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1.
Rheumatol Ther ; 2019 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-31410787

RESUMO

INTRODUCTION: Peficitinib is a novel orally bioavailable, once-daily Janus kinase (JAK) inhibitor approved in Japan for the treatment of rheumatoid arthritis (RA). This 2-year extension study of two global phase IIb trials investigated the long-term safety and effectiveness of peficitinib. METHODS: All eligible patients with moderate-to-severe RA including patients in the placebo group who participated in one of two global phase IIb trials ('with methotrexate' or 'without methotrexate') were included in this 2-year open-label extension study and were converted to peficitinib 100 mg once daily. The primary objective was to evaluate an additional 2 years of safety by assessing treatment-emergent adverse events (AEs) and clinical laboratory evaluations for 105 weeks. Evaluation of an additional 2 years of effectiveness using American College of Rheumatology (ACR) 20/50/70 responses was the exploratory objective. RESULTS: Overall, 611 patients were enrolled in the extension study: 319 (52.2%) patients completed the study and 292 (48%) discontinued treatment, including for withdrawal of patient consent (n = 96), failure to achieve low disease activity (n = 62), and AE not including death (n = 41). AEs were reported in 463 (76%) patients. The most common AEs (per 100 patient-years) were upper respiratory tract infections (9.9) and urinary tract infections (7.2). Serious AEs were reported in 80 (13%) patients, with incidences per 100 patient-years of serious infections 2.7, herpes zoster 1.5 (including one herpes zoster ophthalmic), and malignancies 0.6 (most frequently basal cell carcinoma). At week 105, 269 (44%) patients demonstrated an ACR20 response relative to their respective phase IIb trial baselines. CONCLUSION: Among 319 patients who completed this 2-year extension of two global phase IIb studies, peficitinib 100 mg once daily demonstrated a stable safety profile and sustained effectiveness in patients with moderate-to-severe RA. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01711814. Registered 19 October 2012. FUNDING: Astellas Pharma Global Development, Inc.

3.
Clin Rheumatol ; 2019 Jun 03.
Artigo em Inglês | MEDLINE | ID: mdl-31161486

RESUMO

OBJECTIVES: To identify baseline predictors of remission and low disease activity (LDA) in early rheumatoid arthritis (RA) from the GLADAR (Grupo Latino Americano De estudio de la Artritis Reumatoide) cohort. METHODS: Patients with 1- and 2-year follow-up visits were included. Remission and LDA were defined by DAS28-ESR (< 2.6 and ≤ 3.2, respectively). Baseline predictors examined were gender, ethnicity, age at diagnosis, socioeconomic status, symptoms' duration, DMARDs, RF, thrombocytosis, anemia, morning stiffness, DAS28-ESR (and its components), HAQ-DI, DMARDs and corticosteroid use, and Sharp-VDH score. Multivariable binary logistic regression models (excluding DAS28-ESR components to avoid over adjustment) were derived using a backward selection method (α-level set at 0.05). RESULTS: Four hundred ninety-eight patients were included. Remission and LDA/remission were met by 19.3% and 32.5% at the 1-year visit, respectively. For the 280 patients followed for 2 years, these outcomes were met by 24.3% and 38.9%, respectively. Predictors of remission at 1 year were a lower DAS28-ESR (OR 1.17; CI 1.07-1.27; p = 0.001) and HAQ-DI (OR 1.48; CI 1.04-2.10; p = 0.028). At 2 years, only DAS28-ESR (OR 1.40; CI 1.17-1.6; p < 0.001) was a predictor. Predictors of LDA/remission at 1 year were DAS28-ESR (OR 1.42; CI 1.26-1.61; p < 0.001), non-use of corticosteroid (OR 1.74; CI 1.11-2.44; p = 0.008), and male gender (OR 1.77; CI 1.2-2.63; p = 0.036). A lower baseline DAS28-ESR (OR 1.45; CI 1.23-1.70; p < 0.001) was the only predictor of LDA/remission at 2 years. CONCLUSIONS: A lower disease activity consistently predicted remission and LDA/remission at 1 and 2 years of follow-up in early RA patients from the GLADAR cohort. Key Points • In patients with early RA, a lower disease activity at first visit is a strong clinical predictor of achieving remission and LDA subsequently. • Other clinical predictors of remission and LDA to keep in mind in these patients are male gender, non-use of corticosteroids and low disability at baseline. • Not using corticosteroids at first visit is associated with a lower disease activity and predicts LDA/remission at 1 year in these patients.

