{
  "abstract": "Introduction Systemic sclerosis (SSc) is a chronic connective tissue disease characterized by progressive vasculopathy that may lead to the development of digital ulcers (DUs). The CURE clinical study objective was to evaluate the severity of Raynaud’s phenomenon and the effectiveness of bosentan treatment in Greek patients with SSc and DU.Material and Methods CURE was a multicenter, prospective, observational clinical study ( NCT05168215) that recruited 211 patients with SSc, having either active or a history of digital ulcers. There were 118 patients with diffuse (56%) and 93 (44%) with limited SSc, 179 (84%) were females and 32 males, and had a mean age of 56 years (±13) and a mean disease duration of 108 months (±85). All patients received bosentan, up to 125 mg twice daily, in addition to various regimens of standard medications for SSc. The study observational period consisted of 4 follow-up visits (scheduled at 4, 8, 12 and 18 months after baseline). For the assessment of the severity of Raynaud’s phenomenon, the Raynaud’s Condition Score (RCS) was used. The effectiveness of bosentan was also evaluated by assessing the change in the number of digital ulcers and the occurrence of new ulcers during follow-up. Univariate analysis was conducted to explore associations between patient characteristics or concomitant therapies and study outcomes.Results Of 211 recruited patients 193 completed the study. The reduction in RCS was 1.20 (p<0.001), from 4.90±2.60 (at baseline) to 3.70 ±2.40 (at 18 months). The mean number of DUs was 2.60 (±3.20) at enrollment, and after 18 months of follow-up it decreased to 1.20 (±2.30; p<0.001). Regarding the occurrence of new ulcers, the mean number at 4, 8, 12 months, and at the final visit, was 0.3 (±0.9), 0.4 (±1.1), 0.4 (±1.1) and 0.2 (±0.7), respectively. ACA positivity was associated with a greater improvement in RCS (p=0.004) and reduction in DUs (p=0.003). Limited SSc (p=0.002) and the absence of pulmonary fibrosis (p=0.016) were also associated with a reduced number of DUs at last visit. No new safety signals were observed; 2 patients (0.9%) discontinued the study due to adverse events and 2 patients (0.9%) died during the follow-up period.Conclusions The CURE observational study showed a significant improvement in the severity of Raynaud’s phenomenon with a parallel reduction in the number of DUs in Greek patients with SSc treated with bosentan for 18 months.",
  "authors": [
    {
      "affiliations": [
        "First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, NKUA, Athens, Greece"
      ],
      "name": "Katerina Laskari"
    },
    {
      "affiliations": [
        "2nd Department of Medicine and Laboratory, Clinical Immunology-Rheumatology Unit, School of Medicine, NKUA, Athens, Greece"
      ],
      "name": "Dimitrios Vassilopoulos"
    },
    {
      "affiliations": [
        "4th Department of Medicine, Aristotle University, Thessaloniki, Greece"
      ],
      "name": "Theodoros Dimitroulas"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Patras University Hospital, University of Patras Medical School, Patras, Greece"
      ],
      "name": "Dimitrios Daoussis"
    },
    {
      "affiliations": [
        "Department of Rheumatology, School of Health Sciences, Faculty of Medicine, University of Ioannina, Ioannina, Greece"
      ],
      "name": "Paraskevi Voulgari"
    },
    {
      "affiliations": [
        "Rheumatology Clinic, Naval Hospital of Athens, Athens, Greece"
      ],
      "name": "Gkikas Katsifis"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology, University Hospital of Heraklion and University of Crete Medical School, Heraklion, Greece"
      ],
      "name": "George Bertsias"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology, University Hospital of Heraklion and University of Crete Medical School, Heraklion, Greece"
      ],
      "name": "Argiro Repa"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Evangelismos General Hospital, Athens, Greece"
      ],
      "name": "George Katsikas"
    },
    {
      "affiliations": [
        "First Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece"
      ],
      "name": "Nikolaos Papadopoulos"
    },
    {
      "affiliations": [
        "4th Department of Medicine, Aristotle University, Thessaloniki, Greece"
      ],
      "name": "Eleni Pagkopoulou"
    },
    {
      "affiliations": [
        "Private Rheumatology Site, Athens, Greece"
      ],
      "name": "Theofanis Karageorgas"
    },
    {
      "affiliations": [
        "Medical Department, ELPEN Pharmaceutical Co. Inc., Athens, Greece"
      ],
      "name": "Alexandros Ginis"
    },
    {
      "affiliations": [
        "Medical Department, ELPEN Pharmaceutical Co. Inc., Athens, Greece"
      ],
      "name": "Georgios Tsioumas"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Clinical Immunology, Faculty of Medicine, University of Thessaly, Larissa, Greece"
      ],
      "name": "Theodora Simopoulou"
    },
    {
      "affiliations": [
        "Department of Rheumatology and Clinical Immunology, Faculty of Medicine, University of Thessaly, Larissa, Greece"
      ],
      "name": "Dimitrios Bogdanos"
    },
    {
      "affiliations": [
        "First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, NKUA, Athens, Greece"
      ],
      "name": "Petros Sfikakis"
    }
  ],
  "title": "P.281 Real-life observational study to evaluate raynaud’s severity and the change in digital ulcers in Greek patients with systemic sclerosis treated with bosentan. The cure study",
  "uid": "b11f4cb7-8690-51ab-89ea-ec3e002785bf"
}