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Simon Tarp, Daniel E Furst, Anna Dossing, Mikkel Østergaard, Tove Lorenzen, Michael S Hansen, Jasvinder A Singh, Ernest H Choy, Maarten Boers, Maria E Suarez-Almazor, Lars E Kristensen, Henning Bliddal, Robin Christensen
OBJECTIVES: To summarize and compare the benefits and harms of biological agents used as monotherapy for rheumatoid arthritis (RA) in order to inform decisions for patients who are intolerant to conventional DMARD therapy. METHODS: We searched MEDLINE, EMBASE, CENTRAL, and other sources for randomised trials that compared biological monotherapy with methotrexate, placebo, or other biological monotherapies. Primary outcomes were ACR50 and the number of patients who discontinued due to adverse events...
September 14, 2016: Seminars in Arthritis and Rheumatism
Athanasios Tragiannidis, Ioannis Kyriakidis, Ilse Zündorf, Andreas H Groll
Macromolecular immunosuppressive monoclonal antibodies and fusion proteins directed against molecules or cells involved in inflammation and immunity represent a recent and important addition to our therapeutic armamentarium. Tumor necrosis alpha (TNFα) is a cytokine involved in systemic inflammation and clinical utilization of its antagonists has revolutionized treatment of juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Clinical utility has also been demonstrated for use against steroid-refractory graft-vs-host disease and other immune-mediated conditions...
October 21, 2016: Mycoses
Tao Gu, Neel Shah, Gaurav Deshpande, Derek H Tang, Debra F Eisenberg
BACKGROUND: The relative cost of biologics in the treatment of autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, psoriasis, and ankylosing spondylitis, is a key consideration for managed care payers. OBJECTIVES: Our objective was to estimate biologic costs and treatment patterns in US managed care patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis. METHODS: This retrospective study used administrative claims data from the HealthCore Integrated Research Database (HIRD(SM)) for adults with rheumatoid arthritis, psoriatic arthritis, psoriasis, and/or ankylosing spondylitis who received abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or ustekinumab between 1 July 2009 and 31 January 2013...
October 18, 2016: Drugs—Real World Outcomes
Keith A Betts, Jenny Griffith, Yan Song, Manish Mittal, Avani Joshi, Eric Q Wu, Arijit Ganguli
INTRODUCTION: Biologic therapies have improved the clinical management of ankylosing spondylitis (AS). Few head-to-head studies have directly compared the efficacy of these agents. This study was conducted to indirectly compare the efficacy of biologic agents for treatment of active AS. METHODS: A targeted literature review was conducted to identify randomized clinical trials for adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, and secukinumab for the treatment of active AS...
July 25, 2016: Rheumatol Ther
Sergio Iannazzo, Gianluca Furneri, Federica Demma, Chiara Distante, Simone Parisi, Veronica Berti, Enrico Fusaro
INTRODUCTION: Chronic inflammatory rheumatic diseases (RDs) trigger high costs for healthcare systems and society due to the disability and comorbidity associated with these disease entities. The aim of this study was to analyze patients with RD, assess the use of conventional synthetic and biologic therapies, and estimate the overall cost of treatment in Italy. METHODS: Administrative healthcare claims from the Piedmont region in Northwest Italy were reviewed to identify patients who received disease-modifying antirheumatic drugs (DMARDs) between 2007 and 2010...
June 2016: Rheumatol Ther
Roger A Levy, Renato Guzman, Gilberto Castañeda-Hernández, Manuel Martinez-Vazquez, Guilherme Damian, Carlos Cara
Biologics are increasingly being used to modify the course of immune-mediated inflammatory diseases. Some main agents are monoclonal antibodies and a fusion-protein that target TNF. This group includes adalimumab, infliximab, certolizumab pegol, golimumab and etanercept. Although the efficacy of anti-TNFs is supported by numerous randomized clinical trials, their pharmacokinetics depend on many factors, in particular immunogenicity, which can cause marked and rapid clearance and a consequent decrease in efficacy...
October 14, 2016: Immunotherapy
Rafael Alfonso-Cristancho, Nigel Armstrong, Ramesh Arjunji, Rob Riemsma, Gill Worthy, Rita Ganguly, Jos Kleijnen
Our aim was to establish the comparative effectiveness of rheumatoid arthritis (RA) biologics, using a systematic review and network meta-analysis. The systematic review used randomized controlled trials (RCTs) in adults with RA who failed treatment with conventional disease-modifying agents for rheumatoid disease (cDMARDs). We compared the effectiveness of abatacept, adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and rituximab to tocilizumab, a recent biologic with a different mechanism of action (anti-IL-6 receptor)...
