Cédric Lukas1, Manon Redondin1, Isabelle Pane2, Martin Soubrier3, Eric Houvenagel4, Jean Sibilia5, Bernard Combe1, Jacques Morel6. 1. Department of Rheumatology, CHU Montpellier, Montpellier University, France. 2. Data Manager, Centre d'Épidémiologie Clinique, APHP, France. 3. Department of Rheumatology, CHU Clermont-Ferrand, Clermont-Ferrand University, France. 4. Department of Rheumatology, CHU Lille, Lille University, France. 5. Department of Rheumatology, CHU Strasbourg, Strasbourg University, France. 6. Department of Rheumatology, CHU Montpellier, Montpellier University, France. j-morel@chu-montpellier.fr.
Abstract
OBJECTIVES: Rheumatoid arthritis (RA) is responsible for excess mortality mainly due to cardiovascular disease. Studies have found elevated cholesterol levels in RA patients who received tocilizumab (TCZ). We studied the occurrence of major cardiovascular events in RA patients who received TCZ in current practice. We also analysed cholesterol level changes in these patients. METHODS: Data were collected from the French REGATE Registry, a multicentre observational study including patients with RA treated with TCZ. All cardiovascular complications were analysed. Changes in cholesterol levels were studied. Factors associated with major adverse cardiac and cerebrovascular events were analysed by multivariate analysis, estimating odds ratios and 95% confidence intervals. RESULTS: During an exposure time of 5591 patient-years (PYs), 35 cardiovascular events occurred in 33 patients, corresponding to an incidence of 0.63/100 PYs. The incidence of ischaemic stroke and cardiac ischaemia was 0.41 and 0.21/100 PYs. Age and personal history of cardiovascular events were identified as risk factors associated with cardiovascular events: OR=1.06 [95% CI 1.02-1.09] and 4.10 [1.90-8.83]. Female sex was a protective factor (OR=0.29 [95% CI 0.14-0.64]). Glucocorticoids may play a role but was not statistically significant. All cholesterol variables were increased in level after the third month of treatment with TCZ, with a 15.4%, 18.9% and 13.4% increase for total cholesterol, LDL-C and HDL-C, at 3 months. CONCLUSIONS: In current practice, cardiovascular events occurring under TCZ treatment is in the range of what is expected in RA patients despite a global increase in cholesterol levels.
OBJECTIVES: Rheumatoid arthritis (RA) is responsible for excess mortality mainly due to cardiovascular disease. Studies have found elevated cholesterol levels in RA patients who received tocilizumab (TCZ). We studied the occurrence of major cardiovascular events in RA patients who received TCZ in current practice. We also analysed cholesterol level changes in these patients. METHODS: Data were collected from the French REGATE Registry, a multicentre observational study including patients with RA treated with TCZ. All cardiovascular complications were analysed. Changes in cholesterol levels were studied. Factors associated with major adverse cardiac and cerebrovascular events were analysed by multivariate analysis, estimating odds ratios and 95% confidence intervals. RESULTS: During an exposure time of 5591 patient-years (PYs), 35 cardiovascular events occurred in 33 patients, corresponding to an incidence of 0.63/100 PYs. The incidence of ischaemic stroke and cardiac ischaemia was 0.41 and 0.21/100 PYs. Age and personal history of cardiovascular events were identified as risk factors associated with cardiovascular events: OR=1.06 [95% CI 1.02-1.09] and 4.10 [1.90-8.83]. Female sex was a protective factor (OR=0.29 [95% CI 0.14-0.64]). Glucocorticoids may play a role but was not statistically significant. All cholesterol variables were increased in level after the third month of treatment with TCZ, with a 15.4%, 18.9% and 13.4% increase for total cholesterol, LDL-C and HDL-C, at 3 months. CONCLUSIONS: In current practice, cardiovascular events occurring under TCZ treatment is in the range of what is expected in RA patients despite a global increase in cholesterol levels.
Authors: Kastriot Kastrati; Daniel Aletaha; Gerd R Burmester; Eva Chwala; Christian Dejaco; Maxime Dougados; Iain B McInnes; Angelo Ravelli; Naveed Sattar; Tanja A Stamm; Tsutomu Takeuchi; Michael Trauner; Desirée van der Heijde; Marieke J H Voshaar; Kevin Winthrop; Josef S Smolen; Andreas Kerschbaumer Journal: RMD Open Date: 2022-09