Literature DB >> 32887976

Transforming clinical trials in rheumatology: towards patient-centric precision medicine.

Costantino Pitzalis1, Ernest H S Choy2, Maya H Buch3.   

Abstract

Despite the success of targeted therapies in the treatment of inflammatory arthritides, the lack of predictive biomarkers drives a 'trial and error' approach to treatment allocation, leading to variable and/or unsatisfactory responses. In-depth characterization of the synovial tissue in rheumatoid arthritis, as well as psoriatic arthritis and spondyloarthritis, is bringing new insights into the diverse cellular and molecular features of these diseases and their potential links with different clinical and treatment-response phenotypes. Such progress raises the tantalizing prospect of improving response rates by matching the use of specific agents to the cognate target pathways that might drive particular disease subtypes in specific patient groups. Innovative patient-centric, molecular pathology-driven clinical trial approaches are needed to achieve this goal. Whilst progress is clearly being made, it is important to emphasize that this field is still in its infancy and there are a number of potential barriers to realizing the premise of patient-centric clinical trials.

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Year:  2020        PMID: 32887976     DOI: 10.1038/s41584-020-0491-4

Source DB:  PubMed          Journal:  Nat Rev Rheumatol        ISSN: 1759-4790            Impact factor:   20.543


  56 in total

Review 1.  Rheumatoid arthritis therapy reappraisal: strategies, opportunities and challenges.

Authors:  Josef S Smolen; Daniel Aletaha
Journal:  Nat Rev Rheumatol       Date:  2015-02-17       Impact factor: 20.543

Review 2.  Rheumatoid arthritis.

Authors:  Josef S Smolen; Daniel Aletaha; Iain B McInnes
Journal:  Lancet       Date:  2016-05-03       Impact factor: 79.321

3.  Head-to-head comparison of certolizumab pegol versus adalimumab in rheumatoid arthritis: 2-year efficacy and safety results from the randomised EXXELERATE study.

Authors:  Josef S Smolen; Gerd-Rüdiger Burmester; Bernard Combe; Jeffrey R Curtis; Stephen Hall; Boulos Haraoui; Ronald van Vollenhoven; Christopher Cioffi; Cécile Ecoffet; Leon Gervitz; Lucian Ionescu; Luke Peterson; Roy Fleischmann
Journal:  Lancet       Date:  2016-11-15       Impact factor: 79.321

4.  Long-term infliximab treatment in rheumatoid arthritis: subsequent outcome of initial responders.

Authors:  M H Buch; S J Bingham; D Bryer; P Emery
Journal:  Rheumatology (Oxford)       Date:  2007-05-03       Impact factor: 7.580

5.  Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial.

Authors:  Duncan Porter; Jurgen van Melckebeke; James Dale; C Martina Messow; Alexander McConnachie; Andrew Walker; Robin Munro; John McLaren; Euan McRorie; Jon Packham; Christopher D Buckley; John Harvie; Peter Taylor; Ernest Choy; Costantino Pitzalis; Iain B McInnes
Journal:  Lancet       Date:  2016-05-17       Impact factor: 79.321

Review 6.  Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2016 update of the EULAR recommendations for the management of rheumatoid arthritis.

Authors:  Jackie L Nam; Kaoru Takase-Minegishi; Sofia Ramiro; Katerina Chatzidionysiou; Josef S Smolen; Désirée van der Heijde; Johannes W Bijlsma; Gerd R Burmester; Maxime Dougados; Marieke Scholte-Voshaar; Ronald van Vollenhoven; Robert Landewé
Journal:  Ann Rheum Dis       Date:  2017-03-10       Impact factor: 19.103

Review 7.  Rheumatoid arthritis.

Authors:  Josef S Smolen; Daniel Aletaha; Anne Barton; Gerd R Burmester; Paul Emery; Gary S Firestein; Arthur Kavanaugh; Iain B McInnes; Daniel H Solomon; Vibeke Strand; Kazuhiko Yamamoto
Journal:  Nat Rev Dis Primers       Date:  2018-02-08       Impact factor: 52.329

8.  A personalized medicine approach to biologic treatment of rheumatoid arthritis: a preliminary treatment algorithm.

Authors:  Paul P Tak
Journal:  Rheumatology (Oxford)       Date:  2011-09-02       Impact factor: 7.580

9.  Synovial cellular and molecular signatures stratify clinical response to csDMARD therapy and predict radiographic progression in early rheumatoid arthritis patients.

Authors:  Frances Humby; Myles Lewis; Nandhini Ramamoorthi; Jason A Hackney; Michael R Barnes; Michele Bombardieri; A Francesca Setiadi; Stephen Kelly; Fabiola Bene; Maria DiCicco; Sudeh Riahi; Vidalba Rocher; Nora Ng; Ilias Lazarou; Rebecca Hands; Désirée van der Heijde; Robert B M Landewé; Annette van der Helm-van Mil; Alberto Cauli; Iain McInnes; Christopher Dominic Buckley; Ernest H Choy; Peter C Taylor; Michael J Townsend; Costantino Pitzalis
Journal:  Ann Rheum Dis       Date:  2019-03-16       Impact factor: 19.103

10.  Molecular Portraits of Early Rheumatoid Arthritis Identify Clinical and Treatment Response Phenotypes.

Authors:  Myles J Lewis; Michael R Barnes; Kevin Blighe; Katriona Goldmann; Sharmila Rana; Jason A Hackney; Nandhini Ramamoorthi; Christopher R John; David S Watson; Sarah K Kummerfeld; Rebecca Hands; Sudeh Riahi; Vidalba Rocher-Ros; Felice Rivellese; Frances Humby; Stephen Kelly; Michele Bombardieri; Nora Ng; Maria DiCicco; Désirée van der Heijde; Robert Landewé; Annette van der Helm-van Mil; Alberto Cauli; Iain B McInnes; Christopher D Buckley; Ernest Choy; Peter C Taylor; Michael J Townsend; Costantino Pitzalis
Journal:  Cell Rep       Date:  2019-08-27       Impact factor: 9.423

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  12 in total

Review 1.  Overcoming barriers for intra-articular delivery of disease-modifying osteoarthritis drugs.