October 10, 2016: Clinical Rheumatology
Jae Hee Cheon
Remarkable advances have been made in the treatment of inflammatory bowel disease (IBD) since the introduction of anti-tumor necrosis factor (TNF)-α agents, especially for patients who are refractory to or cannot tolerate conventional therapies. Currently, infliximab, adalimumab, and golimumab are available in the East Asian medical market, and these agents have been shown to be effective for inducing and maintaining long-term remission of IBD. Despite their clinical benefits, anti-TNF therapy can also lead to increased vulnerability to infections, development of autoimmune diseases and malignancy, and decreased immunogenicity of vaccinations...
October 10, 2016: Journal of Gastroenterology and Hepatology
Makoto Naganuma, Shinta Mizuno, Kosaku Nanki, Shinya Sugimoto, Takanori Kanai
Recently, several medical treatments for ulcerative colitis (UC) have been developed, including 5-aminosalicylic acids (5-ASAs), corticosteroids, thiopurine, calcineurin inhibitors, and anti-tumor necrosis factor (TNF) α treatments. Treatment options including calcineurin inhibitors and anti-TNF treatment for refractory UC are discussed in this article. Furthermore, upcoming treatments are introduced, such as golimumab, vedolizumab, AJM300, tofacitinib. Budesonide foamwill be used as one treatment option in patients with distal colitis...
October 3, 2016: Clinical Journal of Gastroenterology
Vanesa Calvo-Río, Montserrat Santos-Gómez, Inmaculada Calvo, Ma Isabel González-Fernández, Berta López Montesinos, Marina Mesquida, Alfredo Adán, María Victoria Hernández, Olga Maíz, Antonio Atanes, Beatriz Bravo, Consuelo Modesto, Gisela Díaz-Cordovés, Natalia Palmou-Fontana, Javier Loricera, M C González-Vela, Rosalía Demetrio-Pablo, J L Hernández, Miguel A González-Gay, Ricardo Blanco
OBJECTIVE: To assess the efficacy of Tocilizumab (TCZ) for Juvenile Idiopathic Arthritis (JIA)-associated uveitis. METHODS: Multicenter study of patients with JIA-associated uveitis refractory to conventional immunosuppressive drugs and anti-TNFα agents. RESULTS: We assessed 25 (21 women) patients (47 affected eyes); mean age 18.5±8.3 years. Uveitis was bilateral in 22. Cystoid macular edema (CME) was present in 9 patients. Ocular sequelae found at TCZ onset included: cataracts (13), glaucoma (7), synechiae (10), band keratopathy (12), maculopathy (9), and amblyopia (5)...
October 1, 2016: Arthritis & Rheumatology
Michael E Mack, Elizabeth Hsia, Daniel Aletaha
OBJECTIVE: The American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) have defined remission using Boolean- or index-based criteria (i.e., the Simplified Disease Activity Index [SDAI] ≤3.3). The Clinical Disease Activity Index (CDAI) ≤2.8) also was included in our comparison of remission definitions to inform endpoint choice for future rheumatoid arthritis (RA) clinical trials. METHODS: We performed post-hoc analyses on clinical remission rates using data from infliximab (ASPIRE/ATTRACT) and golimumab (GO-FORWARD) trials...
October 1, 2016: Arthritis & Rheumatology
Paweł Kawalec, Andrzej Pilc
INTRODUCTION: The aim of the study was to compare adalimumab or golimumab with infliximab in patients with moderately-to-severely active ulcerative colitis (UC). MATERIAL AND METHODS: This paper was prepared according to the PRISMA guidelines. The systematic literature search was performed in PubMed, Embase, and Cochrane Library. No direct head-to-head comparisons for infliximab vs. adalimumab or golimumab were available so an indirect comparison according to the Bucher method was performed after a homogeneity evaluation of the included studies...
October 1, 2016: Archives of Medical Science: AMS
Fedra Ciccarelli, Massimo De Martinis, Maria Maddalena Sirufo, Lia Ginaldi
Tumor necrosis factor alpha (TNF-α) inhibitors revolutionized the management of patients affected by autoimmune diseases such as inflammatory bowel diseases, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. The biologic agents targeted to block TNF-α such as infliximab, adalimumab, certulizumab pegol, etanercept, and golimumab, have a good safety profile; however, with increasing, broader, and prolonged use, patients could be exposed to an increased risk of adverse reactions including a wide spectrum of dermatological conditions of different etiology and morphology...
