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Robin P Choudhury, Jacqueline S Birks, Venkatesh Mani, Luca Biasiolli, Matthew D Robson, Philippe L L'Allier, Marc-Alexandre Gingras, Nadia Alie, Mary Ann McLaughlin, Craig T Basson, Alison D Schecter, Eric C Svensson, Yiming Zhang, Denise Yates, Jean-Claude Tardif, Zahi A Fayad
BACKGROUND: Evidence suggests that interleukin (IL)-1β is important in the pathogenesis of atherosclerosis and its complications and that inhibiting IL-1β may favorably affect vascular disease progression. OBJECTIVES: The goal of this study was to evaluate the effects of IL-1β inhibition with canakinumab versus placebo on arterial structure and function, determined by magnetic resonance imaging. METHODS: Patients (N = 189) with atherosclerotic disease and either type 2 diabetes mellitus or impaired glucose tolerance were randomized to receive placebo (n = 94) or canakinumab 150 mg monthly (n = 95) for 12 months...
October 18, 2016: Journal of the American College of Cardiology
Zdeněk Adam, Anna Šedivá, Renata Koukalová, Zdeněk Řehák, Hana Petrášová, Petr Szturz, Zdenka Adamová, Eva Vetešníková, Luděk Pour, Marta Krejčí, Viera Sandecká, Eva Pourová, Zdeňka Čermáková, Sabina Ševčíková, Zdeněk Král, Jiří Mayer
Schnitzlers syndrome is an acquired auto-inflammatory disease of still unclear origin. The Strasbourg criteria were adopted (non-infectious fever, chronic urticaria, changes in the bone structure, leukocytosis and higher values of inflammatory markers - CRP and presence of monoclonal immunoglobulin mostly of type IgM, very rarely of IgG) to establish this diagnosis. The first-choice therapy for this disease is the blocking of interleukin-1 effects. In practice, the interleukin-1 receptor antagonist, anakinra, is the most commonly used...
2016: Vnitr̆ní Lékar̆ství
Yesim Ozguler, Gulen Hatemi, Serdal Ugurlu, Emire Seyahi, Melike Melikoglu, Sermin Borekci, Ersan Atahan, Gul Ongen, Vedat Hamuryudan
The use of anti-TNF agents is associated with an increased risk of tuberculosis (TB) and anti-TNF agents are stopped when active TB develops. However, discontinuation of treatment can result in flare of the underlying disease. The charts of 22 patients who developed active TB among a cohort of 2754 patients using anti-TNF agents between 2001 and 2013 were reviewed retrospectively. Patients restarting biologics during further follow-up were identified. One patient with miliary TB died within 1 month. A biologic agent was restarted in 16 of the remaining 21 patients (76 %)...
October 3, 2016: Rheumatology International
Karoline Krause, Athanasios Tsianakas, Nicola Wagner, Jörg Fischer, Karsten Weller, Martin Metz, Martin K Church, Marcus Maurer
BACKGROUND: Schnitzler's syndrome is an adult-onset autoinflammatory disease characterized by urticarial exanthema and monoclonal gammopathy accompanied by systemic symptoms such as fever, bone and muscle pain. Up to now, approved treatment options are not available. OBJECTIVE: We here assessed the effects of the anti-IL-1ß monoclonal antibody canakinumab on the clinical signs and symptoms of Schnitzler's syndrome. METHODS: In this phase II, randomized placebo-controlled multi-center study, 20 patients with active disease enrolled in four German study centers...
September 19, 2016: Journal of Allergy and Clinical Immunology
I Kone-Paut, P Quartier, O Fain, G Grateau, P Pillet, P Le Blay, F Bonnet, V Despert, K Stankovic Stojanovic, L Willemin, S Quéré, O Reigneau, E Hachulla
OBJECTIVE: ENVOL was designed to assess the psychosocial impact of disease and therapy in a French cohort of CAPS patients (and caregivers) treated by canakinumab. METHODS: ENVOL was a multicenter, observational study of CAPS patients given ≥1 canakinumab dose. Data were collected pre-treatment, at 6 and 12 months afterwards, and at last visit. Patients and caregivers completed questionnaires assessing changes from the 12 months pre-treatment to 12 months prior to interview...
September 16, 2016: Arthritis Care & Research
Ruby Haviv, Philip J Hashkes
INTRODUCTION: Familial Mediterranean fever (FMF) is the most common hereditary autoinflammatory syndrome. The treatment of choice is colchicine. However, ~40% of patients are only partial responders and 5-10% are non-responders. Advances in the understanding of the role of pyrin in the regulation of interleukin (IL)-1β activation has led to use of anti-IL-1 agents for colchicine-resistant FMF. AREAS COVERED: The authors performed a literature search of anti-IL-1 treatment for FMF, particularly canakinumab, a humanized IL-1β antibody, by searching PubMed/Medline/Scopus since 2001 and proceedings of major rheumatologic conferences since 2011 for unpublished studies...
