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Rheumatology;biologics

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https://www.readbyqxmd.com/read/28917219/reuma-pt-contribution-to-the-knowledge-of-immune-mediated-systemic-rheumatic-diseases
#1
Maria José Santos, Helena Canhão, Ana Filipa Mourão, Filipa Oliveira Ramos, Cristina Ponte, Cátia Duarte, Anabela Barcelos, Fernando Martins, José António Melo Gomes
Patient registries are key instruments aimed at a better understanding of the natural history of diseases, at assessing the effectiveness of therapeutic interventions, as well as identifying rare events or outcomes that are not captured in clinical trials. However, the potential of registries goes far beyond these aspects. For example, registries promote the standardization of clinical practice, can also provide information on domains that are not routinely collected in clinical practice and can support decision-making...
September 14, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28903545/the-road-from-development-to-approval-evaluating-the-body-of-evidence-to-confirm-biosimilarity
#2
Paul Declerck, Mourad Farouk Rezk
Biosimilars are products that contain a similar version of the active substance of an already authorized original biologic medicinal product (reference medicinal product). Their development requires special consideration, as similarity to the reference agent needs to be established through a comprehensive comparability exercise. Given the complex nature of these agents, minor structural differences may emerge, but the process of biosimilarity determination is designed to ascertain that the nature and impact of these differences are not clinically significant...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28903543/biosimilars-in-rheumatology-a-review-of-the-evidence-and-their-place-in-the-treatment-algorithm
#3
Hendrik Schulze-Koops, Alla Skapenko
Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28895041/unmet-needs-in-the-pathogenesis-and-treatment-of-vasculitides
#4
REVIEW
Francesco Muratore, Giulia Pazzola, Alessandra Soriano, Nicolò Pipitone, Stefania Croci, Martina Bonacini, Luigi Boiardi, Carlo Salvarani
Despite the progress in the last years on the field of vasculitides, there are several unmet needs regarding classification, disease activity assessment, predictors of flares and complications, and type of treatment for the different forms. The 1990 American College of Rheumatology (ACR) classification criteria currently used to define giant cell arteritis and Takayasu arteritis were designed to discriminate between different types of vasculitides but not to differentiate vasculitis from other disorders. Recently, efforts have been made to overcome the shortcomings of the ACR criteria...
September 11, 2017: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/28894080/the-portuguese-society-of-rheumatology-position-paper-on-the-use-of-biosimilars-2017-update
#5
Filipe C Araújo, Alexandre Sepriano, Filipa Teixeira, Diogo Jesus, Teresa Martins Rocha, Patrícia Martins, Catarina Tenazinha, Ana Cordeiro, Ana Filipa Mourão, Cândida Silva, Carlos Vaz, Cátia Duarte, Cristina Ponte, Fernando Pimentel Dos Santos, Helena Canhão, Helena Santos, José Bravo Pimentão, José Canas da Silva, Joaquim Pereira, José António Pereira da Silva, Luís Cunha Miranda, Margarida Oliveira, Maria João Saavedra, Pedro Gonçalves, Sandra Falcão, Susana Capela, João Eurico Fonseca
Biosimilars are new and more affordable similar versions of previously approved reference biological drugs. Following the approval of the first monoclonal antibody biosimilar in 2013, the Portuguese Society of Rheumatology issued a position paper on the use of biosimilars in rheumatic conditions covering efficacy, safety, extrapolation, interchangeability, substitution and pharmacovigilance. However, as this is a rapidly evolving field, it was felt that the knowledge and evidence gathered since then justified an update of these statements...
