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Rheumatology and Therapy

Kurt de Vlam, Joseph F Merola, Julie A Birt, David M Sandoval, Steve Lobosco, Rachel Moon, Gary Milligan, Wolf-Henning Boehncke
INTRODUCTION: Psoriatic arthritis (PsA) is an inflammatory arthropathy that exhibits heterogeneity in clinical presentation and severity of skin and joint symptoms. This heterogeneity results in an incomplete understanding of the relationship between the skin and joint components of PsA, and their relative impact on PsA disease activity and patient-reported outcomes. The objective of the study was to Investigate the clinical presentation of joint and active skin symptom involvement and the associated impact on physician- and patient-reported outcomes [patient global assessment (PtGA), health-related quality of life (HRQoL), and physical function), and healthcare resource burden in patients with PsA...
July 6, 2018: Rheumatology and Therapy
Steven Ramael, Benjamin Van Hoorick, Renger Tiessen, Thijs van Iersel, Viktoria Moschetti, Benjamin Lang, Ivo Sonderegger, Sabrina Wiebe, Bernd Liedert, Girish Jayadeva
INTRODUCTION: BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira® . We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). METHODS: Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18-65 years. VOLTAIRE® -AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m2 ...
June 29, 2018: Rheumatology and Therapy
Stephen Hall, Peter Nash, Maureen Rischmueller, David Bossingham, Paul Bird, Nicola Cook, David Witcombe, Koshika Soma, Kenneth Kwok, Krishan Thirunavukkarasu
INTRODUCTION: In Australia, there is an unmet need for improved treatments for rheumatoid arthritis (RA). Tofacitinib is an oral Janus kinase inhibitor for the treatment of RA. To provide an overview of key study outcomes for tofacitinib in Australian patients, we analyzed the efficacy and safety of tofacitinib in the Australian subpopulation of global RA phase III and long-term extension (LTE) studies. METHODS: Data were pooled from the Australian subpopulation of four phase III studies and one LTE study (database not locked at cut-off date: January 2016)...
June 11, 2018: Rheumatology and Therapy
Judith Krämer, Konstantinos Triantafyllias, Wolfgang Kohnen, Martin Leber, Ute Dederichs-Masius, Andrea Zucker, Jürgen Körber, Andreas Schwarting
INTRODUCTION: The aim of this study was to determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) both in rheumatologic and non-rheumatologic rehabilitation centers. In addition, we sought to evaluate the practice value of existing screening recommendations of the German Commission for Hospital Hygiene and Infection Prevention (KRINKO). METHODS: The analysis was performed in four rehabilitation clinics (rheumatology, psychosomatic medicine, oncology, and cardiology) with at least 200 patients per clinic tested for MRSA...
June 2, 2018: Rheumatology and Therapy
Peter Nash, Iain B McInnes, Philip J Mease, Howard Thom, Matthias Hunger, Andreas Karabis, Kunal Gandhi, Shephard Mpofu, Steffen M Jugl
Under Methods section, heading Analyses: Pairwise Comparisons, one of the probability value was published incorrectly in a sentence. The correct sentence should read as follows.
June 1, 2018: Rheumatology and Therapy
Antonio Marchesoni
Details continue to emerge on psoriatic arthritis, expanding our understanding of its pathogenesis and clinical features. This has led to the evolution of management guidelines, which now recognize additional disease manifestations. In this rapidly changing area, it is timely to review the latest evidence and discuss whether management strategies are meeting patients' needs. FUNDING: Celgene Corporation.
June 1, 2018: Rheumatology and Therapy
David M Kern, Lawrence Chang, Kalyani Sonawane, Cynthia J Larmore, Natalie N Boytsov, Ralph A Quimbo, Joseph Singer, John T Hinton, Sze-Jung Wu, Andre B Araujo
INTRODUCTION: To describe treatment patterns in newly diagnosed rheumatoid arthritis (RA) patients in a large, nationally representative managed-care database. METHODS: Newly diagnosed RA patients were identified from 07/01/2006-08/31/2014. Patients had ≥ 1 RA diagnosis by a rheumatologist, or ≥ 2 non-rheumatologist RA diagnoses ≥ 30 days apart, or RA diagnosis followed by a disease-modifying antirheumatic drug (DMARD) prescription fill within 1 year. Patients were ≥ 18 years old at index (earliest date fulfilling diagnostic criteria) and had ≥ 6 and 12 months of pre- and post-index health plan enrollment, respectively...
