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

Annals of the Rheumatic Diseases
Renaud FeltenJacques-Eric Gottenberg

Abstract

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. 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. 110 patients were randomised, 55 patients to tocilizumab (mean (SD) age: 50.9 (12.4) years; women: 98.2%) and 55 patients to placebo (5...Continue Reading

Associated Clinical Trials

References

Jun 30, 2009·Annals of the Rheumatic Diseases·Raphaèle SerorUNKNOWN EULAR Sjögren's Task Force
Apr 15, 2010·Arthritis Care & Research·Raphaèle SerorUNKNOWN European League Against Rheumatism Sjögren's Task Force
Feb 25, 2011·Annals of the Rheumatic Diseases·Raphaèle SerorUNKNOWN EULAR Sjögren's Task Force
Jan 15, 2014·Journal of Autoimmunity·Ya-Zhuo GongJacques-Eric Gottenberg
Apr 15, 2014·Annals of Internal Medicine·Valérie Devauchelle-PensecAlain Saraux
Jul 17, 2014·JAMA : the Journal of the American Medical Association·Jacques-Eric GottenbergXavier Mariette
Oct 29, 2015·RMD Open·Raphaèle SerorCristina Vollenweider
May 7, 2016·Annals of the Rheumatic Diseases·Raphaèle SerorUNKNOWN EULAR Sjögren Task Force
Mar 8, 2018·The New England Journal of Medicine·Xavier Mariette, Lindsey A Criswell
May 8, 2018·Autoimmunity Reviews·Erika P Navarro-MendozaGabriel J Tobón
Nov 26, 2018·Annals of the Rheumatic Diseases·Saba NayarFrancesca Barone
Jan 27, 2019·BMJ : British Medical Journal·Jacques-Eric GottenbergUNKNOWN French Society of Rheumatology and the investigators participating in AIR, ORA, and REGATE registries
Mar 7, 2019·Rheumatology·Gaetane NocturneXavier Mariette

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Citations

Jan 23, 2021·Expert Review of Clinical Immunology·Loukas ChatzisAndreas V Goules
Jun 10, 2021·Rheumatology and Therapy·Anna WesterlundKerry Gairy
Jul 3, 2021·Biomolecules·Nicoletta Del PapaClaudio Vitali
Jul 1, 2021·Nature Reviews. Rheumatology·Raphaèle SerorXavier Mariette
Nov 4, 2021·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Bin WangGuixiu Shi

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