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https://www.readbyqxmd.com/read/28319603/the-path-of-interchangeability-of-biosimilars-in-pediatric-inflammatory-bowel-disease-quality-before-cost-savings
#1
Dimple Patel, K T Park
The advent of biosimilars in inflammatory bowel disease (IBD) represents an opportunity for cost-savings and increased patient access to effective disease-modifying therapies. While preliminary data in adult IBD and rheumatology patients suggest comparable effectiveness and pharmacokinetics between original biologics and biosimilars, long-term immunogenicity data are unknown. Without this data, conclusions about interchangeability should not be made for pediatric patients with IBD. Children affected by IBD, in particular, are a vulnerable group if automatic substitution and non-medical switching are allowed based on limited data in adult patients...
March 17, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28283512/efficacy-of-biological-disease-modifying-antirheumatic-drugs-a-systematic-literature-review-informing-the-2016-update-of-the-eular-recommendations-for-the-management-of-rheumatoid-arthritis
#2
Jackie L Nam, Kaoru Takase-Minegishi, Sofia Ramiro, Katerina Chatzidionysiou, Josef S Smolen, Désirée van der Heijde, Johannes W Bijlsma, Gerd R Burmester, Maxime Dougados, Marieke Scholte-Voshaar, Ronald van Vollenhoven, Robert Landewé
OBJECTIVES: To update the evidence for the efficacy of biological disease-modifying antirheumatic drugs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform European League Against Rheumatism (EULAR) Task Force treatment recommendations. METHODS: MEDLINE, EMBASE and Cochrane databases were searched for phase III or IV (or phase II, if these studies were lacking) randomised controlled trials (RCTs) published between January 2013 and February 2016. Abstracts from the American College of Rheumatology and EULAR conferences were obtained...
March 10, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28270202/rheumatology-in-africa-challenges-and-opportunities
#3
EDITORIAL
Girish M Mody
Africa faces many health challenges despite sustained growth and development over the past decade. Contributory factors are the lack of financial resources, an inadequate health professional workforce, a high burden of communicable diseases, and an increasing burden of non-communicable diseases. Rheumatology services are limited or non-existent in many parts of sub-Saharan Africa. Over the past decade, partnerships with international academic institutions have resulted in some progress in the training of rheumatologists and health professionals and development of rheumatology services in countries such as Kenya, Nigeria, and Zambia...
March 7, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28265837/update-on-biosimilars-in-rheumatology
#4
REVIEW
Adam Rischin, Andrew J K Östör
Biologic agents have become indispensable in the management of autoimmune disease particularly rheumatological conditions. The lives of countless individuals have been improved following treatment with these drugs. Unfortunately, their cost prohibits more widespread use around the globe. This critical issue has been addressed by the introduction of biosimilars into the market. These therapies have been developed to resemble the originator molecule as closely as possible and to increase competition in the therapy area thus allowing costs to be reduced...
March 7, 2017: Inflammopharmacology
https://www.readbyqxmd.com/read/28264816/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-and-biological-disease-modifying-antirheumatic-drugs-2016-update
#5
Josef S Smolen, Robert Landewé, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, Sofia Ramiro, Marieke Voshaar, Ronald van Vollenhoven, Daniel Aletaha, Martin Aringer, Maarten Boers, Chris D Buckley, Frank Buttgereit, Vivian Bykerk, Mario Cardiel, Bernard Combe, Maurizio Cutolo, Yvonne van Eijk-Hustings, Paul Emery, Axel Finckh, Cem Gabay, Juan Gomez-Reino, Laure Gossec, Jacques-Eric Gottenberg, Johanna M W Hazes, Tom Huizinga, Meghna Jani, Dmitry Karateev, Marios Kouloumas, Tore Kvien, Zhanguo Li, Xavier Mariette, Iain McInnes, Eduardo Mysler, Peter Nash, Karel Pavelka, Gyula Poór, Christophe Richez, Piet van Riel, Andrea Rubbert-Roth, Kenneth Saag, Jose da Silva, Tanja Stamm, Tsutomu Takeuchi, René Westhovens, Maarten de Wit, Désirée van der Heijde
Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib)...
