Eun Ha Kang1, Yinzhu Jin2, Angela Y Tong2, Rishi J Desai2, Seoyoung C Kim2,3. 1. Division of Rheumatology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. 2. Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. 3. Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Abstract
OBJECTIVE: To compare the risk of serious infections between the TNF inhibitor (TNFi) plus methotrexate (MTX) versus triple therapy among RA patients in a real-world setting. METHODS: Using claims data from Truven MarketScan (2003-2014), we conducted a cohort study to compare RA patients on MTX who added a TNFi (TNFi plus MTX group) versus hydroxychloroquine and sulfasalazine (triple therapy group). The primary outcome was any serious infection (i.e., a composite endpoint of hospitalized bacterial and opportunistic infections, or herpes zoster). Secondary outcomes were individual components of the composite endpoint. To adjust for baseline confounding, we used propensity score (PS)-based fine stratification and weighting. A weighted Cox proportional hazards model estimated the hazard ratio (HR) and 95% confidence interval (CI) of the outcomes. RESULTS: After PS stratification (PSS) and weighting, we included a total of 45,208 TNFi plus MTX initiators and 1,387 triple therapy initiators. Mean age was 53 years and 70% female. The incidence rate of any serious infection per 100 person-years was 2.46 in TNFi plus MTX and 2.03 in triple therapy. The PSS-weighted HR (95% CI) for any serious infection comparing TNFi plus MTX versus triple therapy was 1.23 (0.87-1.74). For the secondary outcomes, the PSS-weighted HR (95% CI) was 1.41 (0.85-2.34) for bacterial infection and 0.80 (0.55-1.18) for herpes zoster. CONCLUSION: In this real-world cohort of RA patients, we noted no substantially different risk of any serious infection, bacterial infection or herpes zoster after initiating TNFi plus MTX versus triple therapy although confidence intervals were wide. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.
OBJECTIVE: To compare the risk of serious infections between the TNF inhibitor (TNFi) plus methotrexate (MTX) versus triple therapy among RApatients in a real-world setting. METHODS: Using claims data from Truven MarketScan (2003-2014), we conducted a cohort study to compare RApatients on MTX who added a TNFi (TNFi plus MTX group) versus hydroxychloroquine and sulfasalazine (triple therapy group). The primary outcome was any serious infection (i.e., a composite endpoint of hospitalized bacterial and opportunistic infections, or herpes zoster). Secondary outcomes were individual components of the composite endpoint. To adjust for baseline confounding, we used propensity score (PS)-based fine stratification and weighting. A weighted Cox proportional hazards model estimated the hazard ratio (HR) and 95% confidence interval (CI) of the outcomes. RESULTS: After PS stratification (PSS) and weighting, we included a total of 45,208 TNFi plus MTX initiators and 1,387 triple therapy initiators. Mean age was 53 years and 70% female. The incidence rate of any serious infection per 100 person-years was 2.46 in TNFi plus MTX and 2.03 in triple therapy. The PSS-weighted HR (95% CI) for any serious infection comparing TNFi plus MTX versus triple therapy was 1.23 (0.87-1.74). For the secondary outcomes, the PSS-weighted HR (95% CI) was 1.41 (0.85-2.34) for bacterial infection and 0.80 (0.55-1.18) for herpes zoster. CONCLUSION: In this real-world cohort of RApatients, we noted no substantially different risk of any serious infection, bacterial infection or herpes zoster after initiating TNFi plus MTX versus triple therapy although confidence intervals were wide. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.