Randomised controlled trials of biologic immunosuppressants in GCA
| Study ID | Study design | GCA subtype | n | Intervention | Control | Primary outcome | Results (i) | Results (c) | P value |
| Stone et al 81 2017 | Randomised, double-blind placebo-controlled trial | New/relapse |
251
100 (i1); 50 (i2) vs 50 (c1); | (i1): TCZ 162 mg/week s.c +26 week GC taper (i2): TCZ 162 mg/2 weeks s.c. +26 weeks GC taper | (c1): placebo +26 week taper GC (c2): placebo +52 weeks taper GC | Rate of sustained GC-free remission week 52 vs placebo +26 week GC taper | 56%(i1) 53% (i2) | 14% (c1) 18% (c2) | <0.001 |
| Villiger et al 100 2016 | Phase 2, randomised, double-blind, placebo-controlled trial | New/relapse |
30
20 (i) vs 10 (c) | i.v. TCZ 8 mg/kg/4 weeks+PREDNL 1 mg/kg p.o. | placebo | Complete remission at a PREDNL 0.1 mg/kg/day week 12 | 17 (85%) | 4 (40%) | 0.0301 |
| Langford et al 107 2017 | Randomised, double-blind placebo-controlled trial | New/relapse |
41
20 (i) vs 21 (c) | i.v. ABA 10 mg/kg on day 1,15, 29 and weeks 8+GC 40–60 mg/day with 28 weeks taper | GC 40–60 mg/day with 28 weeks taper +placebo | Duration of remission (relapse-free survival rate) mo 12 | 46% | 31% | 0.049 |
| Seror et al 108 2014 | Randomised, double-blind placebo-controlled trial | New |
70
34 (i) vs 36 (c) | ADA s.c. 40 mg/2 weeks+PRED 0.7 mg/kg/day | PRED 0.7 mg/kg/day+placebo | Percentage of patients in remission with <0.1 mg/kg/day PRED week 26 | 20 (58.9%) | 18 (50%) | 0.46 |
| Martínez-Taboada et al 109 2008 | Randomised, double-blind placebo-controlled trial | Established with AE to GC |
17
8 (i) vs 9 (c) | PRED ≥10 mg/day+ETA 25 mg /twice week s.c. | PRED ≥10 mg/day+placebo | Ability to withdraw GC and control disease mo 12 | 50% | 22.2% | NS |
| Hoffman et al 110 2007 | Randomised, double-blind placebo-controlled trial | New in remission |
44
28 (i) vs 16 (c) | IFX (5 mg/kg) weeks 0, 2, 6 then every 8 weeks+GC | GC +placebo | Relapse-free rate through week 22 | 43% | 50% | 0.65 |
ABA, abatacept; ADA, adalimumab; AE, adverse events; c, control; ETA, etanercept; GC, glucocorticoids;GCA, giant cell arteritis; I, intervention; IFX, infliximab; i.v., intravenous; mo, month; p.o., oral route; PRED, prednisone; PREDNL, prednisolone; TCZ, tocilizumab.