Cardiovascular Events, Malignancies, and Efficacy Outcomes in Latin American Patients With Rheumatoid Arthritis Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of the ORAL Surveillance Study.
Journal
Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases
ISSN: 1536-7355
Titre abrégé: J Clin Rheumatol
Pays: United States
ID NLM: 9518034
Informations de publication
Date de publication:
17 Jun 2024
17 Jun 2024
Historique:
medline:
17
6
2024
pubmed:
17
6
2024
entrez:
17
6
2024
Statut:
aheadofprint
Résumé
To assess safety/efficacy of tofacitinib and tumor necrosis factor inhibitors (TNFi) in patients from Latin America (LATAM) in ORAL Surveillance. In ORAL Surveillance, 4362 patients with rheumatoid arthritis aged ≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg twice daily or TNFi. This post hoc analysis stratified patients by geographical location (LATAM, n = 1202; non-LATAM, n = 3160). Incidence rates (IRs; patients with first event/100 patient-years) and hazard ratios for adverse events of special interest were reported. Efficacy outcomes included Clinical Disease Activity Index and American College of Rheumatology 20/50/70 responses. Risk factors associated with cardiovascular disease and malignancies were less prevalent in the LATAM cohort compared with the non-LATAM cohort. IRs for patients receiving tofacitinib (combined doses) versus TNFi were 0.54 versus 0.28 (LATAM) and 1.14 versus 0.92 (non-LATAM) for major adverse cardiovascular events; 0.58 versus 0.27 (LATAM) and 1.33 versus 0.95 (non-LATAM) for malignancies excluding nonmelanoma skin cancer; and 0.69 versus 0.35 (LATAM) and 0.63 versus 0.33 (non-LATAM) for all-cause death. IRs for nonmelanoma skin cancer and venous thromboembolism were also numerically higher with tofacitinib versus TNFi and in the non-LATAM cohort versus LATAM. Efficacy was similar across treatment groups within each cohort. Adverse events of special interest were generally less frequent in LATAM versus non-LATAM patients, reflecting differences in baseline characteristics, and higher with tofacitinib versus TNFi in both cohorts, consistent with the overall findings of ORAL Surveillance. Our findings emphasize the importance of assessing individual risk factors to guide benefit/risk assessment and treatment decisions. NCT02092467.
Sections du résumé
BACKGROUND/OBJECTIVE
OBJECTIVE
To assess safety/efficacy of tofacitinib and tumor necrosis factor inhibitors (TNFi) in patients from Latin America (LATAM) in ORAL Surveillance.
METHODS
METHODS
In ORAL Surveillance, 4362 patients with rheumatoid arthritis aged ≥50 years with ≥1 additional cardiovascular risk factor received tofacitinib 5 or 10 mg twice daily or TNFi. This post hoc analysis stratified patients by geographical location (LATAM, n = 1202; non-LATAM, n = 3160). Incidence rates (IRs; patients with first event/100 patient-years) and hazard ratios for adverse events of special interest were reported. Efficacy outcomes included Clinical Disease Activity Index and American College of Rheumatology 20/50/70 responses.
RESULTS
RESULTS
Risk factors associated with cardiovascular disease and malignancies were less prevalent in the LATAM cohort compared with the non-LATAM cohort. IRs for patients receiving tofacitinib (combined doses) versus TNFi were 0.54 versus 0.28 (LATAM) and 1.14 versus 0.92 (non-LATAM) for major adverse cardiovascular events; 0.58 versus 0.27 (LATAM) and 1.33 versus 0.95 (non-LATAM) for malignancies excluding nonmelanoma skin cancer; and 0.69 versus 0.35 (LATAM) and 0.63 versus 0.33 (non-LATAM) for all-cause death. IRs for nonmelanoma skin cancer and venous thromboembolism were also numerically higher with tofacitinib versus TNFi and in the non-LATAM cohort versus LATAM. Efficacy was similar across treatment groups within each cohort.
CONCLUSIONS
CONCLUSIONS
Adverse events of special interest were generally less frequent in LATAM versus non-LATAM patients, reflecting differences in baseline characteristics, and higher with tofacitinib versus TNFi in both cohorts, consistent with the overall findings of ORAL Surveillance. Our findings emphasize the importance of assessing individual risk factors to guide benefit/risk assessment and treatment decisions.
CLINICAL TRIAL REGISTRATION NUMBER
BACKGROUND
NCT02092467.
Identifiants
pubmed: 38880956
doi: 10.1097/RHU.0000000000002106
pii: 00124743-990000000-00223
doi:
Banques de données
ClinicalTrials.gov
['NCT02092467']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
Références
Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386:316–326.