4.
Reumatol Clin ; 2019 May 15.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-31103432

RESUMO

Therapeutic advances in rheumatoid arthritis require periodic review of treatment guidelines. OBJECTIVE: To update the Mexican College of Rheumatology guidelines on the pharmacological treatment of rheumatoid arthritis. METHOD: Board certified rheumatologists from different health institutions and regions of the country participated. Work teams were formed that reviewed the previous guidelines, elaborated new questions, reviewed the literature, and scored the evidence that was presented and discussed in plenary session. The conclusions were presented to infectologists, gynaecologists and patients. Recommendations were based on levels of evidence according to GRADE methodology. RESULTS: Updated recommendations on the use of available medications for rheumatoid arthritis treatment in Mexico up to 2017 are presented. The importance of adequate and sustained control of the disease is emphasized and relevant safety aspects are described. Bioethical conflicts are included, and government action is invited to strengthen correct treatment of the disease. CONCLUSIONS: The updated recommendations of the Mexican College of Rheumatology on the pharmacological treatment of rheumatoid arthritis incorporate the best available information to be used in the Mexican health care system.

5.
J Rheumatol ; 2019 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-30824636

RESUMO

OBJECTIVE: To determine the predictors of remission and low disease activity state (LDAS) in patients with systemic lupus erythematosus (SLE). METHODS: Three disease activity states were defined: Remission = SLE Disease Activity Index (SLEDAI) = 0 and prednisone ≤ 5 mg/day and/or immunosuppressants (maintenance dose); LDAS = SLEDAI ≤ 4, prednisone ≤ 7.5 mg/day and/or immunosuppressants (maintenance dose); and nonoptimally controlled state = SLEDAI > 4 and/or prednisone > 7.5 mg/day and/or immunosuppressants (induction dose). Antimalarials were allowed in all groups. Patients with at least 2 SLEDAI reported and not optimally controlled at entry were included in these analyses. Outcomes were remission and LDAS. Multivariable Cox regression models (stepwise selection procedure) were performed for remission and for LDAS. RESULTS: Of 1480 patients, 902 were non-optimally controlled at entry; among them, 196 patients achieved remission (21.7%) and 314 achieved LDAS (34.8%). Variables predictive of a higher probability of remission were the absence of mucocutaneous manifestations (HR 1.571, 95% CI 1.064- 2.320), absence of renal involvement (HR 1.487, 95% CI 1.067-2.073), and absence of hematologic involvement (HR 1.354, 95% CI 1.005-1.825); the use of immunosuppressive drugs before the baseline visit (HR 1.468, 95% CI 1.025-2.105); and a lower SLEDAI score at entry (HR 1.028, 95% CI 1.006-1.051 per 1-unit decrease). These variables were predictive of LDAS: older age at entry, per 5-year increase (HR 1.050, 95% CI 1.004-1.098); absence of mucocutaneous manifestations (HR 1.401, 95% CI 1.016-1.930) and renal involvement (HR 1.344, 95% CI 1.049-1.721); and lower SLEDAI score at entry (HR 1.025, 95% CI 1.009-1.042). CONCLUSION: Absence of mucocutaneous, renal, and hematologic involvement, use of immunosuppressive drugs, and lower disease activity early in the course of the disease were predictive of remission in patients with SLE; older age was predictive of LDAS.

6.
Arthritis Rheumatol ; 71(6): 878-891, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30666826

RESUMO

OBJECTIVE: Tofacitinib is an oral JAK inhibitor for the treatment of rheumatoid arthritis (RA). The phase III, 24-month, placebo-controlled Oral Rheumatoid Arthritis (ORAL) Scan trial was undertaken to evaluate the efficacy, including inhibition of structural progression, and safety of tofacitinib in patients with active RA and an inadequate response to methotrexate (MTX). Month 24 data from the completed study are reported here. METHODS: Patients were randomized 4:4:1:1 to receive tofacitinib 5 mg or 10 mg twice daily, or placebo, switched to tofacitinib 5 mg or 10 mg twice daily, with stable background MTX. Patients receiving placebo switched to tofacitinib at month 3 (nonresponders) or month 6 (remaining patients). Clinical efficacy, structural progression, and treatment-emergent adverse events were evaluated. Analyses were performed on the full analysis set with observed data or nonresponder imputation with no advancement penalty for clinical efficacy, and imputation by linear extrapolation for structural progression. RESULTS: Overall, 797 patients were treated; 539 (67.6%) completed 24 months of treatment. Responses according to the American College of Rheumatology criteria for 20% improvement (ACR20), ACR50, and ACR70; the proportion of patients in whom remission or low disease activity was achieved according to the 4-variable Disease Activity Score in 28 joints using the erythrocyte sedimentation rate, Clinical Disease Activity Index, or Simplified Disease Activity Index; Boolean remission; and Health Assessment Questionnaire disability index scores were maintained from month 12 to 24 and were similar between tofacitinib dosages. Limited structural damage was observed at months 12 and 24. Safety events were similar in type and frequency for both tofacitinib dosages, and were consistent with those previously reported. CONCLUSION: Our findings indicate that clinical and radiographic treatment effects are sustained in months 12-24 in patients with RA receiving tofacitinib 5 mg or 10 mg twice daily plus MTX. The safety profile is consistent with that of other tofacitinib studies.

