{
  "abstract": "Introduction Tocilizumab (TCZ) has demonstrated a positive impact on interstitial lung disease (ILD) and potential benefits on skin fibrosis in systemic sclerosis (SSc). This study aims to evaluate the safety and effectiveness of TCZ in a real-life setting, on skin and lung involvements but also other complications, using data from a French-Italian multicenter cohort.Material and Methods A longitudinal retrospective analysis was conducted on SSc patients, treated with TCZ among 15 referral centres. Data were collected at 12 months prior to TCZ introduction, at baseline, at 12 and 24 months after TCZ. Parameters assessed included: modified Rodnan skin score (mRSS), pulmonary function tests, joint Disease Activity Score (DAS28-CRP), cardiovascular domains were investigated using digital ulcer counts, cardiac biomarkers and heart ejection fraction (EF). Lung progression was defined as an absolute drop in predicted forced vital capacity (pFVC) >= 5% over a 12 ± 3 months period of time.Results 197 patients, 88% female, median age 57 (46-69) years, median disease duration 9 (4-15) years, were included; 67% were ATA positive. 52(29%) were on TCZ monotherapy, the most common combination therapy was with methotrexate(35%). In SSc-ILD patients, a significant decline of %pFVC from 12 months prior to TCZ(81 ± 21) to baseline(77 ± 22; p=0.003) was observed. . Upon TCZ, a stabilization of %pFVC was observed at 12 months, progressors dropped from 43% to 24%,p=0.015. Improvement in %pFVC was observed at 24 months(p=0.005). Among dcSSc, a significant reduction in mRSS was observed at month 12 and 24(p <0.001). The percentage of patients with digital ulcers significantly reduced over the 24 months(p=0.001). In patients with arthritis, DAS28-CRP showed a significant decline both at month 12 and 24. Among patients with myocardial involvement, troponin levels reduced over time, together with a stabilization in NT-proBNP. Infections were the most common adverse effects (22.8%). Treatment was suspended in 63 patients (32%) after a median time of 8(4-22) months, the main reason being inefficacy(41%). The presence of PAH(OR 4.01, 1.20-13.38) and older age were associated with TCZ failure, while elevated C-reactive protein(OR 0.34, 0.11-0.99) associated with a better response.Conclusions Our real-life data support the use of tocilizumab in SSc. TCZ was commonly used in combination with other immunosuppressive drugs. We report consistent beneficial effects on lung and skin involvements and extend the effects to peripheral vasculopathy and arthritis. This raise the potential of TCZ to act as a disease modifier thanks to multiple effects, while the costs for safety were limited.",
  "authors": [
    {
      "affiliations": [
        "IRCCS and INFLAGE San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy"
      ],
      "name": "Corrado Campochiaro"
    },
    {
      "affiliations": [
        "IRCCS and INFLAGE San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy",
        "Department of Rheumatology, Cochin Hospital AP-HP Centre Université Paris Cité, Paris, France, Paris, France"
      ],
      "name": "Giulia Buonsante"
    },
    {
      "affiliations": [
        "SC Reumatologia, Fondazione IRCCS Policlinico San Matteo, Scleroderma Unit, Pavia, PAvia, Italy"
      ],
      "name": "Elena Marazzi"
    },
    {
      "affiliations": [
        "Unit of Rheumatology, DiMEPRe-J, University of, Bari, Bari, Italy"
      ],
      "name": "Fabio Cacciapaglia"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology, ASST Spedali Civili di Brescia, Università degli Studi di Brescia, Brescia, Italy, Brescia, Italy"
      ],
      "name": "Maria Grazia Lazzaroni"
    },
    {
      "affiliations": [
        "Rheumatology Unit Department of Medical and Surgical Sciences for Children and Adults, University of Modena and Reggio E, Modena, Italy"
      ],
      "name": "Marco De Pinto"
    },
    {
      "affiliations": [
        "Department of Clinical and Molecular Sciences, Marche Polytechnic University & Department of Internal Medicine, Marche U, Ancona, Italy"
      ],
      "name": "Devis Benfaremo"
    },
    {
      "affiliations": [
        "Scleroderma Unit, Fondazione IRCCS Ca’ Granda, Milan, Milan, Italy"
