Randomised and clinical controlled trials reporting the efficacy of IL-6 inhibitors in sJIA and AOSD
| First author | Study design | Patients (N) | Intervention | CID (%) | Other outcomes (%) | Risk * |
| Woo96 | Open-label | sJIA (18) | TCZ 2 mg/kg/2 weeks cohort I 6 (33%); 4 mg/kg/2 weeks cohort II 6 (33%); 8 mg/kg/2 weeks cohort III 6 (33%) | na | 2.5M: ACR70 3 (17%)(overall three cohorts) | |
| Yokota133 | Escalating dose | sJIA (11) | TCZ in escalating mode | na | LACF: At 2 mg/kg: ACR 70 1/11 (9 %) At 4 mg/kg: ACR 70 4/8 (50%) At 8 mg/kg: ACR 70 3/3 (100%) | |
| Yokota80 | Open label lead-in | sJIA (56) | TCZ intravenous | na | LACF: ACRPed70 38 (68%) | |
| Double-blind randomised | sJIA (20) | TCZ intravenous | na | M3: ACRPed70 15 (75%) | ||
| sJIA (23) | PBO | na | M3: ACRPed70 3 (13%) | |||
| Extension phase | sJIA (50) | TCZ intravenous | na | M11: ACRPed70 43/48 (90%) | ||
| De Benedetti24 | Double-blind randomised | sJIA (75) | TCZ intravenous | na | M3: ACR70 53 (71%) ACR90 28 (37%) | |
| sJIA (37) | PBO | na | M3: ACR70 3 (8%) ACR90 2 (5%) | |||
| Open-label | sJIA (112) | TCZ intravenous | 36/112 (32%) | M12: ACR90 66/112 (59%) | ||
| Yokota81 | LTE from NCT00144599 NCT 00144612 | sJIA (67) | TCZ intravenous | na | 38.6M: JIA-ACR 70 46/61 (75%) JIA-ACR 90 37/61 (61%) | |
| Mallalieu82 | Open-label single arm | sJIA (11) | TCZ intravenous | na | JADAS-71 reduction 5/11 (45% | |
| Ruperto84 | Open-label single arm | sJIA (51) | TCZ subcutaneous | 35/51 (69%) | na | |
| Kaneko83 | Double-blind randomised | AOSD (13) | TCZ intravenous | na | M3: ACR70 6/13 (46%) | |
| AOSD (14) | PBO | na | M3: ACR70 4/13 (31%) | |||
| LTE | AOSD (26) | TCZ intravenous | na | M12: ACR70 8/13 (61%) |
*The RoB was assessed with the RoB2 tool. Red=high, yellow=intermediate, green=low and blue=not assessable.
ACR, American College of Rheumatology; AOSD, adult-onset Still’s disease; CID, clinical inactive disease; JADAS, Juvenile Arthritis Disease Activity Score; LACF, last observation carried forward; LTE, long term extension; M, month; na, not available; PBO, placebo; RoB, risk of bias; sJIA, systemic juvenile idiopathic arthritis; TCZ, tocilizumab.