Main series of patients with pSS treated with rituximab
| Source | No | Study design | Drug (patients, no) | Control (patients, no) | Glandular involvement/sytemic involvement | Primary outcome | No of serious infections/serum sickness-like diseases |
|---|---|---|---|---|---|---|---|
| Gottenberg et al8 | 6 | Retrospective study | Rituximab 4×375 ms (n=5) 2×375 ms (n=1) | None | 1/5 | Systemic involvement: 5/6 with systemic involvement | 0/1 |
| Seror et al9 | 16 | Retrospective study | Rituximab 1 g/15 days (n=1) week 0 and 2 4×375 ms (n=14) 6×375 ms (n=1) | None | 3/16 | Systemic involvement: 4/5 patients with lymphomas, 9/11 patients with systemic involvement. | 0/1 |
| Pijpe et al10 | 15 | Open study | Rituximab4×375 ms | None | 8/11 | Significant improvement of subjective symptoms and an increase in salivary gland function was observed in patients with residual salivary gland function | 1/3 |
| Devauchelle-Pensec et al11 | 16 | Open study | Rituximab 1 g/15 days | None | 16/3 | VAS scores with respect to fatigue and dryness (p<0.05), tender point count (p<0.035), and quality of life were significantly improved | 0/1 |
| Ramos-Casals et al12 | 15 | Registry (BIOGEAS) | Rituximab | None | 0/15 | Systemic involvement: 10 (67%) complete response three (20%) partial response two (13%) non responders | 2/0 |
| Tony et al13 | 6 | Registry (GRAID) | Rituximab mean (SD) dose (mg):2271 (995) | None | NR | Two complete respnses two partial responses | NR |
| Mekinian et al14 | Seventeen including 15 patients of the present study | Registry (AIR) | Rituximab 4×375 ms (n=9) 1 g/15 days (n=8) | None | 0/17 (PNS) | Improvement in 11/17 PNS involvment | 1/0 |
| Mekinian et al15 | Eleven including 10 patients of the present study | Registry (AIR) | Rituximab 1 g/15 days (n=9) 4×375 ms (n=2) | None | 0/11 (CNS) | No neurological change occurred in nine patients. 2 patients were improved | 1/0 |
| Terrier et al16 | Nine including 7 patients of the present study and 1 of Mekinian's study21 | Registry (AIR) | Rituximab 4×375 ms (n=8) 1 g/15 days (n=1) | None | 0/9 (cryoglobulinemias) | Nine clinical complete response six immunologic complete response and three immunologic partial response | 0/2 |
| Dass et al6 | 17 | RCT (6 months) | Rituximab 1 g/15 days (n=8) weeks 0 and 2 | Placebo (n=9) | 8/0 (rituximab group) | Patients with>20% improvement in fatigue VAS (87% vs 56%, p=0.36) | 1/1 |
| Meijer et al5 | 30 | RCT (48 weeks) | Rituximab 1 g/15 days (n=20) weeks 0 and 2 | Placebo (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 study | 78 | Registry (AIR) | Rituximab 1 g/15 days (n=67) 4×375 ms (n=11) | None | 4/74 | Systemic involvement: seven patients (60%) after the 1st cycle of rituximab, including 45 patients (61%) with systemic involvement | 3/1 |
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.