Date: Sunday, November 8, 2015
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Belimumab, a monoclonal anti-B lymphocyte Stimulator (BLyS) antibody is preliminary found to be effective in Sjögren’s syndrome (SS) patients with moderate to high systemic activity in the phase II open-label BELISS study (1). Belimumab was administered for 12 months in 30 SS patients coming from two Centres (Udine, Italy and Paris, France) (1, 2). The ESSDAI score and the serum levels of rheumatoid factor (RF) and IgM immunoglobulins were significantly affected by this treatment in the long term (2). The aim of this study is to report the one year follow-up after the end of the BELISS study in the Italian cohort of patients in order to further support the clinical and biological benefits of belimumab in SS.
Methods: Clinical and laboratory data of 13 SS patients were collected at one year after the end of the belimumab treatment in the BELISS study. No other immunosuppressors were employed in these patients after the end of the trial. Clinical evaluation was also available up to three years for all the patients. Patients (all female, age 54±15) were all anti-SSA and/or anti-SSB positive. Statistical comparisons by t-test were performed between baseline data and month +12 after the end of the trial, and between the last evaluation in the trial (i.e., week 52) and month +12 after the end of the trial. Results are reported as mean±standard deviation (SD).
Results: The ESSDAI score was 8,8±6,9 at baseline, 3,5±3,7 at week 52 (end of the trial) and 7,0±5,7 at month 12 after the end of the trial (baseline vs. month +12, p=0,2; week 52 vs. month +12, p=0,003). Thus, a significant increase in the ESSDAI score was observed between week 52 (end of the trial) and month +12 after the end of the trial, with the mean score coming back in the range of moderate disease activity from the low level. Clinical worsening started between month +6 and month +12. Interestingly, after the end of the trial, the development of B-cell lymphoma from non neoplastic parotid sialadenitis was observed in two patients, and in a third patient a stage progression of local MALT lymphoma was recorded. In an additional patient new onset of hypergammaglobulinemic purpura was documented. RF level was 79,2±86,1 IU/ml at baseline, 59,0±65,7 IU/ml at week 52 (end of the trial), 174,1±220,3 IU/ml at month 12 after the end of the trial (baseline vs. month +12, p=0,5; week 52 vs. month +12, p=0,008). IgM level was 177,6±92,8 mg/dl at baseline, 131,9±73,6 mg/dl at week 52 (end of the trial), 165±84,6 mg/dl at month 12 after the end of the trial (baseline vs. month +12, p=0,3; week 52 vs. month +12, p=0,04).
Conclusion: targeting BLyS by belimumab seems to be effective in SS. A possible control of RF-positive B cell clones in SS by belimumab may be suggested. However, this effect may require a continuous and prolonged suppression of BLyS.
References: (1) Mariette X, et al. Ann Rheum Dis. 2015;74(3):526-31. (2) De Vita S, et al. Ann Rheum Dis 2015;74(Suppl 2):338.
To cite this abstract in AMA style:Quartuccio L, Salvin S, Corazza L, Gandolfo S, Fabris M, De Vita S. Efficacy of Belimumab and Targeting of Rheumatoid Factor Positive B-Cells in Sjögren’s Syndrome: Follow-up of the Open-Label Phase II Study [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/efficacy-of-belimumab-and-targeting-of-rheumatoid-factor-positive-b-cells-in-sjogrens-syndrome-follow-up-of-the-open-label-phase-ii-study/. Accessed August 11, 2020.
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