Efficacy and safety of belimumab in primary Sjögren’s syndrome: results of the BELISS open-label phase II study

• Published in: Annals of the rheumatic diseases Vol. 74; no. 3; pp. 526 - 531
• Main Authors: Mariette, Xavier, Seror, Raphaèle, Quartuccio, Luca, Baron, Gabriel, Salvin, Sara, Fabris, Martina, Desmoulins, Frederic, Nocturne, Gaétane, Ravaud, Philippe, De Vita, Salvatore
• Format: Journal Article
• Language: English
• Published: England 01.03.2015
• Subjects: Adult; Aged; Antibodies, Monoclonal, Humanized - therapeutic use; Fatigue - drug therapy; Fatigue - etiology; Female; Humans; Immunosuppressive Agents - therapeutic use; Keratoconjunctivitis Sicca - drug therapy; Keratoconjunctivitis Sicca - etiology; Middle Aged; Sjogren's Syndrome - complications; Sjogren's Syndrome - drug therapy; Treatment Outcome; Xerostomia - drug therapy; Xerostomia - etiology
• ISSN: 0003-4967; 1468-2060; 1468-2060
• DOI: 10.1136/annrheumdis-2013-203991

Increased expression of B cell activating factor (BAFF or B lymphocyte stimulator) may explain the B cell activation characteristic of primary Sjögren's syndrome (pSS). To evaluate the efficacy and safety of belimumab, targeting BAFF, in patients with pSS. Patients were included in this bi-centric prospective 1-year open-label trial if they fulfilled American European Consensus group criteria, were anti-Sjögren's syndrome A-positive and had current systemic complications or salivary gland enlargement, or early disease (<5 years), or biomarkers of B cell activation. They received belimumab, 10 mg/kg, at weeks 0, 2 and 4 and then every 4 weeks to week 24. The primary end-point, assessed at week 28, was improvement in two of five items: reduction in ≥30% in dryness score on a visual analogue scale (VAS), ≥30% in fatigue VAS score, ≥30% in VAS pain score, ≥30% in systemic activity VAS assessed by the physician and/or >25% improvement in any B cell activation biomarker values. Among 30 patients included, the primary end-point was achieved in 18 (60%). The mean (SD) European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index decreased from 8.8 (7.4) to 6.3 (6.6) (p=0.0015) and EULAR) Sjögren's Syndrome Patient Reported Index from 6.4 (1.1) to 5.6 (2.0) (p=0.0174). The mean dryness, fatigue and pain VAS varied from 7.8 (1.8) to 6.2 (2.9) (p=0.0021), 6.9 (1.8) to 6.0 (2.2) (p=0.0606) and 4.6 (2.6) to 4.7 (2.4) (p=0.89), respectively. Salivary flow and Schirmer's test did not change. These encouraging results justify future randomised controlled trials of belimumab in a selected target population of pSS patients most likely to benefit from treatment.