7.
Reumatol. clín. (Barc.) ; 14(5): 278-284, sept.-oct. 2018. tab, graf
Artigo em Espanhol | IBECS | ID: ibc-175989

RESUMO

Objetivo: Estimar la prevalencia de manifestaciones musculoesqueléticas y discapacidad en la población urbana habitante a gran altura de Juliaca, Puno, Perú; utilizando el cuestionario COPCORD y HAQ-DI. Métodos: Se realizó un estudio transversal en muestra de 1.095 personas. En cada entrevista se desarrolló la metodología COPCORD y el Health Assessment Questionnaire (HAQ) Disability Index (DI). El plano urbano fue dividido en ocho sectores. Resultados: Fueron evaluadas 614 (56,1%) mujeres; 44% pertenecieron a la raza quechua y 5,1% a aymara. Reportaron dolor ME en los últimos 7 días 347 personas (31,69%; IC 95% 28,36-35,02), con predominio en mujeres (218; 35,5%; IC 95% 30,8-40,2); y 132 personas, antes de los 7 días (12,05%; IC 95% 9,99-14,11). Las patologías reumáticas más frecuentes fueron AR: 1,27%, gota de 0,64%, OA de manos: 2,83%, OA de rodillas: 1,55%, OA de cadera 0,37%, fibromialgia: 1,09%, reumatismo de partes blandas: 8,86%. La evolución del HAQ-DI tuvo un incremento progresivo proporcional a la edad. El promedio de HAQ-DI de la población fue 0,18 (±0,36). De ciento setenta y cinco personas con una condición reumática, 10 (5,71%) acudían al servicio de un chamán. Conclusión: Es el primer estudio COPCORD en una población originaria urbana habitante a gran altura en el Perú. La población afectada de una enfermedad reumática crónica, prefería la atención profesional en lugar a la tradicional; población que a su vez contaba con escasa oferta de servicios médicos. El deterioro de la capacidad funcional medida por HAQ-DI se asoció con el incremento de la edad


Objective: Estimate the prevalence of musculoskeletal manifestations and related disabilities of an urban population living at high altitude in Juliaca, Puno, Peru, using the Community Oriented Program for Control of Rheumatic Diseases (COPCORD) questionnaire and Health Assessment Questionnaire (HAQ) disability index. Methods: A cross-sectional study was performed in a sample of 1095 people. In each interview, the COPCORD methodology and the HAQ were applied. The city was divided into 8 sectors. Results: In all, 614 (56.1%) women were evaluated; 44% were from the Quechua community and 5.1% were Aymara. Before the final 7 days of the study, 132 people (12.05%; 95% CI 9.99-14.11) reported musculoskeletal pain. During the final 7 days of the study, 347 people (31.69%; 95% CI 28.36-35.02) who were predominately women (218; 35.5%; 95% CI 30.8-40.2) reported musculoskeletal pain. The most frequent rheumatic diseases were rheumatoid arthritis (1.27%), gout (0.64%), hand osteoarthritis (OA) (2.83%), knee OA (1.55%), hip OA (0.37%), fibromyalgia (1.09%), and soft tissue rheumatism (8.86%). The HAQ showed an incremental increase proportional to age. The HAQ average for the population was 0.18 (±0.36). Ten people (5.71%) of 175 with rheumatic disease received the services of a shaman. Conclusion: It is the first COPCORD study in an urban native population living at high altitude in Peru. The population affected by chronic rheumatic disease preferred professional rather than traditional care; this population had access to limited medical services. Impaired functional capacity measured by HAQ was associated with advanced age


