SAT0120 Evaluation of the risk of overall malignancy and malignant lymphoma with methotrexate and biological agents in patients with rheumatoid arthritis based on the iorra cohort during a 14-year observation period

Abstract

BackgroundWhile dramatic progress has been made in this decade with treatments for rheumatoid arthritis (RA), such as methotrexate (MTX) and biological agents, concern about the safety, including the occurrence of malignancy, of these highly effective drugs still exists in daily clinical practice. There has not been an evident association between the use of biological agents and the occurrence of malignancy in most reports from clinical trials1 and observational studies2, although MTX use might be associated with the development of malignant lymphoma, called MTX-associated lymphoproliferative disorder3, in patients with RA. In an analysis of risk factors for overall and site-specific malignancies in Japanese patients with RA, higher disease activity was identified to be a risk factor for overall malignancies (hazard ratio [HR] 1.10, 95% CI 1.02–1.19), suggesting that tight control of RA disease activity would reduce the occurrence of malignancies in patients with RA4. However, the risk of malignancies with RA treatments including MTX and biological agents was not assessed in that analysis.ObjectivesWe investigated the association between the occurrence of malignancies (overall and malignant lymphoma) and drug use (MTX and biological agents) in a large observational cohort of Japanese patients with RA over a long-term period.MethodsAmong Japanese patients with RA enrolled in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort from April 2000 to September 2013, data for all malignancies were extracted from patients' self-reports and confirmed by medical records. Data for malignancies occurring in patients who dropped out of the IORRA study during the subsequent three months were also collected from medical information from affiliated hospitals. We analysed whether MTX and biological agents were risk factors for overall malignancy and malignant lymphoma using a marginal structural Cox proportional hazards model5 adjusted for age, gender, smoking history, body mass index, RA disease duration, rheumatoid factor positivity and disease activity (28-joint disease activity score).ResultsAmong 11,106 Japanese patients with RA representing 68,483 person-years, 507 overall malignancies, including 68 malignant lymphomas, were confirmed. Neither MTX nor biological agent use was a significant risk factor for overall malignancy, with an HR (95% CI) of 1.18 (0.77–1.81) and 1.01 (0.65–1.57), respectively, or for malignant lymphoma, with an HR (95% CI) of 1.17 (0.55–2.48) and 1.26 (0.43–3.64), respectively.ConclusionsThe use of MTX and biological agents was not significantly associated with the occurrence of overall malignancy or malignant lymphoma during long-term longitudinal observation of Japanese patients with RA.References Moulis G, et al. PLoS One. 2012;7:e48991.Mariette X, et al. Ann Rheum Dis. 2011;70:1895–904.Kameda T, et al. Arthritis Care Res (Hoboken). 2014;66:1302–9.Sugimoto N, et al. EULAR Congress 2016;FRI0143.Choi HK, et al. Lancet. 2002;359:1173–7. Disclosure of InterestN. Sugimoto Speakers bureau: T...

SAT0121 Comorbities and disease activity are relevant for functional disability in rheumatoid arthritis

“…Integrating MM in to current RA care strategies may help achieve better patient outcomes. 3 Rheumatology, University Hospital, Lille; 4 Rheumatology, University Hospital, Clermont-Ferrand; 5 Rheumatology, University Hospital, Bordeaux; 6 Rheumatology, University Hospital, Strasbourg; 7 Pain center, University Hospital, Paris, France Background: Although pain in rheumatoid arthritis (RA) is frequently thought to be inflammatory in nature, some studies reported clinically significant pain despite relatively low rheumatoid arthritis (RA) disease activity. Less than 50% of patients are satisfied by the management of pain.…”