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Felten, Renaud; Devauchelle-Pensec, Valérie; Seror, Raphaèle; Duffau, Pierre; Saadoun, David; Hachulla, Eric; Pierre Yves, Hatron; Salliot, Carine; Perdriger, Aleth; Morel, Jacques; Mékinian, Arsène; Vittecoq, Olivier; Berthelot, Jean-Marie; Dernis, Emanuelle; Le Guern, Veronique; Dieudé, Philippe; Larroche, Claire; Richez, Christophe; Martin, Thierry; Zarnitsky, Charles; Blaison, Gilles; Kieffer, Pierre; Maurier, François; Dellal, Azeddine; [...]

Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial

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  • Medientyp: E-Artikel
  • Titel: Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial
  • Beteiligte: Felten, Renaud; Devauchelle-Pensec, Valérie; Seror, Raphaèle; Duffau, Pierre; Saadoun, David; Hachulla, Eric; Pierre Yves, Hatron; Salliot, Carine; Perdriger, Aleth; Morel, Jacques; Mékinian, Arsène; Vittecoq, Olivier; Berthelot, Jean-Marie; Dernis, Emanuelle; Le Guern, Veronique; Dieudé, Philippe; Larroche, Claire; Richez, Christophe; Martin, Thierry; Zarnitsky, Charles; Blaison, Gilles; Kieffer, Pierre; Maurier, François; Dellal, Azeddine; [...]
  • Erschienen: BMJ, 2021
  • Erschienen in: Annals of the Rheumatic Diseases, 80 (2021) 3, Seite 329-338
  • Sprache: Englisch
  • DOI: 10.1136/annrheumdis-2020-218467
  • ISSN: 0003-4967; 1468-2060
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: ObjectivesNo immunomodulatory drug has been approved for primary Sjögren’s syndrome, a systemic autoimmune disease affecting 0.1% of the population. To demonstrate the efficacy of targeting interleukin 6 receptor in patients with Sjögren’s syndrome-related systemic complications.MethodsMulticentre double-blind randomised placebo-controlled trial between 24 July 2013 and 16 July 2018, with a follow-up of 44 weeks, involving 17 referral centres. Inclusion criteria were primary Sjögren’s syndrome according to American European Consensus Group criteria and score ≥5 for the EULAR Sjögren’s Syndrome Disease activity Index (ESSDAI, score of systemic complications). Patients were randomised to receive either 6 monthly infusions of tocilizumab or placebo. The primary endpoint was response to treatment at week 24. Response to treatment was defined by the combination of (1) a decrease of at least 3 points in the ESSDAI, (2) no occurrence of moderate or severe activity in any new domain of the ESSDAI and (3) lack of worsening in physician’s global assessment on a Visual Numeric Scale ≥1/10, all as compared with enrolment.Results110 patients were randomised, 55 patients to tocilizumab (mean (SD) age: 50.9 (12.4) years; women: 98.2%) and 55 patients to placebo (54.8 (10.7) years; 90.9%). At 24 weeks, the proportion of patients meeting the primary endpoint was 52.7% (29/55) in the tocilizumab group and 63.6% (35/55) in the placebo group, for a difference of −11.4% (95% credible interval −30.6 to 9.0) (Pr[Toc >Pla]=0.14).ConclusionAmong patients with primary Sjögren’s syndrome, the use of tocilizumab did not improve systemic involvement and symptoms over 24 weeks of treatment compared with placebo.Trial registration numberNCT01782235.