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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. [ABSTRACT FROM AUTHOR]

Copyright of Reumatología Clínica is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective American Indian-Europeans, Asians, and African Americans have an excess morbidity from systemic lupus erythematosus (SLE) and a higher prevalence of lupus nephritis than do Caucasians. The aim of this study was to analyze the relationship between genetic ancestry and sociodemographic characteristics and clinical features in a large cohort of American Indian-European SLE patients. Methods A total of 2,116 SLE patients of American Indian-European origin and 4,001 SLE patients of European descent for whom we had clinical data were included in the study. Genotyping of 253 continental ancestry-informative markers was performed on the Illumina platform. Structure and Admixture software were used to determine genetic ancestry proportions of each individual. Logistic regression was used to test the association between genetic ancestry and sociodemographic and clinical characteristics. Odds ratios (ORs) were calculated with 95% confidence intervals (95% CIs). Results The average American Indian genetic ancestry of 2,116 SLE patients was 40.7%. American Indian genetic ancestry conferred increased risks of renal involvement ( P < 0.0001, OR 3.50 [95% CI 2.63- 4.63]) and early age at onset ( P < 0.0001). American Indian ancestry protected against photosensitivity ( P < 0.0001, OR 0.58 [95% CI 0.44-0.76]), oral ulcers ( P < 0.0001, OR 0.55 [95% CI 0.42-0.72]), and serositis ( P < 0.0001, OR 0.56 [95% CI 0.41-0.75]) after adjustment for age, sex, and age at onset. However, age and sex had stronger effects than genetic ancestry on malar rash, discoid rash, arthritis, and neurologic involvement. Conclusion In general, American Indian genetic ancestry correlates with lower sociodemographic status and increases the risk of developing renal involvement and SLE at an earlier age. [ABSTRACT FROM AUTHOR]

Objective To conduct a systematic review to identify and describe the scope and nature of the research evidence on the effectiveness of interventions to improve health care quality or reduce disparities in the care of disadvantaged populations with osteoarthritis (OA) as an example of a common chronic disease. Methods We searched electronic databases from 1950 through February 2010 and grey literature for relevant articles using any study design. Studies with interventions designed explicitly to improve health care quality or reduce disparities in the care of disadvantaged adult populations with OA and including an evaluation were eligible. We used the PROGRESS-Plus framework to identify disadvantaged population subgroups. Results Of 4,701 citations identified, 10 met the inclusion criteria. Eight were community based and 6 targeted race/ethnicity/culture. All 10 studies evaluated interventions aimed at people with OA; 2 studies also targeted the health care system. No studies targeted health care providers. Nine of 10 studies evaluated arthritis self-management interventions; all showed some benefit. Only 1 study compared the difference in effect between the PROGRESS-Plus disadvantaged population and the relevant comparator group. Conclusion There are few studies evaluating the effectiveness of interventions to improve health care quality in disadvantaged populations with OA. Further research is needed to evaluate interventions aimed at health care providers and the health care system, as well as other patient-level interventions. Gap intervention research is also needed to evaluate whether interventions are effective in reducing documented health care inequities. [ABSTRACT FROM AUTHOR]

Measuring quality of life (QOL) is important, but to date, questionnaires to measure QOL in Mexican patients with osteoporosis (OP) have not been validated. A study was carried out to culturally adapt and validate the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) in a Mexican population. Interviews were performed with 160 women, 80 patients with at least one vertebral fracture, and 80 patients with OP as determined by the World Health Organization criteria. Several cultural modifications were made to the Spanish version of the QUALEFFO. Content validity was assessed by a group of experts, and a pilot study was undertaken. At the same time, the Spanish version of the Short Form 36 (Medical Outcomes Study) was applied. The mean age of patients was 71.9 ± 11.1. The QOL questionnaire showed a test–retest reproducibility ( R i = 0.94) and internal consistency ( α = 0.92), while social function scored low ( α = 0.46). Concurrent validity was significant ( r = −0.837, p < 0.001). Significant differences were found between the two groups for pain ( p < 0.05), physical function ( p < 0.01), social function ( p < 0.01), mental function ( p < 0.05), and number of fractures ( p < 0.001). Discriminatory characteristics between the groups were significant for physical ( p < 0.001), social ( p < 0.001), and mental ( p < 0.02) function. The cultural adaptation of the QUALEFFO was consistent, homogenous, and discriminative. It also showed deterioration in the QOL group of Mexicans with vertebral fractures. The QUALEFFO can be used in a Mexican population to measure the QOL in patients with vertebral fractures after some cultural modifications to take into account local sensibilities. [ABSTRACT FROM AUTHOR]

Copyright of Reumatología Clínica is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The objective of our study was to describe knowledge, attitudes and practices of Latin-American rheumatology patients regarding management and follow-up of their disease during COVID-19 pandemic. A cross-sectional observational study was conducted using a digital anonymous survey. Rheumatic patients ≥ 18 years from non-English-speaking PANLAR countries were included. Our survey included 3502 rheumatic patients living in more than 19 Latin-American countries. Median age of patients was 45.8(36–55) years and the majority (88.9%) was female. Most frequently self-reported disease was rheumatoid arthritis (48.4%). At least one anti-rheumatic treatment was suspended by 23.4% of patients. Fear of contracting SARS-Cov2 (27.7%) and economic issues (25%) were the most common reasons for drug discontinuation. Self-rated disease activity increased from 30 (7–50) to 45 (10–70) points during the pandemic. Communication with their rheumatologist during the pandemic was required by 55.6% of patients, mainly by telephone calls (50.2%) and social network messages (47.8%). An adequate knowledge about COVID-19 was observed in 43% of patients. Patients with rheumatic diseases in Latin America were negatively affected by the COVID-19 pandemic. An increase in self-rated disease activity, a reduction in medication adherence, and hurdles for medical follow-up were reported. Teleconsultation was perceived as a valid alternative to in-person visits during the pandemic. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]