November 2016: Expert Opinion on Biological Therapy
Betul Sozeri, Nesrin Gulez, Malik Ergin, Erkin Serdaroglu
INTRODUCTION: Familial Mediterranean fever (FMF) is an autosomal recessive disease characterized by self-limited recurrent attacks of fever and serositis. Patients may develop renal amyloidosis. Colchicine prevents attacks and renal amyloidosis. Five to 10 % of the patients with FMF are resistant or intolerant to colchicine. CASE DESCRIPTION: Herein, we reported our experience with clinical-laboratory features and treatment responses of a pediatric FMF patient with amyloidosis treated with canakinumab...
December 2016: Molecular and Cellular Pediatrics
Chris Paget
BACKGROUND: Cytokine modulators (adalimumab, infliximab, etanercept, anakinra, canakinumab, rituximab, tocilizumab and abatacept) are high-cost biologics used primarily in paediatrics to treat patients with juvenile idiopathic arthritis.1 Funding mechanisms are unreliable and inconsistent hence appropriate dose rounding is a key cost-saving measure.2 However, there is a lack of evidence-based guidance for dose rounding in paediatrics.3 AIMS AND OBJECTIVES: Determine if 100% of inpatient cytokine modulator prescriptions in rheumatology are dose rounded up or down to the nearest whole vial, pen or syringe if within 5 or 10% of the dose for patients less or more than 10 kg respectively...
September 2016: Archives of Disease in Childhood
Magnus Diller, Martin Fleck
Muskuloskeletal ultrasound and dual-energy-CT (DECT) findings are increasingly relevant for the establishment of the diagnosis of gout, and are therefore incorporated into the novel ACR / EULAR classification criteria. Canakinumab, a monoclonal antibody directed against interleukin-1β (IL-1β) has been approved in 2013 for the treatment of acute gout and for prophylaxis of flares. In patients demonstrating an inadequate response upon treatment with allopurinol or febuxostat, combination therapy with lesinurad might reduce uric acid levels to the target of < 6 mg / dl (< 5 mg / dl in tophaceous gout)...
August 2016: Deutsche Medizinische Wochenschrift
Rebecca Torene, Nanguneri Nirmala, Laura Obici, Marco Cattalini, Vincent Tormey, Roberta Caorsi, Sandrine Starck-Schwertz, Martin Letzkus, Nicole Hartmann, Ken Abrams, Helen Lachmann, Marco Gattorno
OBJECTIVE: To explore whether gene expression profiling can identify a molecular mechanism for the clinical benefit of canakinumab treatment in patents with tumour necrosis factor receptor-associated periodic syndrome (TRAPS). METHODS: Blood samples were collected from 20 patients with active TRAPS who received canakinumab 150 mg every 4 weeks for 4 months in an open-label proof-of-concept phase II study, and from 20 aged-matched healthy volunteers. Gene expression levels were evaluated in whole blood samples by microarray analysis for arrays passing quality control checks...
July 29, 2016: Annals of the Rheumatic Diseases
Janet E Orrock, Norman T Ilowite
INTRODUCTION: Canakinumab, a fully human monoclonal antibody against interleukin-1β, is a relatively new medication approved for treatment of systemic juvenile idiopathic arthritis (SJIA). Here, we review data supporting use of canakinumab for patients with active SJIA, as compared to other available biologic medications. AREAS COVERED: This article provides an overview of chemistry of canakinumab as well as the phase II and phase III trials that led to approval for treatment of active SJIA...
August 2016: Expert Review of Clinical Pharmacology
Nora S Ali, Julio C Sartori-Valinotti, Alison J Bruce
Periodic fever, aphthous stomatitis, pharyngitis, and adenitis (PFAPA) syndrome, the most common periodic disorder of childhood, presents with the cardinal symptoms of periodic fever, aphthous stomatitis, pharyngitis, and adenitis typically before age 5. This review presents the recent literature on PFAPA and summarizes key findings in the pathogenesis, evaluation, and treatment of the disease. Theories surrounding the pathogenesis of PFAPA include a faulty innate immunologic response in conjunction with dysregulated T-cell activation...
July 2016: Clinics in Dermatology
Caroline Barranco
No abstract text is available yet for this article.
August 2016: Nature Reviews. Rheumatology
Orhan Kucuksahin, Mustafa Turgut Yildizgoren, Ufuk Ilgen, Askin Ates, Gülay Kinikli, Murat Turgay, Sukran Erten
OBJECTIVE: To investigate the effect of anti-interleukin-1 (anti-IL-1) treatment on the frequency and severity of attacks and other disease-related clinical parameters and to evaluate the adverse effects associated with anti-IL-1 treatment in 26 patients with refractory familial mediterranean fever (FMF). METHODS: The study included 26 FMF patients followed up in our centre using colchicine for 4 months to 30 years. The treatment was switched to anti-IL-1 treatment for various reasons; 20 cases were resistant to colchicine, 8 were intolerant to colchicine, and 3 had prolonged arthritis under colchicine...
