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Rheumatoid Arthritis: HELP
Articles from Russia
Based on 126 articles published since 2009
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These are the 126 published articles about Arthritis, Rheumatoid that originated from Russia during 2009-2019.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4 · 5 · 6
1 Editorial [Prospects for rheumatoid arthritis pharmacotherapy: New opportunities and recommendations]. 2016

Nasonov, E L. ·V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia. ·Ter Arkh · Pubmed #28139553.

ABSTRACT: The paper considers a current strategy, international and Russian recommendations for the pharmacotherapy of rheumatoid arthritis (RA), one of the most common and severe human immune-mediated inflammatory diseases. It emphasizes the need for early diagnosis and therapy with disease-modifying antirheumatic drugs, primarily methotrexate (MT), starting at the onset of the disease, and careful monitoring of therapeutic effectiveness, allowing RA remission to be achieved with a treatment-to-target strategy. The author discusses recent RA pharmacotherapy advances that are related to the rational use of MT, biological agents, and the new targeted JAK inhibitor tofacitinib.

2 Editorial Does Russia need a treat-to-target initiative? 2015

Nasonov, Eugeny L / Karateev, Dmitry E. ·Department of Vascular Pathology of Rheumatic Diseases and Early Arthritis Department, Research Institute of Rheumatology, Russian Academy of Medical Sciences (RAMS), Moscow, Russian Federation. · Department of Vascular Pathology of Rheumatic Diseases and Early Arthritis Department, Research Institute of Rheumatology, Russian Academy of Medical Sciences (RAMS), Moscow, Russian Federation. karateev@irramn.ru dekar@inbox.ru. ·Rheumatology (Oxford) · Pubmed #24736164.

ABSTRACT: -- No abstract --

3 Review The efficacy of rituximab in the therapy of neuromyelitis optica in a patient with Sjogren's syndrome: case-report and literature review. 2018

Torgashina, A V / Vasilyev, V I. ·V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia. ·Ter Arkh · Pubmed #30701893.

ABSTRACT: This case is the first description of the successful anti-B-cell therapy with rituximab in a patient with Sjogren's syndrome and neuromyelitis optica spectrum disorder in Russia. This article contains the literature data on clinical manifestations and methods of the diagnosis of neuromyelitis optica spectrum disorder. Furthermore, contemporary view on the pathogenesis of the combination of this disease with Sjogren's syndrome are presented here.

4 Review [Analysis of the interrelation between immune factors and inflammatory markers, and the course of chronic heart failiure in patients with rheumathoid arthritis]. 2018

Ankudinov, A S / Kalyagin, A N. ·State Budgetary Educational Institution of Higher Professional Education, "Irkutsk State Medical University" at the RF Ministry of Health Care. ·Kardiologiia · Pubmed #30362424.

ABSTRACT: This review presents relevant information about development and course of chronic heart failure (CHF) associated with rheumatoid arthritis (RA). One of the most discussed issues is the effect of systemic inflammatory process on prognosis of CHF. The review focused on current evidence for significance of this comorbidity in CHF. The diagnostic role of current immune markers, such as galectin 3, pentraxin 3, growth differentiation factor 15, and osteopontin was described. The review discussed the significance of antiinflammatory therapy for prognosis of CHF in the presence of systemic diseases. Possible beneficial effects of the basis therapy for RA on CHF outcomes were assessed. The authors noted a positive prognostic significance of methotrexate for the risk of decompensated CHF.

5 Review Modulation of T-cell responses by anti-tumor necrosis factor treatments in rheumatoid arthritis: a review. 2018

Davignon, Jean-Luc / Rauwel, Benjamin / Degboé, Yannick / Constantin, Arnaud / Boyer, Jean-Fredéric / Kruglov, Andrey / Cantagrel, Alain. ·Centre de Physiopathologie Toulouse Purpan, INSERM-CNRS-UPS, UMR 1043, CHU Purpan, 1 Place Baylac, 31024, Toulouse Cedex, France. jean-luc.davignon@inserm.fr. · Centre de Rhumatologie, CHU de Toulouse, 31059, Toulouse, France. jean-luc.davignon@inserm.fr. · Centre de Physiopathologie Toulouse Purpan, INSERM-CNRS-UPS, UMR 1043, CHU Purpan, 1 Place Baylac, 31024, Toulouse Cedex, France. · Centre de Rhumatologie, CHU de Toulouse, 31059, Toulouse, France. · Faculté de Médecine, Université Paul Sabatier Toulouse III, 31062, Toulouse, France. · Lomonosov Moscow State University, 119991, Moscow, Russia. · German Rheumatism Research Center (DRFZ), 10117, Berlin, Germany. ·Arthritis Res Ther · Pubmed #30314507.

ABSTRACT: Tumor necrosis factor (TNF) is a pleiotropic cytokine involved in many aspects of immune regulation. Anti-TNF biological therapy has been considered a breakthrough in the treatment of chronic autoimmune diseases, such as rheumatoid arthritis (RA). In this review, because of the major involvement of T cells in RA pathogenesis, we discuss the effects of anti-TNF biotherapy on T-cell responses in RA patients. We also outline the potential fields for future research in the area of anti-TNF therapy in RA.This could be useful to better understand the therapeutic efficiency and the side effects that are encountered in RA patients. Better targeting of T cells in RA could help set more specific anti-TNF strategies and develop prediction tools for response.

6 Review Vimentin as antigenic target in autoimmunity: A comprehensive review. 2018

Musaelyan, Aram / Lapin, Sergey / Nazarov, Vladimir / Tkachenko, Olga / Gilburd, Boris / Mazing, Alexandra / Mikhailova, Lilia / Shoenfeld, Yehuda. ·Laboratory for Diagnostics of Autoimmune Diseases, Center for Molecular Medicine, Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russian Federation. · Laboratory for Diagnostics of Autoimmune Diseases, Center for Molecular Medicine, Pavlov First Saint-Petersburg State Medical University, Saint-Petersburg, Russian Federation. Electronic address: autoimmun@mail.ru. · Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel; Sackler Faculty in Medicine, Sheba Medical Center, Tel-Aviv University, Israel. · Laboratory of the Mosaics of Autoimmunity, Saint-Petersburg University, Saint-Petersburg, Russian Federation. ·Autoimmun Rev · Pubmed #30009963.

