Table 3

Main series of patients with pSS treated with rituximab

SourceNoStudy designDrug (patients, no)Control (patients, no)Glandular involvement/sytemic involvementPrimary outcomeNo of serious infections/serum sickness-like diseases
Gottenberg et al86Retrospective studyRituximab 4×375 ms (n=5) 2×375 ms (n=1)None1/5Systemic involvement: 5/6 with systemic involvement0/1
Seror et al916Retrospective studyRituximab 1 g/15 days (n=1) week 0 and 2 4×375 ms (n=14) 6×375 ms (n=1)None3/16Systemic involvement: 4/5 patients with lymphomas, 9/11 patients with systemic involvement.0/1
Pijpe et al1015Open studyRituximab4×375 msNone8/11Significant improvement of subjective symptoms and an increase in salivary gland function was observed in patients with residual salivary gland function1/3
Devauchelle-Pensec et al1116Open studyRituximab 1 g/15 daysNone16/3VAS scores with respect to fatigue and dryness (p<0.05), tender point count (p<0.035), and quality of life were significantly improved0/1
Ramos-Casals et al1215Registry (BIOGEAS)RituximabNone0/15Systemic involvement: 10 (67%) complete response three (20%) partial response two (13%) non responders2/0
Tony et al136Registry (GRAID)Rituximab mean (SD) dose (mg):2271 (995)NoneNRTwo complete respnses two partial responsesNR
Mekinian et al14Seventeen including 15 patients of the present studyRegistry (AIR)Rituximab 4×375 ms (n=9) 1 g/15 days (n=8)None0/17 (PNS)Improvement in 11/17 PNS involvment1/0
Mekinian et al15Eleven including 10 patients of the present studyRegistry (AIR)Rituximab 1 g/15 days (n=9) 4×375 ms (n=2)None0/11 (CNS)No neurological change occurred in nine patients. 2 patients were improved1/0
Terrier et al16Nine including 7 patients of the present study and 1 of Mekinian's study21Registry (AIR)Rituximab 4×375 ms (n=8) 1 g/15 days (n=1)None0/9 (cryoglobulinemias)Nine clinical complete response six immunologic complete response and three immunologic partial response0/2
Dass et al617RCT (6 months)Rituximab 1 g/15 days (n=8) weeks 0 and 2Placebo (n=9)8/0 (rituximab group)Patients with>20% improvement in fatigue VAS (87% vs 56%, p=0.36)1/1
Meijer et al530RCT (48 weeks)Rituximab 1 g/15 days (n=20) weeks 0 and 2Placebo (n=10)Arthralgia: 15; synovitis: 6; renal involvement: 2; vasculitis: 6; polyneuropathy: 1 (rituximab group)Mean change from baseline of whole saliva flow rate (p=0.038 vs placebo)12/1
Present study78Registry (AIR)Rituximab 1 g/15 days (n=67) 4×375 ms (n=11)None4/74Systemic involvement: seven patients (60%) after the 1st cycle of rituximab, including 45 patients (61%) with systemic involvement3/1
  • AIR, AutoImmune and Rituximab registry; CNS, central nervous system; cryo, cryoglobulinaemia; NR, not reported; PNS, peripheral nervous system; RCT, randomised controlled trial; SG, salivary gland; VAS, visual analogue scale.