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Kosuke Ebina, Motomu Hashimoto, Wataru Yamamoto, Akira Ohnishi, Daijiro Kabata, Toru Hirano, Ryota Hara, Masaki Katayama, Shuzo Yoshida, Koji Nagai, Yonsu Son, Hideki Amuro, Kengo Akashi, Takanori Fujimura, Makoto Hirao, Keiichi Yamamoto, Ayumi Shintani, Atsushi Kumanogoh, Hideki Yoshikawa
The purpose of this study was to evaluate the retention and discontinuation reasons of seven biological disease-modifying antirheumatic drugs (bDMARDs) in a real-world setting of patients with rheumatoid arthritis (RA). 1,037 treatment courses with bDMARDs from 2009 to 2016 [female, 81.8%; baseline age, 59.6 y; disease duration 7.8 y; rheumatoid factor positivity 81.5%; Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), 4.4; concomitant prednisolone 43.5% and methotrexate 68...
2018: PloS One
Patrick R Wood, Evan Manning, Joshua F Baker, Bryant England, Lisa Davis, Grant W Cannon, Ted R Mikuls, Liron Caplan
AIM: To determine the scope of acute hypoglycemic effects for certain anti-rheumatic medications in a large retrospective observational study. METHODS: Patients enrolled in the Veterans Affairs Rheumatoid Arthritis (VARA) registry were selected who, during follow-up, initiated treatment with tumor necrosis factor inhibitors (TNFi's, including etanercept, adalimumab, infliximab, golimumab, or certolizumab), prednisone, or conventional disease-modifying anti-rheumatic drugs (DMARDs), and for whom proximate random blood glucose (RBG) measurements were available within a window 2-wk prior to, and 6 mo following, medication initiation...
February 15, 2018: World Journal of Diabetes
Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
Shijie Ren, Iñigo Bermejo, Emma Simpson, Ruth Wong, David L Scott, Adam Young, Matt Stevenson
As part of its single technology appraisal process, the National Institute for Health and Care Excellence invited the manufacturer (Eli Lilly) of baricitinib (BARI; Olumiant® ; a Janus kinase inhibitor that is taken orally) to submit evidence of its clinical and cost effectiveness for the treatment of moderate to severe rheumatoid arthritis (RA) after the failure of disease-modifying antirheumatic drugs (DMARDs). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
March 3, 2018: PharmacoEconomics
Masateru Okazaki, Hisanori Kobayashi, Hirohito Shimizu, Yutaka Ishii, Tsutomu Yajima, Masayoshi Kanbori
INTRODUCTION: Golimumab has been proven as an effective treatment for rheumatoid arthritis in clinical trials. However, there is a scarcity of data regarding its use in elderly patients in a real-world setting. This study aims to evaluate the safety, effectiveness, and treatment persistence of golimumab in elderly Japanese patients (≥ 75 years) with rheumatoid arthritis. METHODS: This study was a post hoc analysis of post-marketing surveillance data on 5137 Japanese patients with active rheumatoid arthritis who received golimumab for 24 weeks...
March 2, 2018: Rheumatology and Therapy
Monika M Schoels, Uriel Landesmann, Farideh Alasti, Daniel Baker, Josef S Smolen, Daniel Aletaha
Objectives: In PsA management, remission and low disease activity represent preferential treatment targets. We aimed at evaluating the predictive value and clinical use of initial therapeutic response for subsequent achievement of these targets. Methods: Based on data of 216 patients enrolled in a randomized controlled trial of golimumab (GO-REVEAL), we performed diagnostic testing analyses using 3- and 6-month disease activity as tests for treatment outcomes to understand the implications of early response...
February 22, 2018: Rheumatology
Belén Atienza-Mateo, Vanesa Calvo-Río, Emma Beltrán, Lucía Martínez-Costa, Elia Valls-Pascual, Marisa Hernández-Garfella, Antonio Atanes, Miguel Cordero-Coma, Joan Miquel Nolla, Carmen Carrasco-Cubero, Javier Loricera, María C González-Vela, Nuria Vegas-Revenga, Carlos Fernández-Díaz, Rosalía Demetrio-Pablo, Lucía C Domínguez-Casas, José Luis Martín-Varillas, Natalia Palmou-Fontana, José L Hernández, Miguel Á González-Gay, Ricardo Blanco
Objective: To assess the efficacy of tocilizumab (TCZ) in refractory uveitis of Behçet's disease (BD). Methods: Multicentre study of patients with BD-associated uveitis. Patients were refractory to conventional and biologic immunosuppressive drugs. The main outcome measures were intraocular inflammation, macular thickness, visual acuity and corticosteroid-sparing effects. Results: We studied 11 patients (7 men) (20 affected eyes); median age 35 years...
