Session Information
Date: Monday, November 14, 2016
Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud's – Clinical Aspects and Therapeutics II
Session Type: ACR Concurrent Abstract Session
Session Time: 2:30PM-4:00PM
Background/Purpose: The modified Rodnan skin score (mRSS) is used as a primary outcome measure in clinical trials of dcSSc. EUSTAR analysis has proposed that a lower mRSS and earlier disease duration are associated with progressive disease, as defined by worsening mRSS [1]. Our objective was to find an optimal cut off for worsening mRSS in 4 cohorts of dcSSc.
Methods: We used 4 cohorts with early dcSSc (defined as ≤60 months from 1st non-RP sign or symptom) – 2 US cohorts [Combined Response Index in Systemic Sclerosis [CRISS] and Prospective Registry in Early Systemic Sclerosis [PRESS]], the UK Royal Free Hospital [RFH] cohort, and the Australian Scleroderma Interest Group [ASIG] cohort. Inclusion criteria included dcSSc diagnosed by a scleroderma physician, mRSS data at 2 time points (12±3 months apart), and availability of disease duration (defined as 1st non Raynaud phenomenon sign or symptom). Worsening of skin fibrosis was defined as increase in mRSS >5 points and ≥25% from baseline to 2nd visit. To identify the optimal cut point of baseline MRSS that yields the highest sensitivity for worsening disease, we developed the ROC curves. For worsening of mRSS, we fitted logistic regression model with worsening as outcome variable and a binary variable of baseline mRSS cut point as predictor.
Results: There were 231 patients with early dcSSc included in the analysis. Mean (SD) disease duration was 26.7 (14.6) months, median=23.67 months. We evaluated 3 cut points for disease duration based on inclusion criterion from recent clinical trials: ≤24, 36, and 60 months. For all disease durations, approximately 10% of patients had mRSS worsening at 1-year period. A mRSS cut off of ≤28 had the highest probability of worsening (Table). mRSS of ≤28 was able to enrich worsening mRSS from 10% to approximately 14% for different cut points but excluded 26-27% of patients with early dcSSc. Worsening in mRSS for the Whole Cohort vs. Cut Point of ≤28
| N | Disease duration ≤ 24 mos. | N | Disease duration ≤ 36 mos. | N | Disease duration ≤ 60 mos. | |
| All subjects who worsened | 122 | 12 (9.84%) | 175 | 18 (10.29%) | 231 | 24 (10.39%) |
| Proportion who worsen with mRSS ≤28 (worsen*/ total cohort with mRSS ≤28 | 89 | 12/89=13.48% | 129 | 18/129=13.95% | 169 | 24/169=14.20% |
| Probability of worsening for mRSS ≤28 (worsen* with mRSS ≤28/all patients who worsened*) | 12 | 12/12=100% | 18 | 18/18=100% | 24 | 24/24=100% |
| Probability of improvement with mRSS ≤28 (improved**/ total cohort with mRSS ≤28 | 34 | 34/89=38.20% | 51 | 51/129=39.53% | 68 | 68/169=40.24% |
| *increase in mRSS>5 points and ≥25% from baseline to second visit | ||||||
| *decrease in mRSS>5 points and ≥25% from baseline to second visit |
Conclusion: In this preliminary analysis, a mRSS≤28 was the optimal cut point for worsening disease in 4 cohorts with dcSSc. This threshold gained an additional 4% of patients who worsened but excluded 26-27% of patients with early dcSSc. Further criteria are needed for enrichment of patients with dcSSc so large proportion of patients are not excluded from participating in RCTs . References: Maurer B Ann Rheum Dis 2015
To cite this abstract in AMA style:
Khanna D, Proudman S, Frech TM, Nihtyanova S, Domsic RT, Berrocal VJ, Stevens W, Nikpour M, P.Denton C. Performance of Modified Rodnan Skin Score in Early Diffuse Cutaneous Scleroderma-Analysis from 4 International Cohorts [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/performance-of-modified-rodnan-skin-score-in-early-diffuse-cutaneous-scleroderma-analysis-from-4-international-cohorts/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/performance-of-modified-rodnan-skin-score-in-early-diffuse-cutaneous-scleroderma-analysis-from-4-international-cohorts/