Table 2

Overview of serious adverse events and adverse events of interest (E (E/100 PYs)) during more than 5 years of ADA treatment
Time windows after the first injection of ADA in ReAct
≤0.5 Y >0.5 to 1 Y >1 to 3 Y >3 to 5 Y >5 Y
N = 6,610 N = 5,922 N = 4,283 N = 2,623 N = 2,000
Adverse event (AE) Overall N = 6,610 (18,272 PYs) (3,059 PYs) (2,256 PYs) (6,149 PYs) (4,549 PYs) (2,260 PYs)
Serious AEs* 2,529 (13.8) 838 (27.4) 419 (18.6) 661 (10.7) 417 (9.2) 194 (8.6)
Fatal AEs 102 (0.6) 29 (0.9) 19 (0.8) 27 (0.4) 17 (0.4) 10 (0.4)
Serious infections* 518 (2.8) 162 (5.3) 83 (3.7) 154 (2.5) 81 (1.8) 38 (1.7)
TB 35 (0.2) 11 (0.4) 11 (0.5) 8 (0.1) 4 (0.1) 1 (<0.1)
Sepsis 35 (0.2) 13 (0.4) 4 (0.2) 7 (0.1) 7 (0.2) 4 (0.2)
Malignancies 121 (0.7) 19 (0.6) 16 (0.7) 45 (0.7) 25 (0.5) 16 (0.7)
Lymphoma 15 (0.1) 1 (<0.1) 0 9 (0.1) 4 (0.1) 1 (<0.1)
NMSC 43 (0.2) 8 (0.3) 2 (0.1) 17 (0.3) 11 (0.2) 5 (0.2)
Serious CHF* 47 (0.3) 15 (0.5) 6 (0.3) 12 (0.2) 13 (0.3) 1 (<0.1)
Cerebrovascular AEs§ 56 (0.3) 13 (0.4) 5 (0.2) 16 (0.3) 15 (0.3) 7 (0.3)
Serious hepatic events* 58 (0.3) 10 (0.3) 13 (0.6) 16 (0.3) 13 (0.3) 6 (0.3)

*Serious adverse events include those that met any of the following criteria: death, life-threatening (that is, would have resulted in immediate fatality without medical intervention), hospitalisation, prolongation of hospitalisation, and persistent or significant disability, or any important medical event requiring medical or surgical intervention to prevent serious outcome. Including two patients with a positive test for latent TB during ADA therapy. Excluding, lymphomas and NMSC. These 121 events occurred in 114 subjects. §Such as stroke and transient ischemic attack. ADA, adalimumab; CHF, congestive heart failure; E, events; NMSC, non-melanoma skin cancer; PYs, patient-years; TB, tuberculosis.

Burmester et al.

Burmester et al. Arthritis Research & Therapy 2014 16:R24   doi:10.1186/ar4452

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