Assuntos
Humanos , Masculino , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Doenças Musculoesqueléticas/epidemiologia , Pessoas com Deficiência/estatística & dados numéricos , Altitude , Doenças Reumáticas/epidemiologia , Peru/epidemiologia , Estudos Transversais , Doenças Reumáticas/etnologia , Medição da Dor , Dor Crônica/epidemiologia
8.
Rev. argent. reumatol ; 29(3): 6-10, set. 2018. tab
Artigo em Espanhol | LILACS | ID: biblio-977290

RESUMO

Objetivos: Estimar el efecto de los antimaláricos (AM) sobre los diferentes dominios del índice de daño SLICC (SDI). Métodos: Se estudiaron pacientes con diagnóstico clínico reciente (≤2 años) de lupus eritematoso sistémico (LES) de la cohorte GLADEL. Variable de estudio: aumento en los dominios del SDI desde el ingreso a la cohorte. Variables independientes: características sociodemográficas, clínicas, laboratorio y tratamientos. El efecto de los AM, como variable dependiente del tiempo, sobre los dominios más frecuentes del SDI (ajustado por factores de confusión) fue examinado con un modelo de regresión de Cox multivariado. Resultados: De 1466 pacientes estudiados, 1049 (72%) recibieron AM con un tiempo medio de exposición de 30 meses (Q1-Q3: 11-57) y 665 pacientes (45%) presentaron daño durante un seguimiento medio de 24 meses (Q1-Q3: 8-55); 301 eventos fueron cutáneos, 208 renales, 149 neuropsiquiátricos, 98 musculoesqueléticos, 88 cardiovasculares y 230 otros. Después de ajustar por factores de confusión, el uso de AM se asoció a un menor riesgo de daño renal (HR 0,652; IC 95%: 0,472-0,901) y en el límite de la significancia estadística (HR 0,701, IC 95%: 0,481-1,024) para el dominio neuropsiquiátrico. Conclusión: En GLADEL, el uso de AM se asoció independientemente a un menor riesgo de daño acumulado renal.


Objective: To assess the effects of antimalarials (AM) over the items of the SLICC Damage Index (SDI). Methods: Patients with recent (≤2 years) diagnosis of systemic lupus erythematosus (SLE) from the GLADEL cohort were studied. End-point: increase in items SDI since cohort entry. Independent variables (socio-demographic, clinical, laboratory and treatment) were included. The effect of AM as a time dependent variable on most frequent SDI items (adjusting for potential confounders) was examined with a multivariable Cox regression model. Results: Of the 1466 patients included in this analysis, 1049 (72%) received AM with a median exposure time of 30 months (Q1-Q3: 11-57). Damage occurred in 665 (45%) patients during a median follow-up time of 24 months (Q1-Q3: 8-55). There were 301 integument, 208 renal, 149 neuropsychiatric, 98 musculoskeletal, 88 cardiovascular and 230 others less frequently represented damages. After adjusting for potential confounders at any time during follow-up, a lower risk of renal damage (HR 0.652; 95% CI: 0.472-0.901) and borderline for neuropsychiatric damage (HR 0.701, 95% CI: 0.481-1.024) was found. Conclusion: In the GLADEL cohort, after adjustment for possible confounding factors, AM were independently associated with a reduced risk of renal damage accrual.


Assuntos
Lúpus Eritematoso Sistêmico , Antimaláricos
9.
Lancet ; 392(10143): 222-231, 2018 07 21.
Artigo em Inglês | MEDLINE | ID: mdl-30043749

RESUMO

BACKGROUND: Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus. METHODS: In this double-blind, multicentre, randomised, placebo-controlled, 24-week phase 2 study, patients were recruited from 78 centres in 11 countries. Eligible patients were aged 18 years or older, had a diagnosis of systemic lupus erythematosus, and had active disease involving skin or joints. We randomly assigned patients (1:1:1) to receive once-daily baricitinib 2 mg, baricitinib 4 mg, or placebo for 24 weeks. The primary endpoint was the proportion of patients achieving resolution of arthritis or rash at week 24, as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, number NCT02708095. FINDINGS: Between March 24, 2016, and April 27, 2017, 314 patients were randomly assigned to receive placebo (n=105), baricitinib 2 mg (n=105), or baricitinib 4 mg (n=104). At week 24, resolution of SLEDAI-2K arthritis or rash was achieved by 70 (67%) of 104 patients receiving baricitinib 4 mg (odds ratio [OR] vs placebo 1·8, 95% CI 1·0-3·3; p=0·0414) and 61 (58%) of 105 patients receiving baricitinib 2 mg (OR 1·3, 0·7-2·3; p=0·39). Adverse events were reported in 68 (65%) patients in the placebo group, 75 (71%) patients in the baricitinib 2 mg group, and 76 (73%) patients in the baricitinib 4 mg group. Serious adverse events were reported in ten (10%) patients receiving baricitinib 4 mg, 11 (10%) receiving baricitinib 2 mg, and five (5%) receiving placebo; no deaths were reported. Serious infections were reported in six (6%) patients with baricitinib 4 mg, two (2%) with baricitinib 2 mg, and one (1%) with placebo. INTERPRETATION: The baricitinib 4 mg dose, but not the 2 mg dose, significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the foundation for future phase 3 trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for systemic lupus erythematosus. FUNDING: Eli Lilly and Company.


