Table 4.
Randomised controlled trials of non-biological immunosuppressants in GCA
| Study ID | Study design | GCA subtype | n | Intervention | Control | Primary outcome | Results (i) | Results (c) | P value |
| MTX | |||||||||
| Hoffman et al 85 2002 | Randomised, double-blind, placebo- controlled trial | New |
98
51 (i) vs 48 (c) |
PRED p.o. (1 mg/kg/day)+MTX p.o. (maximum 15 mg/week) | PRED +placebo | First disease relapse (six mo) | 68.9% | 66.1% | 0.31 |
| Jover et al 86 2001 | Randomised, double-blind, placebo- controlled trial | New |
42
21 (i) vs 21 (c) |
PRED p.o. (60 mg/day) +MTX p.o. (10 mg/week) |
PRED +placebo | No of relapses Cumulative PRED dose (mg) | 9 (45%) 4187±1529 |
16 (84.2%) 5489.5±1396 |
0.018 0.009 |
| Spiera et al 87 2001 | Randomised, double-blind, placebo- controlled trial | New |
21
12 (i) vs 9 (c) |
PRED p.o. (1 mg/kg/day)+MTX p.o. (7.5 mg/week) when PRED dose of 30 mg/day | PRED +placebo | Cumulative GC dose (mg) | 6469±2024 | 5908±2131 | 0.6 |
| van der Veen et al 88 1996 | Randomised, double-blind placebo-controlled trial | New PMR or GCA or both |
40
20 (3 GCA) (i) vs 20 (3 GCA) (c) |
PRED p.o (20 mg/day)+MTX p.o. (7.5 mg/day) | PRED +placebo | Time to remission (days) | 48 | 45 | NS |
| Cyclosporine | |||||||||
| Schaufelberger et al 91 1998 | Open-label, randomised controlled trial | Refractory |
22
11 (i) vs 11 (c) |
PRED (mean 11.8±10 mg/day)+CsA (2 mg/kg/day) | PRED (mean 11.1±7 mg/day) | Cumulative GC dose (g) six mo | 1.41 | 1.44 | NS |
| Schaufelberger et al 92 2006 | Open-label, randomised controlled trial | New |
59
29 (i) vs 30 (c) |
PRED (mean 40±11 mg/day)+CsA (2–3.5 mg/kg/day) | PRED (mean 40±12 mg/day) | Cumulative GC dose 12 mo | NSP | NSP | NSP |
| Dapsone | |||||||||
| Liozon et al 94 1993 | Open-label, randomised controlled trial | New |
47
24 (i) vs 23 (c) |
PRED (0.7 mg/kg/day-1 mg/kg/day if ocular)+Dapsone | PRED (0.7 mg/kg/day-1 mg/kg/day if ocular) | Total duration of GC | 14 mo | 13 mo | NS |
| AZA | |||||||||
| De Silva and Hazleman93 1986 | Randomised, double-blind, placebo- controlled trial | Established PMR/GCA |
31
16 (i) vs 15 (c) |
PREDNL maintenance dose p.o. (8.1 vs 7.4 mg/day)+AZA p.o. (100–150 mg/day) | placebo | GC dose 52 weeks (mg) | 1.9±0.84 | 4.2±0.58 | <0.05 |
AZA, azathioprine; c, control;CsA, cyclosporine; GC, glucocorticoid; GCA, giant cell arteritis;I, intervention; mo, month; MTX, methotrexate; New, newly diagnosed giant cell arteritis; NS, non-significant; NSP, non-specified; PMR, polymyalgia rheumatica; p.o., oral route; PRED, prednisone; PREDNL, prednisolone.