      ],
      "name": "Valentina Longo"
    },
    {
      "affiliations": [
        "Department of precision medicine -University of Campania L. Vanvitelli, Napoli, Italy"
      ],
      "name": "Carlo Iandoli"
    },
    {
      "affiliations": [
        "Department of precision medicine -University of Campania L. Vanvitelli, Napoli, Italy"
      ],
      "name": "Giovanna Cuomo"
    },
    {
      "affiliations": [
        "Unit of Rheumatology, Padova University, PAdova, Italy"
      ],
      "name": "Anna Cuberli"
    },
    {
      "affiliations": [
        "Unit of Rheumatology, Padova University, PAdova, Italy"
      ],
      "name": "Elisabetta Zanatta"
    },
    {
      "affiliations": [
        "University of Rennes CHU Rennes, Inserm, EHESP, Irset -Institut de Recherche en Sante, Environnement et Travail-UMRS, Re, Rennes, France"
      ],
      "name": "Alain Lescoat"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Scleroderma Unit, Department of Experimental and Clinical Medicine, University of Florence, It, Florence, Italy"
      ],
      "name": "Silvia Bellando Randone"
    },
    {
      "affiliations": [
        "Scleroderma Clinic, Dip. Reumatologia, ASST G. Pini-CTO, Milano, Italy, Milan, Italy"
      ],
      "name": "Giorgia Trignani"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Scleroderma Unit, Department of Experimental and Clinical Medicine, University of Florence, It, Florence, Italy"
      ],
      "name": "Serena Guiducci"
    },
    {
      "affiliations": [
        "Scleroderma Unit, Fondazione IRCCS Ca’ Granda, Milan, Milan, Italy"
      ],
      "name": "Lorenzo Beretta"
    },
    {
      "affiliations": [
        "Department of Clinical and Molecular Sciences, Marche Polytechnic University & Department of Internal Medicine, Marche U, Ancona, Italy"
      ],
      "name": "Gianluca Moroncini"
    },
    {
      "affiliations": [
        "Rheumatology Unit Department of Medical and Surgical Sciences for Children and Adults, University of Modena and Reggio E, Modena, Italy"
      ],
      "name": "Dilia Giuggioli"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology, ASST Spedali Civili di Brescia, Università degli Studi di Brescia, Brescia, Italy, Brescia, Italy"
      ],
      "name": "Paolo Airò"
    },
    {
      "affiliations": [
        "Unit of Rheumatology, DiMEPRe-J, University of, Bari, Bari, Italy"
      ],
      "name": "Florenzo Iannone"
    },
    {
      "affiliations": [
        "SC Reumatologia, Fondazione IRCCS Policlinico San Matteo, Scleroderma Unit, Pavia, PAvia, Italy"
      ],
      "name": "Veronica Codullo"
    },
    {
      "affiliations": [
        "Fondazione Policlinico Universitario A. Gemelli - IRCCS, Rome, Italy, Rome, Italy"
      ],
      "name": "Silvia Laura Bosello"
    },
    {
      "affiliations": [
        "Scleroderma Clinic, Dip. Reumatologia, ASST G. Pini-CTO, Milano, Italy, Milan, Italy"
      ],
      "name": "Nicoletta Del Papa"
    },
    {
      "affiliations": [
        "IRCCS and INFLAGE San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy"
      ],
      "name": "Giacomo De Luca"
    },
    {
      "affiliations": [
        "Centre Hospitalier Universitaire de Bordeaux, Rheumatology Department, France, Bordeaux, France"
      ],
      "name": "Marie-Elise Truchetet"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Cochin Hospital AP-HP Centre Université Paris Cité, Paris, France, Paris, France"
      ],
      "name": "Jerome Avouac"
    },
    {
      "affiliations": [
        "IRCCS and INFLAGE San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy"
      ],
      "name": "Lorenzo Dagna"
    },
    {
      "affiliations": [
        "IRCCS and INFLAGE San Raffaele Hospital, Vita-Salute San Raffaele University, Milan, Italy, Milan, Italy"
      ],
      "name": "Marco Matucci-Cerinic"
    },
    {
      "affiliations": [
        "Department of Rheumatology, Cochin Hospital AP-HP Centre Université Paris Cité, Paris, France, Paris, France"
      ],
      "name": "Yannick Allanore"
    }
  ],
  "title": "P.285 Safety and effectiveness of tocilizumab in systemic sclerosis: a multicenter French-Italian study",
  "uid": "25bd0c56-fa92-5f93-b2f7-d7791b4d712e"
}