Assuntos
Artrite/tratamento farmacológico , Azetidinas/administração & dosagem , Exantema/tratamento farmacológico , Inibidores de Janus Quinases/administração & dosagem , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Sulfonamidas/administração & dosagem , Administração Oral , Adulto , Azetidinas/efeitos adversos , Colesterol/sangue , HDL-Colesterol/sangue , Creatina Quinase/sangue , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Infecção/epidemiologia , Inibidores de Janus Quinases/efeitos adversos , Masculino , Pessoa de Meia-Idade , Contagem de Plaquetas , Sulfonamidas/efeitos adversos
10.
Ann Rheum Dis ; 77(11): 1549-1557, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30045853

RESUMO

Systemic lupus erythematosus (SLE), a complex and heterogeneous autoimmune disease, represents a significant challenge for both diagnosis and treatment. Patients with SLE in Latin America face special problems that should be considered when therapeutic guidelines are developed. The objective of the study is to develop clinical practice guidelines for Latin American patients with lupus. Two independent teams (rheumatologists with experience in lupus management and methodologists) had an initial meeting in Panama City, Panama, in April 2016. They selected a list of questions for the clinical problems most commonly seen in Latin American patients with SLE. These were addressed with the best available evidence and summarised in a standardised format following the Grading of Recommendations Assessment, Development and Evaluation approach. All preliminary findings were discussed in a second face-to-face meeting in Washington, DC, in November 2016. As a result, nine organ/system sections are presented with the main findings; an 'overarching' treatment approach was added. Special emphasis was made on regional implementation issues. Best pharmacologic options were examined for musculoskeletal, mucocutaneous, kidney, cardiac, pulmonary, neuropsychiatric, haematological manifestations and the antiphospholipid syndrome. The roles of main therapeutic options (ie, glucocorticoids, antimalarials, immunosuppressant agents, therapeutic plasma exchange, belimumab, rituximab, abatacept, low-dose aspirin and anticoagulants) were summarised in each section. In all cases, benefits and harms, certainty of the evidence, values and preferences, feasibility, acceptability and equity issues were considered to produce a recommendation with special focus on ethnic and socioeconomic aspects. Guidelines for Latin American patients with lupus have been developed and could be used in similar settings.

11.
J Clin Rheumatol ; 2018 Mar 29.
Artigo em Inglês | MEDLINE | ID: mdl-29596208

RESUMO

BACKGROUND: By 2015, the World Health Organization reported that 1% of the world population suffered from rheumatoid arthritis (RA) and in Latin America (LATAM) between 0.5% and 1%. Previously, in May 2014, a consensus meeting was held in Barranquilla, Colombia, where the Project for Implementation and Accreditation of Centers of Excellence (CoE) in RA in LATAM was established, which then became an official special group of the Pan American League of Associations for Rheumatology (PANLAR). OBJECTIVE: The aim of this study was to define the methodological approach for the accreditation process of CoE in RA in LATAM. METHODS: A meeting was held in April 2015 with participation of the members of the REAL-PANLAR Steering Committee, and representatives of several LATAM countries, with the support of 2 experts in accreditation processes and models in Colombia. Then, in November 2015 in San Francisco and in November 2016 in Washington, the REAL-PANLAR Steering Committee met to discuss some final aspects of the project. RESULTS: The following steps for accreditation were defined: application for accreditation, issuance of the concept of assessment of the entity, accreditation decision, and monitoring accreditation. CONCLUSIONS: This is the second REAL-PANLAR consensus paper with the purpose to define the parameters for the accreditation process for future CoE in RA in LATAM.

