ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 3248

Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post-Hoc Analyses from the Scleroderma Lung Study I and II

Rajaie Namas1,2, Donald P. Tashkin3, Holly Wilhalme4, Daniel E. Furst5, Chi-hong Tseng6, Michael Roth6, Suzanne Kafaja7, Elizabeth R. Volkmann4, Philip J. Clements6 and Dinesh Khanna8, 1Division of Rheumatology, University of Michigan, Ann Arbor, MI, 2Department of Medicine [Division of Rheumatology], University of Michigan, Ann Arbor, MI, 3David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, 4University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 5UCLA, Los Angeles, CA, 6Medicine, University of California, Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 7Medicine/Rheumatology, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, CA, 8University of Michigan, Ann Arbor, MI

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: , , ,

Session Information

Date: Wednesday, November 16, 2016

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

Session Type: ACR Concurrent Abstract Session

Session Time: 11:00AM-12:30PM

Efficacy of mycophenolate mofetil and oral cyclophosphamide on skin thickness: post-hoc analyses from the Scleroderma Lung Study I and II.

Background/Purpose: Assess the efficacy of mycophenolate mofetil (MMF) and cyclophosphamide (CYC) on the modified Rodnan skin score (mRSS) in patients enrolled in the Scleroderma Lung Study (SLS)-I and II.

Methods: SLS-I participants received daily oral CYC or matching placebo for one year followed for an additional year off therapy, whereas SLS-II participants received daily MMF for 2 years or daily oral CYC for 1 year followed by placebo for a second year. We assessed the within-treatment impact of MMF and CYC on mRSS in subjects with diffuse cutaneous systemic sclerosis (dcSSc) and limited cutaneous systemic sclerosis (lcSSc) participating in SLS-II over a 24-month period. We also compared the change in mRSS in the patients with dcSSc assigned to CYC and MMF in SLS-II and to the CYC group arm of SLS I with the change in the placebo arm of SLS I over a 24-month period.

Results: In SLS-II, the baseline (mean± SD) mRSS was 14.0±10.6 for CYC and 15.3±10.4 for MMF; 58.5% were classified as dcSSc. Each treatment was associated with a significant improvement in mRSS from baseline over 24 months (P< 0.05 at each time point, Figure 1. A and B) but there were no significant differences between the2 groups at any time point in either the dcSSc or lcSSc subset (p> 0.05 for all comparisons). In the dcSSc subgroup, the changes in mRSS from baseline to 6-, 12-, 18-, and 24-months were similar in the SLS-II pooled cohort (MMF+ CYC) and the SLS-I CYC cohort and showed statistically significant improvements compared to the SLS-I placebo group at 12, 18, and 24 months (Table 1).

Conclusion: In SLS-II, MMF and CYC each resulted in significant improvement from baseline in mRSS in the subset of patients with dcSSc over a 24-month period. In addition, MMF and CYC each resulted in statistically significant improvements in mRSS over the placebo group in the subjects with dcSSc at 12, 18, and 24 months.

Disclosure: R. Namas, None; D. P. Tashkin, None; H. Wilhalme, None; D. E. Furst, Abbott, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, and UCB Pharma, 2,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen IDEC, Janssen, Gilead, GlaxoSmithKline, NIH, Novartis, Pfizer, Roche/Genentech, and UCB Pharma, 5,Abbott, Actelion, Amgen, Bristol-Myers Squibb, Biogen, IDEC, Janssen, Gilead, NIH, Roche/Genentech, and UCB Pharma, 9; C. H. Tseng, None; M. Roth, None; S. Kafaja, None; E. R. Volkmann, None; P. J. Clements, None; D. Khanna, Bristol-Myers Squibb, 2,Pfizer Inc, 2,Roche Pharmaceuticals, 5,Sanofi-Aventis Pharmaceutical, 5,BAYER, 5,CYTORI, 5,EMD Serono, 5,Roche Pharmaceuticals, 2,Actelion Pharmaceuticals US, 5.

To cite this abstract in AMA style:

Namas R, Tashkin DP, Wilhalme H, Furst DE, Tseng CH, Roth M, Kafaja S, Volkmann ER, Clements PJ, Khanna D. Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post-Hoc Analyses from the Scleroderma Lung Study I and II [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-mycophenolate-mofetil-and-oral-cyclophosphamide-on-skin-thickness-post-hoc-analyses-from-the-scleroderma-lung-study-i-and-ii/. Accessed .

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