ABSTRACT: Vimentin is a protein of intermediate filament family, which is expressed in all mesenchymal cells. Vimentin plays a key role in the physiology of the cell, cellular interactions and the functioning of the immune system. Post-translationally modified and native forms of vimentin are involved in the pathogenesis of inflammation and many autoimmune diseases: rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, antiphospholipid syndrome, Crohn's disease, ankylosing spondyloarthritis and idiopathic pulmonary fibrosis. Modifications of the protein lead to the formation of antigenic epitopes and, as a result, to the synthesis of antibodies. Citrullinated, carbamylated and acetylated forms of vimentin participate in the pathogenesis of RA, and antibodies against them serve as diagnostic and prognostic markers of the disease. Epitopes of native vimentin are antigenic in the group of HLA-DRB1*0301 positive patients with sarcoidosis. In addition, vimentin takes part in pathogenesis of tubulointerstitial inflammation and glomerulonephritis in lupus. In antiphospholipid syndrome interactions of vimentin and cardiolipin on the surface of apoptotic cells lead to the formation of an immunogenic complex. Antibodies against vimentin/cardiolipin complex are involved in the mechanism of thrombogenesis and serve to identify patients seronegative for antibodies to cardiolipin and ß2glycoprotein-I with the clinical features. Post-translationally modified form of the protein is citrullinated and MMP-degraded vimentin, which was found in serum of patients with Crohn's disease and ankylosing spondyloarthritis.

7 Review [Molecular genetic examination for dry eye syndrome prognosis]. 2018

Safonova, T N / Zaitseva, G V. ·Research Institute of Eye Diseases, 11 A, B Rossolimo St., Moscow, Russian Federation, 119021. ·Vestn Oftalmol · Pubmed #29953090.

ABSTRACT: The article reviews the results of Russian and foreign studies concerning the search of susceptibility genes for widespread multifactorial diseases: Sjogren's syndrome and rheumatoid arthritis. Studying regularity patterns of genome changes in autoimmune processes with ophthalmic manifestations and their correlation with the severity of dry keratoconjunctivitis will contribute to a better understanding of the etiology and pathogenesis of eye manifestations of the diseases, and will also allow the development of new effective methods of diagnosis and targeted therapy.

8 Review [The specific features of the psycho-emotional status and the application of psychotherapy for the rehabilitative treatment of the patients presenting with rheumatoid arthritis]. 2017

Kukshina, A A / Vereschagina, D A / Kotel'nikova, A V / Zaitsev, V P. ·Moscow Scientific and Practical Centre for Medical Rehabilitation, Restorative and Sports Medicine, Zemlyanoy val, 53, Moscow, Russia, 107120. ·Vopr Kurortol Fizioter Lech Fiz Kult · Pubmed #28884740.

ABSTRACT: The relevance of the problem of rheumatoid arthritis arises from the influence of such factors as its prevalence rate, unpredictability, tendency towards the transition to the chronic form, severe pain syndrome, high levels of disability, and long-term loss of working ability, as well as the accompanying psycho-emotional disorders. The present reviews article was designed to analyze the premorbid personality characteristics, the specifics features of mental health, and the response to the disease in the patients presenting with rheumatoid arthritis. Special emphasis is placed on the discusses of the relationship between the intensity of the pain syndrome and psycho-emotional disorders. The factors responsible for the development of the depressive states associated with rheumatoid arthritis are distinguished; they are shown to be related to both pathogenesis and the clinical symptoms of the underlying pathology as well as the general course of the disease and the specific features of the patients' psychological condition. The most extensively applied psychodiagnostics techniques are described, and the commonest psychotherapeutic approaches to the combined therapy and rehabilitation of the patients presenting with rheumatoid arthritis are overviewed.

9 Review European multicentre pilot survey to assess vitamin D status in rheumatoid arthritis patients and early development of a new Patient Reported Outcome questionnaire (D-PRO). 2017

Vojinovic, Jelena / Tincani, Angela / Sulli, Alberto / Soldano, Stefano / Andreoli, Laura / Dall'Ara, Francesca / Ionescu, Ruxandra / Pasalic, Katarina Simic / Balcune, Inete / Ferraz-Amaro, Ivan / Tlustochowicz, Małgorzata / Butrimiene, Irena / Punceviciene, Egle / Toroptsova, Natalia / Grazio, Simeon / Morovic-Vergles, Jadranka / Masaryk, Pavol / Otsa, Kati / Bernardes, Miguel / Boyadzhieva, Vladimira / Salaffi, Fausto / Cutolo, Maurizio. ·Clinical Centre, Medical Faculty, University of Nis, Bul Zorana Djindjica 81 Nis, Serbia. Electronic address: vojinovic.jelena@gmail.com. · Rheumatology and Clinical Immunology Unit, ASST Spedali Civili of Brescia and Dpt. of Clinical and Experimental Science, University of Brescia, Italy. Electronic address: tincani@med.unibs.it. · Research Laboratory and Academic Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino-Clinical, Viale Benedetto VX/6, 16132 Genova, Italy. · Rheumatology and Clinical Immunology Unit, ASST Spedali Civili of Brescia and Dpt. of Clinical and Experimental Science, University of Brescia, Italy. · Spitalul Sf. Maria, Clinica Medicina Interna Reumatologie, Bulevard Ion Mihalache 37-39, sector 1, Bucarest, Romania. Electronic address: ruxandraionescu1@gmail.com. · Institute of Rheumatology, Resavska 69, Belgrade, Serbia. Electronic address: simicpasalickatarina@gmail.com. · Division of Rheumatology, Paula Stradina Clinical Hospital, Pilsonu 13, Nr. 26, corpuss 10, LV-1001 Riga, Latvia. Electronic address: ine@no.lv. · Hospital Universitario de Canarias, Servicio de Reumatología, Planta 5, Ofra s/n La Cuesta, 38320 Santa Cruz de Tenerife, Spain. Electronic address: iferrazamaro@hotmail.com. · Rheumatology Institute, Military Medical Institute, Ul. Szaserów 128, 04-141 Warszawa, Poland. Electronic address: m.tlustochowicz@gmail.com. · Clinic of Rheumatology, Orthopedics Traumatology and Plastic Surgery, Vilnius University, Santariskiu Str. 2, LT-08406 Vilnius, Lithuania. · Clinic of Rheumatology, Orthopedics Traumatology and Plastic Surgery, Vilnius University, Santariskiu Str. 2, LT-08406 Vilnius, Lithuania. Electronic address: epunceviciene@gmail.com. · Scientific Research Institute of Rheumatology "V.A.Nasonova", Kashirskoye shosse 34A, 115522 Moscow, Russia. Electronic address: epid@irramn.ru. · Department of Rheumatology, Sisters of Mercy Clinical Hospital Centre University, Physical and Rehabilitation Medicine Vinogradska 29, 10000 Zagreb, Croatia. Electronic address: simeon.grazio@zg.t-com.hr. · Department for Clinical Immunology and Rheumatology, Clinical Hospital Dubrava, School of Medicine, University of Zagreb, Croatia. Electronic address: jmorovic@kbd.hr. · National Institute of Rheumatic Diseases, Nábrezie I. Krasku 4, 921 01 Piestany, Slovakia. Electronic address: pavol.masaryk@nurch.sk. · Department of Rheumatology, Tallinn Central Hospital, Pärnu mnt 104, 11312 Tallinn, Estonia. Electronic address: katii.otse@itk.ee. · Rheumatology Department, São João Hospital Center, Faculty of Medicine, University of Porto, Rua Dr Plácido da Costa, 4200-450 Porto, Portugal. Electronic address: mbernardes09@gmail.com. · UMHAT "St. Iv. Rilski" Clinic of Rheumatology, Medical University Sofia, Urvich str, fl 1, 1612 Sofia, Bulgaria. Electronic address: vladimira.boyadzhieva@gmail.com. · Department of Rheumatology, Università Politecnica delle Marche, Ancona, Italy. Electronic address: fausto.salaffi@gmail.com. · Research Laboratory and Academic Division of Rheumatology, Department of Internal Medicine, University of Genova, IRCCS San Martino-Clinical, Viale Benedetto VX/6, 16132 Genova, Italy. Electronic address: mcutolo@unige.it. ·Autoimmun Rev · Pubmed #28279841.

