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Table 5 Number of patients who presented adverse effects in trials with anti TNFα drugs

From: Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety

Trial (reference) Anti-TNFα drug Groups N of patients Withdrawn adverse event Total adverse events Serious adverse events Infections Serious infections Infusion reactions Injection- site reactions Malignancies Mortality
Lipsky et al. (19) Infliximab 3 mg/Kg 8 86 5 _ _ _ _    _ _
  wk +MTX 86 9 _ _ _ _    _ _
  3 mg/Kg 4 87 4 _ _ _ _    _ _
  wk +MTX 81 8 _ _ _ _    _ _
  10 mg/Kg 8 340 26 323 58 244 22    5 5
  wk +MTX 88 7 83 18 53 7 NA   0 3
  10 mg/Kg 4           
  wk +MTX           
  Total           
  Infliximab           
  MTX           
St. Clair et al. (20) Infliximab 3 mg/Kg 8 373 34   _ _ 21 _   0 1
  wk +MTX 378 35   _ _ 19 _   4 1
  6 mg/Kg 8 751 69   103 414 40 135   4 2
  wk +MTX 298 9 NA 32 141 6 20   0 2
  Total           
  Infliximab           
  MTX           
Quinn et al. (22) Infliximab 3 mg/Kg 8 10 1   1   0 1   0 0
  wk +MTX 10 0 NA 0 NA 0 0   0 0
  MTX           
Westhovens et al. (23) Infliximab 3 mg/Kg 8 360 18 _ _   6    2 0
  wk +MTX 361 20 _ _   18    2 2
  10 mg/Kg 8 721 38 512 55   24    4 2
  wk +MTX 363 8 239 27 NA 6 NA   1 1
  Total           
  Infliximab           
  MTX           
Moreland et al. (24) Etanercept 25 mg twice 78 2     0   _ 0 0
  weekly 76 5     0   _ 0 0
  10 mg twice 154 7     0   71 0 0
  weekly 80 3 NA NA NA 0   10 0 0
  Total           
  Etanercept           
  Placebo           
Weinblatt et al. (25) Etanercept 25 mg twice 59 2    30 0   23 0 0
  weekly 30 1 NA NA 19 0   2 0 0
  +MTX MTX           
Bathon et al. (26) Etanercept 25 mg twice 207 11       _ 3 1
  weekly 208 12       _ 2 1
  10 mg twice 415 23       140 5 2
  weekly 217 24 NA NA NA NA   16 2 0
  Total           
  Etanercept           
  MTX           
van der Heijde et al. (28) (TEMPO) Etanercept 25 mg twice 231 37 _ _ _ 23    5 1
  weekly 223 34 _ _ _ 24    5 1
  +MTX 454 71 379 64 285 47   69 10 2
  25 mg twice 228 47 185 37 147 25   4 2 1
  weekly           
  Total           
  Etanercept           
  MTX           
Weinblatt et al. (29) (ARMADA) Adalimumab 40 mg/2 wk 67 0     _   _ _ _
  +MTX 69 4     _   _ _ _
  20 mg/2 wk 73 1     _   _ _ _
  +MTX 209 5     2   32 1 0
  80 mg/2 wk 62 2 NA NA NA 0   2 0 0
  +MTX           
  Total           
  Adalimumab           
  MTX           
van de Putte et al. (30) Adalimumab 40 mg/2 wk 113 7 _ _   _   _ _ 1
  20 mg/2 wk 106 4 _ _   _   _ _ 0
  20 mg/wk 112 3 _ _   _   _ _ 0
  40 mg/wk 103 3         0
  Total 434 17 429 53   10   46 4 3
  Adalimumab 110 2 105 16 NA 0   1 1 1
  Placebo           
Furst et al. (31) (STAR) Adalimumab 40 mg/2 wk 318 9 275 17 166 4   62 1 1
  DMARD 318 8 275 22 157 6   37 0 1
Keystone y cols. (32) Adalimumab 40 mg/2 wk 207 26 _ _ _ 11   _ _ 2
  +MTX* 212 16 _ _ _ 5   _ _ 1
  20 mg/wk 419 42 391 97 269 16   101 4 3
  +MTX 200 13 181 37 111 1   48 0 0
  Total           
  Adalimumab           
  MTX           
Breedveld et al. (33) (PREMIER) Adalimumab 40 mg/2 wk 268 32 _    9    2 1
  +MTX* 274 26 _    3    4 4
  40 mg/2 wk 542 58 524    12    6 5
  Total 257 19 245 NA NA 7   NA 4 1
  Adalimumab           
  MTX           
  1. NA: not available
  2. * Overall data provided although specific data per arm not provided