Table 1

Baseline characteristics of patients

All patients
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 mm25 (83.3%)
Focus score ≥125 (83.3%)
Baseline focus score, mean (SD)1.6 (1.5)
Anti-SSA antibodies29 (96.7%)*
Anti-SSB antibodies22 (73.3%)
Presence of cryoglobulinaemia3/29 (10.3%)
Presence of lymphoma†2 (6.7%)
Current background medication
 Corticosteroids5 (16.7%)
 Hydroxychloroquine8 (26.7%)
 Methotrexate3 (10%)
Previous treatments
 Hydroxychloroquine11 (36.7%)
 Methotrexate2 (6.7%)
 Azathioprine1 (3.3%)
 Anti-TNF (infliximab or etanercept)1 (3.3%)
 Rituximab7 (23.3%)
Reason for inclusion
 Systemic complications20 (71.4%)
 Recent onset disease10 (34.5%)
 Increase in B cell biomarker values22 (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.