Antonis Fanouriakis1, Christina Adamichou2, Sofia Koutsoviti3, Stylianos Panopoulos4, Chrysanthi Staveri5, Anastasia Klagou6, Christina Tsalapaki7, Lamprini Pantazi8, Styliani Konsta9, Clio P Mavragani10, Despoina Dimopoulou11, Styliani Ntali12, Georgios Katsikas9, Kyriaki A Boki8, Dimitrios Vassilopoulos7, Pinelopi Konstantopoulou6, Stamatis-Nick Liossis5, Antonia Elezoglou3, Maria Tektonidou4, Prodromos Sidiropoulos2, Abdulsamet Erden13, Petros P Sfikakis4, George Bertsias2, Dimitrios T Boumpas14. 1. Rheumatology and Clinical Immunology, 4th Department of Medicine, "Attikon" University Hospital, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece-Medical School University of Cyprus, Nikosia, Cyprus. Electronic address: afanour@med.uoa.gr. 2. Rheumatology, Clinical Immunology and Allergy, University Hospital of Heraklion, Heraklion, Greece. 3. Department of Rheumatology, "Asklipieion" General Hospital, Athens, Greece. 4. Rheumatology Unit, First Department of Propaedeutic Internal Medicine, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece. 5. Division of Rheumatology, Department of Internal Medicine, University of Patras Medical School & Patras University Hospital, Rion, Patras, Greece. 6. Department of Rheumatology, "G. Gennimatas" General Hospital, Athens, Greece. 7. 2nd Department of Internal Medicine, "Ippokrateion" General Hospital, Athens, Greece. 8. "Sismanogleio-Amalia Flemming" General Hospital, Athens, Greece. 9. Department of Rheumatology, "Evangelismos" General Hospital, Athens, Greece. 10. Department of Physiology, School of Medicine, University of Athens, Athens, Greece. 11. Department of Rheumatology, "Ippokrateion" General Hospital, Thessaloniki, Greece. 12. Hacettepe University, Ankara, Turkey. 13. Department of Rheumatology, Hacettepe University, Ankara, Turkey. 14. Rheumatology and Clinical Immunology, 4th Department of Medicine, "Attikon" University Hospital, Joint Academic Rheumatology Program, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece-Medical School University of Cyprus, Nikosia, Cyprus.
Abstract
BACKGROUND: Low disease activity is a validated target of current systemic lupus erythematosus (SLE) therapy. The aim of this study was to assess the ability of belimumab to achieve low disease activity states in real-life settings. METHODS: Multicentre prospective observational study of consecutive SLE patients receiving belimumab for at least 3 months, due to active disease refractory to at least one conventional immunosuppressant. Disease activity, including the recently defined lupus low disease activity state (LLDAS) and remission (clinical SLEDAI-2K = 0), accrual of organ damage, flares and side effects were documented. RESULTS: Ninety-one patients were included [94.5% women, mean (SD) age 45.9 (12.5) years]. Most frequent manifestations were arthritis (76.7%), rash (72.5%), serologic activity (low C3/C4 and/or high anti-dsDNA; 54.9%), hair loss (47.2%) and mucosal ulcers (27.5%). Median (range) duration of treatment was 10.5 (3.0-42.1) months. Belimumab significantly decreased average SLEDAI-2K, physician global assessment (PGA) and daily prednisone dose over time, as early as 3 months after initiation, with over 20% of patients discontinuing corticosteroids. Although reduction in clinical (i.e., excluding serology) SLEDAI-2K was more pronounced in patients who were serologically active (from 8 to 1.5 at 12 months) as compared to serologically inactive (from 6 to 4) at baseline, attainment of LLDAS did not differ between the two groups and was reached by more than 40% of completer patients after 9-12 months. In addition, the number of flares and severe flares was reduced by 62% and 50%, respectively, during the first 12 months of treatment. Twenty patients (22.0%) discontinued treatment due to inadequate response and two due to side effects potentially related to the drug. CONCLUSIONS: In real-life, belimumab is efficacious in achieving low disease activity in over 40% of unselected patients, in combination with reduction of corticosteroid dosage and number of flares. Both serologically active and inactive patients respond to the drug.
BACKGROUND:Low disease activity is a validated target of current systemic lupus erythematosus (SLE) therapy. The aim of this study was to assess the ability of belimumab to achieve low disease activity states in real-life settings. METHODS: Multicentre prospective observational study of consecutive SLEpatients receiving belimumab for at least 3 months, due to active disease refractory to at least one conventional immunosuppressant. Disease activity, including the recently defined lupus low disease activity state (LLDAS) and remission (clinical SLEDAI-2K = 0), accrual of organ damage, flares and side effects were documented. RESULTS: Ninety-one patients were included [94.5% women, mean (SD) age 45.9 (12.5) years]. Most frequent manifestations were arthritis (76.7%), rash (72.5%), serologic activity (low C3/C4 and/or high anti-dsDNA; 54.9%), hair loss (47.2%) and mucosal ulcers (27.5%). Median (range) duration of treatment was 10.5 (3.0-42.1) months. Belimumab significantly decreased average SLEDAI-2K, physician global assessment (PGA) and daily prednisone dose over time, as early as 3 months after initiation, with over 20% of patients discontinuing corticosteroids. Although reduction in clinical (i.e., excluding serology) SLEDAI-2K was more pronounced in patients who were serologically active (from 8 to 1.5 at 12 months) as compared to serologically inactive (from 6 to 4) at baseline, attainment of LLDAS did not differ between the two groups and was reached by more than 40% of completer patients after 9-12 months. In addition, the number of flares and severe flares was reduced by 62% and 50%, respectively, during the first 12 months of treatment. Twenty patients (22.0%) discontinued treatment due to inadequate response and two due to side effects potentially related to the drug. CONCLUSIONS: In real-life, belimumab is efficacious in achieving low disease activity in over 40% of unselected patients, in combination with reduction of corticosteroid dosage and number of flares. Both serologically active and inactive patients respond to the drug.
Authors: Christopher F Bell; Julie Priest; Marni Stott-Miller; Hong Kan; Justyna Amelio; Xue Song; Brendan Limone; Virginia Noxon; Karen H Costenbader Journal: Lupus Sci Med Date: 2020-03-26
Authors: Ioannis Parodis; Emil Åkerström; Christopher Sjöwall; Azita Sohrabian; Andreas Jönsen; Alvaro Gomez; Martina Frodlund; Agneta Zickert; Anders A Bengtsson; Johan Rönnelid; Iva Gunnarsson Journal: Int J Mol Sci Date: 2020-05-14 Impact factor: 5.923
Authors: Azita Sohrabian; Ioannis Parodis; Nellie Carlströmer-Berthén; Martina Frodlund; Andreas Jönsen; Agneta Zickert; Christopher Sjöwall; Anders A Bengtsson; Iva Gunnarsson; Johan Rönnelid Journal: Arthritis Res Ther Date: 2019-11-29 Impact factor: 5.156