Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial.
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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, Rist Stephanie, Andres Emmanuel, Contis Anne, Chatelus Emmanuel, Sordet Christelle, Sibilia Jean, Arnold Cécile, Tawk Mira Y, Aberkane Ouafaa, Holterbach Lise, Cacoub Patrice, Saraux Alain, Mariette Xavier, Meyer Nicolas, Gottenberg Jacques-Eric
Аннотация
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.