ABSTRACT: OBJECTIVE: To collect data on vitamin D (25(OH)D) serum levels in a large number of rheumatoid arthritis (RA) patients from different European countries, to investigate their relation with disease activity, disability, quality of life, and possibly to construct a new Patient Reported Outcome (PRO) questionnaire in order to self-estimate if they are at risk for vitamin D insufficiency/deficiency-related clinical implications (D-PRO). METHODS: This was a European League Against Rheumatism (EULAR) supported cross-sectional study (project No CLI064) which involved 625 RA patients (mean age 55±11years, mean disease duration 11±9years), 276 age and sex matched healthy subjects, and rheumatologists working in academic institutions or hospital centres, as well as PARE organizations (patient representatives) from 13 European countries. Serum samples for 25(OH)D level measurement were collected during winter time and analyzed in a central laboratory using chemiluminescence immunoassay (DiaSorin). Patient past medical history was recorded. RA patients were provided with three questionnaires: the Rheumatoid Arthritis Impact Diseases score (RAID), the Health Assessment Questionnaire (HAQ), and the new D-PRO questionnaire at the time of 25(OH)D serum sampling. D-PRO questionnaire consisted of three domains, Symptom Risk Score (SRS), Habitus Risk Score (HRS) and Global Risk Score (SRS+HRS=GRS), constructed with items possibly related to vitamin D deficiency. D-PRO was correlated with both clinical and PRO scores. DAS28-CRP was also evaluated. Statistical analysis was performed by non parametric tests. RESULTS: Mean serum concentration of 25(OH)D in RA patients (17.62±9.76ng/ml) was found significantly lower if compared to the levels obtained in matched controls (18.95±9.45ng/ml) (p=0.01), with statistically significant differences among several European countries. Negative correlations were found between 25(OH)D serum levels and DAS28-CRP (p<0.001), RAID (p=0.05) and HAQ (p=0.04) scores in the RA patients group. Negative correlations were also found in the cohort of enrolled RA patients between 25(OH)D serum concentrations and SRS (p=0.04), HRS (p=0.02) and GRS (p=0.02) domains of the D-PRO questionnaire. CONCLUSIONS: This first multicentre European survey add new evidences that vitamin D insufficiency/deficiency is frequent in RA patients with statistically significant differences among several countries. Vitamin D serum concentrations seem to correlate negatively and significantly with the D-PRO Global Risk Score, clinimetric indexes for quality of life, disease activity and disability in present cohort of RA European patients.

10 Review EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. 2017

Smolen, Josef S / Landewé, Robert / Bijlsma, Johannes / Burmester, Gerd / Chatzidionysiou, Katerina / Dougados, Maxime / Nam, Jackie / Ramiro, Sofia / Voshaar, Marieke / van Vollenhoven, Ronald / Aletaha, Daniel / Aringer, Martin / Boers, Maarten / Buckley, Chris D / Buttgereit, Frank / Bykerk, Vivian / Cardiel, Mario / Combe, Bernard / Cutolo, Maurizio / van Eijk-Hustings, Yvonne / Emery, Paul / Finckh, Axel / Gabay, Cem / Gomez-Reino, Juan / Gossec, Laure / Gottenberg, Jacques-Eric / Hazes, Johanna M W / Huizinga, Tom / Jani, Meghna / Karateev, Dmitry / Kouloumas, Marios / Kvien, Tore / Li, Zhanguo / Mariette, Xavier / McInnes, Iain / Mysler, Eduardo / Nash, Peter / Pavelka, Karel / Poór, Gyula / Richez, Christophe / van Riel, Piet / Rubbert-Roth, Andrea / Saag, Kenneth / da Silva, Jose / Stamm, Tanja / Takeuchi, Tsutomu / Westhovens, René / de Wit, Maarten / van der Heijde, Désirée. ·Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria. · 2nd Department of Medicine, Hietzing Hospital, Vienna, Austria. · Amsterdam Rheumatology & Immunology Center, Amsterdam, The Netherlands. · Zuyderland Medical Center, Heerlen, The Netherlands. · Department of Rheumatology and Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands. · Department of Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Free University and Humboldt University Berlin, Berlin, Germany. · Rheumatology Department, Karolinska Institute, Stockholm, Sweden. · Rhumatologie B, Hopital Cochin, Paris, France. · NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals NHS Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK. · Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands. · Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands. · Division of Rheumatology, Medizinische Klinik und Poliklinik III, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. · Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands. · Birmingham NIHR Wellcome Trust Clinical Research Facility, Rheumatology Research Group, Institute of Inflammation and Ageing (IIA), University of Birmingham, Queen Elizabeth Hospital, Birmingham, UK. · Department of Rheumatology, Hospital for Special Surgery, Weill Cornell Medical College, New York, New York, USA. · Rebecca McDonald Center for Arthritis & Autoimmune Disease, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada. · Centro de Investigación Clínica de Morelia SC, Michoacán, México. · Rheumatology Department, Lapeyronie Hospital, Montpellier University, UMR 5535, Montpellier, France. · Research Laboratory and Division of Clinical Rheumatology, University of Genoa, Genoa, Italy. · Department of Patient & Care and Department of Rheumatology, University of Maastricht, Maastricht, The Netherlands. · Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland. · Fundación Ramón Dominguez, Hospital Clinico Universitario, Santiago, Spain. · Department of Rheumatology, Sorbonne Universités, Pitié Salpêtrière Hospital, Paris, France. · Institut de Biologie Moléculaire et Cellulaire, Immunopathologie, et Chimie Thérapeutique, Strasbourg University Hospital and University of Strasbourg, CNRS, Strasbourg, France. · Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands. · Arthritis Research UK Centre for Epidemiology, Centre for Musculoskeletal Research, University of Manchester, Manchester, UK. · V.A. Nasonova Research Institute of Rheumatology, Moscow, Russian Federation. · European League Against Rheumatism, Zurich, Switzerland. · Cyprus League against Rheumatism, Nicosia, Cyprus. · Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. · Department of Rheumatology and Immunology, Beijing University People's Hospital, Beijing, China. · Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, INSERM U1184, Center for Immunology of viral Infections and Autoimmune Diseases (IMVA), Le Kremlin Bicêtre, France. · Institute of Infection, Immunity and Inflammation, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK. · Organización Médica de Investigación, Buenos Aires, Argentina. · Department of Medicine, University of Queensland, Queensland, Australia. · Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic. · National Institute of Rheumatology and Physiotherapy, Semmelweis University, Budapest, Hungary. · Rheumatology Department, FHU ACRONIM, Pellegrin Hospital and UMR CNRS 5164, Bordeaux University, Bordeaux, France. · Department of Rheumatology, Bernhoven, Uden, The Netherlands. · University of Cologne, Cologne, Germany. · Division of Rheumatology, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA. · Serviço de Reumatologia, Centro Hospitalar e Universitário de Coimbra Praceta Mota Pinto, Coimbra, Portugal. · Section for Outcomes Research, Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University of Vienna, Vienna, Austria. · Keio University School of Medicine, Keio University Hospital, Tokyo, Japan. · Department of Development and Regeneration, Skeletal Biology and Engineering Research Center, KU Leuven, Leuven, Belgium. · Department of Rheumatology, University Hospitals Leuven, Leuven, Belgium. · Department Medical Humanities, VU Medical Centre, Amsterdam, The Netherlands. ·Ann Rheum Dis · Pubmed #28264816.

