Study + comparison | Patients with AE | Withdrawal for toxicity | Pulmonal | Hepatotoxicity | Bone marrow | Infections | Gastrointestinal | Mucocutaneous | ACR20/ACR50 |
Furst et al8 | |||||||||
25–35 mg/week | 8.3† | 7.5† | 0 | 0 | 0 | 3.0 | 11.0* | 7.0† | NA |
vs placebo | (0.8 to 89.5) | (0.5 to 105.3) | (0.2 to 57.4) | (1.0 to 120.4) | (0.8 to 62.0) | ||||
12.5–20 mg/week | 5.4* | 0.9 | 0.9 | ∞ | 0.9 | 2.0 | 5.3* | 4.9† | NA |
vs placebo | (1.2 to 24.5) | (0.1 to 16.4) | (0.1 to 16.4) | (0.1 to 16.4) | (0.2 to 24.5) | (1.2 to 23.3) | (0.8 to 28.7) | ||
5–10 mg/week | 5.6* | 0 | 2.7 | ∞ | 1.3 | 1.3 | 3.5† | 3.1 | NA |
vs placebo | (1.1 to 28.6) | (0.2 to 34.0) | (0.1 to 22.1) | (0.1 to 22.1) | (0.8 to 16.4) | (0.5 to 20.7) | |||
12.5–20 mg/week | 1.0 | ∞ | 0.3 | 0.8 | 0.8 | 1.6 | 1.5 | 1.8 | NA |
vs 5–10 mg/week | (0.2 to 5.4) | (0.03 to 4.3) | (0 to 13.2) | (0 to 13.2) | (0.1 to 19.8) | (0.3 to 6.9) | (0.3 to 7.2) | ||
Schnabel et al9 | |||||||||
25 mg/week | NA | 1.1 | NA | 1.3 | 1.8 | NA | 1.8† | NA | NA |
vs 15 mg/week | (0.5 to 2.5) | (0.7 to 2.3) | (0.3 to 11.0) | (0.9 to 3.8) | |||||
Verstappen et al10 | ACR50 | ||||||||
Fast vs slow | 2.3* | 1.8 | 0.4 | 1.3 | 1.9 | NA | 1.0 | 0.8 | 1.8* |
escalation | (1.02 to 5.3) | (0.8 to 4.0) | (0.1 to 1.4) | (0.7 to 2.3) | (0.7 to 5.2) | (0.6 to 1.7) | (0.4 to 1.4) | (1.1 to 2.8) | |
Lambert et al11 | ACR20 | ||||||||
Intramuscular 15–45 mg/week | NA | 1.0 | 1.5 | 1.0 | NA | ∞ | 1.4 | 2.4 | 1.0 |
vs 15 mg/week | (0.1 to 16.9) | (0.4 to 5.6) | (0.1 to 16.9) | (0.5 to 4.4) | (0.6 to 9.3) | (0.1 to 16.9) | |||
Braun et al12 | ACR20 | ||||||||
Subcutaneous vs oral | 1.2 | 2.3† | 0.6 | 0.4 | NA | 0.9 | 1.2 | 0.8 | 1.5† |
15 mg/week | (0.8 to 1.9) | (0.98 to 5.5) | (0.2 to 1.9) | (0.1 to 1.4) | (0.4 to 2.2) | (0.8 to 1.7) | (0.3 to 2.5) | (0.96 to 2.4) |
*Odds ratio (OR) is significant; †OR shows a trend, ∞, comparator group has zero events; ACR, American College of Rheumatology; AE, adverse event; NA, not available.