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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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  • Media type: E-Article
  • Title: Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial
  • Contributor: 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; [...]
  • Published: BMJ, 2021
  • Published in: Annals of the Rheumatic Diseases, 80 (2021) 3, Seite 329-338
  • Language: English
  • DOI: 10.1136/annrheumdis-2020-218467
  • ISSN: 0003-4967; 1468-2060
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Objectives</jats:title><jats:p>No 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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Multicentre 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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>110 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 &gt;Pla]=0.14).</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Among 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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" specific-use="clinicaltrial results" xlink:href="NCT01782235">NCT01782235</jats:ext-link>.</jats:p></jats:sec>