Standardization of the modified Rodnan skin score for use in clinical trials of systemic sclerosis

Abstract

The modified Rodnan skin score (mRSS) is a measure of skin thickness and is used as a primary or secondary outcome measure in clinical trials of systemic sclerosis (scleroderma). This state-of-art review provides a historical perspective of the development of the mRSS, summarizes the performance of mRSS as an outcome measure, provides guidance on assessing mRSS, and makes recommendations for incorporation of the mRSS into clinical trials.

Conflict of interest statement

CONFLICTS Dr. Khanna has consultancy relationships with Actelion, Bayer, Bristol-Myers Squibb, ChemomAb, Corbus, Cytori, Eicos, EMD Serono, Genentech/Roche, Gilead, Glaxo SmithKline, MedImmune, Medac, and Sanofi-Aventis/Genzyme. He has received research funding from Astra-Zeneca, Bayer, Bristol-Myers Squibb, and Pfizer. This work was funded in part by the NIH/NIAMS K24 AR06312 grant. Dr. Furst has consultancy relationships and/or has received research funding in relationship grant/research from Amgen, BMS, NIH, Novartis, Pfizer, Roche/Genentech, AbbVie, Amgen, BMS, Cytori, Janssen, NIH, Novartis, Pfizer, Roche/Genentech, and UCB. Dr. Clements has no relevant conflicts. Dr. Allanore has consultancy relationships and/or has received research funding in relationship with the treatment of systemic sclerosis from Actelion, Bayer, Biogen Idec, Bristol-Myers Squibb, Genentech/Roche, Inventiva, Medac, Pfizer, Sanofi/Genzyme, Servier and UCB. Dr. Baron has no relevant conflicts. Dr. Czirjak has consultancy relationships with the treatment of systemic sclerosis from Actelion, Bayer, Genentech/Roche, Inventiva, Medac, and Pfizer. Dr. Distler has/had consulting relationships from 4 D Science, Actelion, Active Biotec, Chemom AG, Bayer, BiogenIdec, BMS, Boehringer Ingelheim, ChemomAb, EpiPharm, espeRare foundation, Genentech/Roche, GSK, Inventiva, Lilly, medac, Mepha, MedImmune, Pharmacyclics, Pfizer, Sanofi, Serodapharm, and Sinoxa; and grants from Actelion, Bayer, Boehringer Ingelheim, Pfizer, and Sanofi. Patent licensed: mir-29 for the treatment of systemic sclerosis. Speaker fees from AbbVie, iQone Healthcare, Mepha Dr. Foeldvari has consultancy relationships with Bayer, Roche-Genentech, Novartis, Abbive, Chugai. Speakers fee: Pfizer, Abbvie, and Medac Dr. Kuwana has consultancy or speaker fees from Bayer, Boehringer Ingelheim, Chugai, Actelion, and Glaxo SmithKline, and/or has received research funding from Chugai, Actelion, and Bayer. Dr. Matucci-Cerinic has active consultancies or has received grant support from Amgen, BMS, Pfizer, Bruno farma, and Actelion. Consultant: BMS, Actelion, Pfizer, Inventiva, Chemomab Dr. Mayes has consultancy relationship with and/or has received research funding from Bayer, Boehringer-Ingelheim, Corbus, Cytori, Genentech/Roche. Dr. Medsger has consultancy relationship with iBio. Dr. Merkel has consultancy relationship with and/or has received research funding from Actelion, Bristol-Myers Squibb, ChemoCentryx, Genentech/Roche, Glaxo SmithKline, Kypha, MedImmune/AztraZeneca, PrincipoBio, Sanofi-Aventis/Genzyme. Dr. Pope has consultancy relationship with AbbVie, Actelion, Amgen, Bayer, BMS, Hospira, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, UCB. Dr. Seibold has consultancy relationship with Anthera, Bayer, BioGen IDEC, Blade Therapeutics, Boehringer Ingelheim, Covis Pharma, Cytori, Eiger, EMD Serono, Milestone, Mitsubishi, Sanofi-Aventis, Teva and Xenikos. There are no speaker’s bureaus or stock holdings. Dr. Steen has consultancy fees from Bristol Myers Squibb, Cytori, Bayer, Gilead, and research grant funding from CSL Behring, United Therapeutics and Gilead, and Clinical Trial research funding from Cytori, Roche, Boehringer Ingelheim, EMD Serono, Covis, and Reata Dr. Stevens has consultancy relationship or received research funding form Actelion, GSK, Bayer and Pfizer and has received speakers fees from Actelion and GSK Dr. Denton has consultancy relationships with or speaker fees from Actelion, Bristol-Myers Squibb, GlaxoSmithKline, Bayer, Sanofi-Aventis, Boehringer Ingelheim, Genentech-Roche, and CSL Behring, and research grant funding from GlaxoSmithKline, Actelion, Novartis, CSL Behring.

Figures

Figure 1

Three phases of skin involvement in diffuse cutaneous systemic sclerosis.

Figure 2

Modified Rodnan skin score (mRSS) is assessed in 17 different areas. Case report form to capture mRSS.

Figure 3

Figure 3a: Assessment of mRSS using index finger and thumb or two thumbs to measure thickness. mRSS =0 where there is no appreciable skin thickness. Figure 3b: mRSS =1 where there is mild skin thickness. Figure 3c: mRSS =2 where there is moderate skin thickness. Figure 3d: mRSS =1 where there is severe skin thickness.

Figure 3

Figure 3a: Assessment of mRSS using index finger and thumb or two thumbs to measure thickness. mRSS =0 where there is no appreciable skin thickness. Figure 3b: mRSS =1 where there is mild skin thickness. Figure 3c: mRSS =2 where there is moderate skin thickness. Figure 3d: mRSS =1 where there is severe skin thickness.

Figure 3

Figure 3a: Assessment of mRSS using index finger and thumb or two thumbs to measure thickness. mRSS =0 where there is no appreciable skin thickness. Figure 3b: mRSS =1 where there is mild skin thickness. Figure 3c: mRSS =2 where there is moderate skin thickness. Figure 3d: mRSS =1 where there is severe skin thickness.

Figure 3

Figure 3a: Assessment of mRSS using index finger and thumb or two thumbs to measure thickness. mRSS =0 where there is no appreciable skin thickness. Figure 3b: mRSS =1 where there is mild skin thickness. Figure 3c: mRSS =2 where there is moderate skin thickness. Figure 3d: mRSS =1 where there is severe skin thickness.

Figure 4

Various techniques to assess mRSS of anatomic areas as shown over the forearm and upper arm.

Figure 5

An example of certification to be provided to trainees.