AB1096 Observational safety study of golimumab in treatment of polyarticular juvenile idiopathic arthritis using the german biologics jia registry. (12th June 2018)

• Record Type: Journal Article
• Authors: Horneff, G.; Klein, A.
• Is Part Of: Annals of the rheumatic diseases. Volume 77(2018)Supplement 2
• Page Start: 1657
• Page End: 1657
• Publication Date: 2018-06-12
• Subjects: Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2018-eular.2165
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Background: Golimumab (GLM) received European marketing authorisation for treatment of polyarticular JIA (pJIA). The long-term safety of GLM in clinical preactice has not been characterised. Objectives: The aim of the present project is to conduct a post-authorisation safety study to monitor long-term safety of subcutaneous GLM in the treatment of pJIA in routine clinical practice setting. Methods: Monitoring of GLM in 200 pts with polyarticular JIA (cohort 1) in clinical practice will be performed by the German BiKeR Registry compared to a concurrent cohort 2 with 400 pts newly treated with alternative (approved) TNF-inhibitor, a concurrent cohort 3 with 500 pts newly starting methotrexate, a historic cohort 4 of patients treated with TNF-inhibitors and a historic cohort 5 never exposed to biologics but treated with methotrexate. Efficacy will be assessed by single disease activity markers and JADAS10, safety will be assessed by adverse event reporting and monitoring with a special interest on serious infections including opportunistic infections and TB, malignancies, autoimmune processes and exposure during pregnancy. Results: Recruiting of three new cohorts 1–3 started in July 2017. Historic control cohorts 4 and 5 were obtained from the BIKER data base. Cohort 4 was recruited from 2006 to 2016, cohort 5 from 2005 to 2011. Baseline patients' characteristics are outlined in table 1. So far, patients of the GLM cohort 1 were older, had a much longer disease duration and received pre-treatment with other biologics more often. All patients in this cohort received combination with methotrexate. Since so far GLM is approved for children with body weight of at least 40 kg and in combination with methotrexate, differences were expected. Baseline disease activity indicators are within the range of alternative TNF inhibitors and the historic cohort 4 while patients of the concurrent methotrexate cohort receiving their first treatment approach had the highest baseline disease activity. Conclusions: The BiKeR registry has been collecting data from JIA patients treated with approved biologics in routine clinical practice since 2001. To provide context for interpreting long-term safety and effectiveness of data for GLM, analysis will also include data from contemporary pJIA patients treated with alternative TNF inhibitors and methotrexate. Acknowledgements: This project of the BIKER registry is supported by an unrestricted grant from MSD, Germany Disclosure of Interest: None declared