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10.1136/annrheumdis-2017-211682

http://scihub22266oqcxt.onion/10.1136/annrheumdis-2017-211682
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suck abstract from ncbi


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pmid29066464
      Ann+Rheum+Dis 2018 ; 77 (2 ): 212-220
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  • Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate) #MMPMID29066464
  • Khanna D ; Denton CP ; Lin CJF ; van Laar JM ; Frech TM ; Anderson ME ; Baron M ; Chung L ; Fierlbeck G ; Lakshminarayanan S ; Allanore Y ; Pope JE ; Riemekasten G ; Steen V ; Müller-Ladner U ; Spotswood H ; Burke L ; Siegel J ; Jahreis A ; Furst DE
  • Ann Rheum Dis 2018[Feb]; 77 (2 ): 212-220 PMID29066464 show ga
  • OBJECTIVES: Assess the efficacy and safety of tocilizumab in patients with systemic sclerosis (SSc) in a phase II study. METHODS: Patients with SSc were treated for 48 weeks in an open-label extension phase of the faSScinate study with weekly 162?mg subcutaneous tocilizumab. Exploratory end points included modified Rodnan Skin Score (mRSS) and per cent predicted forced vital capacity (%pFVC) through week 96. RESULTS: Overall, 24/44 (55%) placebo-tocilizumab and 27/43 (63%) continuous-tocilizumab patients completed week 96. Observed mean (SD (95%?CI)) change from baseline in mRSS was -3.1 (6.3 (-5.4 to -0.9)) for placebo and -5.6 (9.1 (-8.9 to-2.4)) for tocilizumab at week 48 and -9.4 (5.6 (-8.9 to -2.4)) for placebo-tocilizumab and -9.1 (8.7 (-12.5 to -5.6)) for continuous-tocilizumab at week 96. Of patients who completed week 96, any decline in %pFVC was observed for 10/24 (42% (95%?CI 22% to 63%)) placebo-tocilizumab and 12/26 (46% (95%?CI 27% to 67%)) continuous-tocilizumab patients in the open-label period; no patients had >10%?absolute decline in %pFVC. Serious infection rates/100 patient-years (95%?CI) were 10.9 (3.0 to 27.9) with placebo and 34.8 (18.0 to 60.8) with tocilizumab during the double-blind period by week 48 and 19.6 (7.2 to 42.7) with placebo-tocilizumab and 0.0 (0.0 to 12.2) with continuous-tocilizumab during the open-label period. CONCLUSIONS: Skin score improvement and FVC stabilisation in the double-blind period were observed in placebo-treated patients who transitioned to tocilizumab and were maintained in the open-label period. Safety data indicated increased serious infections in patients with SSc but no new safety signals with tocilizumab. TRIAL REGISTRATION NUMBER: NCT01532869; Results.
  • |Adult [MESH]
  • |Aged [MESH]
  • |Antibodies, Monoclonal, Humanized/*administration & dosage/adverse effects [MESH]
  • |Antirheumatic Agents/*administration & dosage/adverse effects [MESH]
  • |Double-Blind Method [MESH]
  • |Female [MESH]
  • |Humans [MESH]
  • |Injections, Subcutaneous [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Scleroderma, Systemic/*drug therapy [MESH]
  • |Severity of Illness Index [MESH]
  • |Skin/drug effects/*pathology [MESH]
  • |Treatment Outcome [MESH]


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