JOURNAL ARTICLE

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

Renaud Felten, Valérie Devauchelle-Pensec, Raphaèle Seror, Pierre Duffau, David Saadoun, Eric Hachulla, Hatron Pierre Yves, Carine Salliot, Aleth Perdriger, Jacques Morel, Arsène Mékinian, Olivier Vittecoq, Jean-Marie Berthelot, Emanuelle Dernis, Veronique Le Guern, Philippe Dieudé, Claire Larroche, Christophe Richez, Thierry Martin, Charles Zarnitsky, Gilles Blaison, Pierre Kieffer, François Maurier, Azeddine Dellal, Stephanie Rist, Emmanuel Andres, Anne Contis, Emmanuel Chatelus, Christelle Sordet, Jean Sibilia, Cécile Arnold, Mira Y Tawk, Ouafaa Aberkane, Lise Holterbach, Patrice Cacoub, Alain Saraux, Xavier Mariette, Nicolas Meyer, Jacques-Eric Gottenberg
Annals of the Rheumatic Diseases 2020 November 18
33208345

OBJECTIVES: 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.

METHODS: 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.

RESULTS: 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 >Pla]=0.14).

CONCLUSION: 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.

TRIAL REGISTRATION NUMBER: NCT01782235.

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Christoph Haller

YeeessARR 2015 N41 (100 initial) > Protokoll wurde geändert und SS A negative reingekommen.

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