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Table 2 The rate of ADRs estimated from post-market and RCT data. Numbers indicate the % of recipients suffer an ADR outcome; 95% confidence intervals are provided in parenthesis. For both infliximab ad adalimumab patients, the rate of ADR-associated death estimated from RCTs is not significantly different from zero

From: Pragmatic pharmacoeconomic analyses by using post-market adverse drug reaction reports: an illustration using infliximab, adalimumab, and the Canada vigilance adverse reaction database

ADR outcome

Infliximab (Remicade, Janssen Inc.)

Adalimumab (Humira, AbbVie Inc.)

Post-market

RCTs

Post-market

RCTs

Death

0.21% (0.09–0.33)

0.01% (NS)

0.18% (0.06–0.29)

0.04% (NS)

Serious

18.9% (15.8–22.1)

13.1% (9.5–16.8)

7.3% (4.8–9.7)

16.3% (13.0–19.6)

All

19.8% (16.8–22.8)

74.9% (56.6–93.2)

14.8% (10.2–19.5)

48.7% (36.1–61.3)

  1. NS Not significant