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      Updated consensus statement on the use of rituximab in patients with rheumatoid arthritis

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          Abstract

          Background

          Since initial approval for the treatment of rheumatoid arthritis (RA), rituximab has been evaluated in clinical trials involving various populations with RA. Information has also been gathered from registries. This report therefore updates the 2007 consensus document on the use of rituximab in the treatment of RA.

          Methods

          Preparation of this new document involved many international experts experienced in the treatment of RA. Following a meeting to agree upon the core agenda, a systematic literature review was undertaken to identify all relevant data. Data were then interrogated by a drafting committee, with subsequent review and discussion by a wider expert committee leading to the formulation of an updated consensus statement. These committees also included patients with RA.

          Results

          The new statement covers wide-ranging issues including the use of rituximab in earlier RA and impact on structural progression, and aspects particularly pertinent to rituximab such as co-medication, optimal dosage regimens, repeat treatment cycles and how to manage non-response. Biological therapy following rituximab usage is also addressed, and safety concerns including appropriate screening for hepatitis, immunoglobulin levels and infection risk. This consensus statement will support clinicians and inform patients when using B-cell depletion in the management of RA, providing up-to-date information and highlighting areas for further research.

          Conclusion

          New therapeutic strategies and treatment options for RA, a chronic destructive and disabling disease, have expanded over recent years. These have been summarised in general strategic suggestions and specific management recommendations, emphasising the importance of expedient disease-modifying antirheumatic drug implementation and tight disease control. This consensus statement is in line with these fundamental principles of management.

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          Most cited references77

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          EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs

          Treatment of rheumatoid arthritis (RA) may differ among rheumatologists and currently, clear and consensual international recommendations on RA treatment are not available. In this paper recommendations for the treatment of RA with synthetic and biological disease-modifying antirheumatic drugs (DMARDs) and glucocorticoids (GCs) that also account for strategic algorithms and deal with economic aspects, are described. The recommendations are based on evidence from five systematic literature reviews (SLRs) performed for synthetic DMARDs, biological DMARDs, GCs, treatment strategies and economic issues. The SLR-derived evidence was discussed and summarised as an expert opinion in the course of a Delphi-like process. Levels of evidence, strength of recommendations and levels of agreement were derived. Fifteen recommendations were developed covering an area from general aspects such as remission/low disease activity as treatment aim via the preference for methotrexate monotherapy with or without GCs vis-à-vis combination of synthetic DMARDs to the use of biological agents mainly in patients for whom synthetic DMARDs and tumour necrosis factor inhibitors had failed. Cost effectiveness of the treatments was additionally examined. These recommendations are intended to inform rheumatologists, patients and other stakeholders about a European consensus on the management of RA with DMARDs and GCs as well as strategies to reach optimal outcomes of RA, based on evidence and expert opinion.
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            Chronic hepatitis B.

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              Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update

              Large amounts of new data on the natural history and treatment of chronic hepatitis B virus (HBV) infection have become available since 2005. These include long-term follow-up studies in large community-based cohorts or asymptomatic subjects with chronic HBV infection, further studies on the role of HBV genotype/naturally occurring HBV mutations, treatment of drug resistance and new therapies. In addition, Pegylated interferon α2a, entecavir and telbivudine have been approved globally. To update HBV management guidelines, relevant new data were reviewed and assessed by experts from the region, and the significance of the reported findings were discussed and debated. The earlier “Asian-Pacific consensus statement on the management of chronic hepatitis B” was revised accordingly. The key terms used in the statement were also defined. The new guidelines include general management, special indications for liver biopsy in patients with persistently normal alanine aminotransferase, time to start or stop drug therapy, choice of drug to initiate therapy, when and how to monitor the patients during and after stopping drug therapy. Recommendations on the therapy of patients in special circumstances, including women in childbearing age, patients with antiviral drug resistance, concurrent viral infection, hepatic decompensation, patients receiving immune-suppressive medications or chemotherapy and patients in the setting of liver transplantation, are also included.
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                Author and article information

                Journal
                Ann Rheum Dis
                annrheumdis
                ard
                Annals of the Rheumatic Diseases
                BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0003-4967
                1468-2060
                1 June 2011
                6 March 2011
                : 70
                : 6
                : 909-920
                Affiliations
                [1 ]Section of Musculoskeletal Diseases, Leeds Institute of Molecular Medicine, University of Leeds, Leeds, UK
                [2 ]NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust, Leeds, UK
                [3 ]Department of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Vienna, Austria
                [4 ]Center for Rheumatic Diseases, Hietzing Hospital, Vienna, Austria
                [5 ]Arthritis Care, UK
                [6 ]Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
                [7 ]Department of Rheumatology and Clinical Immunology, Humboldt University, Charite Hospital, Berlin, Germany
                [8 ]Division of Rheumatology, Catholic University of the Sacred Heart, Rome, Italy
                [9 ]Rheumatology Department, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France
                [10 ]Institute of Cellular Medicine, Newcastle University Medical School, Newcastle upon Tyne, UK
                [11 ]Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
                [12 ]Institut Pour la Santé et la Recherche Médicale (INSERM) U 1012, Hôpital Bicêtre, Université Paris-Sud 11, Paris, France
                [13 ]La Paz Hospital, Madrid, Spain
                [14 ]Institute of Rheumatology and Clinic of Rheumatology Charles University, Prague, Czech Republic
                [15 ]Division of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, The Netherlands
                [16 ]Rheumatology Unit, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Solna, Sweden
                Author notes
                Correspondence to Professor Josef S Smolen, Department of Internal Medicine 3, Division of Rheumatology, Medical University of Vienna, Waehringer Guertel 18–20, A-1090 Vienna, Austria; josef.smolen@ 123456wienkav.at

                The first two authors contributed equally.

                Article
                annrheumdis144998
                10.1136/ard.2010.144998
                3086093
                21378402
                b9c4bb90-a0b9-42cd-a36f-7d2f315964b3
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 10 January 2011
                Categories
                Consensus
                1506
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                Immunology
                Immunology

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