Salvatore De Vita1, Luca Quartuccio2, Raphaèle Seror3, Sara Salvin2, Philippe Ravaud4, Martina Fabris5, Gaétane Nocturne6, Saviana Gandolfo2, Miriam Isola7, Xavier Mariette6. 1. Clinic of Rheumatology, Department of Medical and Biological Sciences, Udine University, Udine, Italy, devita.salvatore@aoud.sanita.fvg.it. 2. Clinic of Rheumatology, Department of Medical and Biological Sciences, Udine University, Udine, Italy. 3. Université Paris-Sud, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre, Assistance Publique-Hôpitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Faculty of Medicine, Paris, France. 4. Assistance Publique-Hôpitaux de Paris, Hôtel Dieu Hospital, Centre of Clinical Epidemiology, INSERM, U738, University of Paris Descartes, Faculty of Medicine, Paris, France. 5. Clinic of Rheumatology, Department of Medical and Biological Sciences, Udine University, Udine, Italy, Institute of Clinical Pathology and. 6. Université Paris-Sud, Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris-Sud, INSERM U1012, Le Kremlin Bicêtre. 7. Institute of Statistics, Department of Medical and Biological Sciences, Udine University, Udine, Italy.
Abstract
OBJECTIVE: To report the efficacy and safety of long-term treatment of SS with belimumab, targeting the B-cell-activating factor. METHODS: Patients with primary SS were included in the BELISS open-label phase II study, a 1-year open-label trial, if they were positive for anti-SSA or anti-SSB antibodies and had systemic complications or persistent salivary gland enlargement or early disease or biomarkers of B-cell activation. They received belimumab, 10 mg/kg i.v., at weeks 0, 2 and 4 and then every 4 weeks; if response was observed at week 28, or if the clinician and the patient agreed to continue the study in the absence of side effects, treatment was continued for 1 year. Efficacy and safety were analysed during the 1-year period of treatment. RESULTS: Among the 30 patients recruited, 28 were evaluated at week 28 as already reported. Nineteen terminated the 52-week study, 15 of them being responders and 4 non-responders at week 28. Thirteen of the 15 responders at week 28 also responded at week 52 (86.7%). The improvement in the EULAR Sjögren's Syndrome Disease Activity Index and EULAR Sjögren's Syndrome Patient Reported Index scores observed at week 28 showed a trend to further improvement at week 52, and the amelioration of peculiar EULAR Sjögren's Syndrome Disease Activity Index domains (glandular, lymphadenopathy, articular) appeared of particular relevance. The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52, with RF decreasing further. Salivary flow, Schirmer's test and the focus score of salivary biopsy did not change. Safety of treatment was good. CONCLUSION: Long-term treatment with belimumab may be beneficial in SS. Randomized, double-blind, controlled studies in larger populations are encouraged.
OBJECTIVE: To report the efficacy and safety of long-term treatment of SS with belimumab, targeting the B-cell-activating factor. METHODS:Patients with primary SS were included in the BELISS open-label phase II study, a 1-year open-label trial, if they were positive for anti-SSA or anti-SSB antibodies and had systemic complications or persistent salivary gland enlargement or early disease or biomarkers of B-cell activation. They received belimumab, 10 mg/kg i.v., at weeks 0, 2 and 4 and then every 4 weeks; if response was observed at week 28, or if the clinician and the patient agreed to continue the study in the absence of side effects, treatment was continued for 1 year. Efficacy and safety were analysed during the 1-year period of treatment. RESULTS: Among the 30 patients recruited, 28 were evaluated at week 28 as already reported. Nineteen terminated the 52-week study, 15 of them being responders and 4 non-responders at week 28. Thirteen of the 15 responders at week 28 also responded at week 52 (86.7%). The improvement in the EULAR Sjögren's Syndrome Disease Activity Index and EULAR Sjögren's Syndrome Patient Reported Index scores observed at week 28 showed a trend to further improvement at week 52, and the amelioration of peculiar EULAR Sjögren's Syndrome Disease Activity Index domains (glandular, lymphadenopathy, articular) appeared of particular relevance. The decrease in biomarkers of B-cell activation observed at week 28 persisted unchanged until week 52, with RF decreasing further. Salivary flow, Schirmer's test and the focus score of salivary biopsy did not change. Safety of treatment was good. CONCLUSION: Long-term treatment with belimumab may be beneficial in SS. Randomized, double-blind, controlled studies in larger populations are encouraged.
Authors: J Birnbaum; N M Atri; A N Baer; R Cimbro; J Montagne; L Casciola-Rosen Journal: Arthritis Care Res (Hoboken) Date: 2017-07 Impact factor: 4.794
Authors: Paul J Maglione; Gavin Gyimesi; Montserrat Cols; Lin Radigan; Huaibin M Ko; Tamar Weinberger; Brian H Lee; Emilie K Grasset; Adeeb H Rahman; Andrea Cerutti; Charlotte Cunningham-Rundles Journal: JCI Insight Date: 2019-03-07
Authors: Luiz A Gueiros; Katherine France; Rachael Posey; Jacqueline W Mays; Barbara Carey; Thomas P Sollecito; Jane Setterfield; Sook Bin Woo; Donna Culton; Aimee S Payne; Giovanni Lodi; Martin S Greenberg; Scott De Rossi Journal: Oral Dis Date: 2019-06 Impact factor: 3.511