14.
Reumatol Clin ; 14(5): 278-284, 2018 Sep - Oct.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28284771

RESUMO

OBJECTIVE: Estimate the prevalence of musculoskeletal manifestations and related disabilities of an urban population living at high altitude in Juliaca, Puno, Peru, using the Community Oriented Program for Control of Rheumatic Diseases (COPCORD) questionnaire and Health Assessment Questionnaire (HAQ) disability index. METHODS: A cross-sectional study was performed in a sample of 1095 people. In each interview, the COPCORD methodology and the HAQ were applied. The city was divided into 8 sectors. RESULTS: In all, 614 (56.1%) women were evaluated; 44% were from the Quechua community and 5.1% were Aymara. Before the final 7 days of the study, 132 people (12.05%; 95% CI 9.99-14.11) reported musculoskeletal pain. During the final 7 days of the study, 347 people (31.69%; 95% CI 28.36-35.02) who were predominately women (218; 35.5%; 95% CI 30.8-40.2) reported musculoskeletal pain. The most frequent rheumatic diseases were rheumatoid arthritis (1.27%), gout (0.64%), hand osteoarthritis (OA) (2.83%), knee OA (1.55%), hip OA (0.37%), fibromyalgia (1.09%), and soft tissue rheumatism (8.86%). The HAQ showed an incremental increase proportional to age. The HAQ average for the population was 0.18 (±0.36). Ten people (5.71%) of 175 with rheumatic disease received the services of a shaman. CONCLUSION: It is the first COPCORD study in an urban native population living at high altitude in Peru. The population affected by chronic rheumatic disease preferred professional rather than traditional care; this population had access to limited medical services. Impaired functional capacity measured by HAQ was associated with advanced age.

15.
J Rheumatol ; 44(12): 1804-1812, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29093158

RESUMO

OBJECTIVE: To define whether Amerindian genetic ancestry correlates with clinical and therapeutic variables in admixed individuals with rheumatoid arthritis (RA) from Latin America. METHODS: Patients with RA (n = 1347) and healthy controls (n = 1012) from Argentina, Mexico, Chile, and Peru were included. Samples were genotyped for the Immunochip v1 using the Illumina platform. Clinical data were obtained through interviews or the clinical history. RESULTS: Percentage of Amerindian ancestry was comparable between cases and controls. Morning stiffness (p < 0.0001, OR 0.05), rheumatoid factor (RF; p < 0.0001, OR 0.22), radiographic changes (p < 0.0001, OR 0.05), and higher number of criteria were associated with lower Amerindian ancestry after Bonferroni correction. Higher Amerindian ancestry correlated only with weight loss (pBonferroni < 0.0001, OR 2.85). Increased Amerindian ancestry correlated with higher doses of azathioprine (p < 0.0001, OR 163.6) and sulfasalazine (p < 0.0001, OR 48.6), and inversely with methotrexate (p = 0.001, OR 0.35), leflunomide (p = 0.001, OR 0.16), and nonsteroidal antiinflammatory drugs (pBonferroni = 0.001, OR 0.37). Only the presence of RF and weight loss were modified after confounders adjustment. CONCLUSION: Amerindian ancestry protects against most major clinical criteria of RA, but regarding the association of RF with increased European ancestry, age, sex, and smoking are modifiers. Ancestry also correlates with the therapeutic profiles.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/genética , Genótipo , Fator Reumatoide/genética , Adulto , Fatores Etários , Idoso , Alelos , Argentina , Artrite Reumatoide/diagnóstico por imagem , Artrite Reumatoide/tratamento farmacológico , Chile , Feminino , Humanos , Índios Norte-Americanos , Índios Sul-Americanos , Isoxazóis/uso terapêutico , Leflunomida , Masculino , Metotrexato/uso terapêutico , México , Pessoa de Meia-Idade , Peru , Radiografia , Fatores Sexuais , Sulfassalazina/uso terapêutico
16.
Clin Rheumatol ; 36(12): 2789-2797, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29098475

