Characteristics of the 14 randomised controlled trials reporting serious infections in ankylosing spondylitis and included in the systematic literature review for risks of infections
Control groups (placebo) | Treatment groups | ||||||||
---|---|---|---|---|---|---|---|---|---|
Study | Follow-up (weeks) | Treatment | Patients (N) | Serious infections (N) | Non-serious infections (N) | Treatment | Patients (N) | Serious infections (N) | Non-serious infections (N) |
Barkhuizen et al23 | 12 | Placebo | 156 | 0 | 15 | NSAIDs | 455 | 0 | 42 |
Dougados et al27 | 6 | Placebo | 76 | 0 | 4 | NSAIDs | 170 | 0 | 14 |
van der Heijde et al20 | 6 | Placebo | 93 | 0 | 3 | NSAIDs | 294 | 0 | 9 |
Sieper et al29 | 12 | No placebo | 0 | – | – | NSAIDs versus NSAIDS | 458 | 0 | 20 |
Braun et al24 | 12 | Placebo | 35 | 0 | 18 | Infliximab | 35 | 1 | 12 |
Marzo-Ortega et al28 | 30 | Placebo | 14 | 0 | 2 | Infliximab | 28 | 0 | 6 |
van der Heijde et al22 | 24 | Placebo | 78 | 0 | 27 | Infliximab | 201 | 2 | 84 |
Breban et al30 | 58 | No placebo | 0 | Infliximab continous versus infliximab on demand | 247 | 7 | 130 | ||
Brandt et al19 | 30 | Placebo | 17 | 0 | 6 | Etanercept | 16 | 0 | 6 |
Calin et al25 | 12 | Placebo | 39 | 0 | 0 | Etanercept | 45 | 0 | 0 |
Davis et al26 | 24 | Placebo | 139 | 1 | 25 | Etanercept | 138 | 2 | 36 |
Gorman et al3 | 16 | Placebo | 20 | 0 | 12 | Etanercept | 20 | 0 | 12 |
van der Heijde et al21 | 12 | Placebo | 51 | 0 | 12 | Etanercept | 305 | 2 | 68 |
van der Heijde et al2 | 24 | Placebo | 107 | 1 | 22 | Adalimumab | 208 | 0 | 66 |
Total | 825 | 2 | 146 | 2620 | 14 | 505 |
NSAID, non-steroidal anti-inflammatory drug.