Author | Shima Y, | Fernandes das NM | Frech TM | Shima Y | Khanna D | Elhai M | Saito E | Kono M | Presentcases |
---|---|---|---|---|---|---|---|---|---|
Reference (Year) | Ref10 (2010) | Ref11 (2015) | Ref12 (2015) | Ref13 (2015) | Ref14 (2016) | Ref15 (2013) | ref16 (2014) | ref17 (2017) | 2018 |
Diagnosis | SSc | SSc, (P3 SSc/RA) | SSc | SSc | SSc | SSc/Arthritis | SSc/RA | SSc/RA | SSc/RA |
Country (centers) | Japan | Portugal | USA | Japan | USA | EULAR | Japan | Japan | Japan |
Number of patients (n) | 2 | 3 | 2 | 1 | 43 | 15 | 1 | 2 | 2 |
Age, years (SD or range) | 42, 57 | 55, 42, 54 | 56, 68 | 59 | 51 ± 11.7 | 56 (45–61) | 57 | 25, 32 | 74, 65 |
Duration of SSc, years (SD or range) | 2, 3 | 3, 8, 1 | ns, 0.25 | 4 | 1.46 ± 1.16 | 5 (4–9) | 2.5 | 2, 3 | 1, 6 |
Durationof RA, years | 2.5 | 0.25, 3 | 12, 38 | ||||||
Female, n (%) | 1 (50%) | 3 (100%) | 2 (100%) | 1 (100%) | 32 (74%) | 13 (86.7%) | 1 (100%) | 1 (50%) | 2 (100%) |
Anti-nuclear antibody | 2 (100%) | 3 (100%) | 2 (100%) | + | + | 2 (100%) | 2 (100%) | ||
Anti-RNA polymerase antibody | P1+, P2- | + | 13 (30%) | ||||||
Anti-topoisomerase antibody | P1-, P2+ | P1-, P2+, P3+ | – | 18 (42%) | 10 (76.9%) | P1+, P2- P2:U1-RNP+ | P1-, P2+ | ||
Anti-centromere antibody | – | 1 (7.7%) | P1+, P2- | ||||||
Anti-CCP antibody | P1-, P2-, P3+ | 3 (37.5%) | + | 2 (100%) | 2 (100%) | ||||
Rheumatoid factor | P1-, P2-, P3+ | 3 (37.5%) | + | 2 (100%) | |||||
Previous biological drugs | P3: ADA, ETN | RTX:3, ABT:1, TNF: 2 | IFX | ||||||
Immunosuppressive drugs | P1: CyA | P1: CyA,AZA,HCQ P2: CyA,AZA P3: MTX,HCQ | 22 (51%) | MTX: 8 (57.1%) | MTX, TAC, SASP | P1: IVCY,TAC P2: SASP | P1: MTX, SASP P2: CyA | ||
Concomitant systemic corticosteroid use | 2 (100%) | 3 (100%) | + | 21 (49%) | 11 pts. (73.3%) [≤10 mg] | 2 (100%) | 2 (100%) | ||
Follow-up (months) | 6 | 6 | several, 26 | 16 | 12 | 5 (3 to 11.5) | 9 | 12 | 18 |
Tocilizumab dose | 8 mg/kg/4 w iv | 8 mg/kg/4 w iv | ns | 8 mg/kg/4 w iv | 162 mg/w | 8 mg/kg/month iv | 600 mg/month | P1: iv, P2: sc | 162 mg/2 w |
mRSS baseline | 27, 26 | 17, 41, 7 | 22, 27 | 35 | 26.4 ± 7.2 | 15 (4.5 to 24.0) | 25, 14 | 23, 15 | |
mRSS last infusion | 13, 20 | 11, 25, 5 | 17, 6 | 7 | 19.6 ± 10.1 | 12 (3.8 to 16.3) | Not improved | 8, 5 | 3, 7 |
DAS baseline | P3: 3.82 | 5.2 (3.9 to 6.1) | 5.39 | 2.92, 6.92 | 5.66, 7.14 | ||||
DAS last infusion | P3: 2.87 | 2.8 (2.2 to 3.4) | 1.53 | 1.76, 1.1 | 1.10, 3.70 | ||||
PGA baseline | 70, 70, 60 | 75, 68 | |||||||
PGA last infusion | 40, 30, 10 | 4, 36 | |||||||
Discontinued for lack of efficacy | 1 (2.3%) | 2 (13.3%) | |||||||
Discontinued for adverse events | 1(gastroenterology) | 5 (11.6%) |