Table 4 Summary of events in randomised controlled trials
SourceAnti-TNFDose categorySubjects experiencing adverse events in active treatment groupsSubjects experiencing adverse events in control groups
DeathSerious adverse eventsSerious infectionAny cancerLymphomaNon-cutaneous cancer or melanomaNon-melanoma skin cancerDeathSerious adverse eventsSerious infectionAny cancerLymphomaNon-cutaneous cancer or melanomaNon-melanoma skin cancer
Furst et al30ADARec1174110002260000
van de Putte et al27ADARec02000000700000
High11440000
Weinblatt et al31*,†ADARec0NR100000NR00000
High0NR11010
Keystone et al32ADARec3601641300NR10000
van de Putte et al33‡ADARec2315201111601001
High11131010
Breedveld et al34ADARec5181 Events126060168 Events74130
Moreland et al26ETARecNRNRNRNRNRNRNRNRNRNRNRNRNRNR
Weinblatt et al28 Kremer et al35ETARec21**/4¶0200000
Bathon et al37ETARec1NR741 Year 12 Year 1NR0NR930 Year 12 Year 1NR
Genovese et al36†
Keystone et al38ETARec012††4††1††01††00000000
Klareskog et al23 van der Heidje et al39ETARec264 Year 12710063137 Year 1152011
Combe et al40ETARec010220110100000
Weisman et al29ETARec52382002116103030
Maini et al25IFXRec0NR100000NR00000
High1NR10000
Maini et al42 Lipsky et al24 Maini et al41IFXRec329101010428111001
High471308134
St Clair et al43IFXRec15221000023260000
High151194040
Abe et al44IFXRec00000000110000
High2640000
Westhovens et al45IFXRec§028**/33¶6**/7¶2**/3¶/9††11/3NR12761010
Rec40¶12¶0NR
High2**/1¶27**/34¶18**/12¶2**/5††02NR
Total35**/3¶679**/107¶213**/35¶/4††50**/12¶/15††5**/1¶31**/5¶11**/1¶1125772151103
  • *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.