Table 1.
Trial Characteristics
Treatment Group (n = 4598) | Placebo Group (n = 2313) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Source | Trial Name/Registry Number |
Disease Indicationa |
Permitted Concomitant Systemic Therapyb |
Duration of Placebo- Controlled Trial, wks |
Treatment (Dose)c | No. of Patients |
Patient-years follow-up |
No. of Patients |
Patient-years follow-up |
Mease et al, 200547 |
Study M02-518 / NCT00646386 |
PsA | MTX (≤30 mg/wk) or prednisone (≤10 mg/day) at stable dose; rescue therapy after 12 wks with DMARDS or corticosteroids |
24 | Adalimumab (40 mg eow) | 151 | 66.8 | 162 | 71.1 |
Gordon et al, 200646 |
Study M02-528 / NCT00645814 |
PsO | None | 12 | Adalimumab (40 mg eow) Adalimumab (40 mg weekly) |
45 50 |
10.2 11.2 |
52 | 11.8 |
Genovese et al, 200757 |
Study M02-570 / NCT00646178 |
PsA | MTX (≤30 mg/wk) or prednisone (≤10 mg/day), or other DMARD at stable dose |
12 | Adalimumab (40 mg eow) | 51 | 11.8 | 49 | 10.8 |
Menter et al, 200850 |
Study M03-656 / NCT00237887 |
PsO | None | 16 | Adalimumab (80 mg at wk 0, then 40 mg eow starting at wk 1) |
814 | 250.4 | 398 | 120.7 |
Saurat et al, 200851 |
CHAMPION / Study M04-716 / NCT00235820 |
PsO | None | 16 | Adalimumab (80 mg at wk 0, then 40 mg eow starting at wk 1) MTX (7.5 mg, increased as needed and as tolerated to 25 mg weekly)d |
108 110 |
34.7 34.8 |
52 | 16.3 |
Akihiko et al, 201078 |
Study M04-688 / NCT00338754 |
PsO | None | 24 | Adalimumab (80 mg at wk 0, then 40 mg eow starting at wk 1) Adaliumumab (40 mg eow) Adalimumab (80 mg eow) |
38 43 42 |
16.3 17.2 17.9 |
46 | 19.1 |
Unpublished41 | Study C87040 / NCT00245765 |
PsO | None | 12 | Certolizumab pegol (400 mg at wk 0, then 200 mg every 2 wks) Certolizumab pegol (400 mg every 2 wks) |
59 58 |
Unknown | 59 | Unknown |
Mease et al, 200048 |
Study 20021630 | PsA and PsO |
MTX (≤25 mg/wk) or prednisone (≤10 mg/day) at stable dose |
12 | Etanercept (25 mg twice weekly) | 30 | 6.5 | 30 | 6.1 |
Gottlieb et al, 200352 |
Study 20021632 | PsO | None | 24 | Etanercept (25 mg twice weekly) | 57 | 23.6 | 55 | 14.5 |
Leonardi et al, 200342 |
Study 20021639 | PsO | None | 12 | Etanercept (25 mg weekly) Etanercept (25 mg twice weekly) Etanercept (50 mg twice weekly) |
160 162 164 |
34.3 34.6 35.8 |
166 | 34.9 |
Mease et al, 200449 |
NCT00317499 | PsA | MTX (≤25 mg/wk) or prednisone (≤10 mg/day) at stable dose |
24 | Etanercept (25 mg twice weekly) | 101 | 81.0 | 104 | 59.2 |
Papp et al, 200544 |
Study 20021642 | PsO | None | 12 | Etanercept (25 mg twice weekly) Etanercept (50 mg twice weekly) |
196 194 |
42.9 42.6 |
193 | 41.0 |
Tyring et al, 200755 |
NCT00111449 | PsO | None | 12 | Etanercept (50 mg twice weekly) | 312 | 68.8 | 306 | 65.9 |
van de Kerkhof et al, 200843 |
NCT00333034 | PsO | None | 12 | Etanercept (50 mg weekly) | 96 | Unknown | 46 | Unknown |
Kavanaugh et al, 200945 |
NCT00265096 | PsA | Stable dose of MTX, prednisone, or NSAIDS |
24 with early escape at week |
Golimumab (50 mg every 4 wks) Golimumab (100 mg every 4 wks) All golimumabe |
146 146 343 |
62 67 142 |
113 | 42 |
Gottlieb et al, 200458 |
SPIRIT / NCT00230529 |
PsO | NSAIDS | 30 | Infliximab (3 mg/kg at wks 0, 2, 6) Infliximab (5 mg/kg at wks 0, 2, 6) |
98 99 |
56 58 |
51 | 20.5 |
Antoni et al, 200556 |
IMPACT | PsA | MTX or other DMARD at stable dose |
16 | Infliximab (5 mg/kg at wks 0, 2, 6, 14) | 52 | 16 | 51 | 16 |
Antoni et al, 200540 |
IMPACT 2 / NCT00051623 |
PsA | MTX (≤25 mg/wk) or prednisone (≤10 mg/day) at stable dose |
24 with early escape at wk 16 |
Infliximab (5 mg/kg at wks 0, 2, 6, 14, 22) All infliximabf |
100 150 |
45 53 |
97 | 37 |
Reich et al, 200554 |
EXPRESS I / NCT00106834 |
PsO | NSAIDS | 24 | Infliximab (5 mg/kg at wks 0, 2, 6, 14, 22) | 298 | 135 | 76 | 33 |
Menter et al, 200753 |
EXPRESS II / NCT00106847 |
PsO | NSAIDS | 14 | Infliximab (3 mg/kg at wks 0, 2, 6) Infliximab (5 mg/kg at wks 0, 2, 6) |
313 314 |
85 85 |
207 | 54 |
PsA = psoriatic arthritis; PsO = plaque psoriasis
MTX = methotrexate; DMARDS = disease-modifying antirheumatic drugs; NSAIDS = non-steroidal anti-inflammatory drugs
eow = every other week
Not included in meta-analysis.
All golimumab group includes all patients who received at least one dose of study drug.
All infliximab group includes all those that received at least one dose of study drug.