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Table 4 Rates of adverse events of interest after propensity score matching

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 = 952)

Other TNFi (n = 952)

PY at riska

Eventsb

IR/100 PY (95% CI)

PY at riska

Eventsb

IR/100 PY (95% CI)

Serious infectious events

799

57

7.13 (5.50, 9.25)

814

46

5.65 (4.23, 7.54)

 Joint/bursa

825

2

0.24 (0.06, 0.97)

836

3

0.36 (0.12, 1.11)

 Cellulitis/skin

820

13

1.59 (0.92, 2.73)

833

9

1.08 (0.56, 2.08)

 Sinusitis

826

2

0.24 (0.06, 0.97)

835

2

0.24 (0.06, 0.96)

 Diverticulitis

826

2

0.24 (0.06, 0.97)

835

2

0.24 (0.06, 0.96)

 Sepsis

826

1

0.12 (0.02, 0.86)

836

3

0.36 (0.12, 1.11)

 Pneumonia

821

15

1.83 (1.10, 3.03)

833

9

1.08 (0.56, 2.08)

 Bronchitis

825

5

0.61 (0.25, 1.46)

835

2

0.24 (0.06, 0.96)

 Gastroenteritis

825

4

0.48 (0.18, 1.29)

834

5

0.60 (0.25, 1.44)

 Meningitis/encephalitis

827

0

0 (NC)

837

1

0.12 (0.02, 0.85)

 Urinary tract infection

821

10

1.22 (0.66, 2.26)

834

6

0.72 (0.32, 1.60)

 Upper respiratory infection

827

2

0.24 (0.06, 0.97)

835

3

0.36 (0.12, 1.11)

 Active tuberculosisc

827

0

0 (NC)

837

1

0.12 (0.02, 0.85)

 Other

823

7

0.85 (0.41, 1.78)

832

9

1.08 (0.56, 2.08)

Identified serious infection organism

819

14

1.71 (1.01, 2.89)

831

14

1.69 (1.00, 2.85)

 Opportunistic

827

0

0 (NC)

836

2

0.24 (0.06, 0.96)

 Nonopportunistic

822

8

0.97 (0.49, 1.95)

835

4

0.48 (0.18, 1.28)

 Unknown

824

6

0.73 (0.33, 1.62)

834

8

0.96 (0.48, 1.92)

Malignancies

821

14

1.71 (1.01, 2.88)

827

20

2.42 (1.56, 3.75)

 Lymphoma

827

0

0 (NC)

836

2

0.24 (0.06, 0.96)

 Breast cancer

827

1

0.12 (0.02, 0.86)

837

0

0 (NC)

 Lung cancer

827

2

0.24 (0.06, 0.97)

837

0

0 (NC)

 Skin cancer – melanoma

827

0

0 (NC)

836

2

0.24 (0.06, 0.96)

 Skin cancer – basal/squamous

825

4

0.48 (0.18, 1.29)

833

8

0.96 (0.48, 1.92)

 Other cancer

823

7

0.85 (0.41, 1.78)

833

8

0.96 (0.48, 1.92)

Cardiovascular events

819

17

2.08 (1.29, 3.34)

829

17

2.05 (1.27, 3.30)

 Myocardial infarction

825

3

0.36 (0.12, 1.13)

837

1

0.12 (0.02, 0.85)

 TIA/stroke

824

5

0.61 (0.25, 1.46)

832

10

1.20 (0.65, 2.23)

 Other cardiovascular eventd

822

10

1.22 (0.65, 2.26)

833

9

1.08 (0.56, 2.08)

Other AEs of interest

 Anaphylaxis/allergic reaction

824

4

0.49 (0.18, 1.29)

835

5

0.60 (0.25, 1.44)

 Drug-induced SLE

827

0

0 (NC)

837

0

0 (NC)

 Gastrointestinal perforation

827

0

0 (NC)

837

1

0.12 (0.02, 0.85)

 Hepatic event

827

0

0 (NC)

834

4

0.48 (0.18, 1.28)

 Progressive multifocal leukoencephalopathy

827

0

0 (NC)

837

0

0 (NC)

 Other neurological event (with hospitalization)/other demyelinating disease

827

0

0 (NC)

837

0

0 (NC)

 Spontaneous serious bleeding

827

0

0 (NC)

837

1

0.12 (0.02, 0.85)

  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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