February 19, 2018: Rheumatology
Masateru Okazaki, Hisanori Kobayashi, Yutaka Ishii, Masayoshi Kanbori, Tsutomu Yajima
INTRODUCTION: The aim of this study was to investigate real-world treatment patterns for use of golimumab and concomitant medications in Japanese patients with rheumatoid arthritis. METHODS: This study was a post hoc retrospective analysis from post-marketing surveillance data on 2350 Japanese patients with moderate/severe rheumatoid arthritis who received golimumab for 24 weeks. The study population was divided based on initiation treatment or dose adjustment patterns with golimumab, methotrexate, or oral glucocorticoids...
February 22, 2018: Rheumatology and Therapy
J W Baddley, F Cantini, D Goletti, J J Gómez-Reino, E Mylonakis, R San-Juan, M Fernández-Ruiz, J Torre-Cisneros
BACKGROUND: The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies. AIMS: To review, from an Infectious Diseases perspective, the safety profile of agents targeting tumour necrosis factor-α (TNF-α) and to suggest preventive recommendations. SOURCES: Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family...
February 6, 2018: Clinical Microbiology and Infection
Maurizio Benucci, Arianna Damiani, Francesca Li Gobbi, Francesca Bandinelli, Maria Infantino, Valentina Grossi, Mariangela Manfredi, Guillaume Noguier, Francesca Meacci
Introduction: The aim of this study was to investigate the correlation between human leukocyte antigen (HLA) haplotypes and the development of antidrug antibodies (ADAs) in a cohort of patients with rheumatic diseases. Patients and methods: We evaluated the presence of ADAs in 248 patients with inflammatory rheumatic diseases after 6 months of treatment with anti-TNF drugs: 26 patients were treated with infliximab (IFX; three with rheumatoid arthritis [RA], 13 with ankylosing spondylitis [AS], 10 with psoriatic arthritis [PsA]); 83 treated with adalimumab (ADA; 24 with RA, 36 with AS, 23 with PsA); 88 treated with etanercept (ETA; 35 with RA, 27 with AS, 26 with PsA); 32 treated with certolizumab (CERT; 25 with RA, two with AS, five with PsA); and 19 treated with golimumab (GOL; three with RA, seven with AS, nine with PsA)...
2018: Biologics: Targets & Therapy
Raphael J Dehoratius, Lawrence H Brent, Jeffrey R Curtis, Lorie A Ellis, Kezhen L Tang
BACKGROUND: Patient perceptions of treatment success, including satisfaction/preference, may complement clinical efficacy assessments. OBJECTIVE: Our objective was to evaluate satisfaction with subcutaneous golimumab and its auto-injector in patients with rheumatoid arthritis (RA) and an inadequate adalimumab/etanercept response. METHODS: In the multicenter, assessor-blinded GO-SAVE study, 433 patients with active RA (28-joint Disease Activity Score incorporating erythrocyte sedimentation rate [DAS28-ESR] ≥ 3...
February 9, 2018: Patient
A Campanati, E Molinelli, G Ganzetti, V Brisigotti, A Offidani
BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory disorder, with an estimated global prevalence of 2-3%. Psoriasis is associated with an impaired health-related quality of life and a substantial economic burden. Biologics, which target the pathways involved in the pathogenesis of psoriasis, represent an established therapeutic approach for moderate-to-severe plaque psoriasis, with remarkable efficacy and safety profile extensively examined and monitored. METHODS: Biological therapies currently available can be divided into three main categories: the TNFα antagonists (infliximab, adalimumab, etanercept, golimumab, certolizumab pegol), the interleukin (IL)-12/23 monoclonal antibody (ustekinumab), and IL-17 inhibitor (secukinumab, ixekizumab)...
February 9, 2018: Current Pharmaceutical Biotechnology
(no author information available yet)
No abstract text is available yet for this article.
February 2018: Journal of Rheumatology
Ennio Lubrano, Fabio Massimo Perrotta, Maria Manara, Salvatore D'Angelo, Olga Addimanda, Roberta Ramonda, Leonardo Punzi, Ignazio Olivieri, Carlo Salvarani, Antonio Marchesoni
OBJECTIVE: The aim of this study was to evaluate the influence of sex on response to treatment and disease remission in patients with axial spondyloarthritis (axSpA). METHODS: In this retrospective multicenter study, patients with axSpA, according to the Assessment of Spondyloarthritis international Society (ASAS) criteria for axSpA, and treated with adalimumab, etanercept, golimumab, or infliximab, were studied. We compared clinical characteristics, patient-reported outcomes, disease activity, function, and response to treatment in male and female patients with this disease...