July 21, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28894079/portuguese-recommendations-for-the-use-of-biological-therapies-in-patients-with-axial-spondyloarthritis-2016-update
#6
Pedro Machado, Marcos Cerqueira, Pedro Ávila-Ribeiro, Renata Aguiar, Alexandra Bernardo, Alexandre Sepriano, Ana Águeda, Ana Cordeiro, Ana Raposo, Ana M Rodrigues, Anabela Barcelos, Armando Malcata, Carina Lopes, Cláudia Vaz, Dolores Nour, Fátima Godinho, Fernando Alvarenga, Fernando Pimentel-Santos, Helena Canhão, Helena Santos, Inês Cunha, Joana Sousa Neves, João Eurico Fonseca, João Lagoas Gomes, José Tavares-Costa, Lúcia Costa, Luís Cunha-Miranda, Luís Maurício, Margarida Cruz, Maria Carmo Afonso, Maria José Santos, Miguel Bernardes, Paula Valente, Ricardo Figueira, Sofia Pimenta, Sofia Ramiro, Teresa Pedrosa, Tiago Afonso Costa, Elsa Vieira-Sousa
OBJECTIVE: To update the recommendations for the treatment of axial spondyloarthritis (axSpA) with biological therapies, endorsed by the Portuguese Society of Rheumatology. METHODS: These treatment recommendations were formulated by Portuguese rheumatologists based on literature evidence and consensus opinion. At a national meeting, the 7 recommendations included in this document were discussed and updated. A draft of the full text of the recommendations was then circulated and suggestions were incorporated...
June 25, 2017: Acta Reumatológica Portuguesa
https://www.readbyqxmd.com/read/28884287/incidence-of-comprehensive-hospitalization-due-to-infection-cardiovascular-disease-fractures-and-malignancies-in-patients-with-rheumatoid-arthritis
#7
Naoki Sugimoto, Ayako Nakajima, Eisuke Inoue, Kumi Shidara, Hiroyuki Yamashita, Akio Mimori, Hitoshi Tokuda, Yohei Seto, Eiichi Tanaka, Shigeki Momohara, Atsuo Taniguchi, Hisashi Yamanaka
To comprehensively analyze the overall incidence of hospitalization for comorbidities in patients with rheumatoid arthritis (RA). We prospectively analyzed overall hospitalizations for comorbidities using the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort. The incidence of hospitalized comorbidity was calculated. Risk factors for the most frequent hospitalized comorbidities were determined by multivariate logistic regression analysis. Among 5519 RA patients contributing 5336.5 person-years of observation, 435 incidences of hospitalized comorbidity [8...
September 7, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28880684/reduction-of-methotrexate-and-glucocorticoids-use-after-the-introduction-of-biological-disease-modifying-anti-rheumatic-drugs-in-patients-with-rheumatoid-arthritis-in-daily-practice-based-on-the-iorra-cohort
#8
Yoko Shimizu, Eiichi Tanaka, Eisuke Inoue, Kumi Shidara, Naoki Sugimoto, Yohei Seto, Ayako Nakajima, Shigeki Momohara, Atsuo Taniguchi, Hisashi Yamanaka
OBJECTIVES: To evaluate usage patterns for methotrexate (MTX) and/or glucocorticoids in rheumatoid arthritis (RA) patients receiving biological disease-modifying antirheumatic drugs (bDMARDs) in daily practice. METHODS: Data from RA patients who commenced treatment with bDMARDs (infliximab [IFX], etanercept [ETN], tocilizumab [TCZ], or adalimumab [ADA]) from 2008 to 2010 were extracted from the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) database. The proportions of patients taking concomitant MTX and glucocorticoids and doses of these medications were evaluated before and 2 years after initiation of each bDMARD...
September 7, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28879047/treatment-of-polyarteritis-nodosa-with-tocilizumab-a-new-therapeutic-approach
#9
Aurélie Saunier, Nahéma Issa, Marie-Anne Vandenhende, Philippe Morlat, Marie-Sylvie Doutre, Fabrice Bonnet
We describe the effect of interleukin 6 (IL-6) blockade using tocilizumab (TCZ) for inducing and maintaining remission of refractory polyarteritis nodosa (PAN). Three patients with refractory PAN defined according to the American College of Rheumatology criteria were treated with TCZ infusions (8 mg/kg) on a monthly basis. All of them had severe cutaneous and articular involvement with elevated biological inflammatory markers. One suffered from a neuritis multiplex and one from renal and digestive damage...
