Skip to main content

Advertisement

Table 6 Adverse events in patients being treated with anti-TNFα drugs versus control

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

ADVERSE EVENTS (anti TNFα vs. control) (references) Anti-TNFα Anti-TNFα Adverse events/total Controls Adverse events/total RR (95%CI) NNH(95%CI) Q I2 %
Withdrawn adverse event Adalimumab 131/1922 44/947 1.4(1.0–2.0) 47(26–251) 1.2 0
(4826 vs. 2261) Etanercept 103/1082 75/555 0.7(0.5–0.9) -26(-143 a -14) 2.4 0
** (19,20,22,23,24,25,26,28,29,30,31,32,33) Infliximab 134/1822 24/759 2.0(1.3–3.1) 24(17–41) 4.9 0
  Total 368/4826 143/2261 1.3(0.7–2.4) NS 29.3* 59
Total adverse events (3228 vs. 1564) (19,23,28,30,31,32,33) Adalimumab 1619/1713 806/885 1.1(0.9–1.1) NS 1.9 0
(3228 vs. 1564) Etanercept 379/454 185/228 1.0(0.9–1.1) NS 0 0
(19,23,28,30,31,32,33) Infliximab 835/1061 322/45 1.0(0.9–1.0) NS 1.6 39
  Total 2833/3228 1313/1564 1.0(1.0–1.5) 27(17–59) 2.9 0
Serious adverse events Adalimumab 167/1171 75/628 1.0(0.7–1.4) NS 2.6 25
(3235 vs. 1615) Etanercept 64/454 37/228 0.9(0.5–1.6) NS 0 0
(19,20,22,23,28,30,31,32) Infliximab 217/1610 77/759 1.4(1.0–2.0) 31(17–167) 6.2 52
  Total 448/3235 189/1615 1.1(0.8–1.6) NS 14.3* 51
Infections Adalimumab 435/737 268/518 1.1(0.9–1.2) NS 0.7 0
(2341 vs. 1162) Etanercept 315/513 166/258 1.0(0.9–1.0) NS 0.9 0
(19,20,25,28,31,32,33) Infliximab 658/1091 194/386 1.2(1.1–1.3) 10(7–24) 0.03 0
  Total 1408/2341 628/1162 1.9(0.9–1.2) NS 8.6 41
Serious infections Adalimumab 44/1922 14/947 1.2(0.6–2.8) NS 5.8 31
(4188 vs.1937) Etanercept 47/454 25/28 0.9(0.4–2.3) NS 0 0
(19,20,22,23,24,25,28,29,30,31,32,33) Infliximab 90/1812 19/726 1.8(0.9–3.4) NS 2.7 26
  Total 181/4188 58/1937 1.4(0.8–2.2) NS 11.8 32
Infusión reactions (761 vs. 308) (20,22) Infliximab 136/761 20/308 2.7(1.7–4.2) 9(7–14) 0.005 0
Injection-site reactions Adalimumab 241/1380 88/690 1.7(1.0–3.0) 22(13–67) 12.6* 72
(2454 vs. 1245) Etanercept 303/1074 32/555 5.1(2.9–8.8) 5(4–6) 2.3 0
(24,25,26,28,29,30,31,32) Total 544/2454 120/1245 3.0(1.0–8.6) 8(7–10) 51.8* 86
Malignancies Adalimumab 16/1922 5/947 1.1(0.4–2.7) NS 1.6 0
(4826 vs. 2261) Etanercept 15/1082 4/555 1.9(0.6–5.7) NS 0.3 0
(19,20,22,23,24,25,26,28,29,30,31,32,33) Infliximab 13/1822 1/759 2.6(0.6–11.6) NS 1.1 0
  Total 44/4826 10/2261 1.5(0.8–3.0) NS 3.3 0
Mortality Adalimumab 10/1922 3/947 1.3(0.4–4.7) NS 2.0 0
(4826 vs. 2261) Etanercept 4/1082 1/555 1.5(0.2–9.5) NS 0.2 0
(19,20,22,23,24,25,26,28,29,30,31,32,33) Infliximab 9/1822 5/759 0.5(0.2–1.4) NS 0.4 0
  Total 23/4826 9/2261 0.8(0.3–2.1) NS 4.4 0
  1. RR (95%CI): relative risk (95% confidence limits)
  2. NNH: number needed to harm
  3. Q: Cochrane's Q
  4. I2: percentage of variability in study results attributable to between-study differences
  5. * statistical heterogeneity
  6. NS: non-significant results
  7. ** this figure include 208 patients of the Bathon trial not included in efficacy studies as efficacy date were not reported