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Table 3 Rates of adverse events of interest before propensity score matching (all initiators)

From: One-year risk of serious infection in patients treated with certolizumab pegol as compared with other TNF inhibitors in a real-world setting: data from a national U.S. rheumatoid arthritis registry

 

CZP (n = 975)

Other TNFi (n = 5240)

PY at riska

Eventsb

IR/100 PY (95% CI)

PY at riska

Eventsb

IR/100 PY (95% CI)

Serious infectious events

820

59

7.20 (5.58, 9.29)

4566

215

4.71 (4.12, 5.38)

 Joint/bursa

847

2

0.24 (0.06, 0.94)

4660

16

0.34 (0.21, 0.56)

 Cellulitis/skin

841

13

1.55 (0.90, 2.66)

4650

36

0.77 (0.56, 1.07)

 Sinusitis

847

2

0.24 (0.06, 0.94)

4660

10

0.21 (0.12, 0.40)

 Diverticulitis

847

2

0.24 (0.06, 0.94)

4660

10

0.21 (0.12, 0.40)

 Sepsis

848

1

0.12 (0.02, 0.84)

4657

16

0.34 (0.21, 0.56)

 Pneumonia

842

15

1.78 (1.07, 2.95)

4641

58

1.25 (0.97, 1.62)

 Bronchitis

846

5

0.59 (0.25, 1.42)

4660

11

0.24 (0.13, 0.43)

 Gastroenteritis

847

4

0.47 (0.18, 1.26)

4659

14

0.30 (0.18. 0.51)

 Meningitis/encephalitis

848

0

0 (NC)

4665

2

0.04 (0.01, 0.17)

 Urinary tract infection

842

10

1.19 (0.64, 2.21)

4650

29

0.62 (0.43, 0.90)

 Upper respiratory infection

848

2

0.24 (0.06, 0.94)

4660

10

0.21 (0.12, 0.40)

 Active tuberculosisc

848

0

0 (NC)

4664

2

0.04 (0.01, 0.17)

 Other

844

9

1.07 (0.55, 2.05)

4649

36

0.77 (0.56, 1.07)

Identified serious infectious organism

839

15

1.79 (1.08, 2.96)

4636

65

1.40 (1.10, 1.79)

 Opportunistic

848

0

0.00 (NC)

4664

2

0.04 (0.01, 0.17)

 Nonopportunistic

843

8

0.95 (0.47, 1.90)

4648

30

0.65 (0.45, 0.92)

 Unknown

844

7

0.83 (0.40, 1.74)

4648

34

0.73 (0.52, 1.02)

Malignancies

841

15

1.78 (1.08, 2.96)

4622

96

2.08 (1.70, 2.54)

 Lymphoma

848

0

0 (NC)

4664

4

0.09 (0.03, 0.23)

 Breast cancer

848

1

0.12 (0.02, 0.84)

4660

9

0.19 (0.10, 0.37)

 Lung cancer

848

2

0.24 (0.06, 0.94)

4664

3

0.06 (0.02, 0.20)

 Skin cancer – melanoma

848

0

0 (NC)

4662

6

0.13 (0.06, 0.29)

 Skin cancer – basal/squamous

845

5

0.59 (0.25, 1.42)

4641

49

1.06 (0.80, 1.40)

 Other cancer

844

7

0.83 (0.40, 1.74)

4655

26

0.56 (0.38, 0.82)

Cardiovascular events

840

17

2.02 (1.26, 3.26)

4633

77

1.66 (1.33, 2.08)

 Myocardial infarction

847

3

0.35 (0.11, 1.10)

4661

11

0.24 (0.13, 0.43)

 TIA/stroke

846

5

0.59 (0.25, 1.42)

4650

34

0.73 (0.52, 1.02)

 Other cardiovascular eventd

843

10

1.19 (0.64, 2.20)

4649

43

0.93 (0.69, 1.25)

Other AEs of interest

 Anaphylaxis/allergic reaction

845

4

0.47 (0.18, 1.26)

4660

14

0.30 (0.18, 0.51)

 Drug-induced SLE

848

0

0 (NC)

4665

0

0 (NC)

 Gastrointestinal perforation

848

0

0 (NC)

4663

3

0.06 (0.02, 0.20)

 Hepatic event

848

0

0 (NC)

4660

10

0.21 (0.12, 0.40)

 Progressive multifocal leukoencephalopathy

848

0

0 (NC)

4665

0

0 (NC)

 Other neurological event (with hospitalization)/other demyelinating disease

848

0

0 (NC)

4664

4

0.09 (0.03, 0.23)

 Spontaneous serious bleeding

848

0

0 (NC)

4664

5

0.11 (0.04, 0.26)

  1. Abbreviations: AE Adverse events, PS Propensity score, CZP Certolizumab pegol, TNFi Tumor necrosis factor inhibitor, PY Patient-years, IR Incidence rate, NC Not calculable, CVE Cardiovascular event, TIA Transient ischemic attack, SLE Systemic lupus erythematosus
  2. aTime at risk was measured from drug initiation up to either the occurrence of the first event of interest under that category, 90 days following discontinuation/switch of TNFi, or up to 12 months after drug initiation
  3. bPatients may have experienced more than one AE, so the sum of individual conditions may be greater than the total number of first AEs for the overall categories; however, only the time to the first event was considered to calculate the corresponding IRs
  4. cLatent tuberculosis was not included
  5. dIncluded congestive heart failure with hospitalization, cardiac revascularization procedure, ventricular arrhythmia, cardiac arrest, acute coronary syndrome, unstable angina, hypertension with hospitalization, peripheral arterial thromboembolic event, urgent peripheral arterial revascularization, peripheral ischemia or gangrene (necrosis), and other CVEs
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Arthritis Research & Therapy

ISSN: 1478-6362

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