Using epidemiological registry data to provide background rates as context for adverse events in a rheumatoid arthritis drug development program: a coordinated approach

Author:

Nyberg Fredrik12,Askling Johan34,Berglind Niklas5,Franzén Stefan5,Ho Meilien6,Holmqvist Marie3,Horne Laura7,Lampl Kathy8,Michaud Kaleb910,Pappas Dimitrios A.11,Reed George12,Symmons Deborah1314,Tanaka Eiichi15,Tran Trung N.16,Verstappen Suzanne M. M.14,Wesby-van Swaay Eveline17,Yamanaka Hisashi15,Greenberg Jeffrey D.1819

Affiliation:

1. Medical Evidence & Observational Research Centre, Global Medicines Development; AstraZeneca R&D; Mölndal Sweden

2. Occupational and Environmental Medicine, Sahlgrenska Academy; University of Gothenburg; Gothenburg Sweden

3. Clinical Epidemiology Unit, Department of Medicine Solna; Karolinska Institutet; Stockholm Sweden

4. Department of Rheumatology; Karolinska University Hospital; Stockholm Sweden

5. Biometric & Information Sciences, Global Medicines Development; AstraZeneca R&D; Mölndal Sweden

6. Clinical, Global Medicines Development; AstraZeneca R&D; Macclesfield UK

7. Medical Evidence & Observational Research Centre, Global Medicines Development; AstraZeneca; Wilmington DE USA

8. Clinical, Global Medicines Development; AstraZeneca; Wilmington DE USA

9. University of Nebraska Medical Center; Omaha NE USA

10. National Data Bank for Rheumatic Diseases; Wichita KS USA

11. The College of Physicians and Surgeons; Columbia University Medical Center; New York NY USA

12. University of Massachusetts Medical School; Worcester MA USA

13. NIHR Manchester Musculoskeletal Biomedical Research Unit; Central Manchester NHS Foundation Trust, Manchester Academic Health Science Centre; Manchester UK

14. Arthritis Research UK Centre for Epidemiology; The University of Manchester; Manchester UK

15. Institute of Rheumatology; Tokyo Women's Medical University; Tokyo Japan

16. MedImmune; Gaithersburg MD USA

17. Patient Safety, GRAPSQA, Global Medicines Development; AstraZeneca R&D; Macclesfield UK

18. NYU School of Medicine; New York NY USA

19. Corrona LLC; Southborough MA USA

Funder

AstraZeneca

Arthritis Research UK

AbbVie

Amgen

Janssen

Genentech

Eli Lilly and Company

Novartis

Pfizer

Regeneron

Vertex

UCB

CORRONA

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference25 articles.

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