Develop a New Platform for Post-Marketing Vigilance Though Smart System of Disease Management (SSDM) Mobiles Tools: A Real World Cohort Study of RA Patients from China

Yongfu Wang¹, Hua Wei², Jing Yang³, Chun Li⁴, Rong Mu⁵, Bin Wu⁶, Hongzhi Wang⁷, Yong Wang⁸, Xiaohan Wang⁹, Huifang Guo¹⁰, Jing Xue¹¹, Jinli Ru¹², Xiafei Xin¹³, Fengxiao Zhang¹⁴, Lirong Kang¹, Hong Liu³, Xiaoling Liu¹⁵, Tong Xie¹⁶, Lingxun Shen¹⁷, Huiqin Yang¹⁸, Shouxin Li¹⁹, Fen Li²⁰, Fen Wang²¹, Rui Wu²², Yuan Liu²³, Hui Xiao²³, Yuhua Jia²³, Fei Xiao²³ and Jianlin Huang²⁴, ¹The First Affiliated Hospital of BaoTou Medical College, Baotou, China, ²Northern Jiangsu People's Hospital, Yangzhou, China, ³Department of rheumatology, Central Hospital of MianYang, Sichuan, Mian Yang, China, ⁴Peking University People's Hospital, Beijing, China, ⁵Department of Rheumatology and Immunology, Peking University People's Hospital, Beijing, China, ⁶Department of Rheumatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, China, ⁷The First Hospital of Jiaxing, Jiaxing, China, ⁸The first Hospital Affiliated to AMU (Southernwest Hospital), Chongqing, China, ⁹Department of Rheumatology and Immunology, Anyang district hospital, Anyang, China, ¹⁰The Second Hospital of Hebei Medical University, Shijiazhuang, China, ¹¹88 Jiefang Road, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China, ¹²The Second hospital of Shanxi Medical University, Taiyuan, China, ¹³Department of Rheumatology and Immunology, NingBo First Hospital, Zhejiang, Ningbo, China, ¹⁴Department of Rheumatology and Immunology, Hebei General Hospital, Shijiazhuang, China, ¹⁵The 1st Affiliated Hospital of Guangzhou University of TCM, Guangzhou, China, ¹⁶Affiliated hospital of Guangdong medical University, Zhanjiang, China, ¹⁷Union Hospital Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China, ¹⁸Wuhan No 1 Hospital, wuhan, China, ¹⁹Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology, wuhan, China, ²⁰The Second Xiangya Hospital of Central South University, Changsha, China, ²¹Department of Rheumatology, First Affiliated Hospital of Medical University Of Anhui, Hefei, China, ²²The First Affiliated Hospital of Nanchang University, Nanchang, China, ²³Shanghai Gothic Internet Technology Co., Ltd., Shanghai, China, ²⁴Department of rheumatology, The Sixth Hospital Affiliated to Sun yat-sen University, Guangzhou, China

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Adverse events, combination therapies and rheumatoid arthritis (RA), DMARDs

Session Information

Date: Tuesday, October 23, 2018

Title: Health Services Research Poster III – ACR/ARHP

Session Type: ACR/ARHP Combined Abstract Session

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

Background/Purpose: Adverse events (AE) during treatment in RA patients are unavoidable. Monitoring AEs in real time during long-term treatment is critical for AE detection and rational management. The current AE report system in MedWatch can only collect rare AE, but could not support post marketing vigilance and reevaluation for drugs, especially in real world combination therapy.

To develop and validate SSDM as a new platform for post-marketing vigilance through monitoring AEs with common mono- and combination therapies in treatment of rheumatoid arthritis (RA).

Methods: The SSDM is a mobile App which includes two applications for both physicians and patients. Patients were educated to input the data of lab test records and treatment regiments and perform disease activity evaluation once a month. After data entry, patients can synchronize data to the mobile terminal of their authorized rheumatologist and upload onto cloud, which formed a large patient self-management database.

Results: From Aug 2014 to May 2018, a total of 10,903 RA patients from 480 centers in China were entered in the cohort study. These patients contributed more than 18,823 patient-years (PY) follow-up data. The mean age was 49.29 +/- 16.08 (18 to 99) years and the median disease duration was 27.4 months. The treatment regimens include 11 mono and 39 combination therapies. Taken ALT as an example, the profile of AE of ALT elevation for top ten mono therapy regimens is plot (Figure 1). In the database there are thirty-six MTX based combinations treatment regimens. The specifications of elevation of ALT in MTX combination therapy are drafted based on relative risk ratio comparing with rate in MTX mono therapy (Figure 2). Both AE profiles in mono therapy and specification in combination treatment alerted clinicians for unsafe regiments avoidance and timely adjustment.

Conclusion: The findings show that the AEs may be well collected and described via SSDM database through empowering patient. Rheumatologists are able to monitor the real world profile of adverse events in real time. SSDM is able to assist Rheumatologist in making rational clinical decision. SSDM may serve as new platform for post-marketing vigilance.

Disclosure: Y. Wang, None; H. Wei, None; J. Yang, None; C. Li, None; R. Mu, None; B. Wu, None; H. Wang, None; Y. Wang, None; X. Wang, None; H. Guo, None; J. Xue, None; J. Ru, None; X. Xin, None; F. Zhang, None; L. Kang, None; H. Liu, None; X. Liu, None; T. Xie, None; L. Shen, None; H. Yang, None; S. Li, None; F. Li, None; F. Wang, None; R. Wu, None; Y. Liu, None; H. Xiao, None; Y. Jia, None; F. Xiao, None; J. Huang, None.

To cite this abstract in AMA style:

Wang Y, Wei H, Yang J, Li C, Mu R, Wu B, Wang H, Wang Y, Wang X, Guo H, Xue J, Ru J, Xin X, Zhang F, Kang L, Liu H, Liu X, Xie T, Shen L, Yang H, Li S, Li F, Wang F, Wu R, Liu Y, Xiao H, Jia Y, Xiao F, Huang J. Develop a New Platform for Post-Marketing Vigilance Though Smart System of Disease Management (SSDM) Mobiles Tools: A Real World Cohort Study of RA Patients from China [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/develop-a-new-platform-for-post-marketing-vigilance-though-smart-system-of-disease-management-ssdm-mobiles-tools-a-real-world-cohort-study-of-ra-patients-from-china/. Accessed .

« Back to 2018 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/develop-a-new-platform-for-post-marketing-vigilance-though-smart-system-of-disease-management-ssdm-mobiles-tools-a-real-world-cohort-study-of-ra-patients-from-china/