ABSTRACT: 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). Monotherapy, combination therapy, treatment strategies (treat-to-target) and the targets of sustained clinical remission (as defined by the American College of Rheumatology-(ACR)-EULAR Boolean or index criteria) or low disease activity are discussed. Cost aspects were taken into consideration. As first strategy, the Task Force recommends MTX (rapid escalation to 25 mg/week) plus short-term GC, aiming at >50% improvement within 3 and target attainment within 6 months. If this fails stratification is recommended. Without unfavourable prognostic markers, switching to-or adding-another csDMARDs (plus short-term GC) is suggested. In the presence of unfavourable prognostic markers (autoantibodies, high disease activity, early erosions, failure of 2 csDMARDs), any bDMARD (current practice) or Jak-inhibitor should be added to the csDMARD. If this fails, any other bDMARD or tsDMARD is recommended. If a patient is in sustained remission, bDMARDs can be tapered. For each recommendation, levels of evidence and Task Force agreement are provided, both mostly very high. These recommendations intend informing rheumatologists, patients, national rheumatology societies, hospital officials, social security agencies and regulators about EULAR's most recent consensus on the management of RA, aimed at attaining best outcomes with current therapies.

11 Review Semaphorins 4A and 4D in chronic inflammatory diseases. 2017

Chapoval, Svetlana P / Vadasz, Zahava / Chapoval, Andrei I / Toubi, Elias. ·SemaPlex LLC, 3435 Plumtree Drive, Ellicott City, MD, 21042, USA. schapoval@som.umaryland.edu. · Department of Microbiology and Immunology, Center for Vascular and Inflammatory Diseases, Program in Oncology at the Greenebaum Cancer Center, University of Maryland School of Medicine, 800 West Baltimore Street, Baltimore, MD, 21201, USA. schapoval@som.umaryland.edu. · Division of Allergy and Clinical Immunology, Bnai Zion Medical Center, Technion Faculty of Medicine, 4940, Haifa, Israel. · The Russian-American Anti-Cancer Center, Altai State University, Barnaul, 656049, Russia. · The Biodesign Institute, Arizona State University, 1001 S McAllister Ave, Tempe, AZ, 85281, USA. ·Inflamm Res · Pubmed #27554682.

ABSTRACT: Long-term inflammatory processes directed at a particular endogenous or exogenous antigen, or sometimes of unknown etiology, form the pathogenetic basis for many debilitating conditions, such as cardiovascular, pulmonary, autoimmune, neurologic diseases, and cancer. Recent discoveries of neuroimmune semaphorins 4A and 4D (Sema4A and Sema4D, respectively) expression and function in the immune system and their key regulatory roles in fine tuning of inflammatory processes made them the molecules of interest for a potential immunotherapy. In this short review, we discuss the current knowledge in the Sema4A and Sema4D actions in chronic inflammation underlying the outlined above diseases.

12 Review [Cardiovascular Complications of Rheumatoid Arthritis: Prevalence and Pathogenesis]. 2016

Krougly, L B / Fomicheva, O A / Karpov, Yu A / Popkova, T V / Novikova, D S / Nasonov, E L. ·Myasnikov Clinical Cardiology Institute, Russian Cardiology Research Center, Moscow, Russia. · V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia. ·Kardiologiia · Pubmed #28290854.

ABSTRACT: Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with high risk of cardiovascular events. Among main causes of death in RA are: myocardial infarction, cerebrovascular accident, sudden cardiac death, which are determined by the early development and rapid progression of atherosclerotic vascular lesions. According to studies high risk of cardiovascular events is not explained by only classical risk factors. It is assumed that there are additional mechanisms of development of adverse outcomes such as systemic inflammation, increased arterial stiffness, and endothelial dysfunction. In this literature review we present various risk factors of cardiovascular events in patients with RA and their relation to RA pathogenesis.

13 Review From TGN1412 to TAB08: the return of CD28 superagonist therapy to clinical development for the treatment of rheumatoid arthritis. 2016

Tyrsin, Dmitry / Chuvpilo, Sergey / Matskevich, Alexey / Nemenov, Daniil / Römer, Paula S / Tabares, Paula / Hünig, Thomas. ·TheraMAB LLC, Würzburg, Germany, and Moscow, Russia. · Institute for Virology and Immunobiology, University of Würzburg, Germany. · Institute for Virology and Immunobiology, University of Würzburg, Germany. huenig@vim.uni-wuerzburg.de. ·Clin Exp Rheumatol · Pubmed #27586803.

