TY - JOUR
T1 - Infection rates in patients from five rheumatoid arthritis (RA) registries
T2 - Contextualising an RA clinical trial programme
AU - Yamanaka, Hisashi
AU - Askling, Johan
AU - Berglind, Niklas
AU - Franzen, Stefan
AU - Frisell, Thomas
AU - Garwood, Christopher
AU - Greenberg, Jeffrey D.
AU - Ho, Meilien
AU - Holmqvist, Marie
AU - Novelli Horne, Laura
AU - Inoue, Eisuke
AU - Michaud, Kaleb
AU - Pappas, Dimitrios A.
AU - Reed, George
AU - Symmons, Deborah
AU - Tanaka, Eiichi
AU - Tran, Trung N.
AU - Verstappen, Suzanne M.M.
AU - Wesby-Van Swaay, Eveline
AU - Nyberg, Fredrik
PY - 2017/10/1
Y1 - 2017/10/1
N2 - 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.
AB - 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.
KW - epidemiology
KW - infections
KW - outcomes research
KW - rheumatoid arthritis
UR - http://www.scopus.com/inward/record.url?scp=85031110593&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85031110593&partnerID=8YFLogxK
U2 - 10.1136/rmdopen-2017-000498
DO - 10.1136/rmdopen-2017-000498
M3 - Article
C2 - 29081988
AN - SCOPUS:85031110593
VL - 3
JO - RMD Open
JF - RMD Open
SN - 2056-5933
IS - 2
M1 - e000498
ER -