March 6, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28262590/the-implications-of-biologic-therapy-for-elective-foot-and-ankle-surgery-in-patients-with-rheumatoid-arthritis
#6
REVIEW
Ross Diaper, Ernest Wong, Stuart A Metcalfe
INTRODUCTION: Rheumatoid arthritis (RA) is one of a number of inflammatory arthropathies resulting in foot pain and deformity. Patients with this disease may require surgical intervention as part of their management. Many of these patients are now taking biologic agents which pose several risks to patients in the perioperative phase. The surgical team therefore need to be aware of these associated complications and how to manage these cases. AIM: This paper aims to review the current literature about perioperative needs (foot and ankle surgery) associated with patients with rheumatoid arthritis receiving biologic therapy...
January 27, 2017: Foot
https://www.readbyqxmd.com/read/28254789/tumour-necrosis-factor-inhibitor-treatment-and-occurrence-of-anterior-uveitis-in-ankylosing-spondylitis-results-from-the-swedish-biologics-register
#7
Elisabeth Lie, Ulf Lindström, Tatiana Zverkova-Sandström, Inge C Olsen, Helena Forsblad-d'Elia, Johan Askling, Meliha C Kapetanovic, Lars Erik Kristensen, Lennart T H Jacobsson
OBJECTIVES: Tumour necrosis factor-α inhibitor (TNFi) treatment has been shown to reduce the rates of anterior uveitis (AU) in patients with ankylosing spondylitis (AS). Our objective was to compare the effect of adalimumab (ADA), etanercept (ETN) and infliximab (IFX) on AU occurrence in AS, using real-world data. METHODS: Patients with AS starting ADA, ETN or IFX as their first TNFi from January 2003 to December 2010 were extracted from the Swedish Rheumatology Quality Register...
March 2, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28243133/determinants-of-biological-drug-survival-in-rheumatoid-arthritis-evidence-from-a-hungarian-rheumatology-center-over-8-years-of-retrospective-data
#8
Valentin Brodszky, Anikó Bíró, Zoltán Szekanecz, Boglárka Soós, Petra Baji, Fanni Rencz, László Tóthfalusi, László Gulácsi, Márta Péntek
OBJECTIVE: To compare drug survival of biological therapies in patients with rheumatoid arthritis (RA), and analyze the determinants of discontinuation probabilities and switches to other biological therapies. MATERIALS AND METHODS: Consecutive RA patients initiating first biological treatment in one rheumatology center between 2006 and 2013 were included. Log-rank test was used to analyze the differences between the survival curves of different biological drugs...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28238086/misalignment-between-physicians-and-patient-satisfaction-with-psoriatic-arthritis-disease-control
#9
Daniel E Furst, Melody Tran, Emma Sullivan, James Pike, James Piercy, Vivian Herrera, Jacqueline B Palmer
The main objective of the present study is to evaluate the misalignment between psoriatic arthritis (PsA) patient- and physician-reported satisfaction with PsA control. Data came from the Adelphi Rheumatology Disease Specific Programme, a retrospective, cross-sectional survey of US-based rheumatologists and patients. Physicians provided satisfaction and clinical characteristics on tender joint count, swollen joint count, and percent body surface area (BSA) affected by psoriasis. Patients provided data on satisfaction, the Work Productivity Activity Impairment and Health Assessment Questionnaire-Disability Index (HAQ-DI) questionnaires...
February 25, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28236221/safety-and-efficacy-of-ocrelizumab-in-rheumatoid-arthritis-patients-with-an-inadequate-response-to-methotrexate-or-tumor-necrosis-factor-inhibitors-a-systematic-review-and-meta-analysis
#10
Abdelrahman Ibrahim Abushouk, Hussien Ahmed, Ammar Ismail, Ahmed Elmaraezy, Ahmed Said Badr, Mohamed Gadelkarim, Mohammed Elnenny
We conducted this systematic reviews and meta-analysis to investigate the safety and efficacy of ocrelizumab in patients with active rheumatoid arthritis (RA) who exhibited resistance or intolerance to methotrexate or biological therapy. We performed a web-based literature search of PubMed, Google Scholar, EBSCO, Scopus, Embase, and Web of science for studies that compared ocrelizumab plus methotrexate versus methotrexate plus placebo in RA patients. Data were extracted from eligible studies and pooled as risk ratios (RR), using RevMan software...
