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Abstract Number: 15

Adverse Events and Persistency of Biologics in Rheumatoid Arthritis Patients with Interstitial Lung Disease

Dam Kim1, Soo-Kyung Cho2, Soyoung Won3, Hoon-Suk Cha4, Chan-Bum Choi5, Seung-Jae Hong6, Jisoo Lee7, Dong-Hyuk Sheen8, Dae-Hyun Yoo9, Sang-Cheol Bae10 and Yoon-Kyoung Sung1, 1Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 2Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea, The Republic of, 3Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, 4Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, 5Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, South Korea, 6Dept. of Rheumatology, #1 Hoeg, KyungHee University Medical Center, SEOUL, South Korea, 7Int Medicine, Ewha Woman's Univ Schl of Med, Seoul, Korea, Republic of, 8Division of Rheumatology, Eulji University, Daejeon, Korea, The Republic of, 9Division of Rheumatology, Department of Internal Medicine, Hanyang University Hospital for Rheumatic Diseases, Seoul, South Korea, 10Clinical Research Center for Rheumatoid Arthritis (CRCRA), Seoul, Korea, The Republic of

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: adverse events and rheumatoid arthritis (RA), Biologic agents

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Session Information

Date: Sunday, November 13, 2016

Title: Epidemiology and Public Health - Poster I

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose:  Interstitial lung disease (ILD) is one of the most important extra-articular manifestations of rheumatoid arthritis (RA). The prevalence of RA associated ILD (RA-ILD) is reported as 1-58% depending on the study population and the definition of ILD, and RA-ILD is known to be associated with increased respiratory infection and higher mortality in RA patients. Recently, use of biologics is increasing; however, the safety and persistency of biologics in RA-ILD patients are not established. We aimed to compare the incidence of adverse events (AEs) and persistency of biologics in RA patients with or without ILD.

Methods:  A total of 981 RA patients with chest radiograph or chest computed tomography (CT) data at enrollment were extracted from BIOlogics Pharmacoepidemiologic StudY (BIOPSY) cohort, a nationwide multicenter prospective inception cohort for biologic users of RA patients in Korea. We classified them into two groups: 1) RA-ILD group as patients with ILD, and 2) RA-non ILD group as patients without ILD detected by chest radiograph or CT. We compared the incidence of AEs including respiratory infection and mortality during use of biologics between two groups, and then tested the differences of drug discontinuation rates due to AEs, infection, and respiratory infection between RA-ILD and RA-non ILD groups using Kaplan-Meier survival analysis and log-rank test. In addition, crude and multivariable Cox proportional hazard model were used to identify the impact of ILD on AEs in RA patients with biologics.

Results:  The 42 patients (4.3%) revealed to have RA-ILD by chest radiograph or chest CT, and the rest of 939 patients were included in RA-non ILD group. Patients in RA-ILD group were older (62.6 ± 9.6 vs. 51.8 ± 13.2 years, p<0.01), and male patients were more in RA-ILD group (31.0% vs. 13.3%, p<0.01). During mean follow-up of 20 months with 1,611 person years (PY), the incidence of AEs was higher in RA-ILD group compared with RA-non ILD group (IRR 1.55, CI 1.11-2.17). In addition, the incidence of infection and respiratory infection were higher in RA-ILD group (IRR 2.38, CI 1.32-4.30 for infection, IRR 3.00, CI 1.50-5.99 for respiratory infection, respectively). The biologics discontinuation rate due to AEs was comparable in two groups (p=0.13), whereas the biologics discontinuation rate due to infection (p=0.03) and respiratory infection (p<0.01) were significantly higher in RA-ILD group. After adjusting for variables, age (HR 1.27, CI 1.15-1.41) and having ILD (HR 10.77, CI 2.26-51.41) were risk factors for mortality in RA patients with biologics.

Conclusion:  The incidence of adverse events, especially respiratory infections were higher in RA-ILD patients with biologics compared with RA-non ILD patients. In addition, the biologics discontinuation rate due to infection, especially respiratory infection was significantly higher in RA-ILD patients. Concerning the mortality, ILD increased the mortality in RA patients with biologics.


Disclosure: D. Kim, None; S. K. Cho, None; S. Won, None; H. S. Cha, None; C. B. Choi, None; S. J. Hong, None; J. Lee, None; D. H. Sheen, None; D. H. Yoo, CELLTRION,Inc., 5; S. C. Bae, None; Y. K. Sung, None.

To cite this abstract in AMA style:

Kim D, Cho SK, Won S, Cha HS, Choi CB, Hong SJ, Lee J, Sheen DH, Yoo DH, Bae SC, Sung YK. Adverse Events and Persistency of Biologics in Rheumatoid Arthritis Patients with Interstitial Lung Disease [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/adverse-events-and-persistency-of-biologics-in-rheumatoid-arthritis-patients-with-interstitial-lung-disease/. Accessed .
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