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
N1 - Funding Information:
Funding astraZeneca funded this study and collaborated with the researchers in the design, analysis and interpretation. Five independent registries have own funding support, but those funding sources are not involved in the design, analysis of this study. nOar is funded by arthritis research UK. Srr has or has had research agreements with abbVie, Pfizer, BMS, UcB, Merck, astraZeneca, Sobi, and roche. iOrra is supported by various grants from a large number of pharmaceutical companies, including astraZeneca. cOrrOna inc. has received funding in the past 2 years from abbVie, amgen, astraZeneca, Janssen, genentech, lilly, novartis, Pfizer, regeneron, Vertex and UcB, through contracted subscriptions
Funding Information:
Competing interests Fn, nB, tnt, eW-vS and MeH are employees of astraZeneca. Fn, nB, lH, tnt, eW-vS, MeH and SF hold astraZeneca stocks and/or options. lH and SF were employees of astraZeneca during the time in which the research was conducted, and cg was affiliated with the arthritis research UK centre for epidemiology. Ja has had grant/research support from astraZeneca and has been a consultant for astraZeneca. tF has received honoraria for advisory board participation from Pfizer. JDg is a shareholder of cOrrOna, inc., and has consulted for astraZeneca, cOrrOna, novartis and Pfizer. DaP is an employee of cOrrOna and has been a paid instructor for novartis. gr is an employee of cOrrOna. KM has grant/research support from acr rheumatology research Foundation and is codirector of the national Data Bank for rheumatic Diseases (nDB), which has received funds from astraZeneca. HY leads the iOrra cohort and has been a consultant for astraZeneca. DS has had grant/research support from astraZeneca and has been a consultant for astraZeneca.
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
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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 -