FRI0598 A SYSTEMATIC REVIEW OF THE EFFECTIVENESS AND SAFETY OF PHARMACOLOGICAL TREATMENTS IN PATIENTS WITH SYSTEMIC IDIOPATHIC JUVENILE ARTHRITIS (SJIA)

Background Treatment options for SJIA include canakinumab, tocilizumab (both approved by US FDA and EMA) and anakinra (approved by EMA), while anti-tumor necrosis factor inhibitors, steroids, disease-modifying anti-rheumatic drugs and non-steroidal anti-inflammatory drugs are also used.1 A recent systematic review included only randomized controlled trials (RCTs) of biologics. We aimed to generate a more comprehensive evidence on the effectiveness and safety of treatments used in SJIA. Objectives To assess evidence on the effectiveness and safety of therapeutic agents for SJIA from RCTs and real-world studies. Methods A systematic literature review was conducted using Cochrane methodology2 from 2000 to Jan 2018. Sources included Embase®, MEDLINE®, MEDLINE®-In Process and Cochrane library. Studies were searched for English language publications as full-text articles (2000 to Jan 2018) or conference abstracts (2015 to Jan 2018). Studies with ≤15 pts were excluded. Results Of the 62 included studies, 8 were RCTs and 54 were real-world studies. The interventions included in the RCTs were anakinra (ANA), canakinumab (CAN), etanercept (ETN), methotrexate (MTX) and tocilizumab (TCZ) (1 RCT each and 1 withdrawal trial for TCZ), and 2 RCTs for rilonacept (RLN); all vs. placebo (PLB). In addition to the interventions mentioned in the RCTs, real-world studies also included other interventions such as abatacept, adalimumab (ADA), infliximab (INF), non-steroidal anti-inflammatory drugs and steroids. Juvenile idiopathic arthritis - American college of rheumatology (JIA ACR)-30 was the most common composite outcome reported across studies. In RCTs, the JIA ACR-30 (+ no fever) responses were significantly superior vs. PLB for CAN (81% vs. 10%), TCZ (85% vs. 24%), and ANA (92% vs. 50%) (p In real-world studies, the JIA-ACR 30 response rates reported for ANA, ANA or CAN (patients were on either therapy), TCZ and ETN were 50%-55%, 57%-60%, 47%-100% and 47%-73% at short-term follow-up period (FUP, All interventions were generally well tolerated by SJIA patients; infections, injection site reactions and macrophage activation syndrome were reported for all biologics. Other complications included gastrointestinal disorders, pharyngitis, skin disorders, increase in liver enzymes etc. Conclusion The current interventions especially ANA, CAN, ETN and TCZ were found to be effective and generally well tolerated in SJIA. However, the lack of head-to-head studies limits a rigorous comparison. References [1] Ringold, et al. 2013. Arthritis Rheum;65:2499-512. [2] Higgins, et al. 2011. Cochrane Handbook for Systematic Reviews of Interventions Version5.1.0. Disclosure of Interests Jasmin Kuemmerle-Deschner Grant/research support from: Jasmin Kuemmerle-Deschner is an employee of University of Tuebingen, Germany, and received consultants/speakers fees from Novartis and SOBI pharmaceuticals and grant support from SOBI and Novartis., Consultant for: Jasmin Kuemmerle-Deschner is an employee of University of Tuebingen, Germany, and received consultants/speakers fees from Novartis and SOBI pharmaceuticals and grant support from SOBI and Novartis., Speakers bureau: Jasmin Kuemmerle-Deschner is an employee of University of Tuebingen, Germany, and received consultants/speakers fees from Novartis and SOBI pharmaceuticals and grant support from SOBI and Novartis., Lalit Thakur Employee of: Lalit Thakur is an employee of Novartis Healthcare Pvt. Ltd., Hyderabad, India, Aneesh George Employee of: Aneesh George is an employee of Novartis Healthcare Pvt Ltd., Peter Hur Employee of: Peter Hur is an employee of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA