SAT0288 A SYSTEMATIC REVIEW OF SYSTEMIC SCLEROSIS CLINICAL TRIALS SINCE 2005. LACK OF EARLY DISEASE TARGETING, CONFUSION RELATED TO DISEASE DURATION DEFINITION AND LOW LEVEL OF INCORPORATION OF THE NEW CLASSIFICATION CRITERIA

Abstract

Background It is still unknown whether treatment in very early systemic sclerosis (SSc) can affect long term outcomes. Objectives To systematically review clinical trials in SSc during the last 14 years aiming at answering the following questions: 1) how many clinical trials in SSc have targeted early disease and whether treatment of patients with early disease leads to better clinical outcomes, 2) how is disease duration defined in SSc clinical trials and whether data on duration since Raynaud’s onset are provided and 3) whether the new 2013 ACR/EULAR SSc criteria have been incorporated in clinical trials throughout the last 5 years. Methods A search in published studies indexed in MEDLINE was performed from Jan-2005 to Dec-2018. The Clinical Trial filter was activated and the terms “systemic sclerosis treatment” used. Studies were included if they evaluated adult patients with systemic sclerosis, concerned systemic treatments, presented data for clinical endpoints assessing fibrosis and were prospective in design. Results Seventy-three studies with a total number of 3078 patients met the inclusion criteria and were subjected to data extraction. The total weighted mean disease duration (adjusted to the number of patients in each study) was 38.55 months which is more than 3 years, the usual threshold for defining early disease. Baseline total weighted mean MRSS was 21.54 indicating that most patients had full blown fibrotic disease. Only 24 studies (32.9%) recruited early ( Conclusion 1) The majority of patients recruited in clinical trials throughout the last 14 years do not have early disease, 2) Only one third of the studies were specifically designed to target early disease, 3) The question of whether early implementation of therapy may lead to better clinical outcomes cannot be definitely answered based on existing data, 4) there is confusion related to disease duration definition across SSc clinical trials but an obvious trend towards improvement was evident throughout the last few years and 5) there is still a very low level of incorporation of the new classification criteria in SSc trials. Disclosure of Interests None declared