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J Autoimmun. 2018 Jan;86:1-8. doi: 10.1016/j.jaut.2017.09.004. Epub 2017 Sep 19.

Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Results of a large, multicentric, nationwide study.

Author information

1
Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy.
2
Rheumatology and Clinical Immunology, Spedali Civili and University of Brescia, Brescia, Italy.
3
Rheumatology Unit, Department of Medicine, University of Perugia, Perugia, Italy.
4
Medical Sciences, UOC of Rheumatology, University Hospital S. Anna, Ferrara, Italy.
5
Rheumatology Unit, Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.
6
Rheumatology Unit, Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Italy.
7
Clinic of Rheumatology, Department of Medical and Biological Sciences, University Hospital "Santa Maria della Misericordia", Udine, Italy.
8
Internal Interdisciplinary Medicine, Centre for Rare Cardiovascular and Immunological Diseases, Lupus Clinic, AOU Careggi, Florence, Italy.
9
Department of Surgery and Translational Medicine, University of Florence, Italy.
10
Rheumatology Department, University of Milan, Istituto Ortopedico Gaetano Pini, Milano, Italy.
11
Rheumatology Unit, University of Pisa, Pisa, Italy.
12
Rheumatology Unit, Internal Medicine Department, Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia, Italy.
13
Biostatistics, Epidemiology and Public Health Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padova, Italy.
14
Division of Rheumatology, Department of Medicine-DIMED, University of Padova, Padova, Italy. Electronic address: adoria@unipd.it.

Abstract

OBJECTIVE:

To investigate efficacy, safety and survival of belimumab and to identify predictors of drug response and drug discontinuation in patients with active SLE in clinical practice.

PATIENTS AND METHODS:

Data of SLE patients, treated with belimumab, from 11 Italian prospective cohorts were analyzed. SLEDAI-2K, anti-dsDNA, C3, C4, prednisone daily dose, DAS-28, 24-h proteinuria, CLASIa (Cutaneous LE Disease Area and Severity Index Activity) were recorded at baseline and every 6 months. SLE Responder Index-4 (SRI-4) was calculated at 12 and 24 months. Demographic and clinical features and comorbidities were included in the univariate and multivariate analysis. Adverse events were recorded at each visit. Statistics was performed using the SPSS software.

RESULTS:

We studied 188 SLE patients, mean follow-up 17.5 ± 10.6 months. The most frequent manifestations, which required the use of belimumab, were polyarthritis (45.2%) and skin rashes (25.5%). SRI-4 was achieved by 77.0% and 68.7% of patients at 12 and 24-months. Independent predictors of 12-month response were SLEDAI-2K ≥ 10 (OR 40.46, p = 0.001) and polyarthritis (OR 12.64, p = 0.001) and of 24-month response were SLEDAI-2K ≥ 10 (OR 15.97, p = 0.008), polyarthritis (OR 32.36, p = 0.006), and prednisone ≥7.5 mg/day (OR 9.94, p = 0.026). We observed a low rate of severe adverse events. Fifty-eight patients (30.8%) discontinued belimumab after a mean follow-up of 10.4 ± 7.5 months. The drug survival was 86.9%, 76.9%, 69.4%, 67.1%, and 61.9% at 6, 12, 18, 24, and 30 months, respectively. No factors associated with drug discontinuation were found.

CONCLUSION:

Belimumab is effective and safe when used in clinical practice setting.

KEYWORDS:

Belimumab; Biologic drugs; Drug survival; Predictors of response; Systemic lupus erythematous

PMID:
28935492
DOI:
10.1016/j.jaut.2017.09.004

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