ABSTRACT: CD28 superagonists (CD28SA) are CD28-specific monoclonal antibodies which are able to activate T-cells without overt TCR engagement. In rodents, CD28SA efficiently activate regulatory T-cells and are therapeutically effective in multiple models of autoimmunity, inflammation and transplantation. However, a phase I study of the human CD28SA TGN1412 in 2006 resulted in a life-threatening cytokine storm. This brief review summarises preclinical work before and since the failed phase I trial with an emphasis on understanding the reasons why there had been no warning of toxicity, and how a novel assay paved the way for a new phase I, phase Ib (both completed), and an ongoing phase II study.

14 Review [Anemic syndrome in rheumatoid arthritis: Diagnostic approaches and treatment opportunities]. 2016

Grinshtein, Yu I / Shabalin, V V / Kusaev, V V. ·Prof. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia, Krasnoyarsk, Russia. ·Ter Arkh · Pubmed #27458626.

ABSTRACT: Anemia of chronic disease (ACD) is a leading cause of anemic syndrome in patients with rheumatoid arthritis (RA). Enhanced hepcidin production mainly stimulated by excess interleukin-6 levels is a key pathodgentic component of ACD (frequently known as anemia of inflammation) by causing the degradation of the transmembrane protein ferroportin, hepcidin impairs iron metabolism. On the basis of the material of recent publications the review gives present-day views on the pathodgenesis of ACD in RA, approaches to the diagnosis and differential diagnosis of ACD, especially in its concomitance with iron-deficiency anemia, as well as approaches to therapy for the type of anemic syndrome with the complex mechanism for its development.

15 Review [Interleukin-6 inhibition and cardiovascular disease in patients with rheumatoid arthritis]. 2016

Popkova, T V / Novikova, D S / Nasonov, E L. ·V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia. ·Ter Arkh · Pubmed #27458623.

ABSTRACT: Rheumatoid arthritis (RA) is a' disease conferring high risk for cardiovascular events (CVE). Systemic inflammation underlying RA favors development of CVE. The safety of biological agents, acting on the cardiovascular system has been inadequately investigated. On the one hand, they decrease RA activity and, on the other, may increase the risk of CVE. This review analyzes' the literature data predominantly published in recent years on the effect of an IL-6 receptor inhibitor on the cardiovascular system. Tocilizumab is shown to be a promising agent to reduce cardiovascular risk the findings need to be clinically verified. Long-term prospective investigations should be conducted to determine more exactly the impact of IL-6 receptor inhibition on. the development of CVE.

16 Review MicroRNAs in rheumatoid arthritis: altered expression and diagnostic potential. 2015

Churov, Alexey V / Oleinik, Eugenia K / Knip, Mikael. ·Institute of Biology of Karelian Research Centre Russian Academy of Sciences, 185910 Petrozavodsk, Russian Federation. Electronic address: achurou@yandex.ru. · Institute of Biology of Karelian Research Centre Russian Academy of Sciences, 185910 Petrozavodsk, Russian Federation. Electronic address: ole@krc.karelia.ru. · Children`s Hospital, University of Helsinki and Helsinki University Hospital, Helsinki, Finland; Research Programs Unit, Diabetes and Obesity, University of Helsinki, Helsinki, Finland; Folkhälsan Research Center, Helsinki, Finland; Tampere Center for Child Health Research, Tampere University Hospital, Tampere, Finland. Electronic address: mikael.knip@helsinki.fi. ·Autoimmun Rev · Pubmed #26164649.

ABSTRACT: Rheumatoid arthritis (RA) is a polygenic disease characterized by autoimmunity and systemic inflammation with progressive impairment of joints that results in lifelong disability and increased mortality. Early diagnosis and therapeutic intervention or treatment can prevent severe disease manifestations in patients suffering from RA. The use of appropriate predictive biomarkers may improve the efficiency of RA therapy. The general aim of this review is to highlight the most recent findings on miRNAs expression profiles in RA patients and to discuss their potential as new biomarkers for diagnostic purposes. The current literature demonstrates that a variety of miRNAs is frequently dysregulated in RA patients. To date, the majority of miRNAs have been found to be overexpressed during the natural course of RA. MiR-16, miR-146a/b, miR-150, miR-155, and miR-223 described here were shown to be overexpressed at the systemic level: in both the periphery and RA joints. Circulating peripheral blood miRNAs, especially miR-16, miR-21, miR-24, miR-26a, miR-125a-5p, miR-125b, miR-126-3p, miR-223, and miR-451, which are elevated in the plasma or serum, are considered to be the most promising non-invasive biomarkers for the detection of RA.

17 Review [Primary hepatic lymphoma in a female patient with Sjögren's disease: A case report and literature review]. 2015

Gorodetskiy, V R / Probatova, N A / Vasilyev, V I / Vardaev, L I / Ipatkin, R V / Gabunia, Z R / Petukhova, S V / Ivannikov, I O. ·V.A. Nasonova Research Institute of Rheumatology, Moscow, Russia. · N.N. Blokhin Russian Cancer Research Center, Moscow, Russia. · N.A. Semashko Central Clinical Hospital Two, OAO 'RZhD', Moscow, Russia. · Central Clinical Hospital with Polyclinic, Department for Presidential Affairs of the Russian Federation, Moscow, Russia. ·Ter Arkh · Pubmed #26155625.

ABSTRACT: The paper describes a case of primary hepatic diffuse large B-cell lymphoma in a 52-year-old woman with a 27-year history of Sjögren's disease. It gives the data available in the literature on the etiology, diagnosis, and morphological characteristics of primary hepatic lymphoma and touches upon the issues of differential diagnosis.

18 Review Anti-arthritic agents: progress and potential. 2015

Laev, Sergey S / Salakhutdinov, Nariman F. ·Vorozhtsov Institute of Organic Chemistry, Siberian Division, Russian Academy of Sciences, pr. akademika Lavrent'eva 9, Novosibirsk 630090, Russian Federation. Electronic address: sergey@nioch.nsc.ru. · Vorozhtsov Institute of Organic Chemistry, Siberian Division, Russian Academy of Sciences, pr. akademika Lavrent'eva 9, Novosibirsk 630090, Russian Federation; Novosibirsk State University, Pirogova str. 2, Novosibirsk 630090, Russian Federation. ·Bioorg Med Chem · Pubmed #26014481.

