title: A multicenter, open-label, comparative study of B-cell depletion therapy with Rituximab for systemic sclerosis-associated interstitial lung disease.
abstract: Rituximab (RTX) may favorably affect lung function and skin fibrosis in patients with systemic sclerosis (SSc). We aimed to assess long-term efficacy and safety of RTX in SSc compared to standard treatment.
  
  
  
  A total of 51 patients with SSc-associated interstitial lung disease were recruited and treated with RTX (n = 33) or conventional treatment (n = 18). Median follow-up was 4 years (range: 1-7). Conventional treatment consisted of azathioprine (n = 2), methotrexate (n = 6), and mycophenolate mofetil (n = 10).
  
  
  
  Patients in the RTX group showed an increase in FVC at 2 years (mean ± SD of FVC: 80.60 ± 21.21 vs 86.90 ± 20.56 at baseline vs 2 years, respectively, p = 0.041 compared to baseline). In sharp contrast, patients in the control group had no change in FVC during the first 2 years of follow-up. At the 7 year time point the remaining patients in the RTX group (n = 5) had higher FVC compared to baseline (mean ± SD of FVC: 91.60 ± 14.81, p = 0.158 compared to baseline) in contrast to patients in the control group (n = 9) where FVC deteriorated (p < 0.01, compared to baseline). Direct comparison between the 2 groups showed a significant benefit for the RTX group in FVC (p = 0.013). Improvement of skin thickening was found in both the RTX and the standard treatment group; however, direct comparison between groups strongly favored RTX at all-time points. Adverse events were comparable between groups.
  
  
  
  Our data indicate that RTX has a beneficial effect on lung function and skin fibrosis in patients with SSc. Randomized controlled studies are highly needed.
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece. Electronic address: jimdaoussis@hotmail.com.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Daoussis
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Melissaropoulos
authors.affiliation: Department of Medical Physics, University of Patras, Patras, Greece.
authors.forename: Georgios
authors.initials: G
authors.lastname: Sakellaropoulos
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Antonopoulos
authors.affiliation: Department of Rheumatology, Ioannina University Hospital, University of Ioannina Medical School, Ioannina, Greece.
authors.forename: Theodora E
authors.initials: TE
authors.lastname: Markatseli
authors.affiliation: Department of Rheumatology, Larissa University Hospital, University of Thessaly Medical School, Larissa, Greece.
authors.forename: Theodora
authors.initials: T
authors.lastname: Simopoulou
authors.affiliation: Department of Rheumatology, Agios Andreas District Hospital, Patras, Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Georgiou
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece.
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Andonopoulos
authors.affiliation: Department of Rheumatology, Ioannina University Hospital, University of Ioannina Medical School, Ioannina, Greece.
authors.forename: Alexandros A
authors.initials: AA
authors.lastname: Drosos
authors.affiliation: Department of Rheumatology, Larissa University Hospital, University of Thessaly Medical School, Larissa, Greece.
authors.forename: Lazaros
authors.initials: L
authors.lastname: Sakkas
authors.affiliation: Division of Rheumatology, Department of Internal Medicine, Patras University Hospital, University of Patras Medical School, 26504 Rion, Patras, Greece.
authors.forename: Stamatis-Nick
authors.initials: SN
authors.lastname: Liossis
mesh_terms: D000328:Adult; D000368:Aged; D001402:B-Lymphocytes / Q000187:drug effects* / Q000276:immunology; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008168:Lung / Q000187:drug effects / Q000473:pathology; D017563:Lung Diseases, Interstitial / Q000150:complications / Q000188:drug therapy*; D008212:Lymphocyte Depletion; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects; D012595:Scleroderma, Systemic / Q000150:complications / Q000188:drug therapy*; D012867:Skin / Q000187:drug effects / Q000473:pathology; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D000069283:Rituximab
keywords: B cells; Fibrosis; Interstitial lung disease; Rituximab; Scleroderma; Systemic sclerosis