February 24, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28229823/cardiovascular-complications-in-paediatric-onset-systemic-lupus-erythematosus-in-saudi-arabian-patients
#11
Ahmad S Azhar, Omneyah Mohamed Awlia, Mohammed A Muzaffer
OBJECTIVES: To assess the prevalence and types of cardiovascular complications in Saudi patients with paediatric-onset systemic lupus erythematosus (pSLE). METHODS: Retrospective record review of pSLE patients following from January 2014 to September 2015 at the rheumatology clinic of King Abdul-Aziz University Hospital, Jeddah. Laboratory data such as C-reactive protein (CRP), antinuclear antibodies (ANA), anti-double stranded DNA antibody (anti-dsDNA), C3 and C4 complements, were collected...
February 10, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28225511/treatment-satisfaction-in-systemic-lupus-erythematosus-development-of-a-patient-reported-outcome-measure
#12
Susan D Mathias, Pamela Berry, Katie Pascoe, Jane de Vries, Anca D Askanase, Hilary H Colwell, David J Chang
OBJECTIVE: The aim of this study was to develop a patient-reported outcome measure specific for systemic lupus erythematosus (SLE) to assess patient satisfaction with treatment, treatment options, and medical care. METHODS: Patients with SLE were recruited from four US rheumatology practices. Concept elicitation interviews identified aspects that patients considered important and relevant regarding satisfaction with treatment and medical care. Concept elicitation interviews and clinical input were used to draft the Lupus Satisfaction Questionnaire (LSQ)...
March 2017: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
https://www.readbyqxmd.com/read/28219691/hepatitis-b-reactivation-associated-with-immune-suppressive-and-biological-modifier-therapies-current-concepts-management-strategies-and-future-directions
#13
REVIEW
Rohit Loomba, T Jake Liang
Hepatitis B reactivation associated with immune suppressive and biological therapies is emerging to be an important cause of morbidity and mortality in patients with current or prior exposure to hepatitis B virus infection. The population at risk for HBV reactivation includes those who are either currently infected with HBV or have past exposure to HBV. Since curative and eradicative therapy for HBV is not currently available, there is a large reservoir of individuals at risk for HBV reactivation in the general population...
February 17, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28216072/smoking-and-pre-existing-organ-damage-reduce-the-efficacy-of-belimumab-in-systemic-lupus-erythematosus
#14
REVIEW
Ioannis Parodis, Christopher Sjöwall, Andreas Jönsen, Daniel Ramsköld, Agneta Zickert, Martina Frodlund, Azita Sohrabian, Laurent Arnaud, Johan Rönnelid, Vivianne Malmström, Anders A Bengtsson, Iva Gunnarsson
OBJECTIVES: Belimumab is the first biologic drug approved for Systemic Lupus Erythematosus (SLE). Here, we aimed to investigate the effects of belimumab on clinical and serologic outcomes, and sought to identify predictors of treatment response in three Swedish real-life settings. METHODS: Fifty-eight patients were enrolled at initiation of belimumab and followed longitudinally for up to 53months. Surveillance outcomes included the SLE Disease Activity Index 2000 (SLEDAI-2K), 100mm Visual Analogue Scales for Physician"s Global Assessment (PGA), fatigue, pain and general health, and the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI)...
February 12, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28215362/efficacy-and-safety-of-sirukumab-in-patients-with-active-rheumatoid-arthritis-refractory-to-anti-tnf-therapy-sirround-t-a-randomised-double-blind-placebo-controlled-parallel-group-multinational-phase-3-study
#15
Daniel Aletaha, Clifton O Bingham, Yoshiya Tanaka, Prasheen Agarwal, Regina Kurrasch, Paul P Tak, Sharon Popik
BACKGROUND: Sirukumab, a human monoclonal antibody that selectively binds to the interleukin-6 cytokine with high affinity, is under development for the treatment of rheumatoid arthritis and other diseases. We aimed to assess the efficacy and safety of sirukumab for rheumatoid arthritis in a phase 3 study (SIRROUND-T). METHODS: We did a randomised, double-blind, placebo-controlled, parallel-group, multicentre study at 183 hospitals and private rheumatology clinics in 20 countries (Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Russia, South Korea, Spain, Taiwan, UK, and USA)...
