Infection rates in patients from five rheumatoid arthritis (RA) registries: Contextualising an RA clinical trial programme

Hisashi Yamanaka, Johan Askling, Niklas Berglind, Stefan Franzen, Thomas Frisell, Christopher Garwood, Jeffrey D. Greenberg, Meilien Ho, Marie Holmqvist, Laura Novelli Horne, Eisuke Inoue, Kaleb D Michaud, Dimitrios A. Pappas, George Reed, Deborah Symmons, Eiichi Tanaka, Trung N. Tran, Suzanne M.M. Verstappen, Eveline Wesby-Van Swaay, Fredrik Nyberg

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article numbere000498
JournalRMD Open
Volume3
Issue number2
DOIs
StatePublished - Oct 1 2017

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Registries
Rheumatoid Arthritis
Clinical Trials
Infection
Rheumatology
North America
Population
Quality of Health Care
Health
Research
Sweden
Arthritis
Comorbidity
Japan
Incidence
Therapeutics

Keywords

  • epidemiology
  • infections
  • outcomes research
  • rheumatoid arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

Cite this

Yamanaka, H., Askling, J., Berglind, N., Franzen, S., Frisell, T., Garwood, C., ... Nyberg, F. (2017). Infection rates in patients from five rheumatoid arthritis (RA) registries: Contextualising an RA clinical trial programme. RMD Open, 3(2), [e000498]. https://doi.org/10.1136/rmdopen-2017-000498

Infection rates in patients from five rheumatoid arthritis (RA) registries : Contextualising an RA clinical trial programme. / Yamanaka, Hisashi; Askling, Johan; Berglind, Niklas; Franzen, Stefan; Frisell, Thomas; Garwood, Christopher; Greenberg, Jeffrey D.; Ho, Meilien; Holmqvist, Marie; Novelli Horne, Laura; Inoue, Eisuke; Michaud, Kaleb D; Pappas, Dimitrios A.; Reed, George; Symmons, Deborah; Tanaka, Eiichi; Tran, Trung N.; Verstappen, Suzanne M.M.; Wesby-Van Swaay, Eveline; Nyberg, Fredrik.

In: RMD Open, Vol. 3, No. 2, e000498, 01.10.2017.

Research output: Contribution to journalArticle

Yamanaka, H, Askling, J, Berglind, N, Franzen, S, Frisell, T, Garwood, C, Greenberg, JD, Ho, M, Holmqvist, M, Novelli Horne, L, Inoue, E, Michaud, KD, Pappas, DA, Reed, G, Symmons, D, Tanaka, E, Tran, TN, Verstappen, SMM, Wesby-Van Swaay, E & Nyberg, F 2017, 'Infection rates in patients from five rheumatoid arthritis (RA) registries: Contextualising an RA clinical trial programme', RMD Open, vol. 3, no. 2, e000498. https://doi.org/10.1136/rmdopen-2017-000498
Yamanaka, Hisashi ; Askling, Johan ; Berglind, Niklas ; Franzen, Stefan ; Frisell, Thomas ; Garwood, Christopher ; Greenberg, Jeffrey D. ; Ho, Meilien ; Holmqvist, Marie ; Novelli Horne, Laura ; Inoue, Eisuke ; Michaud, Kaleb D ; Pappas, Dimitrios A. ; Reed, George ; Symmons, Deborah ; Tanaka, Eiichi ; Tran, Trung N. ; Verstappen, Suzanne M.M. ; Wesby-Van Swaay, Eveline ; Nyberg, Fredrik. / Infection rates in patients from five rheumatoid arthritis (RA) registries : Contextualising an RA clinical trial programme. In: RMD Open. 2017 ; Vol. 3, No. 2.
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abstract = "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.",
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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 D

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

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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.

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