Authors:  Jingjing Gao; Ziting Xia; Helna B Mary; John Joseph; James N Luo; Nitin Joshi
Journal:  Trends Pharmacol Sci       Date:  2022-01-24       Impact factor: 14.819

Review 2.  The promise of precision medicine in rheumatology.

Authors:  Joel M Guthridge; Catriona A Wagner; Judith A James
Journal:  Nat Med       Date:  2022-07-04       Impact factor: 87.241

Review 3.  Precision medicine: the precision gap in rheumatic disease.

Authors:  Chung M A Lin; Faye A H Cooles; John D Isaacs
Journal:  Nat Rev Rheumatol       Date:  2022-10-10       Impact factor: 32.286

4.  Rituximab versus tocilizumab in rheumatoid arthritis: synovial biopsy-based biomarker analysis of the phase 4 R4RA randomized trial.

Authors:  Felice Rivellese; Anna E A Surace; Katriona Goldmann; Elisabetta Sciacca; Cankut Çubuk; Giovanni Giorli; Christopher R John; Alessandra Nerviani; Liliane Fossati-Jimack; Georgina Thorborn; Manzoor Ahmed; Edoardo Prediletto; Sarah E Church; Briana M Hudson; Sarah E Warren; Paul M McKeigue; Frances Humby; Michele Bombardieri; Michael R Barnes; Myles J Lewis; Costantino Pitzalis
Journal:  Nat Med       Date:  2022-05-19       Impact factor: 87.241

5.  Longitudinal analysis of blood DNA methylation identifies mechanisms of response to tumor necrosis factor inhibitor therapy in rheumatoid arthritis.

Authors:  Antonio Julià; Antonio Gómez; María López-Lasanta; Francisco Blanco; Alba Erra; Antonio Fernández-Nebro; Antonio Juan Mas; Carolina Pérez-García; Ma Luz García Vivar; Simón Sánchez-Fernández; Mercedes Alperi-López; Raimon Sanmartí; Ana María Ortiz; Carlos Marras Fernandez-Cid; César Díaz-Torné; Estefania Moreno; Tianlu Li; Sergio H Martínez-Mateu; Devin M Absher; Richard M Myers; Jesús Tornero Molina; Sara Marsal
Journal:  EBioMedicine       Date:  2022-05-13       Impact factor: 11.205

6.  Clinical application of personalized rheumatoid arthritis risk information: Translational epidemiology leading to precision medicine.

Authors:  Jeffrey A Sparks
Journal:  Expert Rev Precis Med Drug Dev       Date:  2020-12-14

7.  Rituximab versus tocilizumab in anti-TNF inadequate responder patients with rheumatoid arthritis (R4RA): 16-week outcomes of a stratified, biopsy-driven, multicentre, open-label, phase 4 randomised controlled trial.

Authors:  Frances Humby; Patrick Durez; Maya H Buch; Myles J Lewis; Hasan Rizvi; Felice Rivellese; Alessandra Nerviani; Giovanni Giorli; Arti Mahto; Carlomaurizio Montecucco; Bernard Lauwerys; Nora Ng; Pauline Ho; Michele Bombardieri; Vasco C Romão; Patrick Verschueren; Stephen Kelly; Pier Paolo Sainaghi; Nagui Gendi; Bhaskar Dasgupta; Alberto Cauli; Piero Reynolds; Juan D Cañete; Robert Moots; Peter C Taylor; Christopher J Edwards; John Isaacs; Peter Sasieni; Ernest Choy; Costantino Pitzalis
Journal:  Lancet       Date:  2021-01-23       Impact factor: 79.321

8.  The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design.

Authors:  Jared C Roach; Junko Hara; Deborah Fridman; Jennifer C Lovejoy; Kathleen Jade; Laura Heim; Rachel Romansik; Adrienne Swietlikowski; Sheree Phillips; Molly K Rapozo; Maria A Shay; Dan Fischer; Cory Funk; Lauren Dill; Michael Brant-Zawadzki; Leroy Hood; William R Shankle
Journal:  Alzheimers Dement (N Y)       Date:  2022-07-26

9.  Responding to and Driving Change in Rheumatology: Report from the 12th International Immunology Summit 2021.

Authors:  Renaud Felten; Nicolas Rosine
Journal:  Rheumatol Ther       Date:  2022-03-12

Review 10.  Single Cell RNA Sequencing in Autoimmune Inflammatory Rheumatic Diseases: Current Applications, Challenges and a Step Toward Precision Medicine.

Authors:  Tadeja Kuret; Snežna Sodin-Šemrl; Brane Leskošek; Polonca Ferk
Journal:  Front Med (Lausanne)       Date:  2022-01-18
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