RESUMO

Health education is fundamental in the management of RA patients. This study explored patient needs for educational material appropriate for RA patients in our region through a website. This study includes seven focus groups and semi-structured interviews across 4 countries (Argentina, Chile, Colombia, and Mexico) with 71 RA patients. Transcripts were analyzed by anthropologists using qualitative analysis (QA), resulting in themes and subthemes to be developed. Five themes and over 50 subthemes of interest were identified by patients. Grouped into categories as follows: (1) knowing the disease, (2) living with arthritis, (3) treatment and therapies for RA, (4) psychosocial support, and (5) information for families. A response was written by the team in plain Spanish on patient subthemes of interest including additional areas that the team considered relevant. Three videos for YouTube were produced: on patient-doctor relationships, patients at work, and home and at the clinic. Illustrations in a comic book format on RA diagnosis were created. The educational site on RA of PANLAR can be found at htpp://artritisreumatoide.cl. This project accomplished a comprehensive list of RA patient interests, revealing the complex relationship between the information on the disease, the experience of a chronic disease, and the way in which patients approach, conceive, and manage their disease. We expect to gather information on how the website will be used in the future for patients and their families and maintain and improve the website as well as adapt its content to different socioeconomic realities.


Assuntos
Artrite Reumatoide/terapia , Gerenciamento Clínico , Educação em Saúde , Internet , Educação de Pacientes como Assunto , Antirreumáticos/uso terapêutico , Artrite Reumatoide/diagnóstico , Região do Caribe , Humanos , América Latina
17.
Ann Rheum Dis ; 76(12): 2071-2074, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28939626

RESUMO

OBJECTIVE: To evaluate disease activity statuses' (DAS') impact on systemic lupus erythematosus (SLE) outcomes. MATERIALS AND METHODS: Four DAS were defined: remission off-therapy: SLE Disease Activity Index (SLEDAI)=0, no prednisone or immunosuppressive drugs (IS); remission on-therapy: SLEDAI=0, prednisone ≤5 mg/day and/or IS (maintenance); low (L) DAS: SLEDAI ≤4, prednisone ≤7.5 mg/day and/or IS (maintenance); non-optimally controlled: SLEDAI >4 and/or prednisone >7.5 mg/day and/or IS (induction). Antimalarials were allowed in all. Predefined outcomes were mortality, new damage (increase of at least one Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) damage index (SDI) point) and severe new damage (increase of at least 3 SDI points). Univariable and multivariable Cox regression models were performed to define the impact of DAS, as time-dependent variable, on these outcomes. RESULTS: 1350 patients were included, 79 died during follow-up, 606 presented new and 177 severe new damage. In multivariable analyses, remission (on/off-therapy) was associated with a lower risk of new (HR 0.60; 95% CI 0.43 to 0.85), and of severe new damage (HR 0.32; 95% CI 0.15 to 0.68); low disease activity status (LDAS) was associated with a lower risk of new damage (HR 0.66; 95% CI 0.48 to 0.93) compared with non-optimally controlled. No significant effect on mortality was observed. CONCLUSIONS: Remission was associated with a lower risk of new and severe new damage; LDAS with a lower risk of new damage after adjusting for other damage confounders.


Assuntos
Anti-Inflamatórios/uso terapêutico , Progressão da Doença , Hispano-Americanos/estatística & dados numéricos , Lúpus Eritematoso Sistêmico/tratamento farmacológico , Prednisona/uso terapêutico , Adulto , Estudos de Coortes , Feminino , Seguimentos , Humanos , Lúpus Eritematoso Sistêmico/etnologia , Lúpus Eritematoso Sistêmico/mortalidade , Masculino , Modelos de Riscos Proporcionais , Indução de Remissão , Fatores de Risco , Índice de Gravidade de Doença , Resultado do Tratamento , Estados Unidos , Adulto Jovem
18.
J Clin Rheumatol ; 23(7): 376-382, 2017 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28937473

RESUMO

BACKGROUND: There is limited information about the factors related with the development of long-term permanent work disability (PWD) in rheumatoid arthritis (RA) treated with a combination of conventional synthetic disease-modifying antirheumatic drugs (cs-DMARDs). OBJECTIVE: The aim of this study was to evaluate incidence and factors associated with the development of PWD in RA treated with combination therapy using conventional synthetic cs-DMARDs. METHODS: We assessed in multivariate models the effect of clinical and demographic factors in the development of PWD in a long-term retrospective cohort of 180 workers with RA who were treated with a combination of cs-DMARDs. RESULTS: Incidence rates of PWD were 2.2% at 1 year, 7.7% at 5 years, 24.9% at 10 years, 34.9% at 15 years, and 45% at 20 years. In the adjusted Cox regression analysis, factors associated with PWD development were the first failure with combination of cs-DMARDs (hazard ratio [HR], 2.4; 95% confidence interval [CI], 1.05-5.46; P = 0.03), poor functioning at time of cohort onset (HR, 2.2; 95% CI, 1.05-4.70; P = 0.03), and requirement for joint replacement (HR, 3.3; 95% CI, 1.28-8.79; P = 0.01). CONCLUSIONS: Around 25% of workers with combination therapy with cs-DMARDs developed PWD in 10 years following the diagnosis of RA. Some factors increase the risk of disability. Permanent work disability generates a relevant society burden and increases health care costs. Therefore, indicators predicting failure of combination therapies with cs-DMARDs might provide clinicians of useful tools for modifying treatments avoiding the disease progression.


