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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
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)...
October 24, 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
Khalid Shirazy, Najia Hajjaj-Hassouni, Constance Hammond, Heather Jones, Aicha Ladjouze Rezig, Ron Pedersen, Bonnie Vlahos
INTRODUCTION: Information is limited on the prevalence and clinical characteristics of nonradiographic axial spondyloarthritis (nr-axSpA) among patients with inflammatory back pain (IBP) in African countries. A global study estimated the prevalence of nr-axSpA among patients with IBP from 19 countries in Latin America, Europe, Asia, and Africa. This post hoc subset analysis focused on estimating prevalence of nr-axSpA and clinical characteristics among patients with IBP from Northwest Africa (Morocco and Algeria) and South Africa...
August 2, 2018: Rheumatology and Therapy
Binoy J Paul, Shajit Sadanand
Chikungunya (CHIK) is an arboviral infection caused by the chikungunya virus. An unusual feature of CHIK is its long periods of quiescence followed by an epidemic of devastating severity that can involve millions of people. Manifestations of CHIK range from a mild self-limiting febrile illness with arthralgia and rash to crippling acute and lingering debilitating arthritis. In about 10-60% of patients, musculoskeletal symptoms may persist for up to 3-5 years. Management is mainly symptomatic, with analgesics, antipyretics and non-steroidal anti-inflammatory agents...
July 25, 2018: 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
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
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