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Table 2 CERTAIN patients who have been exposed to at least 1 TNF-α inhibitor (population used for primary comparative effectiveness analyses)

From: Design characteristics of the CORRONA CERTAIN study: a comparative effectiveness study of biologic agents for rheumatoid arthritis patients

 

All

Anti-TNF agents initiators

Non-anti-TNF agents initiators

Standardized absolute mean difference

Total, n

1321

558

763

 

Age (median, IQR), years

57 [47,65]

56 [47,64]

57 [48,66]

0.137

Female, n (%)

1037 (79.9)

434 (79.1)

603 (80.5)

0.036

Caucasian, n (%)

1091 (83.9)

446 (81.1)

645 (85.9)

0.129

RA disease duration (median, IQR), years

7 [3,14]

6 [3,12]

8 [4,15]

0.213

CDAI (median, IQR)

28 [21,38]

27 [20,38]

28 [21,38]

0.072

DAS28-CRP (median, IQR)

4.9 [4.2,5.6]

4.7 [4,5.4]

5.0 [4.3,5.7]

0.259

Biologic Monotherapy, n (%)

436 (33)

188 (33.7)

248 (32.5)

0.025

Concurrent DMARDs, n (%)

885 (67)

370 (66.3)

515 (67.5)

0.025

  MTX only, n (%)

586 (44.4)

258 (46.2)

328 (43)

0.065

  MTX dose (med, IQR) mg

20 [15,20]

20 [15,20]

20 [15,20]

0.018

  MTX plus other DMARDs, n (%)

95 (7.2)

40 (7.2)

55 (7.2)

0.002

  Leflunomide only, n (%)

78 (5.9)

28 (5)

50 (6.6)

0.066

  Sulfasalazine only, n (%)

18 (1.4)

4 (0.7)

14 (1.8)

0.100

  Hydroxychloroquine only, n (%)

53 (4)

20 (3.6)

33 (4.3)

0.038

Concomitant prednisone, n (%)

460 (34.8)

198 (35.5)

262 (34.3)

0.024

 Prednisone dose (median, IQR) mg/day

5 [5,10]

5 [5,10]

7 [5,10]

0.155

 No use, n (%)

877 (66.4)

363 (65.1)

514 (67.4)

0.049

 Prednisone <5 mg, n (%)

53 (4)

18 (3.2)

35 (4.6)

0.070

 Prednisone 5- <10 mg, n (%)

202 (15.3)

100 (17.9)

102 (13.4)

0.125

 Prednisone ≥ 10 mg, n (%)

189 (14.3)

77 (13.8)

112 (14.7)

0.025

Number of prior biologics exposed to (median, IQR)

1 [1,2]

1 [1,2]

1 [1,3]

0.427

Number of prior non-biologic DMARDs exposed to (median, IQR)

2 [1,3]

2 [1,2]

2 [1,3]

0.272

Biologic started at enrollment, n (%)

    

 Adalimumab

122 (9.2)

122 (21.9)

N/A

N/A

 Infliximab

127 (9.6)

127 (22.8)

N/A

N/A

 Etanercept

101 (7.6)

101 (18.1)

N/A

N/A

 Golimumab

71 (5.4)

71 (12.7)

N/A

N/A

 Certolizumab

137 (10.4)

137 (24.6)

N/A

N/A

 Rituximab

125 (9.5)

N/A

125 (16.4)

N/A

 Abatacept

334 (25.3)

N/A

334 (43.8)

N/A

 Tocilizumab

304 (23)

N/A

304 (39.8)

N/A

Co-morbidities, n (%)

    

 History of Cardiovascular disease*

104 (7.9)

42 (7.5)

62 (8.1)

0.022

 History of Hypertension

333 (31.9)

144 (33.6)

189 (30.7)

0.063

 History of Diabetes Mellitus

102 (10)

45 (10.8)

57 (9.5)

0.042

 Hyperlipidemia (Defined as: Total cholesterol > 240 mg/dL at baseline visit)

156 (13)

70 (13.6)

86 (12.5)

0.032

 History of Malignancy (includes non -melanoma skin cancers)

100 (7.6)

41 (7.3)

59 (7.7)

0.015

  1. Note: Standardized Absolute Mean Differences of 0.1 or less were considered clinically unimportant.
  2. Abbreviations: IQR interquartile range, MTX methotrexate, CDAI clinical disease activity index, DAS28_CRP disease activity score with 28 joint counts and CRP (C– reactive protein) as the inflammatory marker.
  3. *History of cardiovascular disease included: cardiac revascularization procedures, ventricular arrhythmias, cardiac arrests, myocardial infarctions, acute coronary syndromes, unstable angina, coronary artery disease, congestive heart failure, stroke, transient ischemic attacks.
  4. (Data for patients enrolled as of October 7th 2013).