ABSTRACT: Osteoarthritis and rheumatoid arthritis are the two most common types of arthritis. Cartilage breakdown is a key feature of both diseases which contributes to the pain and joint deformity experienced by patients. Therefore, anti-arthritis drugs are of great importance. The aim of this review is to present recent progress in studies of various agents against osteoarthritis and rheumatoid arthritis. The structures and activities of anti-arthritic agents, which used in medical practice or are in development, are presented and discussed. The effects and mechanisms of action of opioids, glucocorticoids, non-steroidal anti-inflammatory drugs, disease-modifying anti-rheumatic drugs, natural products derived from plants, nutraceuticals, and a number of new and perspective agents are considered. Various perspective targets for the treatment of osteoarthritis and rheumatoid arthritis are also discussed. Trials of good quality are needed to draw solid conclusions regarding efficacy of many of the studied agents. Unfortunately, to date, there is no pharmacologic agent proven to prevent the progression of both diseases, and there is an urgent need for further development of better anti-arthritic agents.

19 Review Cardiovascular effects of methotrexate in rheumatoid arthritis revisited. 2015

Popkova, Tatyana V / Novikova, Diana S / Gasparyan, Armen Yuri / Nasonov, Evgeny L. ·Department of Vascular Pathology of Rheumatic Diseases, V.A. Nasonova Research Institute of Rheumatology, Russian Academy Sciences, Kashirskoe Shosse, 34A, Moscow, 115522, Russian Federation. popkovatv@mail.ru. ·Curr Med Chem · Pubmed #25876749.

ABSTRACT: Cardiovascular events such as myocardial infarction (MI) and stroke due to enhanced inflammatory atherosclerosis account for increased premature mortality in rheumatoid arthritis (RA). Accumulated evidence suggests that accelerated atherosclerosis and related cardiovascular comorbidities in RA are confounded not only by traditional risk factors (TRF) but also by a number of immune and inflammatory pathways. Since chronic inflammation and autoimmune disorders play a key role in atherosclerosis and related cardiovascular complications in RA, effective suppression of systemic inflammation can be viewed as a strategy for cardiovascular therapy and prevention in this disease. This article overviews some mechanisms of action of methotrexate on TRF, clinical and subclinical manifestations of RA-induced atherosclerosis, and related cardiovascular morbidity and mortality.

20 Review The effect of anti-B-cell therapy on the development of atherosclerosis in patients with rheumatoid arthritis. 2012

Novikova, Diana S / Popkova, Tatyana V / Nasonov, Eugeny L. ·Research Institute of Rheumatology, Russian Academy of Medical Sciences, Department of Vascular Pathology of Rheumatic Diseases, 34a, Kashirskoe shosse, Moscow, 115522, Russian Federation. diananovikova75@yandex.ru ·Curr Pharm Des · Pubmed #22364135.

ABSTRACT: Accelerated development of atherosclerosis (AT) in rheumatoid arthritis (RA) stems from common immune-inflammatory mechanisms underlying the diseases. While the key role of activation of the T-cell immune system component is considered to be proved, the role of B-lymphocytes has been investigated insufficiently. Earlier experimental models demonstrated the "atheroprotective" role of B-cells. At the same time, AT development is associated with activation of the B-cell immune system component and manifested by hyperproduction of antibodies to oxidized low density lipoproteins (oxLDL), heat shock proteins, etc. Wide applications of anti-B-cell therapy stimulate active research on effects of B-lymphocytes and their depletion on AT development in RA patients that have a high risk of cardiovascular events (CVE). Experimental models demonstrated that depletion of B2 cells instead of B1 cells under anti-CD20 treatment resulted in a slower development and progression of AT. Research on cardiovascular effects of chimeric antiCD20 monoclonal antibody (rituximab, RTX) in RA is definitely of high interest. Use of RTX in a combination with methotrexate does not increase the risk of serious side effects, including CVE, compared with the sole use of methotrexate. Currently, only few pilot research reports on favorable effects of RTX on the lipid profile and endothelial function in RA patients have been published. According to other authors, the frequency of CVE in RA patients receiving RTX therapy was somewhat higher than that in patients not treated with RTX. In rare cases such side effects as hypotension and arrhythmia were reported under RTX infusion. In addition, investigation of the combined use of statins and RTX is important, since some data are available on a reduced efficacy of RTX when administered with statins. Therefore, further research is required to clarify the role of the B-cell immune system component in AT development and the impact of anti-B cell therapy on the pathogenetic mechanisms of AT and CVE in RA patients.

21 Clinical Trial Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial. 2019

Suh, Chang-Hee / Yoo, Dae Hyun / Berrocal Kasay, Alfredo / Chalouhi El-Khouri, Elia / Cons Molina, Francisco Fidenci / Shesternya, Pavel / Miranda, Pedro / Medina-Rodriguez, Francisco G / Wiland, Piotr / Jeka, Slawomir / Chavez-Corrales, Jose / Linde, Thomas / Hrycaj, Pawel / Abello-Banfi, Mauricio / Hospodarskyy, Ihor / Jaworski, Janusz / Piotrowski, Mariusz / Brzosko, Marek / Krogulec, Marek / Shevchuk, Sergii / Calvo, Armando / Andersone, Daina / Park, Won / Shim, Seung Cheol / Lee, Sang Joon / Lee, Sung Young. ·Department of Rheumatology, Ajou University School of Medicine, Suwon, Republic of Korea. · Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea. dhyoo@hanyang.ac.kr. · ABK Reuma SRL-Medicentro Biociencias, Lima, Peru. · Clinica Internacional, Lima, Peru. · Centro de Investigación en Artritis y Osteoporosis, Mexicali, Mexico. · Krasnoyarsk State Medical University, Krasnoyarsk, Russia. · Centro de Estudios Reumatológicos, Santiago, Chile. · La Salle University, Mexico City, Mexico. · Medical University of Wroclaw, Wrocław, Poland. · Department of Rheumatology and Connective Tissue Diseases, University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland. · Clinica San Borja, Lima, Peru. · MVZ für Rheumatologie und Autoimmundiagnostik, Halle (Salle), Germany. · Department of Rheumatology, Koscian Municipal Hospital, Koscian, Poland. · Centro Integral de Reumatologia del Caribe, Barranquilla, Colombia. · Ternopil State Medical University, Ternopil, Ukraine. · Reumatika-Centrum Reumatologii, Warsaw, Poland. · Department of Rheumatology, Medical University of Lublin, Lublin, Poland. · Department of Rheumatology, Internal Diseases and Geriatrics, Pomeranian Medical University in Szczecin, Szczecin, Poland. · Rheumatology Clinic MAK-MED, Nadarzyn, Poland. · National Pirogov Memorial Medical University, Vinnytsya, Ukraine. · Centro de Investigación Clínica Inunoreumatología, Clínica San Felipe, Universidad Peruana Cayetano Heredia, Lima, Peru. · University of Latvia, Riga, Latvia. · School of Medicine, Medicine/Rheumatology, IN-HA University, Incheon, Republic of Korea. · Department of Internal Medicine, Chungnam National University Hospital, Daejeon, Republic of Korea. · CELLTRION, Inc., Incheon, Republic of Korea. ·BioDrugs · Pubmed #30719632.

