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Infection rates in patients from five rheumatoid arthritis (RA) registries: Contextualising an RA clinical trial programme
- Yamanaka, H. (författare)
-
- Askling, J. (författare)
- Karolinska Institutet
- Berglind, N. (författare)
- visa fler...
- Franzen, S. (författare)
- Garwood, C. (författare)
- Greenberg, J. D. (författare)
- Ho, M. (författare)
- Novelli Horne, L. (författare)
- Inoue, E. (författare)
- Michaud, K. (författare)
- Pappas, D. A. (författare)
- Reed, G. (författare)
- Symmons, D. (författare)
- Tanaka, E. (författare)
- Tran, T. N. (författare)
- Verstappen, S. M. M. (författare)
- Wesby-Van Swaay, E. (författare)
- visa färre...
- (creator_code:org_t)
- 2017-10-10
- 2017
- Engelska.
- Ingår i: RMD Open. - : BMJ. - 2056-5933. ; 3:2
- Tidskriftsartikel (refereegranskat)
Abstract
Ämnesord
Stäng
- 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. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reumatologi och inflammation (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Rheumatology and Autoimmunity (hsv//eng)
Nyckelord
- epidemiology
- infections
- outcomes research
- rheumatoid arthritis
- adult
- age
- aged
- Article
- clinical trial
- cohort analysis
- comorbidity
- disease activity
- disease registry
- female
- follow up
- gender
- Health Assessment Questionnaire
- hospital infection
- human
- incidence
- infection rate
- infection risk
- major clinical study
- male
- middle aged
- prospective study
- sensitivity analysis
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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- Av författaren/redakt...
- Yamanaka, H.
- Askling, J.
- Berglind, N.
- Franzen, S.
- Frisell, T.
- Garwood, C.
- visa fler...
- Greenberg, J. D.
- Ho, M.
- Holmqvist, M.
- Novelli Horne, L ...
- Inoue, E.
- Michaud, K.
- Pappas, D. A.
- Reed, G.
- Symmons, D.
- Tanaka, E.
- Tran, T. N.
- Verstappen, S. M ...
- Wesby-Van Swaay, ...
- Nyberg, Fredrik, ...
- visa färre...
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- Karolinska Institutet
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