , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Etanercepte/uso terapêutico , Humanos , Tailândia , Resultado do Tratamento
12.
Artigo em Inglês | MEDLINE | ID: mdl-34360449

RESUMO

The purpose of this study is to evaluate the relationship between hydroxychloroquine (HCQ) and diabetic retinopathy (DR) via the national health insurance research database (NHIRD) of Taiwan. All patients with newly diagnosed type 2 diabetes (n = 47,353) in the NHIRD (2000-2012) were enrolled in the study. The case group consists of participants with diabetic ophthalmic complications; 1:1 matching by age (±1 year old), sex, and diagnosis year of diabetes was used to provide an index date for the control group that corresponded to the case group (n = 5550). Chi-square test for categorical variables and Student's t-test for continuous variables were used. Conditional logistic regression was performed to estimate the adjusted odds ratio (aOR) of DR. The total number of HCQ user was 99 patients (1.8%) in the case group and 93 patients (1.7%) in the control group. Patients with hypertension (aOR = 1.21, 95% CI = 1.11-1.31) and hyperlipidemia (aOR = 1.65, 95% CI = 1.52-1.79) significantly increased the risk of diabetic ophthalmic complications (p < 0.001). Conversely, the use of HCQ and the presence of rheumatoid diseases did not show any significance in increased risk of DR. HCQ prescription can improve systemic glycemic profile, but it does not decrease the risk of diabetic ophthalmic complications.


Assuntos
Antirreumáticos , Artrite Reumatoide , Diabetes Mellitus Tipo 2 , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Humanos , Hidroxicloroquina/efeitos adversos , Fatores de Risco , Taiwan/epidemiologia
13.
Curr Rheumatol Rep ; 23(9): 74, 2021 07 16.
Artigo em Inglês | MEDLINE | ID: mdl-34269903

RESUMO

PURPOSE OF REVIEW: We reviewed the current data on infections associated with rituximab use published over the last 5 years. RECENT FINDINGS: New literature was available on rates of serious infections, Hepatitis B reactivation and screening, and infection with Severe Acute Respiratory Syndrome Coronavirus 2. Rates of infection varied by study and population, however, higher risk of infection in patients with underlying rheumatologic diseases was seen in those who required a therapy switch, had a smoking history, and those undergoing retreatment who had a serious infection with their first course of therapy. With regards to HBV, the proportion of patients screened continues to be inadequate. Despite the upfront cost, HBV screening and prophylaxis were found to be cost effective. There is still limited data regarding COVID-19 severity in the setting of rituximab, however, rituximab, especially in combination with steroids, may lead to more severe disease and higher mortality.


Assuntos
Antirreumáticos/uso terapêutico , COVID-19/epidemiologia , Hepatite B/epidemiologia , Infecções Oportunistas/epidemiologia , Rituximab/uso terapêutico , Antivirais/uso terapêutico , Hepatite B/diagnóstico , Hepatite B/tratamento farmacológico , Hepatite B/prevenção & controle , Humanos , Hospedeiro Imunocomprometido , Infecção Latente/diagnóstico , Infecção Latente/tratamento farmacológico , Infecção Latente/epidemiologia , Infecção Latente/prevenção & controle , Programas de Rastreamento , Risco , SARS-CoV-2 , Viroses/epidemiologia
14.
Syst Rev ; 10(1): 205, 2021 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-34274019

RESUMO

BACKGROUND: Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide. The expiration of patents for these biologics has driven the production of biosimilar drugs, which are potentially less costly and remarkably similar, albeit not identical to the reference molecules. This paper aims to outline the protocol of a systematic review that will investigate the efficacy and safety profile of biosimilars compared to biologics (objective 1) and the impact of switching between biosimilar drugs and reference biologics on the management of RA patients (objective 2). METHODS: We will investigate the effects of any biosimilars of adalimumab, etanercept, and infliximab on RA patients. We will include randomized controlled trials (RCTs) or quasi-RCTs to assess efficacy and safety outcomes and RCTs with two- or multiple-part designs to evaluate the consequences of switching from reference biologics to biosimilar drugs (and vice-versa). Electronic searches will be performed through MEDLINE (via PubMed), EMBASE, LILACS, and CENTRAL (from inception to April 2021). Two independent reviewers will screen studies, extract data, and evaluate the risk of bias. The latter will be carried out considering specific domains from equivalence trials and switching studies. Random-effects models will be fitted to obtain summary estimates using either relative risk or standardized mean difference as a metric. The primary outcome will be the rate of treatment success according to the American College of Rheumatology 20 (ACR20), and the co-primary outcome will be the Health Assessment Questionnaire-Disability Index (HAQ-DI). Conclusions will be based on equivalence hypothesis testing using predefined margins of equivalence elicited from a group of experienced rheumatologists and prior studies. The overall certainty of the evidence will be assessed based on the GRADE system. DISCUSSION: The present investigation proposes a comprehensive, clinician-oriented approach to assess the equivalence and the impact of switching between biosimilars and biologics on the management of patients with RA. Our results will elucidate the efficacy, safety, immunogenicity of biosimilars, and the clinical consequences of substituting biologics with biosimilars in the management of RA. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019137152 and CRD42019137155.


