Source | Anti-TNF | Dose category | Subjects experiencing adverse events in active treatment groups | Subjects experiencing adverse events in control groups | ||||||||||||
Death | Serious adverse events | Serious infection | Any cancer | Lymphoma | Non-cutaneous cancer or melanoma | Non-melanoma skin cancer | Death | Serious adverse events | Serious infection | Any cancer | Lymphoma | Non-cutaneous cancer or melanoma | Non-melanoma skin cancer | |||
Furst et al30 | ADA | Rec | 1 | 17 | 4 | 1 | 1 | 0 | 0 | 0 | 22 | 6 | 0 | 0 | 0 | 0 |
van de Putte et al27 | ADA | Rec | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 |
High | 1 | 14 | 4 | 0 | 0 | 0 | 0 | |||||||||
Weinblatt et al31*,† | ADA | Rec | 0 | NR | 1 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 | 0 | 0 | 0 |
High | 0 | NR | 1 | 1 | 0 | 1 | 0 | |||||||||
Keystone et al32 | ADA | Rec | 3 | 60 | 16 | 4 | 1 | 3 | 0 | 0 | NR | 1 | 0 | 0 | 0 | 0 |
van de Putte et al33‡ | ADA | Rec | 2 | 31 | 5 | 2 | 0 | 1 | 1 | 1 | 16 | 0 | 1 | 0 | 0 | 1 |
High | 1 | 11 | 3 | 1 | 0 | 1 | 0 | |||||||||
Breedveld et al34 | ADA | Rec | 5 | 181 Events | 12 | 6 | 0 | 6 | 0 | 1 | 68 Events | 7 | 4 | 1 | 3 | 0 |
Moreland et al26 | ETA | Rec | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR | NR |
Weinblatt et al28 Kremer et al35 | ETA | Rec | 1¶ | 2 | 1**/4¶ | 3¶ | 1¶ | 1¶ | 1¶ | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
Bathon et al37 | ETA | Rec | 1 | NR | 7 | 4 | 1 Year 1 | 2 Year 1 | NR | 0 | NR | 9 | 3 | 0 Year 1 | 2 Year 1 | NR |
Genovese et al36† | ||||||||||||||||
Keystone et al38 | ETA | Rec | 0 | 12†† | 4†† | 1†† | 0 | 1†† | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Klareskog et al23 van der Heidje et al39 | ETA | Rec | 2 | 64 Year 1 | 27 | 10 | 0 | 6 | 3 | 1 | 37 Year 1 | 15 | 2 | 0 | 1 | 1 |
Combe et al40 | ETA | Rec | 0 | 10 | 2 | 2 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Weisman et al29 | ETA | Rec | 5 | 23 | 8 | 2 | 0 | 0 | 2 | 1 | 16 | 10 | 3 | 0 | 3 | 0 |
Maini et al25 | IFX | Rec | 0 | NR | 1 | 0 | 0 | 0 | 0 | 0 | NR | 0 | 0 | 0 | 0 | 0 |
High | 1 | NR | 1 | 0 | 0 | 0 | 0 | |||||||||
Maini et al42 Lipsky et al24 Maini et al41 | IFX | Rec | 3 | 29 | 10 | 1 | 0 | 1 | 0 | 4 | 28 | 11 | 1 | 0 | 0 | 1 |
High | 4 | 71 | 30 | 8 | 1 | 3 | 4 | |||||||||
St Clair et al43 | IFX | Rec | 1 | 52 | 21 | 0 | 0 | 0 | 0 | 2 | 32 | 6 | 0 | 0 | 0 | 0 |
High | 1 | 51 | 19 | 4 | 0 | 4 | 0 | |||||||||
Abe et al44 | IFX | Rec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
High | 2 | 6 | 4 | 0 | 0 | 0 | 0 | |||||||||
Westhovens et al45 | IFX | Rec§ | 0 | 28**/33¶ | 6**/7¶ | 2**/3¶/9†† | 1 | 1/3 | NR | 1 | 27 | 6 | 1 | 0 | 1 | 0 |
Rec | 1¶ | 40¶ | 12¶ | 6¶ | 0 | 1¶ | NR | |||||||||
High | 2**/1¶ | 27**/34¶ | 18**/12¶ | 2**/5†† | 0 | 2 | NR | |||||||||
Total | 35**/3¶ | 679**/107¶ | 213**/35¶/4†† | 50**/12¶/15†† | 5**/1¶ | 31**/5¶ | 11**/1¶ | 11 | 257 | 72 | 15 | 1 | 10 | 3 |
*US Food and Drug Administration dossier used to assign serious infections reported in the trial to appropriate treatment groups. †These studies had long-term extensions that were not included due to difficulty in allocating adverse events. ‡Malignancies assigned to groups as per Bongartz et al.47 §Dose increases allowed after week 22. ¶After crossover. **Before crossover. ††Events unable to be allocated to controlled or uncontrolled portion of trial. ADA, adalimumab; ETA, etanercept; IFX, infliximab; NR, not reported; Rec, recommended dose; TNF, tumour necrosis factor.