February 2018: Journal of Rheumatology
Katherine Li, Richard Strauss, Jodie Ouahed, Daphne Chan, Shannon E Telesco, Dror S Shouval, James B Canavan, Carrie Brodmerkel, Scott B Snapper, Joshua R Friedman
BACKGROUND: Efficacy data from adult ulcerative colitis (UC) clinical trials are often extrapolated for pediatric prescribing. Consequently, it is important to understand similarities/differences in pediatric and adult UC. Pediatric UC tends to have more extensive disease at presentation, yet genetic studies have not detected pathways that distinguish the populations, and differences in mucosal gene expression between adult and pediatric UC are not well characterized. METHODS: Using colonic microarray data from a phase 3 trial of golimumab in adult UC (87 UC; 21 healthy), the GSE10616 pediatric dataset (10 UC; 11 healthy), and a phase 1B trial of golimumab in pediatric UC (n = 19), UC expression profiles were compared and unique genes were defined as those with significant changes (|FC|>2x, adjusted p < 0...
February 3, 2018: Journal of Pediatric Gastroenterology and Nutrition
Ana Iglesias Plaza, Maribel Iglesias Sancho, Mónica Quintana Codina, Javier García Miguel, Montse Salleras Redonnet
Inhibitors of tumor necrosis factor-alpha (anti-TNF-alpha) are widely used in different medical specialties. The main adverse effect of these agents is the increased risk of infection. We report the case of a 30-year-old man with ankylosing spondylitis who had begun receiving golimumab two weeks earlier. He presented with a 10-day history of salmon-colored lesions on trunk, palms and soles. The clinical suspicion was secondary syphilis. Treponemal and nontreponemal tests confirmed the diagnosis of syphilis...
February 2, 2018: Reumatología Clinica
Séverine Vermeire, Ann Gils, Paola Accossato, Sadiq Lula, Amy Marren
Crohn's disease and ulcerative colitis are chronic inflammatory disorders of the gastrointestinal tract. Treatment options include biologic therapies; however, a proportion of patients lose response to biologics, partly due to the formation of anti-drug antibodies (ADAbs). Concomitant immunosuppressive agents reduce the development of ADAbs. This review article aims to assess the immunogenicity of biologic therapies and their clinical implications. A comprehensive literature search was conducted for articles published January 2009 to August 2015 reporting immunogenicity to adalimumab (ADM), certolizumab pegol (CZP), golimumab, infliximab (IFX), ustekinumab, and vedolizumab in inflammatory bowel disease (IBD)...
2018: Therapeutic Advances in Gastroenterology
Juliette Sheridan, Carol Ann Coe, Peter Doran, Laurence Egan, Garret Cullen, David Kevans, Jan Leyden, Marie Galligan, Aoibhlinn O'Toole, Jane McCarthy, Glen Doherty
Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), often leading to an impaired quality of life in affected patients. Current treatment modalities include antitumour necrosis factor (anti-TNF) monoclonal antibodies (mABs) including infliximab, adalimumab and golimumab (GLM). Several recent retrospective and prospective studies have demonstrated that fixed dosing schedules of anti-TNF agents often fails to consistently achieve adequate circulating therapeutic drug levels (DL) with consequent risk of immunogenicity treatment failure and potential risk of hospitalisation and colectomy in patients with UC...
2018: BMJ Open Gastroenterology
Sean M McConachie, Sheila M Wilhelm, Ashish Bhargava, Pramodini B Kale-Pradhan
OBJECTIVE: To review the mechanism and association of infectious risk among the tumor-necrosis factor α (TNF-α) antagonists used in inflammatory bowel disease. DATA SOURCES: A PubMed literature search was performed using the following search terms: infliximab, adalimumab, certolizumab, golimumab, inflammatory bowel disease, crohn's, ulcerative colitis, adverse effects, adverse events, safety, and infection. STUDY SELECTION AND DATA EXTRACTION: Meta-analyses and cohort studies with outcomes pertaining to quantitative infectious risk were reviewed...
January 1, 2018: Annals of Pharmacotherapy
Gerd R Burmester, Iain B McInnes, Joel M Kremer, Pedro Miranda, Jiří Vencovský, Alex Godwood, Marius Albulescu, M Alex Michaels, Xiang Guo, David Close, Michael Weinblatt
OBJECTIVE: Mavrilimumab, a human monoclonal antibody, targets granulocyte-macrophage colony-stimulating factor receptor alpha. We report mavrilimumab long-term safety and efficacy in rheumatoid arthritis patients in two phase IIb studies (1071, 1107) and open-label extension (OLE; NCT01712399). METHODS: In 1071, patients with disease-modifying antirheumatic drug (DMARD)-inadequate responses received mavrilimumab 30, 100, 150 mg, or placebo every other week (eow), plus methotrexate...
January 23, 2018: Arthritis & Rheumatology
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