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Article Dans Une Revue Annals of the Rheumatic Diseases Année : 2021

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

David Saadoun
Eric Hachulla
Pierre-Yves Hatron
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Arsène Mékinian
Christophe Richez
Gilles Blaison
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Emmanuel Chatelus
Patrice Cacoub
Alain Saraux
Xavier Mariette

Résumé

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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Dates et versions

hal-03229642 , version 1 (19-05-2021)

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Renaud Felten, Valérie Devauchelle-Pensec, Raphaèle Seror, Pierre Duffau, David Saadoun, et al.. Interleukin 6 receptor inhibition in primary Sjögren syndrome: a multicentre double-blind randomised placebo-controlled trial. Annals of the Rheumatic Diseases, 2021, 80 (3), pp.329-338. ⟨10.1136/annrheumdis-2020-218467⟩. ⟨hal-03229642⟩
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