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Worldwide, 3-Year, Post-Marketing Surveillance Experience with Tofacitinib in Rheumatoid Arthritis

. Stanley Cohen has received consultancies, speaking fees, and honoraria from AbbVie, Amgen, Astellas, BMS, Lilly, Genentech, Gilead, Janssen, Novartis, Pfizer Inc, Roche, and Sandoz. Jeffrey R. Curtis has

Defining and characterizing sustained remission in patients with rheumatoid arthritis

Birmingham , 510 20th Street South, Birmingham, AL 35294 , USA 3 Jeffrey R. Curtis 4 Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital, NIHR Leeds

A somatization comorbidity phenotype impacts response to therapy in rheumatoid arthritis: post-hoc results from the certolizumab pegol phase 4 PREDICT trial

Comorbidities may contribute to disease activity and treatment response in rheumatoid arthritis (RA) patients. We defined a somatization comorbidity phenotype (SCP) and examined its influence on response to certolizumab pegol (CZP) using data from the PREDICT trial. Patients in PREDICT were randomized to the patient-reported Routine Assessment of Patient Index Data 3 (RAPID3) or...

Is gout a risk equivalent to diabetes for stroke and myocardial infarction? A retrospective claims database study

Gout is a risk factor for cardiovascular disease, but associations with specific cardiovascular outcomes, myocardial infarction (MI), and stroke are unclear. Our objective in the present study was to assess whether gout is as strong a risk factor as diabetes mellitus (DM) for incident MI and incident stroke. In this retrospective study, we used U.S. claims data from 2007 to 2010...

Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib

Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). To characterise the relative safety profile of tofacitinib to biologic disease-modifying antirheumatic drugs (bDMARDs), the accrued patient-years (pt-yrs) of exposure needed in an RA clinical trial programme to detect a potential increase in risk of specific adverse events (AEs) was...

Comparative Effectiveness of Etanercept and Adalimumab in Patient Reported Outcomes and Injection-Related Tolerability

Objective To describe patient preferences in selecting specific biologics and compare clinical response using patient reported outcomes (PROs) among patients with rheumatoid arthritis (RA) started on different anti-tumor necrosis factor (TNF) therapies. Methods Participants were enrollees in Kaiser Permanente Northern California. Patients with RA who had at least two provider...

Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry

. Pappas is an employee of Corrona, LLC, and a paid instructor for Novartis. Ani John is an employee of Genentech, Inc. Jeffrey R. Curtis has received consulting fees, honoraria, and research grants from

Clinical Outcomes and Biologic Costs of Switching Between Tumor Necrosis Factor Inhibitors in US Veterans with Rheumatoid Arthritis

Introduction The purpose of this study was to evaluate clinical outcomes and drug/administration costs of treatment with tumor necrosis factor inhibitor (TNFi) agents in US veterans with rheumatoid arthritis (RA) initiating TNFi therapy. The analysis compared patients initiating and continuing a single TNFi with patients who subsequently switched to a different TNFi. Methods Data...

Treatment patterns in psoriatic arthritis patients newly initiated on oral nonbiologic or biologic disease-modifying antirheumatic drugs

Analysis Group Inc., which has received consultancy fees from Celgene Corporation. Jeffrey R Curtis is an employee of the University of Alabama at Birmingham who has received consultancy fees from Celgene

The Validity of Claims-Based Algorithms to Identify Serious Hypersensitivity Reactions and Osteonecrosis of the Jaw

Validation of claims-based algorithms to identify serious hypersensitivity reactions and osteonecrosis of the jaw has not been performed in large osteoporosis populations. The objective of this project is to estimate the positive predictive value of the claims-based algorithms in older women with osteoporosis enrolled in Medicare. Using the 2006-2008 Medicare 5% sample data, we...

Safety of biologic and nonbiologic disease-modifying antirheumatic drug therapy in veterans with rheumatoid arthritis and hepatitis B virus infection: a retrospective cohort study

retrospective cohort study Mary Jane Burton 0 1 Jeffrey R Curtis Shuo Yang Lang Chen Jasvinder A Singh Ted R Mikuls Kevin L Winthrop John W Baddley 0 University of Mississippi Medical Center , 2500 North State

Heterogeneous Disease Trajectories Explain Variable Radiographic, Function and Quality of Life Outcomes in the Canadian Early Arthritis Cohort (CATCH)

Our objective was to identify distinct trajectories of disease activity state (DAS) and assess variation in radiographic progression, function and quality of life over the first two years of early rheumatoid arthritis (ERA). The CATCH (Canadian early ArThritis CoHort) is a prospective study recruiting ERA patients from academic and community rheumatology clinics in Canada...

Claims-based algorithms for identifying Medicare beneficiaries at high estimated risk for coronary heart disease events: a cross-sectional study

Background Databases of medical claims can be valuable resources for cardiovascular research, such as comparative effectiveness and pharmacovigilance studies of cardiovascular medications. However, claims data do not include all of the factors used for risk stratification in clinical care. We sought to develop claims-based algorithms to identify individuals at high estimated risk...

Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size

Lisa C Gary,1,2,3 Ana L Oliveira,1,2,3 Mary Melton,1,2,3 Nicole C Wright,1,2,3 Jeffrey R Curtis,1,2,3 Elizabeth Delzell,1,2,3 T Michael Harrington,1,2,3 Meredith L Kilgore,1,2,3 Cora Elizabeth Lewis

The use, safety, and effectiveness of herpes zoster vaccination in individuals with inflammatory and autoimmune diseases: a longitudinal observational study

Jie Zhang 0 Elizabeth Delzell 0 Fenglong Xie John W Baddley Claire Spettell Raechele M Mcmahan Joaquim Fernandes Lang Chen Kevin Winthrop Jeffrey R Curtis 0 0 Department of Epidemiology, School of

Derivation and preliminary validation of an administrative claims-based algorithm for the effectiveness of medications for rheumatoid arthritis

Introduction Administrative claims data have not commonly been used to study the clinical effectiveness of medications for rheumatoid arthritis (RA) because of the lack of a validated algorithm for this outcome. We created and tested a claims-based algorithm to serve as a proxy for the clinical effectiveness of RA medications. Methods We linked Veterans Health Administration (VHA...

The delivery of evidence-based preventive care for older Americans with arthritis

Introduction Previous research suggests patients with rheumatoid arthritis (RA) may receive suboptimal care with respect to preventive tests and services. We evaluated the proportion of older Americans with RA, psoriatic arthritis (PsA), and osteoarthritis (OA) receiving these services and the specialty of the providers delivering this care. Methods Using data from 1999 to 2006...

Development of a Multi-Biomarker Disease Activity Test for Rheumatoid Arthritis

Background Disease activity measurement is a key component of rheumatoid arthritis (RA) management. Biomarkers that capture the complex and heterogeneous biology of RA have the potential to complement clinical disease activity assessment. Objectives To develop a multi-biomarker disease activity (MBDA) test for rheumatoid arthritis. Methods Candidate serum protein biomarkers were...

Leg-length inequality is not associated with greater trochanteric pain syndrome

Introduction Greater trochanteric pain syndrome (GTPS) is a common condition, the pathogenesis of which is incompletely understood. Although leg-length inequality has been suggested as a potential risk factor for GTPS, this widely held assumption has not been tested. Methods A cross-sectional analysis of greater trochanteric tenderness to palpation was performed in subjects with...