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SAT0450 Rituximab in Systemic Sclerosis. Results of an up to Seven Years, Open Label, Multicenter Study with a Follow-up of 89 Patient-Years
  1. K. Melissaropoulos1,
  2. D. Daoussis1,
  3. I. Antonopoulos1,
  4. T.E. Markatseli2,
  5. P. Georgiou3,
  6. G. Yiannopoulos1,
  7. A.A. Drosos2,
  8. A.P. Andonopoulos1,
  9. S.N. Liossis1
  1. 1University Hospital Patras, Patras
  2. 2University Hospital Ioannina, Ioannina
  3. 3Agios Andreas General Hospital, Patras, Greece

Abstract

Background We have previously shown that rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc).

Objectives To assess long term data on efficacy and safety of RTX in SSc

Methods Thirty patients with SSc were recruited from three rheumatology departments. Patients were treated at baseline, 6, 12 and 18 months. Beyond two years, retreatment with RTX was decided by the treating physician. Follow-up data exist for 30, 16, 13, 6 and 4 patients at 1, 2, 3, 5 and 7 year time points, respectively.

Results Patients were predominantly female (n=22) with a median age of 56 and median disease duration of 4 years. Data from serology, concomitant treatment, skin involvement, PFTs, transthoracic echocardiogram, high resolution lung CT and undesirable effects were recorded. FVC showed significant improvement at 1 year compared to baseline (mean ± SEM: FVC: 83.5±3.4 vs 78.2±3.6 respectively, p<0.001), with a further significant improvement at 2 years (86.2±5.5 p=0.018) and a stabilization thereafter (84.3±6.5 at 5 years, p=0.04). DLco significantly improved at two years compared to baseline (62.4±4.5 vs 57.3±3.2 respectively, p=0.012). Three patients who had initially shown improvement or stabilization of their PFTs with continuous treatment, showed deterioration of PFTs after RTX cessation at three years; these patients did not respond to RTX retreatment later on. Skin thickening (MRSS) improved significantly early (p<0,001 at all time points compared to baseline). During the follow-up period, six cases of respiratory infection requiring hospitalization, one case of hepatitis B reactivation, one case of herpes zoster and two cases of mild infusion reactions were recorded. One patient was diagnosed with lung cancer and another one with prostate cancer. Five deaths were recorded. Two patients died because of end stage respiratory failure, one patient of lung cancer, one of sudden death while the cause of death in the fifth patient is unknown.

Conclusions Our data indicate that continuous treatment with RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Treatment was generally well-tolerated. Randomized controlled studies are highly needed.

Disclosure of Interest None declared

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