Baseline characteristics of patients
| All patients n=30 | |
|---|---|
| Age (years), mean (SD) | 49.5 (16.5) |
| Female (%) | 30 (100.0%) |
| Disease duration (years), mean (SD) | 5.7 (5.6) |
| Whole unstimulated salivary flow (<0.1 mL/min) | 23 (76.7%) |
| Schirmer's test ≤5 mm | 25 (83.3%) |
| Focus score ≥1 | 25 (83.3%) |
| Baseline focus score, mean (SD) | 1.6 (1.5) |
| Anti-SSA antibodies | 29 (96.7%)* |
| Anti-SSB antibodies | 22 (73.3%) |
| Presence of cryoglobulinaemia | 3/29 (10.3%) |
| Presence of lymphoma† | 2 (6.7%) |
| Current background medication | |
| Corticosteroids | 5 (16.7%) |
| Hydroxychloroquine | 8 (26.7%) |
| Methotrexate | 3 (10%) |
| Previous treatments | |
| Hydroxychloroquine | 11 (36.7%) |
| Methotrexate | 2 (6.7%) |
| Azathioprine | 1 (3.3%) |
| Anti-TNF (infliximab or etanercept) | 1 (3.3%) |
| Rituximab | 7 (23.3%) |
| Reason for inclusion | |
| Systemic complications | 20 (71.4%) |
| Recent onset disease | 10 (34.5%) |
| Increase in B cell biomarker values | 22 (81.5%) |
| ESSDAI (0–123), mean (SD) | 8.8 (7.4) |
| ESSPRI (0–10), mean (SD) | 6.4 (1.1) |
| Dryness (0–10), mean (SD) | 7.8 (1.8) |
| Pain (0–10), mean (SD) | 4.6 (2.6) |
| Fatigue (0–10), mean (SD) | 6.9 (1.8) |
*One patient with previous anti-SSA antibodies was found to be negative using the centralised dosage.
†In both cases, it was stable parotid low-grade stage IE lymphoma of MALT type; these patients were not treated with belimumab due to lymphoma, but due to active cutaneous vasculitis (one case), sicca symptoms and B cell hyperactivation (one case), according to the study protocol.
anti-SSA, anti-Sjögren's syndrome A; ESSDAI, EULAR Sjögren's Syndrome Disease Activity Index; ESSPRI, EULAR Sjögren's Syndrome Patient Reported Index; MALT, mucosa-associated lymphoid tissue; TNF, tumour necrosis factor.