Session Information
Title: Systemic Sclerosis, Fibrosing Syndromes, and Raynaud’s - Clinical Aspects and Therapeutics II
Session Type: Abstract Submissions (ACR)
Background/Purpose: Microangiopathy in systemic sclerosis is progressive over time [1, 2]. This study assesses microangiopathic evolution by nailfold videocapillarocopic (NVC) analysis after two treatment course (month 0/6) with rituximab in early diffuse systemic sclerosis (dcSSc) patients.
Methods: Twelve months follow-up (open-label study) of six consecutive patients with early dcSSc. Patients received an infusion of two times 1000 mg rituximab at month 0 and 6, together with 100 mg methylprednisolone. All patients were on a stable dose methotrexate (10-25 mg/week) as background therapy since at least 12 weeks. Capillaroscopic assessment, clinical read outs (modified Rodnan skin score [mRSS], lung function and echocardiography) and disease activity score (DAS) were performed at 0, 3, 6 and 12 months.
Results: There was a clinical significant change in skin score with a mean (SD) mRSS of 24.8 (5.95) at baseline and 10.2 (1.17) at month 12 (Mixed Model Analyses [MMA] p<0.001) and a significant decrease in DAS, with a median of 3.8 at baseline (range: 2.0-7.0) and 0.5 at month 12 (range: 0.0-2.0) ( MMA p<0.001). Indices of internal organ involvement remained stable. Semi-quantitatively scored NVC parameters remained stable showing no progression of the microvascular damage during the twelve months follow-up: mean score (SD) of capillary loss at baseline/12 months: 2.170 (0.408)/ 1.830 (0.408) (MMA p=0.341), mean score (SD) of giants at baseline/ 12 months: 0.670 (0.516)/ 1.17 (0.408) (MMA p=0.093), mean score of haemorrhages at baseline/12 months: 0.670 (0.516)/1.00 (0.000) (MMA p=0.529) and mean score of neoangiogenesis at baseline/12 months: 0.830 (0.408)/ 0.830 (0.753) (MMA p=0.383).
Conclusion: This is the first open pilot study to show that two immunosuppressive treatment courses with rituximab may not only have potential efficacy for skin and stabilisation of internal organ involvement but also additional stabilisation of microangiopathic parameters in early dcSSc.
References:
1. Koenig M, Joyal F, Fritzler MJ, Roussin A, Abrahamowicz M, Boire G et al. Autoantibodies and microvascular damage are independent predictive factors for the progression of Raynaud’s phenomenon to systemic sclerosis: A twenty-year prospective study of 586 patients, with validation of proposed criteria for early systemic sclerosis. Arthritis Rheum 2008; 58: 3902-12.
2. Sulli A, Secchi ME, Pizzorni C, Cutolo M. Scoring the nailfold microvascular changes during the capillaroscopic analysis in systemic sclerosis patients. Ann Rheum Dis 2008; 67: 885-7.
Disclosure:
V. Smith,
Actelion Pharmaceuticals US,
5;
C. Pizzorni,
None;
V. Riccieri,
None;
S. Decuman,
None;
Y. P. Piette,
None;
E. Deschepper,
None;
F. De Keyser,
Abott,
5,
UCB,
5,
MSD,
5,
Roche Pharmaceuticals,
5,
GSK,
5;
M. Cutolo,
Actelion Pharmaceuticals US,
2,
BMS,
2,
Mundipharm,
2,
Sanofi-Aventis Pharmaceutical,
2.
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