ABSTRACT: OBJECTIVE: The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. METHODS: In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. RESULTS: Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (- 2.7 and - 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. CONCLUSION: CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. CLINICALTRIALS. GOV IDENTIFIER: NCT02149121.

22 Clinical Trial Comparison of biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: a randomized controlled Phase 3 trial. 2018

Park, Won / Božić-Majstorović, Ljubinka / Milakovic, Dragana / Berrocal Kasay, Alfredo / El-Khouri, Elias Chalouhi / Irazoque-Palazuelos, Fedra / Molina, Francisco Fidencio Cons / Shesternya, Pavel / Miranda, Pedro / Medina-Rodriguez, Francisco G / Wiland, Piotr / Jeka, Slawomir / Chavez-Corrales, Jose / Garmish, Olena / Linde, Thomas / Rekalov, Dmytro / Hrycaj, Pawel / Krause, Andreas / Fomina, Natalia / Piura, Olena / Abello-Banfi, Mauricio / Suh, Chang-Hee / Shim, Seung Cheol / Lee, Sang Joon / Lee, Sung Young / Kim, Sung Hwan / Yoo, Dae Hyun. ·a Medicine/Rheumatology , IN-HA University, School of Medicine , Incheon , Republic of Korea. · b University Clinical Centre of the Republic of Srpska , Banja Luka , Bosnia and Herzegovina. · c ABK Reuma SRL - Medicentro Biociencias , Lima , Peru. · d Clinica Internacional , Lima , Peru. · e Centro de Investigación y Tratamiento Reumatológico S.C ., Mexico City , Mexico. · f Centro de Investigación en Artritis y Osteoporosis , Mexicali , Mexico. · g Krasnoyarsk State Medical University , Krasnoyarsk , Russia. · h Centro de Estudios Reumatológicos , Santiago , Chile. · i La Salle University , Mexico City , Mexico. · j Medical University of Wroclaw , Wroclaw , Poland. · k Department of Rheumatology and Connective Tissue Diseases , University Hospital No. 2, Collegium Medicum UMK , Bydgoszcz , Poland. · l Clinica San Borja , Lima , Peru. · m Institute of Cardiology named by M.D. Strazhesko NAMS of Ukraine , Kyiv , Ukraine. · n MVZ für Rheumatologie und Autoimmundiagnostik, Halle (Salle) , Germany. · o Department of Internal Diseases , Zaporizhzhia State Medical University , Zaporizhzhia , Ukraine. · p Department of Rheumatology and Clinical Immunology , Poznań University of Medical Sciences , Poznań , Poland. · q Medical Centre for Rheumatology Berlin-Buch, Immanuel Krankenhaus Berlin , Berlin , Germany. · r Kemerovo Regional Clinical Hospital , Kemerovo , Russian Federation. · s Department of Rheumatology , Kyiv Regional Clinical Hospital , Kyiv , Ukraine. · t Centro Integral de Reumatologia del Caribe , Barranquilla , Colombia. · u Department of Rheumatology , Ajou University School of Medicine , Suwon , Republic of Korea. · v Department of Internal Medicine , Chungnam National University Hospital , Daejeon , Republic of Korea. · w CELLTRION, Inc ., Incheon , Republic of Korea. · x Division of Rheumatology , Hanyang University Hospital for Rheumatic Diseases , Seoul , Republic of Korea. ·MAbs · Pubmed #30010481.

ABSTRACT: This multinational, randomized, double-blind trial, (ClinicalTrials.gov identifier NCT02149121) was designed to demonstrate equivalence in pharmacokinetics and efficacy between CT-P10 and innovator rituximab (RTX) in patients with rheumatoid arthritis (RA). Adults with active RA were treated with CT-P10, United States-sourced RTX (US-RTX; Rituxan®), or European Union-sourced RTX (EU-RTX; MabThera®) at weeks 0 and 2. The co-primary pharmacokinetic endpoints were area under the serum concentration-time curve (AUC) from time zero to last measurable concentration (AUC

23 Clinical Trial Quantitative assessment of betamethasone dual-acting formulation in urine of patients with rheumatoid arthritis and ankylosing spondylitis after single-dose intramuscular administration and its application to long-term pharmacokinetic study. 2018

Kopylov, Arthur T / Novikov, Alexander A / Kaysheva, Anna L / Vykhodets, Igor T / Karateev, Dmitry E / Zgoda, Victor G / Lisitsa, Andrey V. ·V. N. Orekhovich Research Institute of Biomedical Chemistry, 10 Pogodinskaya str. bld. 8, 119121 Moscow, Russian Federation. Electronic address: a.t.kopylov@gmail.com. · V. A. Nasonova Clinical Institute of Rheumatoid Arthritis, 34A Kashirskoe Highway, 115522 Moscow, Russian Federation. · V. N. Orekhovich Research Institute of Biomedical Chemistry, 10 Pogodinskaya str. bld. 8, 119121 Moscow, Russian Federation. · Pirogov Russian National Research Medical University, 1 Ostrovitianov str., 117997 Moscow, Russian Federation. ·J Pharm Biomed Anal · Pubmed #29128828.

ABSTRACT: Quantitative evaluation and assessment of pharmacokinetic parameters of Diprospan

24 Clinical Trial Efficacy, Safety and Pharmacokinetics of Up to Two Courses of the Rituximab Biosimilar CT-P10 Versus Innovator Rituximab in Patients with Rheumatoid Arthritis: Results up to Week 72 of a Phase I Randomized Controlled Trial. 2017

Yoo, Dae Hyun / Suh, Chang-Hee / Shim, Seung Cheol / Jeka, Slawomir / Molina, Francisco Fidencio Cons / Hrycaj, Pawel / Wiland, Piotr / Lee, Eun Young / Medina-Rodriguez, Francisco G / Shesternya, Pavel / Radominski, Sebastiao / Stanislav, Marina / Kovalenko, Volodymyr / Sheen, Dong Hyuk / Myasoutova, Leysan / Lim, Mie Jin / Choe, Jung-Yoon / Lee, Sang Joon / Lee, Sung Young / Kim, Sung Hwan / Park, Won. ·Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea. · Ajou University School of Medicine, Suwon, Republic of Korea. · Chungnam National University Hospital, Daejeon, Republic of Korea. · Collegium Medicum UMK, University Hospital No. 2, Bydgoszcz, Poland. · Centro de Investigación en Artritis y Osteoporosis, Mexicali, Mexico. · Poznań University of Medical Sciences, Poznań, Poland. · Medical University of Wrocław, Wrocław, Poland. · Seoul National University College of Medicine, Seoul, Republic of Korea. · La Salle University, Mexico City, Mexico. · Krasnoyarsk State Medical University, Krasnoyarsk, Russia. · Universidade Federal do Paraná, Curitiba, Brazil. · Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia. · National Scientific Center, Kiev, Ukraine. · Eulji University Hospital, Daejeon, Republic of Korea. · Research Medical Complex Vashe Zdorovie, Kazan, Russia. · School of Medicine, IN-HA University, Incheon, Republic of Korea. · School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea. · CELLTRION, Inc., Incheon, Republic of Korea. · School of Medicine, IN-HA University, Incheon, Republic of Korea. parkwon@inha.ac.kr. ·BioDrugs · Pubmed #28612179.