2017: RMD Open
https://www.readbyqxmd.com/read/28865740/repetitive-18-f-fdg-pet-ct-in-patients-with-large-vessel-giant-cell-arteritis-and-controlled-disease
#10
Hubert de Boysson, Nicolas Aide, Eric Liozon, Marc Lambert, Jean-Jacques Parienti, Jacques Monteil, Damien Huglo, Boris Bienvenu, Alain Manrique, Achille Aouba
OBJECTIVE: (18)F-FDG PET/CT can detect large-vessel involvement in giant-cell arteritis (GCA) with a good sensitivity. In patients with clinically and biologically controlled disease, we aimed to assess how vascular uptakes evolve on repetitive FDG-PET/CT. PATIENTS AND METHODS: All included patients had to satisfy the 4 following criteria: 1) diagnosis of GCA was retained according to the criteria of the American College of Rheumatology or based on the satisfaction of 2 criteria associated with the demonstration of large-vessel involvement on FDG-PET/CT; 2) all patients had a positive PET/CT that was performed at diagnosis before treatment or within the first 10days of treatment; 3) another FDG-PET/CT was performed after at least 3months of controlled disease without any relapse; 4) patients were followed-up at least for 12months...
August 30, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/28865469/comics-as-an-educational-tool-for-children-with-juvenile-idiopathic-arthritis
#11
Amir Mendelson, Noa Rabinowicz, Yonit Reis, Gil Amarilyo, Liora Harel, Philip J Hashkes, Yosef Uziel
BACKGROUND: This study examined whether the comic book Neta and the Medikidz Explain JIA would improve disease-related knowledge and treatment adherence among patients with juvenile idiopathic arthritis (JIA). METHODS: In this prospective cohort study, JIA patients answered 20 multiple-choice knowledge questions about their disease, before and after reading the comic book. Demographic, clinical, health-related quality of life and adherence data were recorded and correlated to the responses...
September 2, 2017: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/28855200/real-world-validation-of-the-minimal-disease-activity-index-in-psoriatic-arthritis-an-analysis-from-a-prospective-observational-biological-treatment-registry
#12
Proton Rahman, Michel Zummer, Louis Bessette, Philip Baer, Boulos Haraoui, Andrew Chow, John Kelsall, Suneil Kapur, Emmanouil Rampakakis, Eliofotisti Psaradellis, Allen J Lehman, Francois Nantel, Brendan Osborne, Cathy Tkaczyk
OBJECTIVE: To describe the minimal disease activity (MDA) rate over time in patients with psoriatic arthritis (PsA) receiving antitumour necrosis factor agents, evaluate prognostic factors of MDA achievement and identify the most common unmet criteria among MDA achievers. DESIGN: Biologic Treatment Registry Across Canada (BioTRAC): ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis or PsA with infliximab (IFX), golimumab (GLM) or ustekinumab...
August 30, 2017: BMJ Open
https://www.readbyqxmd.com/read/28852832/down-titration-of-biologics-for-the-treatment-of-rheumatoid-arthritis-a-systematic-literature-review
#13
Chak Sing Lau, Allan Gibofsky, Nemanja Damjanov, Sadiq Lula, Lisa Marshall, Heather Jones, Paul Emery
Biologic therapies have improved the management of rheumatoid arthritis (RA) and the treat-to-target approach has resulted in many patients achieving remission. In the current treatment landscape, clinicians have begun considering dose reduction/tapering for their patients. Rheumatology guidelines in Asia, Europe, and the United States include down-titration of biologics but admit that the level of evidence is moderate. We conducted a systematic literature review to assess the published studies that evaluate down-titration of biologics in RA...
August 29, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28840348/posttraumatic-stress-disorder-and-correlates-of-disease-activity-among-veterans-with-ankylosing-spondylitis
#14
Jean Liew, J Lucas Williams, Steven Dobscha, Jennifer L Barton
The objective of this retrospective study was to evaluate the prevalence of comorbid Posttraumatic stress disorder (PTSD) and the association of PTSD with pain, disease activity, and medication use in ankylosing spondylitis (AS). Veterans with one or more visit to an outpatient rheumatology clinic at a single Veterans Affairs site during a 2-year study period were identified by ICD codes for AS and included if there was documentation of AS diagnosis by a rheumatologist. Data were collected on PTSD diagnosis, demographics, pain scores, disease activity by the Bath AS Disease Activity Index (BASDAI), and medication use...
