Sjögren’s Patients Could Benefit from Lupus Drug

B-cells that are active in systemic lupus erythematosus (SLE) could also play a role in Sjögren’s syndrome. Now, a new study finds that the same B-cell depleter drug, belimumab (Benlysta) approved for lupus, might also benefit patients with Sjögren’s. Sjögren's syndrome is rare a chronic autoimmune disorder in which effective treatments are lacking. Scientists know that the B-cell-activating factor (BAFF) increases in both the serum and the salivary pathological lesions of patients with Sjögren's syndrome.  Excessive levels of BAFF are also associated with systemic lupus erythmatosis, rheumatoid arthritis and other autoimmune diseases. So researchers reasoned that B-cell drugs might benefit patients with Sjögren’s.[[{"type":"media","view_mode":"media_crop","fid":"40587","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_1854624354746","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4190","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"font-size: 13.0080003738403px; line-height: 1.538em; float: right;","title":" ","typeof":"foaf:Image"}}]] Led by Salvatore De Vita, MD, of Azienda Ospedaliero-Universitaria in Italy, researchers conducted a small open trial of belimumab in a 52-week, phase II trial of 30 patients. They saw beneficial results in 60% of the patients at six months with the positive results persisting for one year. The study appears in the August 7 online issue of Rheumatology. The patients received 10 mg/kg of intravenous belimumab at weeks 0, 2 and 4 and then every four weeks. The treatment was continued for one year if, after 28 weeks, there was a positive response and there were no serious side effects. Among the group, 15 patients showed a decrease in biomarkers of B-cell activation at 28 weeks - and 13 out of the 15 (86.7%) maintained that decrease at 1 year. The autoantibody rheumatoid factor also declined at 28 weeks and went down even further at 1 year. “Overall, when considering the results at 6 months without new safety concerns, and given the current absence of effective treatments to modify the course of SS, the present data encourage further exploration of the therapeutic potential of belimumab inSS,” the researchers wrote. At baseline the patients, all women with a mean age of 40, were positive for anti-Sjögren’s syndrome A (SSA) antibodies or anti-Sjögren’s syndrome B (SSB) antibodies. They had systemic complications (such as dry eye, pain or fatigue), persistent salivary gland enlargement or biomarkers of B-cell activation.  Belimumab suppresses B-cell activating factor (BAFF) and depletes the numbers of autoimmune B-cells that attack healthy tissue in systemic lupus erythematosus -- and moisture-producing tissues in Sjögren’s.  The responders also displayed improvement in quality of life scores and in European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) domains: glandular (parotid enlargement), lymphadenopathy, and joint (articular) involvement.  However, signs of dryness – reduced salivary flow and low tear production as measured by a Schirmer's test -- and the focus score of lymphocyte infiltration seen on salivary lip biopsy, were virtually unchanged.  Patient-reported negative outcomes, such as fatigue and pain were only modestly improved, but the researchers speculate that very prolonged treatment with belimumab might be needed to have an impact - and more clinical trials are needed.  

Disclosures:

The Efficacy and Safety of Belimumab in Subjects with Primary Sjögren’s Syndrome (BELISS) trial was funded, in part, by an unrestricted research grant from Human GenomeScience/GlaxoSmithKline. 

References:

De Vita S, Quartuccio L, Seror R, et al., Efficacy and safety of belimumab given for 12 months in primary Sjögren's syndrome: the BELISS open-label phase II study. Rheumatology.  Aug. 7, 2015. doi:10.1093/rheumatology/kev257