Kristensen LE, Danese S, Yndestad A, et al. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023;82:901–910.
Charles-Schoeman C, Buch MH, Dougados M, et al. Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance. Ann Rheum Dis. 2023;82:119–129.
Li Z, Lin L, Wu H, et al. Global, regional, and national death, and disability-adjusted life-years (DALYs) for cardiovascular disease in 2017 and trends and risk analysis from 1990 to 2017 using the global burden of disease study and implications for prevention. Front Public Health. 2021;9:559751.
Roth GA, Mensah GA, Johnson CO, et al. Global burden of cardiovascular diseases and risk factors, 1990–2019: update from the GBD 2019 study. J Am Coll Cardiol. 2020;76:2982–3021.
Ramamoorthy A, Kim HH, Shah-Williams E, et al. Racial and ethnic differences in drug disposition and response: review of new molecular entities approved between 2014 and 2019. J Clin Pharmacol. 2022;62:486–493.
Castañeda OM, Romero FJ, Salinas A, et al. Safety of tofacitinib in the treatment of rheumatoid arthritis in Latin America compared with the rest of the world population. J Clin Rheumatol. 2017;23:193–199.
Radominski SC, Cardiel MH, Citera G, et al. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of Latin American patients with rheumatoid arthritis: pooled efficacy and safety analyses of phase 3 and long-term extension studies. Reumatol Clin. 2017;13:201–209.
American College of Cardiology, American Heart Association. ASCVD Risk Estimator. American College of Cardiology; 2022. Available at: https://tools.acc.org/ldl/ascvd_risk_estimator/index.html#!/calulate/estimator/ Accessed November 14, 2022.
Agca R, Heslinga SC, Rollefstad S, et al. EULAR recommendations for cardiovascular disease risk management in patients with rheumatoid arthritis and other forms of inflammatory joint disorders: 2015/2016 update. Ann Rheum Dis. 2017;76:17–28.
Goff DC Jr., Lloyd-Jones DM, Bennett G, et al. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25 Suppl 2):S49–S73.
Hussain-Gambles M, Atkin K, Leese B. Why ethnic minority groups are under-represented in clinical trials: a review of the literature. Health Soc Care Community. 2004;12:382–388.
Ramos-Remus C, Sierra-Jimenez G, Skeith K, et al. Latitude gradient influences the age of onset in rheumatoid arthritis patients. Clin Rheumatol. 2007;26:1725–1728.
Barragán-Martínez C, Amaya-Amaya J, Pineda-Tamayo R, et al. Gender differences in Latin-American patients with rheumatoid arthritis. Gend Med. 2012;9:490–510.e495.
GBD 2021 Rheumatoid Arthritis Collaborators. Global, regional, and national burden of rheumatoid arthritis, 1990–2020, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5:e594–e610.
Semb AG, Ikdahl E, Kerola AM, et al. A clinical audit of cardiovascular risk factors and disease in patients with rheumatoid arthritis—SURF-RA. Mediterr J Rheumatol. 2022;33:201–217.
Solomon DH, Reed GW, Kremer JM, et al. Disease activity in rheumatoid arthritis and the risk of cardiovascular events. Arthritis Rheumatol. 2015;67:1449–1455.
Karpouzas GA, Szekanecz Z, Baecklund E, et al. Rheumatoid arthritis disease activity and adverse events in patients receiving tofacitinib or tumor necrosis factor inhibitors: a post hoc analysis of ORAL Surveillance. Ther Adv Musculoskelet Dis. 2023;15:1759720X231201047.
Van Spall HGC, Averbuch T, Damman K, et al. Risk and risk reduction in trials of heart failure with reduced ejection fraction: absolute or relative? Eur J Heart Fail. 2021;23:1437–1444.
Gabriel SE, Crowson CS. Risk factors for cardiovascular disease in rheumatoid arthritis. Curr Opin Rheumatol. 2012;24:171–176.
Ketfi C, Boutigny A, Mohamedi N, et al. Risk of venous thromboembolism in rheumatoid arthritis. Joint Bone Spine. 2020;88:105122.
Yoshimura M, Fujieda Y, Sugawara M, et al. Disease activity as a risk factor for venous thromboembolism in rheumatoid arthritis analysed using time-averaged DAS28CRP: a nested case-control study. Rheumatol Int. 2022;42:1939–1946.
De Cock D, Hyrich K. Malignancy and rheumatoid arthritis: epidemiology, risk factors and management. Best Pract Res Clin Rheumatol. 2018;32:869–886.
Lopez-Jaramillo P, Joseph P, Lopez-Lopez JP, et al. Risk factors, cardiovascular disease, and mortality in South America: a PURE substudy. Eur Heart J. 2022;43:2841–2851.