February 15, 2017: Lancet
https://www.readbyqxmd.com/read/28185680/recurrent-pericarditis
#16
M Imazio, A Battaglia, L Gaido, F Gaita
Recurrent pericarditis is the most troublesome complication of pericarditis occurring in 15 to 30% of cases. The pathogenesis is often presumed to be immune-mediated although a specific rheumatologic diagnosis is commonly difficult to find. The clinical diagnosis is based on recurrent pericarditis chest pain and additional objective evidence of disease activity (e.g. pericardial rub, ECG changes, pericardial effusion, elevation of markers of inflammation, and/or imaging evidence of pericardial inflammation by CT or cardiac MR)...
February 6, 2017: La Revue de Médecine Interne
https://www.readbyqxmd.com/read/28183342/rheumatology-around-the-world-perspectives-from-australia-and-new-zealand
#17
EDITORIAL
Fiona M F McQueen
Rheumatology continues to be an exciting and vibrant specialty for specialists practising in New Zealand and Australia. Clinicians follow treat-to-target regimens to manage peripheral and axial inflammatory arthritides using conventional and biological agents, which have revolutionised management of rheumatic disease over the past two decades. However, optimal clinical practice has significant pharmacoeconomic implications which impact on health funding at a national level, and the advent of biosimilars is keenly awaited...
February 10, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28183330/th17-and-cd24-hi-cd27-regulatory-b-lymphocytes-are-biomarkers-of-response-to-biologics-in-rheumatoid-arthritis
#18
Sarah Salomon, Caroline Guignant, Pierre Morel, Gauthier Flahaut, Clément Brault, Clément Gourguechon, Patrice Fardellone, Jean-Pierre Marolleau, Brigitte Gubler, Vincent Goëb
BACKGROUND: The aim was to describe the regulatory B and T cells (Breg and Treg) and T helper 17 (Th17) lymphocytes before and under treatment with biologic drugs, and to assess their potential predictive value as biomarkers of response in rheumatoid arthritis (RA). METHODS: This was a non-randomised, single-centre, prospective study. Patients with active RA (American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) 2010) who required the initiation or switch to any biologic drug except rituximab were included...
February 10, 2017: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/28178439/juvenile-idiopathic-arthritis-in-the-era-of-international-cooperation
#19
REVIEW
Yosef Uziel
Juvenile idiopathic arthritis (JIA) is the most common chronic disease of childhood. Improved understanding of its pathogenesis has led to international cooperation in clinical studies. Multicenter, international collaborations and research facilitate rapid enrollment of enough patients to enable a variety of studies, including those of epidemiology, diagnostic and classification criteria, genetic disease predisposition, pathogenesis, outcomes, and treatment protocols. In the last 20 years, the vision of the Pediatric Rheumatology International Trial Organization (PRINTO) has become a reality of worldwide collaboration in pediatric rheumatology research, including North American and European research groups...
January 30, 2017: Rambam Maimonides Medical Journal
https://www.readbyqxmd.com/read/28174236/merkel-cell-carcinomas-arising-in-autoimmune-disease-affected-patients-treated-with-biological-drugs-including-tnf
#20
John C Rotondo, Ilaria Bononi, Andrea Puozzo, Marcello Govoni, Valentina Foschi, Giovanni Lanza, Roberta Gafà, Antoine Touzè, Pauline Gaboriaud, Rita Selvatici, Fernanda Martini, Mauro Tognon
PURPOSE: The purpose of this investigation was to characterize Merkel cell carcinomas (MCC) arising in patients affected by auto-immune diseases, treated with biologic drugs. EXPERIMENTAL DESIGN: Serum samples from MCC patients were analyzed for the presence and titer of antibodies against antigens of the oncogenic Merkel cell polyomavirus (MCPyV). IgG antibodies against the viral oncoproteins Large T (LT) and small t (ST) antigens and the viral capsid protein 1 were analyzed by indirect E...
February 7, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
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