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Rheumatology and Therapy

Fernando Perez-Ruiz, Tim L Jansen, Anne-Kathrin Tausche, Pascal Richette, Frédéric Lioté, Alexander K So, Austin Stack
INTRODUCTION: The rate of adverse renal events has been shown to be higher in patients treated with lesinurad plus a xanthine-oxidase inhibitor (XOI) than in patients treated only with a XOI. We reassessed the risks for various adverse renal events from a different perspective and devised a hypothesis to explain the results. METHODS: We used data from phase 3 trials that were publicly available from the full prescribing information document and estimated the relative risk and the number needed to treat for increased serum creatinine (sCri), renal failure, and renal lithiasis...
February 14, 2019: Rheumatology and Therapy
Andrew I Spitzer, John C Richmond, Virginia B Kraus, Andreas Gomoll, Deryk G Jones, Kim M Huffman, Charles Peterfy, Amy Cinar, Joelle Lufkin, Scott D Kelley
INTRODUCTION: The aim of this work is to assess the safety and efficacy of repeat administration of triamcinolone acetonide extended-release (TA-ER) in patients with symptomatic knee osteoarthritis (OA), including those with advanced radiographic severity. METHODS: In this phase 3b, single-arm, open-label study, patients aged ≥ 40 years received the first intra-articular TA-ER injection on day 1. Patients received the second injection timed to the response to the first injection (at either week 12, 16, 20, or 24)...
February 11, 2019: Rheumatology and Therapy
Fabio Massimo Perrotta, Silvia Scriffignano, Antonia De Socio, Ennio Lubrano
INTRODUCTION: The present study aimed (a) to evaluate the clinical and radiographic characteristics of hand erosive osteoarthritis (EOA) in a group of consecutive patients, (b) to correlate the severity of radiographic involvement with clinical and laboratory findings and (c) to associate the levels of pain and functional impairment with some radiographic findings. METHODS: Patients with EOA were consecutively enrolled. Inclusion criteria required the American College of Rheumatology (ACR) criteria for hand osteoarthritis and the presence of at least one joint in "E" or "R" phase according to Verbruggen-Veys...
February 6, 2019: Rheumatology and Therapy
Sara Gale, Huong Trinh, Katie Tuckwell, Neil Collinson, John H Stone, Khaled Sarsour, Jinglan Pei, Jennie Best, Christine Birchwood, Shalini V Mohan
INTRODUCTION: The safety profile of tocilizumab (TCZ) in patients with rheumatoid arthritis (RA) is well established. TCZ was approved to treat giant cell arteritis (GCA) in 2017 in the USA and Europe, and its safety profile in patients with GCA continues to be defined. The objective of this analysis was to examine incidence rates (IRs) of adverse events of special interest (AESI) occurring during the TCZ clinical development program and in healthcare claims data in patients with GCA or RA...
February 1, 2019: Rheumatology and Therapy
Jean Darloy, Nicolas Segaud, Jean-Hugues Salmon, Jean-Paul Eschard, Vincent Goëb, Xavier Deprez, Marie-Hélène Guyot, Eric Houvenagel, Nicolas Lecuyer, Laurent Marguerie, Samuel Gally, David Pau, Isabelle Idier, Guy Baudens, René-Marc Flipo
INTRODUCTION: The main objective of this work was to assess the maintenance of effectiveness of subcutaneous tocilizumab 6 months after switching from intravenous to subcutaneous formulation in patients with rheumatoid arthritis (RA) in a real-world setting. Secondary objectives aimed to describe the characteristics of patients and disease, the effectiveness at 12 months after switching, the therapeutic maintenance, and to search for predictive factors of switching. METHODS: We analyzed all the RA patients of the shared medical file "RIC Nord de France", treated with tocilizumab, switching or not from intravenous to subcutaneous tocilizumab, between April 2015 and January 2016...
January 10, 2019: Rheumatology and Therapy
Prashanth Sunkureddi, Dominick Latremouille-Viau, Mark K Meiselbach, Jipan Xie, Peter Hur, Reeti Joshi
INTRODUCTION: Secukinumab is a fully human anti-interleukin 17A monoclonal antibody approved for the treatment of psoriatic arthritis (PsA) in the United States. Few studies have investigated prescribing patterns among rheumatologists who have initiated secukinumab for the treatment of patients with PsA in real-world settings. This US medical chart review describes clinical and treatment characteristics of patients with psoriatic arthritis (PsA) who were prescribed secukinumab and rheumatologist-reported reasons for prescribing secukinumab in clinical practice...