August 24, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28836745/use-of-biologics-and-biosimilars-in-rheumatology
#15
Shefali Khanna Sharma
Prior to the availability of biologics, synthetic DMARDs (Disease modifying anti-rheumatic drugs) were the mainstay of the treatment in rheumatology. With the introduction of biologics, the scenario is changing to become more promising. These drugs have innovative mechanism of action, based on the targeted inhibition of specific molecular or cellular targets directly involved in disease pathogenesis. The biosimilars are highly similar copies of originator biologics approved through pre-defined, stringent regulatory processes after rigorous physicochemical, non-clinical, and clinical evaluations...
May 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28831751/discontinuation-of-biologic-therapy-in-rheumatoid-arthritis-analysis-from-the-corrona-ra-registry
#16
Vibeke Strand, Paul Miller, Setareh A Williams, Katherine Saunders, Shannon Grant, Joel Kremer
INTRODUCTION: Despite the availability of multiple effective therapies, discontinuation/switching of treatment is common for many patients with rheumatoid arthritis (RA). This study was designed to examine initiation of biologic disease-modifying anti-rheumatic drugs (bDMARDs) within the Consortium of Rheumatology Researchers of North America (Corrona) RA Registry, and characterize reasons for discontinuation. METHODS: Inclusion criteria were: Corrona-registered adults (≥18 years) with RA (2002-2011); age of RA onset: ≥16 years; ≥6 months' follow-up after initiation of first/subsequent bDMARD...
August 22, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28831712/treatment-with-biologicals-in-rheumatoid-arthritis-an-overview
#17
REVIEW
Philipp Rein, Ruediger B Mueller
Management and therapy of rheumatoid arthritis (RA) has been revolutionized by the development and approval of the first biological disease-modifying antirheumatic drugs (bDMARDs) targeting tumor necrosis factor (TNF) α at the end of the last century. Today, numerous efficacious agents with different modes of action are available and achievement of clinical remission or, at least, low disease activity is the target of therapy. Early therapeutic interventions aiming at a defined goal of therapy (treat to target) are supposed to halt inflammation, improving symptoms and signs, and preserving structural integrity of the joints in RA...
August 22, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28821941/rheumatologic-care-of-nursing-home-residents-with-rheumatoid-arthritis-a-comparison-of-the-year-before-and-after-nursing-home-admission
#18
Andres Luque Ramos, Katinka Albrecht, Angela Zink, Falk Hoffmann
The purpose of this study was to investigate health care for patients with rheumatoid arthritis (RA) before and after admission to nursing homes. Data of a German health insurance fund from persons with diagnostic codes of RA, aged ≥65 years, admitted to a nursing home between 2010 and 2014 and continuously insured 1 year before and after admission were used. The proportion of patients with ≥1 rheumatologist visit and ≥1 prescription of biologic or conventional synthetic disease-modifying antirheumatic drugs (bDMARDs or csDMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs (NSAIDs) in the year before and after admission were calculated...
August 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28817201/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-2-continuous-model
#19
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul A Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
Population pharmacokinetic/pharmacodynamic (PK/PD) models were developed to quantitate the exposure-response relationships using continuous longitudinal data on American College of Rheumatology (ACR) subcomponents, that is, tender-joint count (TJC), swollen-joint count (SJC), C-reactive protein, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, and patient's assessment of physical function for 5 biologics approved for use in rheumatoid arthritis...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28817199/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-1-binary-model
#20
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
American College of Rheumatology (ACR) response criteria is used to assess improvement in tender and swollen joint counts and in 3 of the 5 core measures (acute-phase reactant, physician global assessment, patient global assessment, pain, and physical function). From the clinical trial data on 5 approved biological products for the treatment of rheumatoid arthritis, population pharmacokinetic/pharmacodynamic models were developed to quantitatively describe the relationship between exposure and response rates of 3 individual components of ACR response criteria...
September 2017: Journal of Clinical Pharmacology
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