May 30, 2018: Rheumatology and Therapy
Vibeke Strand, Arthur Kavanaugh, Alan J Kivitz, Désirée van der Heijde, Kenneth Kwok, Ermeg Akylbekova, Arif Soonasra, Mark Snyder, Carol Connell, Eustratios Bananis, Josef S Smolen
INTRODUCTION: Here we examine the relationship between achieving different levels of disease activity with tofacitinib (an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis), long-term structural progression, and patient-reported physical function. METHODS: This was a post hoc analysis of two 24-month, phase III randomized controlled trials in methotrexate (MTX)-naïve (ORAL Start [NCT01039688]) or MTX-inadequate responder (IR) patients (ORAL Scan [NCT00847613]) receiving tofacitinib 5 or 10 mg twice daily as either monotherapy or with background MTX...
May 14, 2018: Rheumatology and Therapy
Sara Gale, Jessica C Wilson, Jenny Chia, Huong Trinh, Katie Tuckwell, Neil Collinson, Sophie Dimonaco, Susan Jick, Christoph Meier, Shalini V Mohan, Khaled Sarsour
INTRODUCTION: Treatment of giant cell arteritis (GCA) involves immediate initiation of high-dose glucocorticoid therapy with slow tapering of the dose over many months. Chronic exposure to glucocorticoids is associated with serious comorbidities. The objective of this analysis was to determine the glucocorticoid exposure and risk of glucocorticoid-related adverse events (AEs) in real-world patients with GCA. METHODS: Data from the Truven Healthcare MarketScan® database (from January 1, 2000, to June 30, 2015) and the Clinical Practice Research Datalink (CPRD; from January 1, 1995, to August 31, 2013) were used to retrospectively analyze patients aged ≥ 50 years with GCA in the USA and UK, respectively...
May 11, 2018: Rheumatology and Therapy
Allan H Morton, Tony Hosey, Brian LaMoreaux
INTRODUCTION: Pegloticase, a potent uricolytic biologic enzyme, has been shown to be an effective therapeutic option in patients with uncontrolled gout. However, there are limited data on clinical response after a gap in therapy and retreatment with pegloticase. CASE SERIES: This report describes four patients with chronic gout who were successfully managed with pegloticase and were retreated following a gap in therapy. Patient charts from a practice-based rheumatology clinic were retrospectively analyzed; four male patients, aged 70-75 years, with chronic gout and a more than 4-week gap in pegloticase therapy were reviewed...
May 3, 2018: Rheumatology and Therapy
Alvin F Wells, Maria Greenwald, John D Bradley, Jahangir Alam, Vipin Arora, Cynthia E Kartman
INTRODUCTION: This article evaluates the efficacy and safety of baricitinib 4 mg versus placebo in United States including Puerto Rico (US) and rest of the world (ROW) subpopulations using data pooled from RA-BEAM and RA-BUILD, which enrolled patients with moderate-to-severe adult-onset rheumatoid arthritis (RA). METHODS: In RA-BEAM, patients with an inadequate response (IR) to methotrexate, at least one X-ray erosion, and high sensitivity C-reactive protein (hsCRP) ≥ 6 mg/L were randomized to placebo or orally administered baricitinib 4 mg daily or subcutaneously administered adalimumab 40 mg every other week...
June 2018: Rheumatology and Therapy
Rebekah H Borse, Sumesh Kachroo, Chloe Brown, Eilish McCann, Ralph P Insinga
INTRODUCTION: The aim of this study is to assess the cost-effectiveness of golimumab for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA) vs. conventional therapy and other tumor necrosis factor inhibitors from the Scottish payer perspective. METHODS: A model comprising a short-term decision tree and a long-term Markov model was developed to compare cost-effectiveness (incremental costs per quality-adjusted life-year [QALY]) for patients in Scotland with nr-axSpA treated by conventional therapy, adalimumab, certolizumab pegol, etanercept, or golimumab for a lifetime period...
June 2018: Rheumatology and Therapy
Louis Bessette, Gerald Lebovic, Brad Millson, Katia Charland, Krishna Donepudi, Tania Gaetano, Valencia Remple, Martin G Latour, Sandra Gazel, Marie-Claude Laliberté, Carter Thorne
INTRODUCTION: Adalimumab (ADA) is a tumor necrosis factor (TNF)-alpha inhibitor indicated for the treatment of inflammatory autoimmune diseases, including ankylosing spondylitis (AS). Patients receiving ADA in Canada are eligible to enroll in the AbbVie Care™ patient support program (AC-PSP), which provides personalized services, including care coach calls (CCCs). We estimated the likelihood of controlled disease in a cohort of AS patients treated with ADA enrolled in the AC-PSP and who received CCCs versus those who did not...
