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      Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study

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          Abstract

          Background

          Baricitinib is an oral, reversible, selective Janus kinase 1 and 2 inhibitor.

          Methods

          In this phase III, double-blind 24-week study, 684 biologic disease-modifying antirheumatic drug (DMARD)-naïve patients with rheumatoid arthritis and inadequate response or intolerance to ≥1 conventional synthetic DMARDs were randomly assigned 1:1:1 to placebo or baricitinib (2 or 4 mg) once daily, stratified by region and the presence of joint erosions. Endpoint measures included American College of Rheumatology 20% response (ACR20, primary endpoint), Disease Activity Score (DAS28) and Simplified Disease Activity Index (SDAI) score ≤3.3.

          Results

          More patients achieved ACR20 response at week 12 with baricitinib 4 mg than with placebo (62% vs 39%, p≤0.001). Compared with placebo, statistically significant improvements in DAS28, SDAI remission, Health Assessment Questionnaire-Disability Index, morning joint stiffness, worst joint pain and worst tiredness were observed. In a supportive analysis, radiographic progression of structural joint damage at week 24 was reduced with baricitinib versus placebo. Rates of adverse events during the treatment period and serious adverse events (SAEs), including serious infections, were similar among groups (SAEs: 5% for baricitinib 4 mg and placebo). One patient had an adverse event of tuberculosis (baricitinib 4 mg); one patient had an adverse event of non-melanoma skin cancer (baricitinib 4 mg). Two deaths and three major adverse cardiovascular events occurred (placebo). Baricitinib was associated with a decrease in neutrophils and increases in low-density and high-density lipoprotein.

          Conclusions

          In patients with rheumatoid arthritis and an inadequate response or intolerance to conventional synthetic DMARDs, baricitinib was associated with clinical improvement and inhibition of progression of radiographic joint damage.

          Trial registration number

          NCT01721057; Results.

          Related collections

          Most cited references14

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          Measurement of patient outcome in arthritis.

          A structure for representation of patient outcome is presented, together with a method for outcome measurement and validation of the technique in rheumatoid arthritis. The paradigm represents outcome by five separate dimensions: death, discomfort, disability, drug (therapeutic) toxicity, and dollar cost. Each dimension represents an outcome directly related to patient welfare. Quantitation of these outcome dimensions may be performed at interview or by patient questionnaire. With standardized, validated questions, similar scores are achieved by both methods. The questionnaire technique is preferred since it is inexpensive and does not require interobserver validation. These techniques appear extremely useful for evaluation of long term outcome of patients with rheumatic diseases.
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            American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis.

            Trials of rheumatoid arthritis (RA) treatments report the average response in multiple outcome measures for treated patients. It is more clinically relevant to test whether individual patients improve with treatment, and this identifies a single primary efficacy measure. Multiple definitions of improvement are currently in use in different trials. The goal of this study was to promulgate a single definition for use in RA trials. Using the American College of Rheumatology (ACR) core set of outcome measures for RA trials, we tested 40 different definitions of improvement, using a 3-step process. First, we performed a survey of rheumatologists, using actual patient cases from trials, to evaluate which definitions corresponded best to rheumatologists' impressions of improvement, eliminating most candidate definitions of improvement. Second, we tested 20 remaining definitions to determine which maximally discriminated effective treatment from placebo treatment and also minimized placebo response rates. With 8 candidate definitions of improvement remaining, we tested to see which were easiest to use and were best in accord with rheumatologists' impressions of improvement. The following definition of improvement was selected: 20% improvement in tender and swollen joint counts and 20% improvement in 3 of the 5 remaining ACR core set measures: patient and physician global assessments, pain, disability, and an acute-phase reactant. Additional validation of this definition was carried out in a comparative trial, and the results suggest that the definition is statistically powerful and does not identify a large percentage of placebo-treated patients as being improved. We present a definition of improvement which we hope will be used widely in RA trials.
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              How to read radiographs according to the Sharp/van der Heijde method.

              This article is a short overview of the development of the Sharp/van der Heijde methods for scoring radiographs of hands and feet in rheumatoid arthritis, in addition to a detailed description on how to use the scoring method.
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                Author and article information

                Journal
                Ann Rheum Dis
                Ann. Rheum. Dis
                annrheumdis
                ard
                Annals of the Rheumatic Diseases
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                0003-4967
                1468-2060
                January 2017
                29 September 2016
                : 76
                : 1
                : 88-95
                Affiliations
                [1 ]Department of Rheumatology, Paris Descartes University, Hôpital Cochin, Assistance Publique, Hôpitaux de Paris, INSERM (U1151), Clinical Epidemiology and Biostatistics, PRES Sorbonne Paris-Cité , Paris, France
                [2 ]Leiden University Medical Center , Leiden, The Netherlands
                [3 ]Division of Rheumatology, Department of Internal Medicine, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Kaohsiung, Taiwan; Chang Gung Memorial Hospital - Kaohsiung Medical Center, Chang Gung University College of Medicine, Taiwan
                [4 ]Desert Medical Advances , Palm Desert, California, USA
                [5 ]Veszprém Csolnoky Ferenc County Hospital , Veszprém, Hungary
                [6 ]Eli Lilly and Company , Indianapolis, Indiana, USA
                [7 ]Leeds Institute of Rheumatic and Musculoskeletal Medicine, NIHR Leeds Musculoskeletal Biomedical Research Unit, LTHT, University of Leeds , Leeds, UK
                Author notes

                Handling editor Tore K Kvien

                [Correspondence to ] Maxime Dougados, Department of Rheumatology, Paris-Descartes University, Assistance Publique Hôpitaux de Paris, Cochin Hospital, 27 rue du Faubourg Saint-Jacques, Paris 75014, France; maxime.dougados@ 123456cch.aphp.fr
                Author information
                http://orcid.org/0000-0002-5781-158X
                Article
                annrheumdis-2016-210094
                10.1136/annrheumdis-2016-210094
                5264214
                27689735
                4025786a-b8fb-41c6-b155-e4cd6637dc96
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 21 June 2016
                : 6 September 2016
                : 8 September 2016
                Categories
                1506
                Clinical and Epidemiological Research
                Extended report
                Custom metadata
                unlocked

                Immunology
                rheumatoid arthritis,treatment,dmards (synthetic)
                Immunology
                rheumatoid arthritis, treatment, dmards (synthetic)

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