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Abstract Number: 1676

Improving Sensitivity to Change of the Modified Rodnan Skin Score over Time

Annel M. Fernandez1, Robert F. Spiera2, Jackie Szymonifka2 and Jessica K. Gordon2, 1Medicine- Rheumatology/ Research, Hospital For Special Surgery, New York, NY, 2Rheumatology, Hospital for Special Surgery, New York, NY

Meeting: 2017 ACR/ARHP Annual Meeting

Date of first publication: September 18, 2017

Keywords: clinical trials, Outcome measures, scleroderma and systemic sclerosis

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Session Information

Date: Monday, November 6, 2017

Title: Systemic Sclerosis, Fibrosing Syndromes and Raynaud's – Clinical Aspects and Therapeutics Poster II

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose:

The Modified Rodnan Skin Score (MRSS) assesses global dermal thickness through the examination of 17 body areas scored by clinical palpation using a 4 point Likert scale (0 = normal skin; 1 = mild thickness; 2 = moderate thickness; 3 = severe thickness). The MRSS, due to its reliability, reproducibility, validity and responsiveness to change, has been used as the primary outcome measure in numerous clinical trials in systemic sclerosis. It has been observed that finger MRSS scores remain relatively static over time in the context of clinical trials. We tested this clinical observation using our MRSS data and further tested the hypothesis that modifying the MRSS to exclude assessment of fingers would improve sensitivity to change of the MRSS.

Methods:

This was a retrospective study using compiled MRSS data from three single institution investigator-initiated clinical trials. Sixty-one patients were followed for a total of 593 visits, with a mean of 9.7 visits per patient (range 2-19), and a median follow-up of 17.7 months (range 0.9 – 54.2 months). We compared the proportion of visits that demonstrates a change from baseline using finger-only MRSS (0-6) and a “fingerless” MRSS (0-45), using Fisher’s exact test. We used linear mixed effects modeling to evaluate whether the MRSS excluding finger scores changed at similar rates to finger-only MRSS scores over time. To assess the correlation between “fingerless” MRSS and “standard” MRSS (0-51), we used Spearman partial correlation.

Results:

Finger-only MRSS were unchanged in 62% (331/532) of follow up visits whereas 45 point MRSS excluding fingers were unchanged in only 14% (72/532) of follow-up visits (p=0.009). The finger-only MRSS scores did not show any significant change over time. However, the “fingerless” MRSS decreased by a mean of 0.24 points per month (p<0.001). Although the 45 point MRSS are slightly lower given that fewer body parts are being assessed, the rate of change over time did not differ significantly from the standard 51 point MRSS with a correlation coefficient of 0.99.

Conclusion:

Our study demonstrated skin scores of fingers show lower propensity for change than skin scores of other body areas. The rate of change of the MRSS excluding fingers was not significantly different than the standard MRSS, but may result in a greater percent change. Future studies should consider removing the finger skin score from the MRSS score to improve sensitivity to change over time and assess whether this better reflects changes in patient-level outcomes.

Mixed Effects Model Comparing 6 point (Finger-Only) versus 45 (Fingerless) MRSS

Mixed Effects Modeling Term

β Coefficient ±

Standard Error

p-value

Intercept

22.70 ± 0.59

< 0.001

Group=finger-only score

-17.47 ± 0.39

< 0.001

Group=”fingerless” score

reference

—

Time

-0.24 ± 0.02

< 0.001

Interaction of time and finger-only score

0.24 ± 0.02

< 0.001

Interaction of time and “fingerless” score

reference

—


Disclosure: A. M. Fernandez, None; R. F. Spiera, Roche-Genetech, 2,GSK, 2,BMS, 2,Celgene, 2,Boehringer Ingelheim, 2,Cytori, 2,Chemocentryx, 2,Corbus Pharmaceuticals, 2,Prism, 2,Roche-Genetech, 5,GSK, 5,Boehringer Ingelheim, 5; J. Szymonifka, None; J. K. Gordon, Corbus Pharmaceuticals, 2,Cumberland Pharmaceuticals, 2,Bayer Pharmaceuticals, 2.

To cite this abstract in AMA style:

Fernandez AM, Spiera RF, Szymonifka J, Gordon JK. Improving Sensitivity to Change of the Modified Rodnan Skin Score over Time [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/improving-sensitivity-to-change-of-the-modified-rodnan-skin-score-over-time/. Accessed .
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