Table 6 Adverse events in patients being treated with anti-TNFα drugs versus control
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Withdrawn adverse event | Adalimumab | 131/1922 | 44/947 | 1.4(1.0–2.0) | 47(26–251) | 1.2 | 0 |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 |