Τίτλος:
Low disease activity—irrespective of serologic status at baseline—associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: A real-life observational study
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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. © 2018 Elsevier Inc.
Συγγραφείς:
Fanouriakis, A.
Adamichou, C.
Koutsoviti, S.
Panopoulos, S.
Staveri, C.
Klagou, A.
Tsalapaki, C.
Pantazi, L.
Konsta, S.
Mavragani, C.P.
Dimopoulou, D.
Ntali, S.
Katsikas, G.
Boki, K.A.
Vassilopoulos, D.
Konstantopoulou, P.
Liossis, S.-N.
Elezoglou, A.
Tektonidou, M.
Sidiropoulos, P.
Erden, A.
Sfikakis, P.P.
Bertsias, G.
Boumpas, D.T.
Περιοδικό:
Seminars in Arthritis and Rheumatism
Λέξεις-κλειδιά:
azathioprine; belimumab; cyclophosphamide; cyclosporine; hydroxychloroquine; leflunomide; methotrexate; mycophenolate mofetil; prednisone; rituximab; belimumab; corticosteroid; immunosuppressive agent; monoclonal antibody; prednisone, achilles tendon rupture; adult; arthritis; Article; clinical feature; cohort analysis; demyelinating disease; disease activity; disease exacerbation; drug efficacy; drug safety; drug withdrawal; female; gastroenteritis; Global Assessment of Functioning; hair loss; hemarthrosis; herpes zoster; human; immunosuppressive treatment; infusion related reaction; interstitial cystitis; low drug dose; lupus erythematosus cell test; major clinical study; major depression; male; malignant neoplasm; middle aged; multiple organ failure; observational study; priority journal; prospective study; psychosis; pyramidal sign; rash; refractory period; remission; skin infection; SLEDAI; soft tissue infection; systemic lupus erythematosus; treatment duration; treatment response; blood; clinical trial; combination drug therapy; multicenter study; severity of illness index; systemic lupus erythematosus; treatment outcome, Adrenal Cortex Hormones; Adult; Antibodies, Monoclonal, Humanized; Drug Therapy, Combination; Female; Humans; Immunosuppressive Agents; Lupus Erythematosus, Systemic; Male; Middle Aged; Prednisone; Prospective Studies; Severity of Illness Index; Treatment Outcome
DOI:
10.1016/j.semarthrit.2018.02.014
