Efficacy and safety of belimumab in primary Sjogren's syndrome: results of the BELISS open-label phase II study
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.
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An open-label trial showed a reduction in the mean ESSDAI score from 8.7 to 5.7 at week 28 (P<0.0001), with a decrease of at least four points in 40% of cases and improvements in parotid swelling in 77% of cases, in patients with primary Sjögren syndrome treated by belimumab.
“An open-label trial showed a reduction in the mean ESSDAI score from 8.7 to 5.7 at week 28 (P < 0.0001), with a decrease of at least four points in 40% of cases and improvements in parotid swelling in 77% of cases, in patients with pSS treated by BLM.140”
From Autoimmune diseases and immune-checkpoint inhibitors for cancer therapy: Review of the literature and personalized risk-based prevention strategy (2020) · cites this paper as [140]
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- Authors
- Mariette, X., Seror, R., Quartuccio, L., Baron, G., Salvin, S., Fabris, M., Desmoulins, F., Nocturne, G., Ravaud, P., & De Vita, S.
- Affiliations
- University of Udine (IT)
- Inserm (FR)
- Venue
- Annals of the Rheumatic Diseases
- Publisher
- Elsevier BV
- Published
- 2015-03
- Volume
- 74
- Issue
- 3
- Pages
- 526-531
- ISSN
- 0003-4967 (ISSN-L)
- OpenAlex
- W2097783436
- Cited by
- 329
- References
- 28
- Citations by year
- 2026: 21 · 2025: 19 · 2024: 23 · 2023: 25 · 2022: 22 · 2021: 33 · 2020: 27 · 2019: 26 · 2018: 31 · 2017: 19 · 2016: 34 · 2015: 33 · 2014: 15 · 2012: 1
- FWCI
- 18.93
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of the Rheumatic Diseases (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System (University of Udine) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Salivary Gland Disorders and Functions
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ocular Surface and Contact Lens
- Keywords
- belimumab, primary Sjögren's syndrome, BAFF, B-cell activating factor, B cell activation, dryness, fatigue, disease activity, salivary flow, Schirmer test, anti-SSA antibodies, open-label extension, treatment efficacy and safety
- MeSH terms
- Adult, Aged, Fatigue, Female, Humans, Immunosuppressive Agents, Keratoconjunctivitis Sicca, Middle Aged, Sjogren's Syndrome, Xerostomia, Treatment Outcome, Antibodies, Monoclonal, Humanized
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