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Table 3 Rates of adverse events of interest through 3 years of treatment

From: Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial

AE

Overall safety population (n = 190; 412.2 patient-years)

MRI/CRP-positive safety subpopulation (n = 145; 320.9 patient-years)

No. (%)

Events/100 patient-years

No. (%)

Events/100 patient-years

Serious AEs

33 (17.4)

10.9

25 (17.2)

9.7

Serious infection

8 (4.2)

2.4

6 (4.1)

2.2

Tuberculosis

1 (0.5)

0.2

1 (0.7)

0.3

Lupus-like reaction and systemic lupus erythematosus

1 (0.5)

0.2

1 (0.7)

0.3

Pulmonary embolism

1 (0.5)

0.2

1 (0.7)

0.3

New-onset psoriasis

2 (1.1)

0.5

1 (0.7)

0.3

Hepatic-related AEs

2 (1.1)

0.5

1 (0.7)

0.3

Diverticulitis

1 (0.5)

0.2

1 (0.7)

0.3

Death

2 (1.1)

0.5

2 (1.4)

0.6

  1. Abbreviations: AE Adverse event, CRP C-reactive protein, MRI Magnetic resonance imaging
  2. Includes all patients who received at least one dose of adalimumab, including patients who were excluded from the efficacy analyses because of noncompliance at the investigative site