Author, year (study acronym) | Subjects randomly assigned (n) | Biological agent studied (dose, frequency) | Combination therapy group (n) | Methotrexate monotherapy group (n) | Study duration (weeks) | Clinical remission outcome | Radiographic non-progression outcome |
---|---|---|---|---|---|---|---|
St Clair et al, 200417 (ASPIRE) | 1004 | Infliximab (3 mg/kg, q 8 weekly) | 359 | 282 | 54 | DAS28 ≤2.6 | SDD ≤9.03 units |
Quinn et al, 200518 | 20 | Infliximab (3 mg/kg, q 8 weekly) | 10 | 10 | 54 | ACR criteria | mTSS ≤0.5 units |
Breedveld et al, 200619 (PREMIER) | 525 | Adalimumab (40 mg, q 2 weekly) | 268 | 257 | 52 | DAS28 ≤2.6 | mTSS ≤0.5 units |
Durez et al, 200720 | 29 | Infliximab (3 mg/kg, q 8 weekly) | 15 | 14 | 52 | DAS28 ≤2.6 | – |
Emery et al, 200821 (COMET) | 528 | Etanercept (50 mg, q weekly) | 265 | 263 | 52 | DAS28 ≤2.6 | mTSS ≤0.5 units |
Bejarano et al, 200822 | 148 | Adalimumab 40 mg, q 2 weekly) | 75 | 73 | 56 | DAS28 ≤2.6 | |
Westhovens et al, 200923 (AGREE) | 509 | Abatacept, (10 mg/kg, q 4 weekly) | 256 | 253 | 52 | DAS28 ≤2.6 | mTSS* ≤0 units |
↵* Genant-modified Sharp scoring system.
ACR, American College of Rheumatology; DAS28, 28-joint disease activity score; mTSS, van der Heijde-modified total Sharp score; SDD, smallest detectable difference in van der Heijde-modified total Sharp score.