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Abstract Number: 2555

Results of the Beliss Study, the First Open Phase 2 Study of Belimumab in Primary Sjogren’s Syndrome

Xavier Mariette1, Luca Quartuccio2, Raphaèle Seror3, Sara Salvin4, Frederic Desmoulins1, Martina Fabris5, Sara Villeneuve6, Philippe Ravaud7 and Salvatore De Vita2, 1Rheumatology, Université Paris-Sud, Le Kremlin Bicetre, France, 2Rheumatology, DSMB, University Hospital Santa Maria della Misericordia, Udine, Italy, 3Rheumatology, Bicetre university hospital, LE Kremlin-Bicetre, France, 4Rheumatology Clinic, DSMB, University of Udine, Italy, Udine, Italy, 5Institute of Clinical Pathology, Udine, Italy, 6Epidemiology departement, Hospital Hotel dieu, Paris, France, 7Epidemiology, Hopital Hotel Dieu, Paris Descartes University, Paris, France

Meeting: 2012 ACR/ARHP Annual Meeting

Keywords: BAFF, Sjogren's syndrome and belimumab

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Session Information

Title: Sjögren's Syndrome II - Clinical

Session Type: Abstract Submissions (ACR)

Background/Purpose:

The BAFF (or BLyS) cytokine plays a key role in pathogenesis of primary Sjogren’s syndrome (pSS). Belimumab, the first biological treatment inhibiting soluble BAFF, has proved its effectiveness and has been recently approved in systemic lupus. Lupus and pSS share a lot of pathogenic mechanism including interferon signature and BAFF involvement. Thus we run the first open label study of belimumab in pSS patients.

Methods:

Patients were included in 2 simultaneous and identical studies in 2 European Centres. Patients had to fulfill AECG criteria, to be anti-SSA/SSB positive and had to have at the time of inclusion either systemic complications, early disease (≤ 5 years), or the presence of at least one other biomarker of B-cell activation (increase in IgG, free light chains or of beta2-microglobulin, decrease of C4, presence of cryoglobulinemia or monoclonal component).The patients were treated with belimumab 10 mg/kg W0, W2, W4 and then every four weeks until W24.

The primary end-point was evaluated at W28 and consisted of improvement of 2 of the 5 following items : 1- ≥ 30% reduction of patient’s dryness VAS, 2- ≥ 30% reduction of patient’s fatigue VAS, 3- ≥ 30% reduction of patient’s musculoskeletal pain VAS, 4- ≥ 30% reduction of physician’s systemic activity VAS , 5- ≥ 25% reduction of any of the following B cell activation biomarkers (free light chains of immunogobulins, beta2-microglobulin, monoclonal component, cryoglobulinemia,  IgG) or ≥ 25% C4 increase

Results:

Thirty patients were included, 15 in each center (all female, mean age = 49.5 yrs ±16.5, mean disease duration = 5.7 yrs ± 5.6). 15 patients had systemic complications, 11 had early disease and 20 had at least one other biomarker of B-cell activation. 19/30 (63%) reached the primary end-point. For each individual component the response was as follows: VAS dryness: 10 (33%), VAS fatigue: 7 (23%), VAS pain: 7 (23%), VAS physician’s systemic activity: 12 (40%), biological component: 18 (60%). The percentage of responders was 8/11 (73%) in early disease and  7/15 (47%) in systemic disease.

The ESSDAI (EULAR Sjogren’s Syndrome Disease Activity Index) score decreased from 8.8±7.39 to 5.59±5.49 (p<0.0001). The ESSPRI (EULAR Sjogren’s Syndrome Patients Reported Index) score decreased from 6.44 ±1.11 to 5.56 (p=0.01). There was no significant change of salivary flow (0.62±1.23 to 0.75±1.23;p=0.43) and Schirmer test (4.09±7.23 to 4.72±8.08; p=0.17).

The treatment induced significant changes of some biological data: serum IgG from 20.92±10.25 to 18.53 ±7.21 (p<0.0001); serum IgA from 4.08 ±3.02 to 3.23 ±1.87 (p=0.001), kappa free light chain from 33.15±24.65 to 25.59 ±23.42 (p<0.0001), lambda free light chain from 28.31 ±16.59 to 20.85 ±12.24 (p<0.0001), rheumatoid factor from 146 ±174 to 97 ±91 (p<0.0001).

Concerning safety, we observed 1 severe adverse event which was a pneumococcus meningitis after 6 infusions of the drug. This patient, who was responder to belimumab, recovered completely without any sequellae.

Conclusion:

Results of this first open phase 2 study of belimumab in pSS patients are very encouraging and justify the realization of randomized control trials with the drug in selected populations of patients with pSS.


Disclosure:

X. Mariette,

Human Genome Sciences, Inc.,

2,

GlaxoSmithKline,

5;

L. Quartuccio,
None;

R. Seror,

Human Genome Sciences, Inc.,

2,

GlaxoSmithKline,

5;

S. Salvin,
None;

F. Desmoulins,
None;

M. Fabris,
None;

S. Villeneuve,
None;

P. Ravaud,
None;

S. De Vita,

Human Genome Sciences, Inc.,

2.

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