ABSTRACT: BACKGROUND: CT-P10 is a biosimilar of innovator rituximab (RTX), a biological therapy used to treat patients with rheumatoid arthritis (RA) who have responded inadequately to anti-tumor necrosis factor agents. OBJECTIVE: Our objective was to compare the clinical profile of CT-P10 versus RTX in patients with RA who received up to two courses of treatment and were followed for up to 72 weeks. METHODS: In this multicenter double-blind phase I study, patients were randomized 2:1 to receive CT-P10 1000 mg or RTX 1000 mg at weeks 0 and 2. Based on disease activity, patients could receive a second course of treatment between weeks 24 and 48. Efficacy endpoints, including mean change from baseline in Disease Activity Score using 28 joints (DAS28), safety, immunogenicity, pharmacokinetics, and pharmacodynamics were evaluated. RESULTS: In total, 154 patients were randomized to CT-P10 or RTX (n = 103 and 51, respectively); 137 (n = 92 and 45) completed the first course of treatment, of whom 83 (n = 60 and 23) were re-treated. Improvements from baseline in all efficacy endpoints were highly similar between the CT-P10 and RTX groups over both treatment courses. At week 24 after the second course, mean change from week 0 of the first course in DAS28 erythrocyte sedimentation rate was -2.47 and -2.04 for CT-P10 and RTX, respectively, (p = 0.1866) and in DAS28 C-reactive protein was -2.32 and -2.00, respectively (p = 0.3268). The proportion of patients positive for antidrug antibodies at week 24 after the second treatment course was 20.0% and 21.7% in the CT-P10 and RTX groups, respectively. The safety profile of CT-P10 was comparable to that of RTX, and pharmacokinetic and pharmacodynamic properties were similar. CONCLUSIONS: In patients with RA, efficacy, safety, and other clinical data were comparable between CT-P10 and RTX after up to two courses of treatment over 72 weeks. (ClinicalTrials.gov identifier NCT01534884).

25 Clinical Trial Efficacy and Safety of Switching from Innovator Rituximab to Biosimilar CT-P10 Compared with Continued Treatment with CT-P10: Results of a 56-Week Open-Label Study in Patients with Rheumatoid Arthritis. 2017

Park, Won / Suh, Chang-Hee / Shim, Seung Cheol / Molina, Francisco Fidencio Cons / Jeka, Slawomir / Medina-Rodriguez, Francisco G / Hrycaj, Pawel / Wiland, Piotr / Lee, Eun Young / Shesternya, Pavel / Kovalenko, Volodymyr / Myasoutova, Leysan / Stanislav, Marina / Radominski, Sebastiao / Lim, Mie Jin / Choe, Jung-Yoon / Lee, Sang Joon / Lee, Sung Young / Kim, Sung Hwan / Yoo, Dae Hyun. ·School of Medicine, IN-HA University, Incheon, Republic of Korea. · Ajou University School of Medicine, Suwon, Republic of Korea. · Chungnam National University Hospital, Daejeon, Republic of Korea. · Centro de Investigación en Artritis y Osteoporosis, Mexicali, Mexico. · University Hospital No. 2, Collegium Medicum UMK, Bydgoszcz, Poland. · La Salle University, Mexico City, Mexico. · Poznań University of Medical Sciences, Poznań, Poland. · Medical University of Wrocław, Wrocław, Poland. · Seoul National University College of Medicine, Seoul, Republic of Korea. · Krasnoyarsk State Medical University, Krasnoyarsk, Russia. · National Scientific Center, Kiev, Ukraine. · Research Medical Complex Vashe Zdorovie, Kazan, Russia. · Research Rheumatology Institute n. a. V.A. Nassonova, Moscow, Russia. · Universidade Federal do Paraná, Curitiba, Brazil. · School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea. · CELLTRION, Inc., Incheon, Republic of Korea. · Division of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, 222-1 Wangsimni-Ro, Seongdong-Gu, Seoul, 04763, Republic of Korea. dhyoo@hanyang.ac.kr. ·BioDrugs · Pubmed #28600696.

ABSTRACT: BACKGROUND: CT-P10 is a biosimilar candidate of innovator rituximab (RTX) that demonstrated a comparable clinical profile to RTX in a phase I randomized controlled trial (RCT) in rheumatoid arthritis (RA) (ClinicalTrials.gov identifier: NCT01534884). OBJECTIVE: This open-label extension (OLE) study (NCT01873443) compared the efficacy and safety of CT-P10 in patients with RA who received CT-P10 from the outset (i.e., from the start of the RCT and also in the OLE; 'maintenance group') with those who received RTX during the RCT and switched to CT-P10 during the OLE ('switch group'). METHODS: Patients who completed the RCT were recruited. Based on the Disease Activity Score using 28 joints (DAS28) and predefined safety criteria, patients could receive up to two courses of CT-P10 during the OLE. Efficacy [DAS28 and European League Against Rheumatism (EULAR) response], safety and immunogenicity were assessed. RESULTS: Eighty-seven patients were enrolled; 58 and 29 had previously received CT-P10 or RTX, respectively, in the RCT. Of these, 38 (65.5%) and 20 (69.0%) were treated with CT-P10 in the OLE and therefore comprised the maintenance and switch groups, respectively. The mean change in DAS28-erythrocyte sedimentation rate (ESR) from baseline (week 0 of RCT) at week 24 of the first OLE treatment course in the maintenance and switch groups was -2.7 and -2.4, respectively. The proportion of patients with good/moderate EULAR responses was also comparable between groups. Antidrug antibodies were detected in 13.2 and 15.0% of patients in the maintenance and switch groups, respectively, at week 24 of the first OLE course. CT-P10 treatment was well-tolerated when administered for up to 2 years or after switching from RTX. CONCLUSION: In this study population, comparable efficacy and safety profiles were observed in patients who switched from RTX to CT-P10 and those maintained on CT-P10 throughout treatment.

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