Elizabeth V Arkema1, Jerker Jonsson2, Eva Baecklund3, Judith Bruchfeld4, Nils Feltelius5, Johan Askling6. 1. Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 2. Swedish Institute for Infectious Disease Control, Solna, Sweden Infectious Diseases Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 3. Unit of Rheumatology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 4. Infectious Diseases Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. 5. Medical Products Agency, Uppsala, Sweden Rheumatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden. 6. Clinical Epidemiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden Rheumatology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
Abstract
OBJECTIVE: To estimate the risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA) both with and without exposure to biological therapy and to directly compare the risks between therapies. METHODS: Data from the Swedish National Population Registers, Tuberculosis Register and the Swedish Biologics Register were used to conduct a prospective population-based national cohort study (2002-2011). We estimated the rate of incident TB in the general population and in a cohort of biological-naïve and biological-exposed patients diagnosed with RA. Cox models were used to estimate HRs with particular attention to risks by calendar and follow-up time and individual biologics. RESULTS: Compared to the general population, RA patients not exposed to biologicals had a fourfold increased risk of TB (HR 4.2; 95% CI 2.7 to 6.7), which did not decline over calendar time. In contrast, the risk of TB in the biological-exposed RA population decreased since 2002 compared with biological-naïve; from HR=7.9 (95% CI 3.3 to 18.9) in 2002-2006 to HR=2.4 (95% CI 0.9 to 6.1) in 2007-2011. The HRs for most recent exposure to adalimumab and infliximab compared with etanercept were 3.1 (95% CI 0.8 to 12.5) and 2.7 (95% CI 0.7 to 10.9), respectively, and the HR for etanercept compared with biological-naïve RA was 1.7 (95% CI 0.6 to 4.6). CONCLUSIONS: In the past decade, the risk of TB has decreased among biological-exposed RA patients but remains higher than in biological-naïve RA patients. Most cases of TB in RA occur in biological-naïve RA patients, underscoring the elevated risk also in these patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
OBJECTIVE: To estimate the risk of tuberculosis (TB) in patients with rheumatoid arthritis (RA) both with and without exposure to biological therapy and to directly compare the risks between therapies. METHODS: Data from the Swedish National Population Registers, Tuberculosis Register and the Swedish Biologics Register were used to conduct a prospective population-based national cohort study (2002-2011). We estimated the rate of incident TB in the general population and in a cohort of biological-naïve and biological-exposed patients diagnosed with RA. Cox models were used to estimate HRs with particular attention to risks by calendar and follow-up time and individual biologics. RESULTS: Compared to the general population, RApatients not exposed to biologicals had a fourfold increased risk of TB (HR 4.2; 95% CI 2.7 to 6.7), which did not decline over calendar time. In contrast, the risk of TB in the biological-exposed RA population decreased since 2002 compared with biological-naïve; from HR=7.9 (95% CI 3.3 to 18.9) in 2002-2006 to HR=2.4 (95% CI 0.9 to 6.1) in 2007-2011. The HRs for most recent exposure to adalimumab and infliximab compared with etanercept were 3.1 (95% CI 0.8 to 12.5) and 2.7 (95% CI 0.7 to 10.9), respectively, and the HR for etanercept compared with biological-naïve RA was 1.7 (95% CI 0.6 to 4.6). CONCLUSIONS: In the past decade, the risk of TB has decreased among biological-exposed RApatients but remains higher than in biological-naïve RApatients. Most cases of TB in RA occur in biological-naïve RApatients, underscoring the elevated risk also in these patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: K L Winthrop; S-H Park; A Gul; M H Cardiel; J J Gomez-Reino; Y Tanaka; K Kwok; T Lukic; E Mortensen; D Ponce de Leon; R Riese; H Valdez Journal: Ann Rheum Dis Date: 2015-08-28 Impact factor: 19.103
Authors: X Mariette; J Vencovsky; O Lortholary; J Gomez-Reino; M de Longueville; P Ralston; M Weinblatt; R van Vollenhoven Journal: RMD Open Date: 2015-04-28