Assuntos
Antirreumáticos , Artrite Reumatoide , Medicamentos Biossimilares , Anticorpos Monoclonais/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Medicamentos Biossimilares/uso terapêutico , Humanos , Metanálise como Assunto , Revisões Sistemáticas como Assunto , Resultado do Tratamento
15.
Sci Rep ; 11(1): 15097, 2021 07 23.
Artigo em Inglês | MEDLINE | ID: mdl-34302004

RESUMO

There is little data describing trends in the use of hydroxychloroquine for COVID-19 following publication of randomized trials that failed to demonstrate a benefit of this therapy. We identified 13,957 patients admitted for active COVID-19 at 85 U.S. hospitals participating in a national registry between March 1 and August 31, 2020. The overall proportion of patients receiving hydroxychloroquine peaked at 55.2% in March and April and decreased to 4.8% in May and June and 0.8% in July and August. At the hospital-level, median use was 59.4% in March and April (IQR 48.5-71.5%, range 0-100%) and decreased to 0.3% (IQR 0-5.4%, range 0-100%) by May and June and 0% (IQR 0-1.3%, range 0-36.4%) by July and August. The rate and hospital-level uniformity in deimplementation of this ineffective therapy for COVID-19 reflects a rapid response to evolving clinical information and further study may offer strategies to inform deimplementation of ineffective clinical care.


Assuntos
Antirreumáticos/uso terapêutico , COVID-19/tratamento farmacológico , Doenças Cardiovasculares/tratamento farmacológico , Hidroxicloroquina/uso terapêutico , Idoso , COVID-19/complicações , COVID-19/mortalidade , Doenças Cardiovasculares/complicações , Estudos Transversais , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros
16.
RMD Open ; 7(2)2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34226183

RESUMO

BACKGROUND: Pain is a core domain of psoriatic arthritis (PsA). This post hoc analysis evaluated time to pain improvement and the impact of baseline pain severity on pain response in patients with PsA receiving tofacitinib. METHODS: Data from two trials (NCT01877668; NCT01882439) in patients receiving tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib) or adalimumab (NCT01877668 only) were included. Improvement in pain (≥30%/≥50% decrease from baseline in Visual Analogue Scale pain score) was assessed; median time to initial (first post-baseline visit)/continued (first two consecutive post-baseline visits) pain improvement was estimated (Kaplan-Meier) for all treatment arms. A parametric model was used to determine the relationship between baseline pain severity and time to pain response in patients receiving tofacitinib. RESULTS: At month 3, more patients experienced pain improvements with tofacitinib/adalimumab versus placebo. Median days (95% CI) to initial/continued pain improvements of ≥30% and ≥50%, respectively, were 55 (29-57)/60 (57-85) and 85 (57-92)/171 (90-not estimable (NE)) for tofacitinib, versus 106 (64-115)/126 (113-173) and 169 (120-189)/NE (247-NE) for placebo-to-tofacitinib. Pain improvements were also experienced more quickly for adalimumab versus placebo. Predicted time to ≥30%/≥50% pain improvement was shorter in patients with higher baseline pain versus lower baseline pain (tofacitinib arm only). CONCLUSIONS: In patients with PsA, pain improvements were experienced by more patients, and more rapidly, with tofacitinib and adalimumab versus placebo. In those receiving tofacitinib, higher baseline pain was associated with faster pain improvements.