January 5, 2019: Rheumatology and Therapy
Roy Fleischmann
No abstract text is available yet for this article.
January 5, 2019: Rheumatology and Therapy
Joseph F Merola, David Shrom, Jennifer Eaton, Christine Dworkin, Craig Krebsbach, Bijal Shah-Manek, Julie Birt
INTRODUCTION: Psoriatic arthritis (PsA) and psoriasis (PsO) have a significant impact on HRQOL and work productivity loss. In patients with both PsA and PsO, the full extent of the physical and emotional burden of joint- and skin-related symptoms is less understood from the patient perspective. METHODS: A cross-sectional study of PsO patients with PsA from the US, France, and Germany was conducted using an online survey. Data on demographics, PsO severity by patient-reported body surface area involvement (BSA), PsA severity by RAPID3, impact of PsO and PsA using Patient Global Assessment (1-5), and novel questions exploring the emotional burden of joint/skin-related symptoms were collected...
January 4, 2019: Rheumatology and Therapy
Antonio Giannelli
Psoriatic arthritis (PsA) is a clinically heterogeneous form of progressive inflammatory arthritis that affects up to 30% of patients with psoriasis. The rapid rate of progression associated with PsA makes early-disease diagnosis and treatment crucial to patients' quality of life and long-term health. With the aim of providing clinical guidance to physician assistants and nurse practitioners, this article gives an overview of the different PsA clinical domains, including peripheral arthritis, axial disease, enthesitis, dactylitis, skin disease, and nail dystrophy, which should be considered as part of diagnosis and treatment strategies...
December 20, 2018: Rheumatology and Therapy
Alain Saraux, Christophe Hudry, Elena Zinovieva, Hélène Herman-Demars
INTRODUCTION: The objective of the study was to compare compliance and acceptability of a new auto-injector (AI) versus syringe for administration of methotrexate (MTX) in patients with rheumatoid arthritis (RA). METHODS: We conducted a randomized, open-label, parallel group study comparing AI to pre-filled syringe (PFS). Adult patients with RA (ACR/EULAR 2010) receiving MTX (orally or by injection) for at least 3 months were allocated to AI or PFS for 6 months and then were allocated to AI for 6 further months...
December 13, 2018: Rheumatology and Therapy
Ronald van Vollenhoven, Cameron Helt, Vipin Arora, Jinglin Zhong, Ana Pinto Correia, Inma de la Torre, David Muram
INTRODUCTION: This study assessed if concomitant use of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or corticosteroids altered the response or safety outcomes to baricitinib in rheumatoid arthritis (RA) patients. METHODS: Patients with ≥ 6 swollen/tender joints and no prior biologic DMARD were eligible for study inclusion. In RA-BUILD, csDMARD-inadequate responder (IR) patients were randomized to placebo or baricitinib (2 or 4 mg) once daily (QD)...
December 2018: Rheumatology and Therapy
Laura J Tucker, Laura C Coates, Philip S Helliwell
Psoriatic arthritis (PsA) is a multifaceted disease, with a high impact on patients' psychological and physical well-being. There is increasing recognition that assessment of both clinical aspects of disease and patient identified concerns, such as fatigue, work disability, and treatment satisfaction need to be addressed. Only then can we fully understand disease burden and make well-informed treatment decisions aimed at improving patients' lives. In recent years, there has been much progress in the development of unidimensional and composite measures of disease activity, as well as questionnaires capturing the patient's perspective in psoriatic disease...
November 23, 2018: Rheumatology and Therapy
Peter Nash, Laura C Coates, Roy Fleischmann, Kim A Papp, Juan Jesus Gomez-Reino, Keith S Kanik, Cunshan Wang, Joseph Wu, Sujatha Menon, Thijs Hendrikx, William C Ports
INTRODUCTION: Tofacitinib is an oral Janus kinase inhibitor for the treatment of psoriatic arthritis (PsA). This post hoc analysis assessed the efficacy of tofacitinib using pooled data from two phase 3 studies of patients with active PsA. METHODS: Data were pooled from OPAL Broaden (NCT01877668) and OPAL Beyond (NCT01882439). Patients had active PsA and either an inadequate response (IR) to ≥ 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) and were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden), or had IR to ≥ 1 TNFi (OPAL Beyond)...
November 9, 2018: Rheumatology and Therapy
Boulos Haraoui, Shahin Jamal, Vandana Ahluwalia, Diana Fung, Tarang Manchanda, Majed Khraishi
INTRODUCTION: This study was conducted to observe patterns of use of the interleukin-6 receptor-alpha inhibitor tocilizumab in routine clinical practice in patients with rheumatoid arthritis (RA). METHODS: This was a 12-month noninterventional, observational study in adult patients with RA who initiated tocilizumab in routine practice in Canada according to the local product monograph. The primary end point was the proportion of patients receiving tocilizumab at 6 months...
