Xavier Mariette1, Raphaèle Seror1, Luca Quartuccio2, Gabriel Baron3, Sara Salvin2, Martina Fabris4, Frederic Desmoulins1, Gaétane Nocturne1, Philippe Ravaud3, Salvatore De Vita2. 1. Université Paris-Sud, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, France. 2. Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy. 3. Faculty of Medicine, AP-HP, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Paris, France. 4. Department of Medical and Biological Sciences, Clinic of Rheumatology, Udine University, Udine, Italy Institute of Clinical Pathology, University Hospital of Udine, Udine, Italy.
Abstract
BACKGROUND: 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). OBJECTIVES: To evaluate the efficacy and safety of belimumab, targeting BAFF, in patients with pSS. METHODS: 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. RESULTS: 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. CONCLUSIONS: These encouraging results justify future randomised controlled trials of belimumab in a selected target population of pSS patients most likely to benefit from treatment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
BACKGROUND: 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). OBJECTIVES: To evaluate the efficacy and safety of belimumab, targeting BAFF, in patients with pSS. METHODS: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. RESULTS: 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. CONCLUSIONS: These encouraging results justify future randomised controlled trials of belimumab in a selected target population of pSSpatients most likely to benefit from treatment. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
Authors: Anastasia Secco; Lucila Marino; Natalia Herscovich; Pedro Aicardi; Lorena Techera; Lorena Takashima; María Lida Santiago; Felix Romanini; Marta Mamani; Antonio C Catalán Pellet Journal: Eur J Rheumatol Date: 2019-12-16
Authors: Clare Oni; Sheryl Mitchell; Katherine James; Wan-Fai Ng; Bridget Griffiths; Victoria Hindmarsh; Elizabeth Price; Colin T Pease; Paul Emery; Peter Lanyon; Adrian Jones; Michele Bombardieri; Nurhan Sutcliffe; Costantino Pitzalis; John Hunter; Monica Gupta; John McLaren; Annie Cooper; Marian Regan; Ian Giles; David Isenberg; Vadivelu Saravanan; David Coady; Bhaskar Dasgupta; Neil McHugh; Steven Young-Min; Robert Moots; Nagui Gendi; Mohammed Akil; Francesca Barone; Ben Fisher; Saaeha Rauz; Andrea Richards; Simon J Bowman Journal: Rheumatology (Oxford) Date: 2015-10-27 Impact factor: 7.580