June 2018: Rheumatology and Therapy
Finbar O'Shea, Peter C Taylor, Gavin Dickie, Andrew Yaworsky, Benjamin Banderas, Sumesh Kachroo
INTRODUCTION: To establish clinical consensus on important and relevant quality-of-care (QoC) attributes in rheumatic disease (RD) treatment that may improve treatment outcomes and guide best practices. METHODS: Twenty-three QoC attributes were identified in a literature review. Fifteen European-based clinicians were selected based on their contributions to RD guidelines, publications, and patient care. A three-round (an interview round and two web-based rounds) modified Delphi panel was conducted to reach consensus and finalize a QoC attribute list...
June 2018: Rheumatology and Therapy
Peter Nash, Iain B McInnes, Philip J Mease, Howard Thom, Matthias Hunger, Andreas Karabis, Kunal Gandhi, Shephard Mpofu, Steffen M Jugl
INTRODUCTION: Secukinumab and adalimumab are approved for adults with active psoriatic arthritis (PsA). In the absence of direct randomized controlled trial (RCT) data, matching-adjusted indirect comparison can estimate the comparative effectiveness in anti-tumor necrosis factor (TNF)-naïve populations. METHODS: Individual patient data from the FUTURE 2 RCT (secukinumab vs. placebo; N = 299) were adjusted to match baseline characteristics of the ADEPT RCT (adalimumab vs...
June 2018: Rheumatology and Therapy
Gurjit S Kaeley, Daryl K MacCarter, Janak R Goyal, Shufang Liu, Kun Chen, Jennifer Griffith, Hartmut Kupper, Vishvas Garg, Jasmina Kalabic
INTRODUCTION: In patients with rheumatoid arthritis (RA), combination treatment with methotrexate (MTX) and adalimumab is more effective than MTX monotherapy. From the patients' perspective, the impact of reduced MTX doses upon initiating adalimumab is not known. The objective was to evaluate the effects of low and high MTX doses in combination with adalimumab initiation on patient-reported outcomes (PROs), in MTX-inadequate responders (MTX-IR) with moderate-to-severe RA. METHODS: MUSICA was a randomized, double-blind, controlled trial evaluating the efficacy of 7...
June 2018: Rheumatology and Therapy
José Kennedy Amaral, Robert T Schoen
INTRODUCTION: Chronic chikungunya (CHIK) arthritis, an inflammatory arthritis, often follows acute CHIK fever (CHIKF), a viral infection. The pathogenesis of chronic CHIK arthritis is poorly characterized, but may resemble other forms of inflammatory arthritis. Clinically, chronic CHIK arthritis sometimes mimics rheumatoid arthritis (RA). CASE REPORT: We report a patient with well-characterized CHIKF followed 2 months later by chronic CHIK arthritis not only resembling RA clinically, but also associated with RA biomarkers and extra-articular features, including Felty's syndrome (FS)...
June 2018: Rheumatology and Therapy
Daniela Marotto, Antonella De Santis, Donatella Chessa, Davide Firinu, Stefano Del Giacco
Gout is the most common form of arthritis in adults. It is often associated with other comorbidities, which contraindicate the use of conventional therapies. The discovery of the role of interleukin-1β (IL-1β) in orchestrating the monosodium urate crystal-induced inflammatory response offered new therapeutic prospects to refractory patients, or to those in whom standard therapies are contraindicated. This paper describes a clinical case of a 65-year-old man with chronic tophaceous gouty arthropathy and subintrant flares, who had comorbidities contraindicating the use of conventional gout therapies-to which he did not respond-who was treated with canakinumab, a monoclonal selective inhibitor of IL-1β...
June 2018: Rheumatology and Therapy
Gergely Bodis, Victoria Toth, Andreas Schwarting
Since the discovery of HLA 60 years ago, it has contributed to the understanding of the immune system as well as of the pathogenesis of several diseases. Aside from its essential role in determining donor-recipient immune compatibility in organ transplantation, HLA genotyping is meanwhile performed routinely as part of the diagnostic work-up of certain autoimmune diseases. Considering the ability of HLA to influence thymic selection as well as peripheral anergy of T cells, its role in the pathogenesis of autoimmunity is understandable...
June 2018: Rheumatology and Therapy
Andrea Rubbert-Roth, Daniel E Furst, Jan Michael Nebesky, Angela Jin, Erhan Berber
Tocilizumab (TCZ) is the first humanized anti-interleukin-6 (IL-6) receptor monoclonal antibody approved for the treatment of patients with rheumatoid arthritis (RA), Castleman's disease, polyarticular and systemic juvenile idiopathic arthritis, and, most recently, giant cell arteritis as well as for the treatment of chimeric antigen receptor T cell therapy-induced cytokine release syndrome. The global clinical development program for TCZ provides a wealth of clinical data on intravenous TCZ, and more recent studies in patients with RA have provided evidence characterizing the role of intravenous TCZ as monotherapy in early disease and led to the introduction of a subcutaneous formulation of TCZ...
June 2018: Rheumatology and Therapy
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