Assuntos
Antirreumáticos , Artrite Psoriásica , Antirreumáticos/uso terapêutico , Artrite Psoriásica/complicações , Artrite Psoriásica/tratamento farmacológico , Humanos , Dor/tratamento farmacológico , Dor/etiologia , Piperidinas , Pirimidinas , Resultado do Tratamento
17.
RMD Open ; 7(2)2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-34253683

RESUMO

Axial spondyloarthritis (axSpA) is a chronic rheumatic disease characterised by inflammation predominantly involving the spine and the sacroiliac joints. In some patients, axial inflammation leads to irreversible structural damage that in the spine is usually quantified by the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). Available therapeutic options include biological disease-modifying antirheumatic drugs (bDMARDs), which have been proven effective in suppressing inflammation in several randomised controlled trials (RCT), the gold standard for evaluating causal treatment effects. RCTs are, however, unfeasible for testing structural effects in axSpA mainly due to the low sensitivity to change of the mSASSS. The available literature therefore mainly includes observational research, which poses serious challenges to the determination of causality. Here, we review the studies testing the effect of bDMARDs on spinal radiographic progression, making use of the principles of causal inference. By exploring the assumptions of causality under counterfactual reasoning (exchangeability, positivity and consistency), we distinguish between studies that likely have reported confounded treatment effects and studies that, on the basis of their design, have more likely reported causal treatment effects. We conclude that bDMARDs might, indirectly, interfere with spinal radiographic progression in axSpA by their effect on inflammation. Innovations in imaging are expected, so that placebo-controlled trials can in the future become a reality. In the meantime, causal inference analysis using observational data may contribute to a better understanding of whether disease modification is possible in axSpA.


Assuntos
Antirreumáticos , Espondilartrite , Espondilite Anquilosante , Antirreumáticos/uso terapêutico , Humanos , Articulação Sacroilíaca , Coluna Vertebral/diagnóstico por imagem , Espondilartrite/tratamento farmacológico , Espondilite Anquilosante/tratamento farmacológico
18.
Arthritis Res Ther ; 23(1): 190, 2021 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-34261541

RESUMO

BACKGROUND: The interleukin-23p19-subunit inhibitor guselkumab effectively treats signs and symptoms of psoriatic arthritis (PsA). We evaluated the effect of guselkumab on fatigue. METHODS: Across two phase 3 trials of guselkumab (DISCOVER-1, DISCOVER-2), patients with active PsA despite standard therapy were randomized to subcutaneous injections of guselkumab 100 mg every 4 weeks (Q4W, N = 373); guselkumab 100 mg at week 0, week 4, and then Q8W (N = 375); or placebo (N = 372) through week 24, after which patients in the placebo group crossed over to guselkumab Q4W. Fatigue was measured as a secondary endpoint using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue instrument (range 0-52, higher scores indicate less fatigue). Least-squares mean changes in FACIT-Fatigue scores were compared between treatments using a mixed-effect model for repeated measures. Mediation analysis was used to adjust for indirect effects on fatigue deriving from improvement in other outcomes, including ≥20% improvement in American College of Rheumatology criteria (ACR20; prespecified), minimal disease activity (MDA; post hoc), or C-reactive protein (CRP; post hoc). RESULTS: Baseline mean (SD) FACIT-Fatigue scores in DISCOVER-1 (N = 381) and DISCOVER-2 (N = 739), ranging from 29.1 (9.5) to 31.4 (10.1), indicated substantial levels of fatigue relative to the United States general population (43.6 [9.4]). Across studies, mean improvements, and proportions of patients with ≥4-point improvements, in FACIT-Fatigue scores at week 24 with guselkumab Q4W and Q8W (5.6-7.6 and 54-63%, respectively) were larger vs placebo (2.2-3.6 and 35-46%). Improvement in FACIT-Fatigue scores with guselkumab was sustained from week 24 to week 52, with moderate-to-large effect sizes (Cohen's d = 0.52-0.81 at week 24; 0.66-0.91 at week 52). Mediation analyses demonstrated that substantial proportions of the effects of guselkumab vs placebo on fatigue were direct effect, after adjusting for achievement of ACR20 (Q4W 69-70%, Q8W 12-36% direct effect) or MDA (72-92% across dosing regimens) response or for change in serum CRP concentrations (82-88% across dosing regimens). CONCLUSIONS: In patients with active PsA, guselkumab 100 mg Q4W or Q8W led to clinically meaningful and sustained improvements in fatigue through 1 year. A substantial portion of the improvement in FACIT-Fatigue scores induced by guselkumab was independent of effects on the achievement of other select outcomes. TRIAL REGISTRATION: Name of the registry: ClinicalTrials.gov Trial registrations: DISCOVER-1, NCT03162796; DISCOVER-2, NCT03158285 Date of registration: DISCOVER-1, May 22, 2017; DISCOVER-2, May 18, 2017 URLs of the trial registry record: DISCOVER-1, https://clinicaltrials.gov/ct2/show/NCT03162796?term=NCT03162796&draw=1&rank=1 DISCOVER-2, https://clinicaltrials.gov/ct2/show/NCT03158285?term=NCT03158285&draw=2&rank=1.


