Department of Medicine, Division of Preventive And Behavioral Medicine
Bacterial Infections and Mycoses | Clinical Trials | Epidemiology | Immune System Diseases | Musculoskeletal Diseases | Skin and Connective Tissue Diseases
OBJECTIVE: Patients with rheumatoid arthritis (RA) have an increased risk of serious infections. Comparing infection rates across RA populations is complicated by differences in background infection risk, population composition and study methodology. We measured infection rates from five RA registries globally, with the aim to contextualise infection rates from an RA clinical trials population.
METHODS: We used data from Consortium of Rheumatology Research of North America (CORRONA) (USA), Swedish Rheumatology Quality of Care Register (Sweden), Norfolk Arthritis Register (UK), CORRONA International (multiple countries) and Institute of Rheumatology Rheumatoid Arthritis (Japan) and an RA clinical trial programme (fostamatinib). Within each registry, we analysed a main cohort of all patients with RA from January 2000 to last available data. Infection definitions were harmonised across registries. Sensitivity analyses to address potential confounding explored subcohorts defined by disease activity, treatment change and/or prior comorbidities and restriction by calendar time or follow-up. Rates of infections were estimated and standardised to the trial population for age/sex and, in one sensitivity analysis also, for Health Assessment Questionnaire (HAQ) score.
RESULTS: Overall, age/sex-standardised rates of hospitalised infection were quite consistent across registries (range 1.14-1.62 per 100 patient-years). Higher and more consistent rates across registries and with the trial programme overall were seen when adding standardisation for HAQ score (registry range 1.86-2.18, trials rate 2.92) or restricting to a treatment initiation subcohort followed for 18 months (registry range 0.99-2.84, trials rate 2.74).
CONCLUSION: This prospective, coordinated analysis of RA registries provided incidence rate estimates for infection events to contextualise infection rates from an RA clinical trial programme and demonstrated relative comparability of hospitalised infection rates across registries.
epidemiology, infections, outcomes research, rheumatoid arthritis
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© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. No commercial use is permitted unless otherwise expressly granted. 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
DOI of Published Version
RMD Open. 2017 Oct 10;3(2):e000498. doi: 10.1136/rmdopen-2017-000498. eCollection 2017. Link to article on publisher's site
Yamanaka H, Reed GW. (2017). Infection rates in patients from five rheumatoid arthritis (RA) registries: contextualising an RA clinical trial programme. Open Access Publications by UMMS Authors. https://doi.org/10.1136/rmdopen-2017-000498. Retrieved from https://escholarship.umassmed.edu/oapubs/3299
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This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License