August 2016: Acta Dermatovenerologica Croatica: ADC
Yehua Wang, Haibo Wang, Jian Jiang, Deyong Zhao, Yong Liu
BACKGROUND: Tumor necrosis factor α (TNFα) antagonists, namely, golimumab, adalimumab, infliximab, etanercept and certolizumab have been prescribed to alleviate and treat ankylosing spondylitis (AS). However, the lack of comparative evidence does not enable us to make constructive recommendations particularly for AS patient populations. METHODS: Eligible controlled trials regarding the above 5 anti-TNFα therapies were searched electronically through PubMed, Embase and Cochrane until April 1, 2015...
September 19, 2016: Cellular Physiology and Biochemistry
Marta Olejárová
UNLABELLED: The biological treatment which is the most effective type of therapy for inflammatory rheumatic diseases, has become part of a standard clinical rheumatology practice in recent years. Thousands of patients in the Czech Republic with rheumatoid arthritis, different forms of spondyloarthritides and with psoriatic arthritis are now successfully treated in this way. The following medications are registered in the Czech Republic for the treatment of rheumatic diseases: infliximab, adalimumab, golimumab, certolizumab pegol, etanercept, abatacept, rituximab, tocilizumab and belimumab, newly also secukinumab...
2016: Vnitr̆ní Lékar̆ství
Martin Soubrier, Bruno Pereira, Thomas Frayssac, Dihya Abdi, Marion Couderc, Coline Daron, Sandrine Malochet-Guinamand, Sylvain Mathieu, Zuzana Tatar, Anne Tournadre, Jean-Jacques Dubost
OBJECTIVES: While several registries have already evaluated the retention of anti-TNF therapy in psoriatic arthritis (PsA), they sometimes reach divergent conclusions. Our study therefore sought to assess therapeutic retention rates and predictive factors of response in a patient cohort from Auvergne, France, followed up in routine clinical practice. METHODS: Medical records of all PsA patients treated from 2002 to May 2015 were analysed. PsA diagnosis was established based on the CASPAR criteria...
August 31, 2016: Clinical and Experimental Rheumatology
Karin A van Schie, Pleuni Ooijevaar-de Heer, Lisanne Dijk, Simone Kruithof, Gertjan Wolbink, Theo Rispens
Tumor necrosis factor (TNF) is a homotrimeric cytokine that is a key mediator of inflammation. It is unstable at physiological concentrations and slowly converts into an inactive form. Here, we investigated the mechanism of this process by using a Förster resonance energy transfer (FRET) assay that allowed monitoring of monomeric subunit exchange in time. We observed continuous exchange of monomeric subunits even at concentrations of TNF high enough to maintain its bioactivity. The kinetics of this process closely corresponds with the appearance of monomeric subunits and disappearance of trimeric TNF in time at ng/ml concentrations as monitored by high-performance size-exclusion chromatography (HP-SEC)...
2016: Scientific Reports
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND AND OBJECTIVES: Biologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD. METHODS: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs...
September 7, 2016: Clinical Drug Investigation
Sunita Paudyal, Frances M Yang, Christopher Rice, Chen-Chun Chen, Michael Skelton, Monique Bethel, Shilpa Brown, Norris Stanley Nahman, Laura Carbone
OBJECTIVES: To determine the frequency of end-stage renal disease (ESRD) in patients with rheumatoid arthritis (RA), the causes of ESRD, and the treatment of RA in the setting of ESRD. METHODS: Cross-sectional study of RA (N = 3754) and non-RA (N = 326,776) patients in the United States Renal Data System (USRDS) during 2011 (N = 330,530). The epidemiology of ESRD in RA was determined and the etiology of ESRD in patients with and without RA was compared. The frequency of patients with RA with at least one filled prescription for prednisone/prednisolone, a DMARD, and/or a biologic in 2011 was determined...
August 2, 2016: Seminars in Arthritis and Rheumatism
Amelie Decock, Gert Van Assche, Séverine Vermeire, Wim Wuyts, Marc Ferrante
BACKGROUND: Since the introduction of anti-tumour necrosis factor [TNF] therapy in inflammatory diseases, paradoxical reactions are increasingly being reported. One of these paradoxical reactions is the development of sarcoidosis-like lesions. This presentation is paradoxical since anti-TNF therapy can also be therapeutic in refractory cases of sarcoidosis. METHODS: We report two cases of sarcoidosis-like lesions under anti-TNF therapy. Both were patients with inflammatory bowel disease [IBD], treated successfully with adalimumab...
September 3, 2016: Journal of Crohn's & Colitis
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