Assuntos
Antirreumáticos , Artrite Psoriásica , Anticorpos Monoclonais Humanizados , Antirreumáticos/uso terapêutico , Artrite Psoriásica/tratamento farmacológico , Método Duplo-Cego , Fadiga/tratamento farmacológico , Humanos , Índice de Gravidade de Doença , Resultado do Tratamento
19.
Arthritis Rheumatol ; 73(8): 1384-1393, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34235883

RESUMO

OBJECTIVE: To provide evidence-based recommendations and expert guidance for the management of systemic polyarteritis nodosa (PAN). METHODS: Twenty-one clinical questions regarding diagnostic testing, treatment, and management were developed in the population, intervention, comparator, and outcome (PICO) format for systemic, non-hepatitis B-related PAN. Systematic literature reviews were conducted for each PICO question. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the quality of evidence and formulate recommendations. Each recommendation required ≥70% consensus among the Voting Panel. RESULTS: We present 16 recommendations and 1 ungraded position statement for PAN. Most recommendations were graded as conditional due to the paucity of evidence. These recommendations support early treatment of severe PAN with cyclophosphamide and glucocorticoids, limiting toxicity through minimizing long-term exposure to both treatments, and the use of imaging and tissue biopsy for disease diagnosis. These recommendations endorse minimizing risk to the patient by using established therapy at disease onset and identify new areas where adjunctive therapy may be warranted. CONCLUSION: These recommendations provide guidance regarding diagnostic strategies, use of pharmacologic agents, and imaging for patients with PAN.


Assuntos
Antirreumáticos/uso terapêutico , Medicina Baseada em Evidências/normas , Poliarterite Nodosa , Reumatologia/normas , Ciclofosfamida/uso terapêutico , Gerenciamento Clínico , Glucocorticoides/uso terapêutico , Humanos , Poliarterite Nodosa/diagnóstico , Poliarterite Nodosa/diagnóstico por imagem , Poliarterite Nodosa/tratamento farmacológico , Estados Unidos
20.
Arthritis Rheumatol ; 73(8): 1366-1383, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34235894

RESUMO

OBJECTIVE: To provide evidence-based recommendations and expert guidance for the management of antineutrophil cytoplasmic antibody-associated vasculitis (AAV), including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), and eosinophilic granulomatosis with polyangiitis (EGPA). METHODS: Clinical questions regarding the treatment and management of AAV were developed in the population, intervention, comparator, and outcome (PICO) format (47 for GPA/MPA, 34 for EGPA). Systematic literature reviews were conducted for each PICO question. The Grading of Recommendations Assessment, Development and Evaluation methodology was used to assess the quality of evidence and formulate recommendations. Each recommendation required ≥70% consensus among the Voting Panel. RESULTS: We present 26 recommendations and 5 ungraded position statements for GPA/MPA, and 15 recommendations and 5 ungraded position statements for EGPA. This guideline provides recommendations for remission induction and maintenance therapy as well as adjunctive treatment strategies in GPA, MPA, and EGPA. These recommendations include the use of rituximab for remission induction and maintenance in severe GPA and MPA and the use of mepolizumab in nonsevere EGPA. All recommendations are conditional due in part to the lack of multiple randomized controlled trials and/or low-quality evidence supporting the recommendations. CONCLUSION: This guideline presents the first recommendations endorsed by the American College of Rheumatology and the Vasculitis Foundation for the management of AAV and provides guidance to health care professionals on how to treat these diseases.


Assuntos
Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos , Antirreumáticos/uso terapêutico , Medicina Baseada em Evidências/normas , Reumatologia/normas , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/diagnóstico , Vasculite Associada a Anticorpo Anticitoplasma de Neutrófilos/tratamento farmacológico , Anticorpos Monoclonais Humanizados/uso terapêutico , Síndrome de Churg-Strauss/diagnóstico , Síndrome de Churg-Strauss/tratamento farmacológico , Gerenciamento Clínico , Granulomatose com Poliangiite/diagnóstico , Granulomatose com Poliangiite/tratamento farmacológico , Humanos , Poliangiite Microscópica/diagnóstico , Poliangiite Microscópica/tratamento farmacológico , Indução de Remissão , Rituximab/uso terapêutico , Estados Unidos
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