ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 2536

The Sjögren’s Syndrome Responder Index, a Data-Driven Combined Endpoint, Could Detect Biologics Efficacy

Divi Cornec1, Valerie Devauchelle-Pensec2, Xavier Mariette3, Sandrine Jousse-Joulin4, Jean-Marie Berthelot5, Aleth Perdriger6, Xavier Puéchal7, Véronique le Guern8, Jean Sibilia9, Jacques Gottenberg10, Laurent Chiche11, Eric Hachulla12, Pierre-Yves Hatron13, Vincent Goëb14, Gilles Hayem15, Jacques Morel16, Charles Zarnitsky17, Jean Jacques Dubost18, Raphaèle Seror19, Jacques-Olivier Pers20, Emmanuel Nowak21 and Alain Saraux22, 1Department of rheumatology and unit of immunology, Brest Occidentale University, Brest, France, 2Department of rheumatology and unit of immunology (EA2216), Brest Occidentale university, Brest, France, 3rheumatology, Université Paris-Sud, Le Kremlin Bicêtre, France, 4Rheumatology, CHU Brest, Brest, France, 5Rheumatology, CHU Nantes (Nantes University Hospital), Nantes, France, 6Rhumatologie, Rennes, France, 7National Referral Center for Rare Systemic Autoimmune Diseases, Hôpital Cochin, AP–HP, Université Paris Descartes, Paris, Paris, France, 8Department of Internal Medicine, Hôpital Cochin, Paris, France, 9Division of Rheumatology, University Hospital of Strasbourg, Strasbourg, France, 10Rheumatology, Strasbourg University Hospital, Strasbourg, France, 11147 Boulevard Baille, CHU Marseille, Marseille, France, 12Internal Medicine, National Scleroderma Centre, Lille CEDEX, France, 13CHU Lille, Lille, France, 14Rheumatology, Amiens University Hospital, Amiens, France, 15CHU Bichat, Paris, France, 16Department of Rheumatology, Hôpital Lapeyronie, Montpellier, France, 17Rheumatology, Le Havre General Hospital, Le Havre, France, 18Rheumatology, CHU G.-Montpied, Clermont-Ferrand, France, 19Rheumatology, Université Paris Sud, Le Kremlin Bicêtre, France, 20CHU Brest, Brest, France, 21CIC, CHU Brest, Brest, France, 22Rheumatology, CHU de la Cavale Blanche and Université Bretagne occidentale, Brest Cedex, France

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: ,

Session Information

Title: Sjogren's Syndrome: Clinical Science

Session Type: Abstract Submissions (ACR)

Background/Purpose

Efficacy of rituximab remains debated in primary Sjögren’s syndrome (pSS), but that could be partly due to the absence of validated endpoint. To determine which outcome measures could detect rituximab efficacy and to create an alternative combined endpoint which could be tested in future trials in pSS.

Methods

We have conducted a post-hoc analysis of the randomized, placebo-controlled, TEARS study (Rituximab versus placebo) conducted in 14 university hospitals in France and included 120 pSS patients. Several outcome measures were prospectively collected at week (W)0, W6, W16 and W24 in the TEARS study. The outcome measures which were able to detect rituximab effect were associated to create a new composite endpoint that we called the Sjögren’s Syndrome Responder Index (SSRI). The SSRI was then tested in the TRIPSS study (Infliximab versus placebo).

Results

The 5 selected outcome measures were fatigue, oral dryness, ocular dryness (patient’s assessment on visual analog scales), unstimulated whole salivary flow and erythrocyte sedimentation rate. In the TEARS study, the proportion of patients fulfilling at least 30% improvement of at least 2/5 outcome measures (SSRI-30 response) was, in the rituximab and placebo groups, respectively 47% vs 21% at W6; 50% vs 7% at W16; and 55% vs 20% at W24 (p<0.01 for all comparisons). The same analysis in the TRIPSS study (Infliximab versus placebo) confirmed that infliximab is not effective in pSS.

Conclusion

We determined a core set of outcome measures which would be able to detect rituximab efficacy in pSS, and we propose response criteria which could be tested as primary outcome measures in future trials in pSS.

Disclosure:

D. Cornec,
None;

V. Devauchelle-Pensec,
None;

X. Mariette,
None;

S. Jousse-Joulin,
None;

J. M. Berthelot,
None;

A. Perdriger,
None;

X. Puéchal,
None;

V. le Guern,
None;

J. Sibilia,
None;

J. Gottenberg,
None;

L. Chiche,
None;

E. Hachulla,
None;

P. Y. Hatron,
None;

V. Goëb,
None;

G. Hayem,
None;

J. Morel,
None;

C. Zarnitsky,
None;

J. J. Dubost,
None;

R. Seror,
None;

J. O. Pers,
None;

E. Nowak,
None;

A. Saraux,
None.

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