LAUSR

Objectives To determine if skin changes over 2 years are associated with changes in organ involvement in early diffuse cutaneous systemic sclerosis (dcSSc). Methods dcSSc with ≤5 years disease duration followed for 2 years from the Canadian Scleroderma Research Group (CSRG) registry were studied for organ involvement using the Medsger Disease Severity Score (DSS) with ≥1 point changes (decrease or increase) considered improvement or progression, correspondingly. Other disease measures were assessed including pulmonary function, patient and physician globals, functional disability and quality of life. Modified Rodnan Skin Score (mRSS) improvement was defined as a decrease of ≥5 points and/or a≥25% reduction. Adjusted regression analysis, ANOVA, chi-square, t-test and Pearson’s tests were used. Results Of the 128 patients, mRSS improved for 50% from 22.6 to 18.1 (p=0.0001). More skin-improvers improved in severity of lung (39% vs 17%, p=0.006), joint/tendon (50% vs 21%, p=0.017), and any visceral organ involvement (renal, cardiac, pulmonary or gastrointestinal) (60% vs 27%, p=0.031) compared to mRSS non-improvers. Skin-improvers less often developed new skin ulcers (0% vs 11%, p=0.015) and GI disease (5% vs 18%, p=0.023), as well as progression of joint/tendon involvement (7% vs 29%, p=0.02). Improving mRSS correlated with changes in total Medsger’s severity score (without skin domain), severity of lung, GI, and peripheral vascular disease (table 1). FVC% stabilised in skin-improvers vs. worsened by 6.5% in non-improvers, p=0.026. Physician global assessments (severity, activity, damage) HAQ-DI, and SF-36 PCS improved more with improved mRSS (p<0.003, p=0.001, p=0.005 respectively). Improvement in Forced Vital Capacity% predicted correlated with skin improvement (r=0.33, p=0.004).Abstract THU0428 – Table 1 Relationship between change in disease measures and change in skin score Outcome measure Skin-improver (n=64) Skin non-improver (n=64) P-valueImprovers vs. Non-improvers Total Medsger’s severity score without skin domain (negative is improvement) −2.57±3.11 0.42±2.98 0.002 Patient global score −0.70±2.69 0.15±2.61 0.088 Physician global score:ActivitySeverityDamage −1.97±2.50−1.33±2.54−0.72±1.87 −0.61±2.63−0.03±2.040.77±1.98 0.0030.0020.000 HAQ-DI −0.19±0.64 0.18±0.47 0.001 SHAQ Numeric Rating Scales:PainRPFinger ulcersGastrointestinalBreathingOverall −0.29±2.590.29±2.930.32±1.96−0.21±3.020.02±2.32−0.70±2.70 0.00±2.550.66±2.300.16±2.320.54±2.970.05±3.34−0.22±2.62 0.5520.4450.6810.1780.9500.340 SF-36 PCS 3.08±9.03 −1.55±8.33 0.005 Conclusions Over two years, improving skin scores in dcSSc were associated with an improvement in lung disease, joint/tendon, physician global assessments, HAQ-DI, SF-36 PCS, and overall visceral organ improvement. Improvement in mRSS as a primary outcome in drug trials is likely to be concordant with improvement in organ involvement and several other disease measurement domains in early dcSSc. Disclosure of Interest T. Nevskaya Grant/research support from: Merck and Co., Inc., Kenilworth NJ, USA, M. Baron Grant/research support from: Merck and Co., Inc., Kenilworth NJ, USA, B. Zheng Grant/research support from: Merck and Co., Inc., Kenilworth NJ, USA, C. Baxter Employee of: MSD Ltd, Hoddesdon, UK, D. Ramey Employee of: Merck and Co., Inc., Kenilworth NJ, USA, J. Pope Grant/research support from: Merck and Co., Inc., Kenilworth NJ, USA