Kaleb Michaud1, Niklas Berglind2, Stefan Franzén2, Thomas Frisell3, Christopher Garwood4, Jeffrey D Greenberg5, Meilien Ho6, Marie Holmqvist3, Laura Horne7, Eisuke Inoue8, Fredrik Nyberg9, Dimitrios A Pappas10, George Reed11, Deborah Symmons12, Eiichi Tanaka8, Trung N Tran13, Suzanne M M Verstappen4, Eveline Wesby-van Swaay14, Hisashi Yamanaka8, Johan Askling15. 1. University of Nebraska Medical Center, Omaha, Nebraska, USA National Data Bank for Rheumatic Diseases, Wichita, Kansas, USA. 2. Biometric & Information Sciences, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden. 3. Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 4. Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK. 5. NYU School of Medicine, New York, New York, USA Corrona LLC, Southborough, Massachusetts, USA. 6. Clinical, Global Medicines Development, AstraZeneca R&D, Macclesfield, UK. 7. Medical Evidence & Observational Research Centre, Global Medicines Development, AstraZeneca, Wilmington, Delaware, USA. 8. Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan. 9. Medical Evidence & Observational Research Centre, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden Occupational and Environmental Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. 10. Corrona LLC, Southborough, Massachusetts, USA The College of Physicians and Surgeons, Columbia University Medical Center, New York, New York, USA. 11. Corrona LLC, Southborough, Massachusetts, USA University of Massachusetts Medical School, Worcester, Massachusetts, USA. 12. Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK NIHR Manchester Musculoskeletal Biomedical Research Unit, Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK. 13. MedImmune, Gaithersburg, Maryland, USA. 14. Patient Safety, GRAPSQA, Global Medicines Development, AstraZeneca R&D, Mölndal, Sweden. 15. Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden Department of Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
Abstract
BACKGROUND: We implemented a novel method for providing contextual adverse event rates for a randomised controlled trial (RCT) programme through coordinated analyses of five RA registries, focusing here on cardiovascular disease (CVD) and mortality. METHODS: Each participating registry (Consortium of Rheumatology Researchers of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (SRR) (Sweden), Norfolk Arthritis Register (NOAR) (UK), CORRONA International (East Europe, Latin America, India) and Institute of Rheumatology, Rheumatoid Arthritis (IORRA) (Japan)) defined a main cohort from January 2000 onwards. To address comparability and potential bias, we harmonised event definitions and defined several subcohorts for sensitivity analyses based on disease activity, treatment, calendar time, duration of follow-up and RCT exclusions. Rates were standardised for age, sex and, in one sensitivity analysis, also HAQ. RESULTS: The combined registry cohorts included 57 251 patients with RA (234 089 person-years)-24.5% men, mean (SD) baseline age 58.2 (13.8) and RA duration 8.2 (11.7) years. Standardised registry mortality rates (per 100 person-years) varied from 0.42 (CORRONA) to 0.80 (NOAR), with 0.60 for RCT patients. Myocardial infarction and major adverse cardiovascular events (MACE) rates ranged from 0.09 and 0.31 (IORRA) to 0.39 and 0.77 (SRR), with RCT rates intermediate (0.18 and 0.42), respectively. Additional subcohort analyses showed small and mostly consistent changes across registries, retaining reasonable consistency in rates across the Western registries. Additional standardisation for HAQ returned higher mortality and MACE registry rates. CONCLUSIONS: This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes. 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/
BACKGROUND: We implemented a novel method for providing contextual adverse event rates for a randomised controlled trial (RCT) programme through coordinated analyses of five RA registries, focusing here on cardiovascular disease (CVD) and mortality. METHODS: Each participating registry (Consortium of Rheumatology Researchers of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (SRR) (Sweden), Norfolk Arthritis Register (NOAR) (UK), CORRONA International (East Europe, Latin America, India) and Institute of Rheumatology, Rheumatoid Arthritis (IORRA) (Japan)) defined a main cohort from January 2000 onwards. To address comparability and potential bias, we harmonised event definitions and defined several subcohorts for sensitivity analyses based on disease activity, treatment, calendar time, duration of follow-up and RCT exclusions. Rates were standardised for age, sex and, in one sensitivity analysis, also HAQ. RESULTS: The combined registry cohorts included 57 251 patients with RA (234 089 person-years)-24.5% men, mean (SD) baseline age 58.2 (13.8) and RA duration 8.2 (11.7) years. Standardised registry mortality rates (per 100 person-years) varied from 0.42 (CORRONA) to 0.80 (NOAR), with 0.60 for RCT patients. Myocardial infarction and major adverse cardiovascular events (MACE) rates ranged from 0.09 and 0.31 (IORRA) to 0.39 and 0.77 (SRR), with RCT rates intermediate (0.18 and 0.42), respectively. Additional subcohort analyses showed small and mostly consistent changes across registries, retaining reasonable consistency in rates across the Western registries. Additional standardisation for HAQ returned higher mortality and MACE registry rates. CONCLUSIONS: This coordinated approach to contextualising RA RCT safety data demonstrated reasonable differences and consistency in rates for mortality and CVD across registries, and comparable RCT rates, and may serve as a model method to supplement clinical trial analyses for drug development programmes. 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/
Authors: Hisashi Yamanaka; Johan Askling; Niklas Berglind; Stefan Franzen; Thomas Frisell; Christopher Garwood; Jeffrey D Greenberg; Meilien Ho; Marie Holmqvist; Laura Novelli Horne; Eisuke Inoue; Kaleb Michaud; Dimitrios A Pappas; George Reed; Deborah Symmons; Eiichi Tanaka; Trung N Tran; Suzanne M M Verstappen; Eveline Wesby-van Swaay; Fredrik Nyberg Journal: RMD Open Date: 2017-10-10
Authors: Pedro Santos-Moreno; Paola Castillo; Laura Villareal; Carlos Pineda; Hugo Sandoval; Omaira Valencia Journal: Open Access Rheumatol Date: 2020-11-06
Authors: J Mark FitzGerald; Trung N Tran; Marianna Alacqua; Alan Altraja; Vibeke Backer; Leif Bjermer; Unnur Bjornsdottir; Arnaud Bourdin; Guy Brusselle; Lakmini Bulathsinhala; John Busby; Giorgio W Canonica; Victoria Carter; Isha Chaudhry; You Sook Cho; George Christoff; Borja G Cosio; Richard W Costello; Neva Eleangovan; Peter G Gibson; Liam G Heaney; Enrico Heffler; Mark Hew; Naeimeh Hosseini; Takashi Iwanaga; David J Jackson; Rupert Jones; Mariko S Koh; Thao Le; Lauri Lehtimäki; Dora Ludviksdottir; Anke H Maitland-van der Zee; Andrew Menzies-Gow; Ruth B Murray; Nikolaos G Papadopoulos; Luis Perez-de-Llano; Matthew Peters; Paul E Pfeffer; Todor A Popov; Celeste M Porsbjerg; Chris A Price; Chin K Rhee; Mohsen Sadatsafavi; Yuji Tohda; Eileen Wang; Michael E Wechsler; James Zangrilli; David B Price Journal: BMC Med Res Methodol Date: 2020-08-14 Impact factor: 4.615