June 22, 2016: Modern Rheumatology
Celia Almeida, Ernest H S Choy, Sarah Hewlett, John R Kirwan, Fiona Cramp, Trudie Chalder, Jon Pollock, Robin Christensen
BACKGROUND: Fatigue is a common and potentially distressing symptom for patients with rheumatoid arthritis (RA), with no accepted evidence-based management guidelines. Evidence suggests that biologic interventions improve symptoms and signs in RA as well as reducing joint damage. OBJECTIVES: To evaluate the effect of biologic interventions on fatigue in rheumatoid arthritis. SEARCH METHODS: We searched the following electronic databases up to 1 April 2014: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Current Controlled Trials Register, the National Research Register Archive, The UKCRN Portfolio Database, AMED, CINAHL, PsycINFO, Social Science Citation Index, Web of Science, and Dissertation Abstracts International...
2016: Cochrane Database of Systematic Reviews
Marco Gattorno, Laura Obici, Marco Cattalini, Vincent Tormey, Ken Abrams, Nicole Davis, Antonio Speziale, Suraj G Bhansali, Alberto Martini, Helen J Lachmann
OBJECTIVE: To evaluate the efficacy of canakinumab, a high-affinity human monoclonal anti-interleukin-1β antibody, in inducing complete or almost complete responses in patients with active tumour necrosis factor receptor-associated periodic syndrome (TRAPS). METHODS: Twenty patients (aged 7-78 years) with active recurrent or chronic TRAPS were treated with canakinumab 150 mg every 4 weeks for 4 months (2 mg/kg for those ≤40 kg) in this open-label, proof-of-concept, phase II study...
June 7, 2016: Annals of the Rheumatic Diseases
Maria Ida Maiorino, Giuseppe Bellastella, Dario Giugliano, Katherine Esposito
Chronic inflammation is supposed to be an important mediator of cardiometabolic dysfunctions seen in type 2 diabetes. In this mini-review, we collected evidence (PubMed) from randomized controlled trials (through March 2016) evaluating the effect of anti-inflammatory drugs on indices of glycemic control and/or cardiovascular events in people with type 2 diabetes. Within the last 25 years, many anti-inflammatory drugs have been tested in type 2 diabetes, including hydroxychloroquine, anti-tumor necrosis factor therapies (etanercept and infliximab), salsalate, interleukin-1 antagonists (anakinra, canakinumab, gevokizumab, LY2189102), and CC-R2 antagonists...
May 26, 2016: Endocrine
Antonio Vitale, Donato Rigante, Giuseppe Lopalco, Carlo Selmi, Mauro Galeazzi, Florenzo Iannone, Luca Cantarini
Behçet's disease (BD) is a systemic inflammatory disorder characterized by a protean clinical spectrum and an enigmatic pathogenesis. After being classified as an autoimmune disorder, spondyloarthritis and vasculitis, today BD is considered at the crossroad between autoimmune and auto-inflammatory syndromes. Many pathogenetic, clinical and therapeutic clues support this recent interpretation, enabling novel treatment choices such as interleukin (IL)-1 inhibition. Thus, in the last decade the IL-1 receptor antagonist anakinra and the anti-IL-1β monoclonal antibody canakinumab were increasingly administered in BD patients resistant to standard therapies, leading to interesting results and intriguing new pathogenetic implications...
March 2016: Israel Medical Association Journal: IMAJ
Haiying Sun, Linh M Van, David Floch, Xuemin Jiang, Ulf R Klein, Ken Abrams, Gangadhar Sunkara
The characterization of the pharmacokinetic (PK) and pharmacodynamic (PD) properties in pediatric patients is essential in supporting the recommended dosage of canakinumab in the relevant population. Here the PK and PD properties of canakinumab-a monoclonal antibody-in pediatric patients with systemic juvenile idiopathic arthritis (SJIA) are presented. Blood samples were obtained from 4 phase 2/3 clinical studies in patients with SJIA. Canakinumab PK properties and total interleukin (IL)-1β kinetic properties were characterized by a population-based PK-binding model...
April 27, 2016: Journal of Clinical Pharmacology
Jeroen Ch van der Hilst, Michel Moutschen, Peter E Messiaen, Bernard R Lauwerys, Steven Vanderschueren
INTRODUCTION: In 5%-10% of patients with familial Mediterranean fever (FMF), colchicine is not effective in preventing inflammatory attacks. Another 5%-10% of patients are intolerant to effective doses of colchicine and experience serious side effects. Treatment with anti-interleukin-1 (IL-1) drugs may be an alternative for these patients, although it is not reimbursed for this indication in many countries. METHODS: We systematically searched PubMed, Web of Science, and Scopus for reports of anti-IL-1 treatment in FMF patients...
2016: Biologics: Targets & Therapy
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