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Introduction RCTs designed so far impose selection of populations enriched for disease progression that often represents a small proportion of real-world cohorts, entailing difficulty in recruitment and poor generalisability of results. As real-world data may offer a useful context, we assessed the proportion of patients meeting DAISY inclusion criteria and those meeting the primary outcome Revised-Composite Response Index in SSc (CRISS)-25 response, utilising the largest database of real-world patient visits for patients with SSc – the European Scleroderma Trials and Research group (EUSTAR) cohort.Material and Methods The EUSTAR database was employed to identify the first visit where patients met 2013 ACR/EULAR classification criteria (EUSTAR CP167). Those with age, disease duration and modified Rodnan skin score (mRSS) data available were included. A simplified version of published DAISY inclusion criteria was applied: age 18-70 yrs; mRSS >10 with either disease duration <18 months or Interstitial lung disease (ILD); disease duration 18 months or more and <6 years, with either ILD or mRSS 15 or more and with active disease (raised inflammatory markers, tendon friction rubs). Those with anti-centromere antibody and Forced Vital Capacity 50% or less were excluded. Included patients with available follow-up were assessed for meeting Step 2 of Revised-CRISS-25 response at 12 months.Results Data fields needed were available for 13139 patients. Of these, 1632 patients would have been eligible for DAISY inclusion (12.4%): 1406 (86.2%) at baseline and 226 at following visits ( table 1). 14% of patients had limited cutaneous subset, median(IQR) mRSS was 19(11), 68% had ILD. 12(+/- 3) month follow-up data was available for 771 eligible patients, with 416 (54%) having data for at least 2 core set domains of the ACR CRISS allowing endpoint estimation. Altogether, 65/416 (16%) patients met the endpoint by improving at least 25% in at least 2 domains while worsening in no more than one (table 2, figure 1).Conclusions This analysis revealed that one in 8 patients with SSc in EUSTAR would meet eligibility criteria, most of which at their baseline visit, highlighting the importance of assessing patients early within their disease process. Despite a population enriched for skin disease and ILD, 14% of eligible patients had limited scleroderma. This population reveals a clear unmet need with less than 16% of patients meeting the revised-CRISS25 endpoint. Within the limitation of incomplete data available and retrospective analysis, our study aims to offer a context for future clinical trial results for representation in real-world data and clinical outcome.Abstract OC.24 Table 1Disease characteristics of EUSTAR patients meeting DAISY inclusionAbstract OC.24 Table 2Disease progression over 12 months of all EUSTAR patients who met DAISY inclusion criteriaAbstract OC.24 Figure 1Distribution of individual patient ACR CRISS-25 response at 12 months for patients meeting DAISY criteria*