Assuntos
Antirreumáticos , Artrite Reumatoide , Efeitos Psicossociais da Doença , Licença Médica/estatística & dados numéricos , Adulto , Antirreumáticos/classificação , Antirreumáticos/uso terapêutico , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/economia , Artrite Reumatoide/fisiopatologia , Avaliação da Deficiência , Quimioterapia Combinada/métodos , Feminino , Custos de Cuidados de Saúde , Humanos , Masculino , México , Pessoa de Meia-Idade , Prognóstico , Estatística como Assunto
19.
Nat Commun ; 8: 16021, 2017 07 17.
Artigo em Inglês | MEDLINE | ID: mdl-28714469

RESUMO

Systemic lupus erythematosus (SLE) is an autoimmune disease with marked gender and ethnic disparities. We report a large transancestral association study of SLE using Immunochip genotype data from 27,574 individuals of European (EA), African (AA) and Hispanic Amerindian (HA) ancestry. We identify 58 distinct non-HLA regions in EA, 9 in AA and 16 in HA (∼50% of these regions have multiple independent associations); these include 24 novel SLE regions (P<5 × 10-8), refined association signals in established regions, extended associations to additional ancestries, and a disentangled complex HLA multigenic effect. The risk allele count (genetic load) exhibits an accelerating pattern of SLE risk, leading us to posit a cumulative hit hypothesis for autoimmune disease. Comparing results across the three ancestries identifies both ancestry-dependent and ancestry-independent contributions to SLE risk. Our results are consistent with the unique and complex histories of the populations sampled, and collectively help clarify the genetic architecture and ethnic disparities in SLE.

20.
J Clin Rheumatol ; 23(4): 193-199, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28145906

RESUMO

OBJECTIVE: Rheumatoid arthritis (RA) is a chronic, autoimmune disease characterized by joint destruction. Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. This post hoc analysis assessed the safety of tofacitinib in Latin American (LA) patients with RA versus the Rest of World (RoW) population. METHODS: Data were pooled from 14 clinical studies of tofacitinib: six Phase 2, six Phase 3 and two long-term extension studies. Incidence rates (IRs; patients with events/100 patient-years of treatment exposure) were calculated for safety events of special interest combined across tofacitinib doses. 95% confidence intervals (CI) for IRs were calculated using the maximum likelihood method. Descriptive comparisons were made between LA and RoW (excluding LA) populations. RESULTS: This analysis included data from 984 LA patients and 4687 RoW patients. IRs for safety events of special interest were generally similar between LA and RoW populations, with overlapping 95% CIs. IRs for discontinuation due to adverse events, serious infections, tuberculosis, all herpes zoster (HZ), serious HZ, malignancies (excluding non-melanoma skin cancer) and major adverse cardiovascular events were numerically lower for LA versus RoW patients; IR for mortality was numerically higher. No lymphoma was reported in the LA population versus eight cases in the RoW population. Exposure (extent and length) was lower in the LA population (2148.33 patient-years [mean = 2.18 years]) versus RoW (10515.68 patient-years [mean = 2.24 years]). CONCLUSION: This analysis of pooled data from clinical studies of tofacitinib in patients with RA demonstrates that tofacitinib has a consistent safety profile across LA and RoW patient populations.


Assuntos
Artrite Reumatoide , Piperidinas , Pirimidinas , Pirróis , Adulto , Idoso , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Ensaios Clínicos como Assunto , Relação Dose-Resposta a Droga , Monitoramento de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Incidência , Inibidores de Janus Quinases/administração & dosagem , Inibidores de Janus Quinases/efeitos adversos , América Latina/epidemiologia , Efeitos Adversos de Longa Duração/epidemiologia , Masculino , Pessoa de Meia-Idade , Segurança do Paciente , Piperidinas/administração & dosagem , Piperidinas/efeitos adversos , Pirimidinas/administração & dosagem , Pirimidinas/efeitos adversos , Pirróis/administração & dosagem , Pirróis/efeitos adversos , Resultado do Tratamento
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