October 28, 2018: Rheumatology and Therapy
Philip J Mease, Désirée van der Heijde, Chitra Karki, Mei Liu, Yujin Park, Jeffrey D Greenberg
INTRODUCTION: Tumor necrosis factor inhibitors (TNFis) have shown efficacy for the treatment of ankylosing spondylitis (AS). However, many patients may discontinue or switch TNFis due to lack of effect or adverse events. As biologics with alternative mechanisms of action become available for the treatment of AS, it is important to better understand the characteristics of patients who discontinue or have an inadequate response to TNFis to help inform treatment choices regarding initiating or switching to a biologic therapy...
October 23, 2018: Rheumatology and Therapy
Leslie R Harrold, George W Reed, Jennie Best, Steve Zlotnick, Joel M Kremer
INTRODUCTION: Controlled clinical studies have shown that the efficacy of tocilizumab (TCZ) monotherapy is superior to that of tumor necrosis factor inhibitor (TNFi) monotherapy and comparable to that of TCZ plus methotrexate (MTX) for the treatment of rheumatoid arthritis (RA). This study compared the real-world effectiveness of TCZ monotherapy vs. TNFis plus MTX in US patients with RA. METHODS: TCZ-naïve patients from the Corrona RA registry with prior exposure to ≥ 1 TNFi who initiated TCZ monotherapy or TNFi + MTX were included...
October 6, 2018: Rheumatology and Therapy
Masako Tsukamoto, Katsuya Suzuki, Tsutomu Takeuchi
INTRODUCTION: Anti-centromere antibody (ACA)-positive Sjögren's syndrome (SS) is considered a subtype of SS. ACA-positive SS patients display several features, such as Raynaud's phenomenon, sclerodactyly, and extraglandular dysfunction. However, information on the features of ACA-positive SS is insufficient and the clinical significance of ACA in SS has not been fully established. The aim of this study was to clarify the features of ACA-positive SS. METHODS: All patients with primary SS who visited our hospital were enrolled...
September 25, 2018: Rheumatology and Therapy
Neil Bodick, Toni Williamson, Vibeke Strand, Becca Senter, Scott Kelley, Rogely Boyce, Ruth Lightfoot-Dunn
INTRODUCTION: Single intra-articular (IA) injections of poly(lactic-co-glycolic acid) (PLGA) microsphere-based triamcinolone acetonide extended-release (TA-ER; formerly FX006) demonstrated sustained, clinically relevant benefits in patients with knee osteoarthritis. The local effects of TA-ER were assessed in normal canine knees in three nonclinical studies. METHODS: Knees were evaluated for up to 6 weeks or 9 months after a single injection of TA-ER (2.1/6.25/18...
September 10, 2018: Rheumatology and Therapy
Alan J Kivitz, Ulf Wagner, Eva Dokoupilova, Jerzy Supronik, Ruvie Martin, Zsolt Talloczy, Hanno B Richards, Brian Porter
INTRODUCTION: To evaluate the efficacy and safety of secukinumab 150 mg, with or without a loading regimen, using a self-administered prefilled syringe in patients with ankylosing spondylitis (AS) over 104 weeks from the MEASURE 4 study. METHODS: Patients (N = 350) with active AS were randomized (1:1:1) to receive subcutaneous secukinumab 150 mg with loading dose (150 mg), without loading dose (150 mg no load), or placebo. All patients received secukinumab or placebo at baseline, weeks 1, 2, and 3 and every 4 weeks starting at week 4...
August 18, 2018: Rheumatology and Therapy
Jessica A Walsh, Xue Song, Gilwan Kim, Yujin Park
INTRODUCTION: In addition to the considerable patient and societal burdens, the financial burdens of ankylosing spondylitis (AS) are substantial. Understanding both all-cause and AS-specific direct costs in patients with AS is important if we are to understand the financial impact on patients with AS and payers in the United States. This study assessed both all-cause and AS-specific healthcare utilization and direct costs in US patients with AS using administrative claims data. METHODS: Adults aged ≥ 18 years enrolled in the MarketScan® Commercial and Medicare databases with ≥ 1 inpatient or ≥ 2 non-rule-out outpatient diagnoses of AS between January 1, 2013, and December 31, 2013, were included...
August 18, 2018: Rheumatology and Therapy
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